Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization.

Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial appendage. One of those patients died from complications related to an infection suffered after the device was retrieved.

The 1st-generation Watchman device showed a 30-day embolization rate of 0 to 0.7% in trials, and a post-approval registry called Ewolution showed a rate of 0.2%. The Watchman FLX device won CE Mark approval in the European Union last November; the original iteration won FDA approval in March 2015.

Watchman FLX will be taken off the shelves until Boston Scientific can determine what’s causing the unexpectedly high embolism rate, Backes told the website.

“With [the original] Watchman, we’re really confident. We’ve seen really low embolization rates,” she said. “With the robust clinical training program that we have in place for physicians before they start implanting the device, we feel really good about that. This doesn’t impact what we’re doing in the U.S. or what we’re doing with the current Watchman device. It’s not raising any concerns for us for the current device.”

Medical officers with the Marlborough, Mass.-based company, speaking at the annual conference of the American College of Cardiology, said they’ll look at whether physician training or implant technique are factors. The company said the sales halt for Watchman FLX will not affect its structural heart sales forecast of $175 million to $200 million this year.

Boston Scientific said earlier this week at ACC 2016 that a review of the 1st 1,000 Watchman patients found similar results as in pre-market trials.

Material from Reuters was used in this report.

The post Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device appeared first on MassDevice.

Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend.

Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lancet. The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients.

Expanding the indication to intermediate-risk patients would more than double the eligible patient pool, chairman & CEO Mike Mussallem told Reuters. That moved investors to send EW shares yesterday to an all-time high of $107.90, before the stock closed at $105.08.

The Partner II data on Sapien 3 showed all-cause mortality of 7.4%, compared with 13.0% for the surgical arm. The cardiovascular death rate was 4.5% for the TAVR arm and 8.1% for the surgical arm; rates of stroke were also lower for the transcatheter group, both in terms of all strokes (4.6% for TAVR, 8.2% for surgical) and disabling stroke (2.3% to 5.9%).

Analysts’ reactions were uniformly positive, which also fueled the buying. The Sapien 3 study results were as good, “if not better than anyone could have expected” and physicians’ response is expected to be “overwhelmingly positive,” J.P. Morgan analyst Michael Weinstein wrote in a note to investors.

“We talked about it being potentially game-changing and it was truly that,” Weinstein wrote. “We expect the treatment paradigm for intermediate-risk patients to change almost overnight and for the TAVR market to accelerate dramatically.”

“As data continue to accumulate supporting the use of percutaneous technology in lower-risk patients, the size of the opportunity continues to expand for TAVR technology,” Wedbush analyst Tao Levy told the Wall Street Journal. “In addition, we would expect patients who previously may have resisted the surgery due to the invasiveness of the procedure may now consider the benefits of replacing their aortic valve through a less invasive, percutaneous approach.”

That gives Edwards a significant edge, as it’s likely to have the only intermediate-risk TAVR on the U.S. market for at least a year, Leerink Partners analyst Danielle Antalffy wrote. Transcatheter valve replacement is slated to capture more than 90% of the intermediate-risk market over the next year to 18 months, Antalffy wrote, citing a pair of high-volume physicians, a cardiologist from the U.S. and a European cardiac surgeon.

“Both physicians believe that capacity is likely to expand driven by infrastructure expansion and procedure optimization as TAVR is already becoming a minimally invasive and lean procedure that can be conducted in cath lab or hybrid operating room (OR) without the need of an extensive team, as was the case in early days,” she wrote. “These physicians believe TAVR will eventually eliminate surgery in all severe aortic stenosis patients except the less than 20% of patients who require some sort of concomitant surgery.”

Mussallem told Reuters that Edwards expects the FDA to review the data behind its bid for an expanded Sapien 3 indication before the end of the year.

The post Edwards Lifesciences hits all-time high on Sapien 3 study appeared first on MassDevice.

ResMed (NYSE:RMD) said it closed the $800 million acquisition of cloud-based healthcare software company Brightree yesterday.

Atlanta, Ga.-based Brightree develops cloud-based software for home or durable medical equipment for home health and hospice care. Its majority owner was private equity shop Battery, which bought its stake in 2008.

“This acquisition furthers ResMed’s position as the leading tech-driven medical device company and gives our customers new tools to help them increase operational efficiency and improve cash-flow while delivering best-in-class patient care. ResMed is already the recognized global leader in remote patient monitoring and connected healthcare solutions. This acquisition will enable us to add to our portfolio of digital solutions to drive operational excellence and improve outcomes for patients, providers and payers,” ResMed CEO Mick Farrell said when the deal was announced in February.

“The Brightree team is very excited to join forces with ResMed to help post-acute care providers navigate the inherent complexities of the healthcare system and ensure that patients get the care they need,” added Brightree CEO Dave Cormack.

ResMed has said it expects the transaction to be accretive to gross margins and non-GAAP diluted earnings per share. Brightree reported net sales of $113 million and an EBITDA of approximately $43 million in 2015. Upon closure of the acquisition, Brightree will continue to operate as a separate entity under its current name, with headquarters remaining in Atlanta, and will be managed independently.

ResMed has been on an M&A tear of late, closing its acquisition of oxygen therapy company Inova Labs in February; in October 2015, the San Diego-based company closed its buyout of Curative Medical.

The post ResMed closes $800m Brightree buy appeared first on MassDevice.

Penumbra said it launched its Lantern peripheral microcatheter and reported Phase IV data from a 100-patient trial of its Indigo peripheral thrombectomy device.

The Lantern device won 510(k) clearance from the FDA in December 2015 for the peripheral and neurovascular delivery of diagnostic agents and therapeutic devices such as occlusion coils. YY-based Penumbra makes the Ruby coil, Penumbra occlusion device and its packing coil.

“Like many Penumbra products, the Lantern microcatheter is unique in its design and helps address physician needs for a low profile, high flow microcatheter,” chairman & CEO Adam Elsesser said in prepared remarks. “It is designed to track distally through the peripheral vasculature, yet can be used for high flow contrast injections, combining these desired properties into one microcatheter.”

Penumbra also said that the 83-patient Prism trial of its Indigo device met its safety and efficacy endpoints, showing serious adverse events in 10 patients (12.0%), none device-related. The efficacy endpoint, vessel patency, was achieved in 89.0% of patients treated with thrombectomy alone and 96.3% of patients treated with thrombectomy plus lytic therapy.

Serious adverse events were reported in 10 patients; none were device related. The results were released at the annual meeting this week of the Society for Interventional Radiology in Vancouver.

“The Penumbra/Indigo System proved safe and effective in restoration of flow to patients suffering from peripheral occlusions relating to events of acute ischemia, failed thrombolysis, and distal emboli as a complication of previous interventions. The PRISM study demonstrated thromo-aspiration to be safe and effective in revascularization of peripheral and visceral arterial occlusions. The final results of this trial supports the utility of this system across a wide range of applications in the peripheral vasculature,” the researchers found.

The post Penumbra launches Lantern peripheral microcatheter appeared first on MassDevice.

Robotic surgery industry leader Intuitive Surgical (NSDQ:ISRG) is looking to grow its Sunnyvale, Calif. campus by approximately 600,000 sq. ft, according to the Silicon Valley Business Journal.

The company plans to expand in 2 buildings, demolishing a cluster of buildings at 1050-1090 Kifer Road and replacing them with 2, 4-story buildings and parking garages. The expansion could house up to 2,150 workers.

“Since its founding, (Intuitive Surgical’s) real estate portfolio has grown by acquiring nearby buildings and parcels along Kifer road as the business grew. While this satisfied immediate space demands, the result has been a sprawling campus of unconnected buildings spread out over 1.3 miles of Kifer Road,” the company wrote in a letter to the city last month, according to the Business Journal.

The expansion grows Intuitive Surgical’s current 924,000 sq. ft facilities on 70 acres of land, which houses 3,211 employees. That’s up 233 from 2014, according to the Business Journal.

The new buildings will be built in 2 phases and sit on roughly 21 acres, according to the Business Journal, and the 1st building could be constructed as soon as permits are received and finished at the end of 2018.

The 2nd building could come as needed, in 2-5 years, according to a letter from the company. Approval will be dependent upon a planning process to rezone the neighborhood at higher densities.

The land Intuitive seeks to build on is currently occupied by several older buildings totally 362,000 sq. ft, the Business Journal said.

The post Intuitive Surgical looks to expand its Sunnyvale campus appeared first on MassDevice.

February 2016 510(k) Clearances

510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016.

TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 213
TOTAL WITH STATEMENTS 11

February 2016 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016

DEVICE: ANI Monitor
MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional)
ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081
6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16
LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DBSWIN and VistaEasy Imaging Software
Durr Dental AG 510(k) NO: K143290(Traditional)
ATTN: Oliver Lange PHONE NO : 49 07142 7050
Hopfigheimer Strasse 17 SE DECISION MADE: 18-FEB-16
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIARS SCREWS
OVERMED SRL. 510(k) NO: K143596(Traditional)
ATTN: DAVIDE PIZZAMIGLIO PHONE NO : 39 02 45712515
VIA LUCANIA 23 BUCCINASCO SE DECISION MADE: 05-FEB-16
MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AnapnoGuard 100 Respiratory Guard System
HOSPITECH RESPIRATION LTD. 510(k) NO: K150157(Traditional)
ATTN: Yoram Levy PHONE NO : 972 3 9191648
20 HAMAGSHIMIM ST. KIRYAT MATALON SE DECISION MADE: 16-FEB-16
PETACH TIKVA IL 49348 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Pain Therapy System, Model PTS-II
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K150277(Traditional)
ATTN: Eagle Eagle PHONE NO : 86 20 38289980
2ND &3RD FLOOR, BLD. 6, DAPIAN INDSE DECISION MADE: 12-FEB-16
GUANGZHOU CN 510665 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Oxyless Blood Tubing Set
Oxyless Ltd 510(k) NO: K150304(Abbreviated)
ATTN: Bob Duffy PHONE NO : 440 207383 9888
Third Floor, Bewlay House, 2 SwallSE DECISION MADE: 24-FEB-16
London GB 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K2 Medical GmbH & Co. KG 510(k) NO: K150468(Traditional)
ATTN: Harald Jung PHONE NO : 49 7462 94799182
Unter Buchsteig 5 SE DECISION MADE: 29-FEB-16
Tuttlingen DE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-Suit NIR Biliary Metallic Stent
MEDINOL LTD. 510(k) NO: K150487(Traditional)
ATTN: Michal Hershkovitz PHONE NO : 972 3 7679000
KIRYAT ATIDIM, BUILDING 8 SE DECISION MADE: 12-FEB-16
TEL AVIV IL 6158101 510(k) STATEMENT

DEVICE: Ora-GUARD Dental Grind Guard
Bite Tech Inc. 510(k) NO: K150492(Traditional)
ATTN: Jeff Padovan PHONE NO : 203 9876898
20 Glover Avenue SE DECISION MADE: 19-FEB-16
Norwalk CT 06850 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
PHADIA AB 510(k) NO: K150597(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
RAPSGATAN 7P SE DECISION MADE: 29-FEB-16
UPPSALA SE 75137 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Nutra Face Lift Model PE8050
NUTRA LUXE MD, LLC 510(k) NO: K150826(Traditional)
ATTN: PETER VON BERG PHONE NO : 1 877 2410459
6835 INTERNATIONAL CENTER BLVD UNISE DECISION MADE: 10-FEB-16
FORT MYERS FL 33912 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
CAREFUSION 2200 INC. 510(k) NO: K151036(Traditional)
ATTN: JANE WEBER PHONE NO : 847 3628094
72 N. FAIRWAY DRIVE SE DECISION MADE: 01-FEB-16
VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K151069(Traditional)
ATTN: Agustin Turriza PHONE NO : 757 2208917
260 F/H Fordham Road SE DECISION MADE: 05-FEB-16
WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex Short Suture Anchors
Arthrex, Inc. 510(k) NO: K151092(Traditional)
ATTN: David L Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 23-FEB-16
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
AESCULAP, INC. 510(k) NO: K151165(Traditional)
ATTN: KATHY A. RACOSKY PHONE NO : 610 9849291
3773 CORPORATE PARKWAY SE DECISION MADE: 17-FEB-16
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
ABL Medical, LLC 510(k) NO: K151185(Traditional)
ATTN: Robert Holladay PHONE NO : 801 7638000
705 E 50 S SE DECISION MADE: 05-FEB-16
American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Nutrisafe 2- ENFit Adaptor
VYGON 510(k) NO: K151237(Traditional)
ATTN: Jillian Mikovich PHONE NO : 800 4735414
2750 MORRIS ROAD, SUITE A200 SE DECISION MADE: 09-FEB-16
LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K151258(Special)
ATTN: Xie Qiongyu PHONE NO : 086 0755 26710795
2/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 18-FEB-16
NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Venturi Gauze Wound Care Sets with Portal Drain
TALLEY GROUP LTD. 510(k) NO: K151263(Traditional)
ATTN: ROBERT MACDONALD PHONE NO : 44 1794 503575
PREMIER WAY, ABBEY PARK INDUSTRIALSE DECISION MADE: 19-FEB-16
ROMSEY GB SO51 9DQ 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dr’s Finder
GOOD DOCTORS CO., LTD. 510(k) NO: K151274(Traditional)
ATTN: Sungro Joo PHONE NO : 82 32 4246325
#208, Woolim Lions Valley B-dong, SE DECISION MADE: 04-FEB-16
Incheon KR 403-911 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICONACY(TM) I-Hip (TM)
ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K151307(Traditional)
ATTN: ROY Y HORI PHONE NO : 574 2694622
4130 CORRIDOR DRIVE SE DECISION MADE: 26-FEB-16
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K151308(Traditional)
ATTN: SANDRA BAUMANN PHONE NO : 49 7666 9080
ROBERT-BOSCH-STR. 1-3 SE DECISION MADE: 09-FEB-16
DENZLINGEN DE 79211 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Safe Block Pen Needle
Artsana S.P.A 510(k) NO: K151311(Abbreviated)
ATTN: Cassani Mauro PHONE NO :
Via Saldarini Catelli 1 SE DECISION MADE: 10-FEB-16
Grandate IT 22070 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Strialite
Centre Light Solutions, LLC 510(k) NO: K151337(Traditional)
ATTN: Carrie Colburn PHONE NO : 574 6123381
611 East Douglas Rd. Suite 108 SE DECISION MADE: 24-FEB-16
Mishawaka IN 46545 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ProTrach Dualcare
ATOS MEDICAL AB 510(k) NO: K151404(Traditional)
ATTN: Ferenc Dahner PHONE NO : 46 415 19800
KRAFTGATAN 8 SE DECISION MADE: 12-FEB-16
HORBY SE SE-242 22 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Cogent Lateral Interbody System
COGENT SPINE LLC 510(k) NO: K151406(Traditional)
ATTN: JUDE PAGANELLI PHONE NO : 858 7747897
101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 25-FEB-16
SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX Compounding System Transfer Set
B. BRAUN MEDICAL INC. 510(k) NO: K151423(Traditional)
ATTN: TRACY MADDOCK PHONE NO : 610 5962545
901 MARCON BLVD. SE DECISION MADE: 19-FEB-16
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
INOVA DIAGNOSTICS, INC. 510(k) NO: K151429(Traditional)
ATTN: GABRIELLA LAKOS PHONE NO : 858 5869900 1393
9900 OLD GROVE ROAD SE DECISION MADE: 12-FEB-16
SAN DIEGO CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRCAT
PHILIPS MEDICAL SYSTEMS MR FINLAND510(k) NO: K151435(Traditional)
ATTN: JANNE MARVOLA PHONE NO : 358 9 615800
AYRITIE 4 SE DECISION MADE: 25-FEB-16
VANTAA FI 01510 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ISUS
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K151439(Traditional)
ATTN: HELEN LEWIS PHONE NO : 717 4871332
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 19-FEB-16
YORK PA 17401 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K151474(Traditional)
ATTN: MARY MOORE PHONE NO : 973 6862498
10 HIGH POINT DRIVE SE DECISION MADE: 18-FEB-16
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EndoChoice Select Injection Needle
ENDOCHOICE, INC. 510(k) NO: K151475(Traditional)
ATTN: THERON GOBER PHONE NO : 1 678 7084420
11810 WILLS RD. SE DECISION MADE: 08-FEB-16
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Beactive Brace
NATURES PILLOWS, INC. 510(k) NO: K151476(Traditional)
ATTN: WILLIAM McALISTER PHONE NO : 215 633 9801
2607 INTERPLEX DRIVE SE DECISION MADE: 26-FEB-16
TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Epix Electrosurgical Probe with Smoke Evacuation
APPLIED MEDICAL RESOURCES 510(k) NO: K151480(Traditional)
ATTN: FRANS VANDENBROEK PHONE NO : 949 7138369
22872 Avenida Empresa SE DECISION MADE: 19-FEB-16
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BCR-30-min BI? and RBIP-ST30? Readout Accessory
BCR DIAGNOSTICS, INC. 510(k) NO: K151482(Traditional)
ATTN: BORIS ROTMAN PHONE NO : 480 8096156
1123 E. THUNDERHILL PL. SE DECISION MADE: 26-FEB-16
PHOENIX AZ 85048 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRENE Locking Compression Plate System
TIANJIN ZHENGTIAN MEDICAL INSTRUME510(k) NO: K151508(Traditional)
ATTN: YIFAN FU PHONE NO : 0086 10 82292929
NO.318, JINGYI ROAD, AIRPORT ECONOSE DECISION MADE: 25-FEB-16
TIANJIN CN 300308 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Star 60
SKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K151512(Traditional)
ATTN: MAHADEVAN J PHONE NO : 91 821 2415559 501
PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 14-FEB-16
MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Oscar 2
SunTech Medical, Inc. 510(k) NO: K151520(Abbreviated)
ATTN: Charles Setzer PHONE NO : 919 6542300
507 Airport Blvd, Suite 117 SE DECISION MADE: 19-FEB-16
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K151529(Traditional)
ATTN: JULIE WARREN PHONE NO : 302 6318722
500 GBC DR. P.O. BOX 6101 M/S 514SE DECISION MADE: 11-FEB-16
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Anterior Cervical Plate System
Osteomed Implantes, LTDA 510(k) NO: K151553(Traditional)
ATTN: J.D. WEBB PHONE NO : 19 3532 3411
Washington Luiz Road, km 172, CondSE DECISION MADE: 10-FEB-16
Rio Claro – SP BR 13501-600 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Tranberg CLS Laser Fiber
Clinical Laserthermia Systems AB 510(k) NO: K151569(Traditional)
ATTN: Lars Erik Eriksson PHONE NO : 46 461 52100
Scheelevagen 2 SE DECISION MADE: 12-FEB-16
Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D.N.E. External Fixation System
DNE, LLC 510(k) NO: K151580(Special)
ATTN: NICHOLAS RICCIONE PHONE NO : 610 4421017
2225 PARK PLACE SE DECISION MADE: 16-FEB-16
SLATINGTON PA 18080 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CapsoCam (SV-1)
CapsoVision, Inc. 510(k) NO: K151635(Traditional)
ATTN: AZIMUN JAMAL PHONE NO : 408 6241488
18805 Cox Ave Suite 250 SE DECISION MADE: 09-FEB-16
Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Masimo Root Vital Signs Monitoring System and Accessories
MASIMO CORPORATION 510(k) NO: K151644(Traditional)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 2977683
52 DISCOVERY SE DECISION MADE: 12-FEB-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
SUQIAN XINGYE GLOVE CO, LTD 510(k) NO: K151680(Traditional)
ATTN: JIAN ZHONG-DENG PHONE NO : 86 527 82860533
DONGWU ROAD, THE ECONOMIC DEVELOPMSE DECISION MADE: 12-FEB-16
SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: twion
Alber GmbH 510(k) NO: K151717(Traditional)
ATTN: Bernd Engels PHONE NO : 490 7432 2006180
Vor dem Weissen Stein 21 SE DECISION MADE: 23-FEB-16
Albstadt DE D72461 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MedicVOD System
Orpheus Medical Ltd. 510(k) NO: K151737(Traditional)
ATTN: Asaf Omer PHONE NO : 972 4 6968800
PO Box 15140 SE DECISION MADE: 25-FEB-16
Haifa IL 31905 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THUNDERBEAT Open Fine Jaw
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K151743(Traditional)
ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 6422694
2951 ISHIKAWA-CHO SE DECISION MADE: 26-FEB-16
HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Actreen Mini Intermittent Urinary Catheters
B. BRAUN MEDICAL INC. 510(k) NO: K151772(Traditional)
ATTN: SIERRA M. MERTZ PHONE NO : 1 610 2660500
901 MARCON BLVD. SE DECISION MADE: 09-FEB-16
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: InMode RF System
INMODE MD LTD. 510(k) NO: K151793(Traditional)
ATTN: AHAVA STEIN PHONE NO : 972 4 9097470
TABOR BUILDING, SHAAR YOKNEAM SE DECISION MADE: 19-FEB-16
YOQNEAM ILLIT IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST-YS Caspofungin <=0.125 – >=8 ug/mL
BIOMERIEUX INC 510(k) NO: K151817(Traditional)
ATTN: KAREN RUSSELL PHONE NO : 314 7318639
595 ANGLUM ROAD SE DECISION MADE: 18-FEB-16
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vital Signs Patch System
LIFEWATCH TECHNOLOGIES LTD. 510(k) NO: K151835(Special)
ATTN: ASHER KASSEL PHONE NO : 1 972 89484000
2 PEKERIS ST. SE DECISION MADE: 05-FEB-16
REHOVOT IL 7670202 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD BACTEC Peds Plus/F Culture Vials (plastic)
BECTON DICKINSON AND COMPANY 510(k) NO: K151866(Traditional)
ATTN: ASHANTI C. BROWN PHONE NO : 410 3164766
7 LOVETON CIRCLE, MC 694 SE DECISION MADE: 25-FEB-16
SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR-FLOW handy 3.0 PLUS
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K151912(Traditional)
ATTN: Suzanne Fassio-Hardy PHONE NO : 41 2299 44700
Rte de Champ-Colin 2 SE DECISION MADE: 03-FEB-16
Nyon CH CH-1260 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
BAUSCH & LOMB INCORPORATED 510(k) NO: K151918(Traditional)
ATTN: Barbara Klube-Falso PHONE NO : 585 3388503
1400 North Goodman Street SE DECISION MADE: 11-FEB-16
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Triumph Resin Dam
DENALI CORPORATION 510(k) NO: K151945(Traditional)
ATTN: JAN G. STANNARD PHONE NO : 1 781 8269190
134 OLD WASHINGTON STREET SE DECISION MADE: 18-FEB-16
HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YuGo System
BIOGAMING LTD. 510(k) NO: K151955(Traditional)
ATTN: RONIT HARPAZ PHONE NO : 972 5 47070792
HAMGSHIMIM 20 SE DECISION MADE: 05-FEB-16
PETACH TIKVA IL 4934829 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FS-PACS
EC-WEB CO., LTD. 510(k) NO: K152034(Traditional)
ATTN: KE-MIN JEN PHONE NO : 886 2 25504790
4F., NO.89, TAIYUAN RD., DATONG DISE DECISION MADE: 23-FEB-16
TAIPEI CITY TW 103 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vesocclude Polymer Ligating Clip
Vesocclude Medical, LLC 510(k) NO: K152082(Traditional)
ATTN: Freddy Cannady PHONE NO : 919 2013142
7429 ACC BLVD Suite 101 SE DECISION MADE: 26-FEB-16
Raleigh NC 27617 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Liquid CO2-2 (LCO2-2)
RANDOX LABORATORIES LTD 510(k) NO: K152085(Traditional)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413 2275
55 DIAMOND ROAD SE DECISION MADE: 24-FEB-16
ARDMORE GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IV-eye
Novarix Limited 510(k) NO: K152088(Traditional)
ATTN: JOHN SCOTT PHONE NO : 44 01235 828292
The Core Business Centre, Milton HSE DECISION MADE: 24-FEB-16
Abingdon GB OX13 6AB 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CorMatrix Tyke
CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K152127(Traditional)
ATTN: ANDREW M. GREEN PHONE NO : 470 5144019
1100 OLD ELLIS ROAD SE DECISION MADE: 04-FEB-16
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Recovery Cone Removal System
C.R. Bard, Inc. 510(k) NO: K152136(Traditional)
ATTN: Joni Creal PHONE NO : 480 6382906
1625 West Third Street SE DECISION MADE: 18-FEB-16
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: High Pressure Tanning Lamps
BLV Licht-und Vakuumtechnik GmbH 510(k) NO: K152141(Traditional)
ATTN: Heinz-Jurgen Wesseling PHONE NO : 49 8094 906206
Munchener Strasse 10 SE DECISION MADE: 25-FEB-16
Steinhoring DE 85643 510(k) STATEMENT

DEVICE: Navik 3D
APN Health, LLC 510(k) NO: K152160(Traditional)
ATTN: David Geddam PHONE NO : 1 844 2768713
4900 Hopyard Road, Suite 100 SE DECISION MADE: 23-FEB-16
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Love Liquid Personal Lubricant
The Kama Sutra Company 510(k) NO: K152168(Traditional)
ATTN: Marla Lee PHONE NO : 805 4957479
2151 Anchor Court SE DECISION MADE: 05-FEB-16
Thousand Oaks CA 91320 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT SHBG
BIOKIT, S.A. 510(k) NO: K152185(Traditional)
ATTN: ANGELS ROMA PHONE NO : 34 938 609000
CAN MALE, S/N SE DECISION MADE: 11-FEB-16
LLICA D AMUNT ES 08186 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
MERETE MEDICAL GMBH 510(k) NO: K152187(Traditional)
ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 49 30 779980114
ALT-LANKWITZ 102 SE DECISION MADE: 12-FEB-16
BERLIN DE 12247 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Erchonia EVRL
ERCHONIA CORPORATION 510(k) NO: K152196(Traditional)
ATTN: STEVEN SHANKS PHONE NO : 214 5442227
2021 COMMERCE DR SE DECISION MADE: 18-FEB-16
MCKINNEY TX 75069 510(k) STATEMENT

DEVICE: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K152231(Traditional)
ATTN: Nikki M Wahlberg PHONE NO : 763 4942381
One Scimed Place SE DECISION MADE: 12-FEB-16
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: The Entasis Dual-Lead Sacroiliac Implant
CoreLink, LLC 510(k) NO: K152237(Traditional)
ATTN: Dan Hoehn PHONE NO : 888 3497808
7606 Forsyth Blvd SE DECISION MADE: 04-FEB-16
St.Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Powder Free Nitrile Patient Examination Gloves, Black color
SUQIAN XINGYE GLOVE CO,LTD 510(k) NO: K152271(Traditional)
ATTN: JIAN ZHANG DENG PHONE NO : 86 527 82860533
DONGWU ROAD,THE ECONOMIC DEVELOPMESE DECISION MADE: 09-FEB-16
SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFLOW II – Irrigation, Warming and Suction System
PROMEPLA SAM 510(k) NO: K152278(Traditional)
ATTN: ALEXANDRE BAREILLE PHONE NO : 377 97 984244
9 AVENUE ALBERT II SE DECISION MADE: 09-FEB-16
MONACO MC 98000 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OBS Anchorage Screw
BOMEI CO., LTD 510(k) NO: K152297(Traditional)
ATTN: LINNEY CHIANG PHONE NO : 886 3 3554989
4F., NO.1492-2, CHUNRIH RD., TAOYUSE DECISION MADE: 09-FEB-16
TAOYUAN CITY TW 33051 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HeartLight Deflectable Sheath
CARDIOFOCUS, INC. 510(k) NO: K152310(Traditional)
ATTN: Seema Paliwal PHONE NO : 508 6587208
500 NICKERSON ROAD SUITE 500-200 SE DECISION MADE: 24-FEB-16
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YAHUA Spinal System
BEIJING WEIGAO YAHUA ARTIFICIAL JO510(k) NO: K152324(Traditional)
ATTN: XINJIAN LV PHONE NO : 86 10 69416956
NO.7, NIUHUI STREET, NIULANSHAN TOSE DECISION MADE: 01-FEB-16
BEIJING CN 101301 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Perfectio LED infrared device
OMM IMPORTS INC DBA ZERO GRAVITY 510(k) NO: K152332(Traditional)
ATTN: OHAD MENACHEM PHONE NO : 954 80548856
1945 S OCEAN DR APT 509 HALLANDLE SE DECISION MADE: 25-FEB-16
HALLANDLE FL 33009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Direct Bilirubin
RANDOX LABORATORIES LIMITED 510(k) NO: K152343(Traditional)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413
55 DIAMOND ROAD, CRUMLIN SE DECISION MADE: 16-FEB-16
COUNTY ANTRIM GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Top Fine Pen Needle
MEDEXEL CO., LTD. 510(k) NO: K152410(Traditional)
ATTN: CHA DONG IK PHONE NO : 82 32 6778004
252, GEUMGWANGOSAN-RO, GUEMGWANG-MSE DECISION MADE: 02-FEB-16
ANSEONG-SI KR 17535 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Indego
PARKER HANNIFIN CORPORATION 510(k) NO: K152416(Traditional)
ATTN: ACHILLEAS DOROTHEOU PHONE NO : 216 8962044
1390 E. HIGHLAND ROAD SE DECISION MADE: 26-FEB-16
MACEDONIA OH 44056 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREND? Free T4 Test System
NANOENTEK USA INC 510(k) NO: K152422(Traditional)
ATTN: JIMMY CHEN PHONE NO : 925 2250108
5627 STONERIDGE DRIVE SUITE 304 SE DECISION MADE: 17-FEB-16
PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PC ECG
EDAN INSTRUMENTS, INC. 510(k) NO: K152427(Traditional)
ATTN: QUEENA CHEN PHONE NO : 86 755 26858736
3/F – B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 05-FEB-16
SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETView VivaSight-SL (TVT) system
ETVIEW LTD. 510(k) NO: K152438(Traditional)
ATTN: YORAM LEVY PHONE NO : 972 72 2607063
M.P MISGAV SE DECISION MADE: 25-FEB-16
MISGAV BUSINESS PARK IL 201790 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Exofin High Viscosity Tissue Adhesive
CHEMENCE MEDICAL PRODUCTS INC. 510(k) NO: K152476(Abbreviated)
ATTN: Kenneth Broadley PHONE NO : 770 2550493
200 Technology Drive SE DECISION MADE: 09-FEB-16
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH Mini Ostial System – 3.0mm x 8mm x 135cm, FLASH Mini Ostial System – 3.5mm x 8mm x 135cm, FLASH Mini Ostial System – 4.0mm x 8mm x 135cm, FLASH Mini Ostial System – 4.5mm x 8mm x 135cm
OSTIAL CORPORATION 510(k) NO: K152485(Traditional)
ATTN: JAKE WOLENBERG PHONE NO : 408 5411006
1221 INNSBRUCK DRIVE SE DECISION MADE: 16-FEB-16
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
PANORAMIC CORP. 510(k) NO: K152489(Traditional)
ATTN: Doug Pack PHONE NO : 800 6542027
4321 Goshen Rd SE DECISION MADE: 04-FEB-16
FT. WAYNE IN 46818 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPX 4 Breast Tissue Expander
MENTOR WORLDWIDE LLC 510(k) NO: K152496(Traditional)
ATTN: Manchi Cheung PHONE NO : 805 7082747
201 MENTOR DRIVE SE DECISION MADE: 19-FEB-16
SANTA BARBARA CA 93111 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C2 NerveMonitor System
INOMED MEDIZINTECHNIK GMBH 510(k) NO: K152505(Traditional)
ATTN: SASCHKA BUSCH PHONE NO : 49 7641 941487
IM HAUSGRUEN 29 SE DECISION MADE: 01-FEB-16
EMMENDINGEN BADEN- WUERTTEMBERG D510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NaturaLase CO2 Laser System
FOCUS MEDICAL, LLC 510(k) NO: K152529(Abbreviated)
ATTN: JOHN B LEE PHONE NO : 203 7308885
23 FRANCIS J CLARKE CIRCLE SE DECISION MADE: 04-FEB-16
BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SpineView X-Pac Expandable Lumbar Cage System
SPINE VIEW, INC. 510(k) NO: K152539(Traditional)
ATTN: Mbithi Muthini PHONE NO : 510 6231931
48810 KATO ROAD SUITE 100E SE DECISION MADE: 24-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dental Implant System
AriaBio International Inc 510(k) NO: K152555(Traditional)
ATTN: Hagai Jacobsen PHONE NO :
229 Overland Ave, Suite 118 SE DECISION MADE: 11-FEB-16
Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
G21 s.r.l. 510(k) NO: K152557(Traditional)
ATTN: Maurizio Foroni PHONE NO : 39 0535 30312
Via S. Pertini, 8 SE DECISION MADE: 23-FEB-16
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-VBR
CARDINAL SPINE, LLC 510(k) NO: K152568(Traditional)
ATTN: NATASHA LONNON PHONE NO : 502 777 4788
12307 OLD LAGRANGE ROAD, SUITE 105SE DECISION MADE: 11-FEB-16
LOUISVILLE KY 40245 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DermaScalp Laser Cap
DERMASCALP LLC 510(k) NO: K152587(Traditional)
ATTN: JOHN CARULLO PHONE NO : 214 6830724
1700 ALMA DR SUITE 400 SE DECISION MADE: 04-FEB-16
PLANO TX 75075 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX EXAMINATION GLOVE POWDER FREE
Careplus (M) SDN BHD 510(k) NO: K152593(Traditional)
ATTN: LIM KWEE SHYAN PHONE NO : 60 6 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 25-FEB-16
SEREMBAN MY 70450 510(k) STATEMENT

DEVICE: Intact® Gen2 System
INTACT MEDICAL CORPORATION 510(k) NO: K152596(Traditional)
ATTN: JOHN VACHA PHONE NO : 508 6557820
550 COCHITUATE RD SUITE 25 SE DECISION MADE: 15-FEB-16
FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V20 system
VIORA LTD. 510(k) NO: K152611(Traditional)
ATTN: OMRI KESLER PHONE NO : 972 9 9551344
3 MASKIT STREET SE DECISION MADE: 19-FEB-16
HERZLIYA IL 4673303 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H3+ Holter Recorder
MORTARA INSTRUMENT, INC 510(k) NO: K152626(Traditional)
ATTN: Margaret Mucha PHONE NO : 414 3541600
7865 NORTH 86TH ST. SE DECISION MADE: 26-FEB-16
MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dictum Health
DICTUM HEALTH, INC 510(k) NO: K152645(Abbreviated)
ATTN: PAUL LANDESMAN PHONE NO : 510 9003590
255 3RD AVENUE, SUITE 102 SE DECISION MADE: 09-FEB-16
OAKLAND CA 94607 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Ennova Self-adhesive Electrode
Suzhou Ennova Electronics Technolo510(k) NO: K152648(Traditional)
ATTN: N/A N/A PHONE NO :
Jinsigang Industrial Park, GuoxianSE DECISION MADE: 18-FEB-16
Suzhou CN 215124 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDS Universal Cement
ESSENTIAL DENTAL SYSTEMS, INC 510(k) NO: K152691(Traditional)
ATTN: JEFFREY WAN PHONE NO : 201 4879090
89 LEUNING STREET, SUITE 8 SE DECISION MADE: 25-FEB-16
SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
ENT BIOTECH SOLUTIONS 510(k) NO: K152702(Traditional)
ATTN: LAURA YAMADA PHONE NO : 313 9224615
75 LEWISTON ROAD SE DECISION MADE: 18-FEB-16
GROSS POINTE FARMS MI 48236 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
HAINING MEDICAL PRODUCTS CO., LTD 510(k) NO: K152715(Traditional)
ATTN: ZHANG LIANG PHONE NO : 86 315 4169201
WEST OF DIANCHANG ROAD LUANNAN COUSE DECISION MADE: 25-FEB-16
TANGSHAN CN 063500 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKIN CARE
C.I.S LTD 510(k) NO: K152736(Traditional)
ATTN: ILAN SHARON PHONE NO : 972 8 9154553
4 BEN GURION ST. SE DECISION MADE: 25-FEB-16
NES ZIONA IL 7403201 510(k) STATEMENT

DEVICE: Electronic Thermometer
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K152739(Traditional)
ATTN: JING LIANG PHONE NO : 86 756 3399967
INNOVATION FIRST ROAD, TECHNOLOGY SE DECISION MADE: 09-FEB-16
ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
MICROLINE SURGICAL, INC. 510(k) NO: K152743(Traditional)
ATTN: ANU GAUR PHONE NO : 978 8671726
50 DUNHAM ROAD SUITE 1500 SE DECISION MADE: 08-FEB-16
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
B.BRAUN INTERVENTIONAL SYSTEMS INC510(k) NO: K152765(Traditional)
ATTN: PETER FLOSDORF PHONE NO : 610 9974694
824 TWELFTH AVENUE SE DECISION MADE: 26-FEB-16
BETHLEHEM PA 18018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
ASSURE TECH. CO., LTD. 510(k) NO: K152768(Traditional)
ATTN: ERIC LIN PHONE NO : 86 871 81022698
2ND. FLOOR, BUILDING 1, NO. 10, XISE DECISION MADE: 24-FEB-16
HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Adena-Zina System
SHANGHAI SANYOU MEDICAL CO, LTD 510(k) NO: K152781(Traditional)
ATTN: DAVID FAN PHONE NO : 86 21 58389980
1988 JIATANG ROAD SE DECISION MADE: 12-FEB-16
JIADIANG DISTRICT CN 201807 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Amecath Peripheral inserted Central Venous Catheter Sets
AMECO MEDICAL INDUSTRIES 510(k) NO: K152819(Traditional)
ATTN: Samy Hamboly PHONE NO : 20 115 383066
INDUSTRIAL AREA B4-PLOT #119 EAST SE DECISION MADE: 05-FEB-16
10TH OF RAMADAN CITY EG 510(k) STATEMENT

DEVICE: Weely Manual Wheelchair
Rupiani 510(k) NO: K152827(Traditional)
ATTN: Jean-Marie Mangenot PHONE NO : 33 6645 5173
74 Avenue Du 8 Mai 1945 SE DECISION MADE: 19-FEB-16
Vaudex En Velin FR 69120 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Spot Skan
SKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K152831(Traditional)
ATTN: MAHADEVAN J PHONE NO : 91 821 2407202
PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 23-FEB-16
MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVIX-S 1012N
VIEWORKS CO., LTD. 510(k) NO: K152855(Traditional)
ATTN: YOONJAE IM PHONE NO : 82 70 70116176
(GWANYANG-DONG) 41-3, BURIM-RO 170SE DECISION MADE: 26-FEB-16
ANYANG-SI KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ExpressBraid Graft Manipulation
BIOMET MANUFACTURING CORP. 510(k) NO: K152868(Traditional)
ATTN: ADAM CARGILL PHONE NO : 574 3711006
56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 08-FEB-16
WARSAW IL 46581 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNTEC Mechanical Wheelchair, model ST-WL-1000
DANYANG SUNTEC AUTO PARTS CO., LTD510(k) NO: K152878(Traditional)
ATTN: JEN KE-MIN PHONE NO : 86 511 86380900
JIEPAI INDUSTRIAL ZONE, JIEPAI, DASE DECISION MADE: 03-FEB-16
ZHENJIANG CN 212300 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVIX-S 1717N
Vieworks Co., Ltd 510(k) NO: K152894(Traditional)
ATTN: Yoonjae Im PHONE NO : 82 70 70116176
(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 26-FEB-16
Anyang-si KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIODE LASER THERAPY SYSTEMS
BEIJING SINCOHEREN SCIENCE AND TEC510(k) NO: K152898(Traditional)
ATTN: XIN WANG PHONE NO : 86 010 57734966
ROOM 305, NO.43, XIZHIMEN NORTH STSE DECISION MADE: 09-FEB-16
BEIJING CN 100044 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K152902(Traditional)
ATTN: YANHONG BAI PHONE NO : 86 755 81885635
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 18-FEB-16
SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ViziShot FLEX
SPIRATION, INC. 510(k) NO: K152922(Traditional)
ATTN: Cyndy J Adams PHONE NO : 425 6365450
6675 185th Ave NE SE DECISION MADE: 19-FEB-16
REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BlastGen
ORIGIO A/S 510(k) NO: K152932(Traditional)
ATTN: TOVE KJAER PHONE NO : 45 4679 0220
KNARDRUPVEJ 2 SE DECISION MADE: 29-FEB-16
MALOV DK 2760 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Medline Anti-Fog Solution
Medline Industries, Inc. 510(k) NO: K152948(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
One Medline Place SE DECISION MADE: 04-FEB-16
Mundelein IL 60060 510(k) STATEMENT

DEVICE: Mammotome revolve Dual Vacuum Assist Biopsy System
DEVICOR MEDICAL PRODUCTS, INC. 510(k) NO: K152989(Traditional)
ATTN: SHAWNA M. ROSE PHONE NO : 513 8649178
300 E-BUSINESS WAY, FIFTH FLOOR SE DECISION MADE: 25-FEB-16
CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OptoWire Deux
OPSENS 510(k) NO: K152991(Traditional)
ATTN: Vanessa Mootoosamy PHONE NO : 418 6829996 239
2014, CYRILLE DUQUET STREET, #125 SE DECISION MADE: 11-FEB-16
QUEBEC CA G1N 4N6 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Adaptivo
Aurora Technology Development, LLC510(k) NO: K152994(Traditional)
ATTN: Gustavo H Olivera PHONE NO : 608 8315419
555 D’Onofrio Dr., Suite 104 SE DECISION MADE: 03-FEB-16
Madison WI 53719 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Clear Guide SCENERGY
CLEAR GUIDE MEDICAL 510(k) NO: K153004(Traditional)
ATTN: Jack Kent PHONE NO : 410 9297720
3600 Clipper Mill Road, Suite 400 SE DECISION MADE: 12-FEB-16
Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
ZIBO HUIYING MEDICAL PRODUCTS, CO.510(k) NO: K153028(Traditional)
ATTN: Fufang Wang PHONE NO : 86 189533 86552
NO. 3 DA WU ROAD SE DECISION MADE: 05-FEB-16
LINZI CN 255400 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N5-1
NUGA MEDICAL CO., LTD 510(k) NO: K153054(Traditional)
ATTN: JONG SOO LEE PHONE NO : 82 33 7300001
185, JIRAEUL-RO, JIJEONG-MYEON SE DECISION MADE: 05-FEB-16
Wonju KR 220-821 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HF1202H PowerPlus Portable X-ray Equipment
MINXRAY, INC. 510(k) NO: K153059(Special)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 COMMERCIAL AVE. SE DECISION MADE: 02-FEB-16
NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
Boston Foundation for Sight 510(k) NO: K153066(Traditional)
ATTN: Eugene Bonte PHONE NO : 781 7267503
464 Hillside Avenue, Suite 205 SE DECISION MADE: 09-FEB-16
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K153077(Traditional)
ATTN: GERHARD FRICK PHONE NO : 41 717 277000
ESPENSTRASSE 139 SE DECISION MADE: 12-FEB-16
WIDNAU CH 9443 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RTVue XR OCT Avanti with AngioVue Software
OPTOVUE, INC. 510(k) NO: K153080(Traditional)
ATTN: EDWARD SINCLAIR PHONE NO : 510 8971575
2800 BAYVIEW DRIVE SE DECISION MADE: 11-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Clear Bi-Light
Michael Todd, LP 510(k) NO: K153081(Traditional)
ATTN: Lilia Friend PHONE NO : 772 3430222
648 Port St Lucie Blvd SE DECISION MADE: 15-FEB-16
Port St Lucie FL 34953 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Rampart A Lumbar Interbody Fusion Device
SPINEOLOGY, INC. 510(k) NO: K153082(Traditional)
ATTN: JACQUELINE A HAUGE PHONE NO : 651 2568500
7800 3RD STREET N, SUITE 600 SE DECISION MADE: 04-FEB-16
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLANT 3D
Media Lab S.r.l. 510(k) NO: K153091(Traditional)
ATTN: Massimo Ivani PHONE NO : 39 018 7517775
Via Trieste 4 SE DECISION MADE: 25-FEB-16
Follo IT 19020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROP Resorbable Hemostasis Material
Resorbable Orthopedic Products, LL510(k) NO: K153095(Traditional)
ATTN: Barry E Constantine PHONE NO : 732 8311797
16633 Dallas Parkway, Suite 250 SE DECISION MADE: 17-FEB-16
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM Vue PACS
CARESTREAM HEALTH, INC. 510(k) NO: K153103(Traditional)
ATTN: Diane Koetter PHONE NO : 585 6276505
150 VERONA STREET SE DECISION MADE: 12-FEB-16
ROCHESTER NY 14468 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K153135(Special)
ATTN: Jin Liang PHONE NO : 86 756 3399967
INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 25-FEB-16
ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DyeVert Contrast Modulation System
OSPREY MEDICAL, INC. 510(k) NO: K153141(Traditional)
ATTN: MELANIE HESS PHONE NO : 952 9558252
5600 ROWLAND ROAD SUITE 250 SE DECISION MADE: 04-FEB-16
MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIO-H DIGITAL RADIOGRAPHY SENSOR
DENTTIO, INC. 510(k) NO: K153144(Traditional)
ATTN: YOUNG HAN PHONE NO : 323 2541000
3235 N. SAN FERNANDO ROAD BLDG 7B SE DECISION MADE: 10-FEB-16
LOS ANGELES CA 90065 510(k) STATEMENT

DEVICE: MOR Implant System
STERNGOLD DENTAL, LLC 510(k) NO: K153173(Abbreviated)
ATTN: MARIA RAO PHONE NO : 508 2265660
23 FRANK MOSSBERG DR SE DECISION MADE: 05-FEB-16
ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Calcium Bridge
DENALI CORPORATION 510(k) NO: K153191(Traditional)
ATTN: Jan G Stannard PHONE NO : 781 8269190
134 OLD WASHINGTON STREET SE DECISION MADE: 26-FEB-16
HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
KCI USA, INC. 510(k) NO: K153199(Traditional)
ATTN: MARGARET MARSH PHONE NO : 210 2556481
6203 FARINON DRIVE SE DECISION MADE: 29-FEB-16
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Navigation Instruments
GLOBUS MEDICAL INC. 510(k) NO: K153203(Traditional)
ATTN: Kelly J Baker PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVENUE SE DECISION MADE: 03-FEB-16
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: In2Bones Kirschner wire
IN2BONES SAS 510(k) NO: K153204(Traditional)
ATTN: Morgane Grenier PHONE NO : 33 4 72292626
28 CHEMIN DU PETIT BOIS SE DECISION MADE: 01-FEB-16
ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-Fix Acromioclavicular Device
CORACOID SOLUTIONS, INC. 510(k) NO: K153211(Traditional)
ATTN: STEVE GOLDEN PHONE NO : 650 7400306
15 NORMANS WAY SE DECISION MADE: 02-FEB-16
PARK CITY UT 84060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SmartBase for Arthrex Glenoid IRIS
Custom Orthopaedic Solutions, Inc.510(k) NO: K153215(Traditional)
ATTN: Keith Grafmeyer PHONE NO : 216 4453403
10000 Cedar Avenue SE DECISION MADE: 19-FEB-16
Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Alpine Cemented Hip System
ORTHO DEVELOPMENT CORPORATION 510(k) NO: K153216(Traditional)
ATTN: Drew Weaver PHONE NO : 801 6193419
12187 SOUTH BUSINESS PARK DRIVE SE DECISION MADE: 18-FEB-16
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex Synergy UHD4 System
ARTHREX, INC. 510(k) NO: K153218(Traditional)
ATTN: DAVID L ROGERS PHONE NO : 239 6435553 71924
1370 CREEKSIDE BOULEVARD SE DECISION MADE: 12-FEB-16
NAPLES OH 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: syngo.CT Single Source Dual Energy (Twin Beam)
Siemens Medical Solutions USA, Inc510(k) NO: K153220(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 19-FEB-16
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VitalStim(R) Plus Electrotherapy System
DJO, LLC 510(k) NO: K153224(Traditional)
ATTN: Natalia Shirina PHONE NO : 760 7345534
1430 DECISION STREET SE DECISION MADE: 17-FEB-16
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Cios Select
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153232(Special)
ATTN: PATRICIA D JONES PHONE NO : 610 4486474
40 LIBERTY BLVD 65-1A SE DECISION MADE: 10-FEB-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PTFE Super Sheath Introducer 2.1
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K153246(Special)
ATTN: COURTNEY NIX PHONE NO : 215 2564201
1499 DELP DR. SE DECISION MADE: 12-FEB-16
HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fusion Compact Navigation System
MEDTRONIC NAVIGATION, INC. 510(k) NO: K153247(Traditional)
ATTN: RISHI SINHA PHONE NO : 269 9034373
826 COAL CREEK CIRCLE SE DECISION MADE: 18-FEB-16
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Aingeal Activity System
Intelesens, Ltd. 510(k) NO: K153275(Traditional)
ATTN: Patricia Pepper PHONE NO : 440 28 90736801
17 Heron Road SE DECISION MADE: 26-FEB-16
Belfast GB BT3 9LE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TandemLung Oxygenator
CARDIAC ASSIST, INC. 510(k) NO: K153295(Traditional)
ATTN: GREG JOHNSON PHONE NO : 412 9637770 266
240 ALPHA DR. SE DECISION MADE: 26-FEB-16
PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Hansen Medical Magellan Robotic Catheter eKit
Hansen Medical, Inc. 510(k) NO: K153304(Traditional)
ATTN: Marysa Loustalot PHONE NO : 650 4045824
800 E Middlefield Road SE DECISION MADE: 01-FEB-16
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HS SutureTape
RIVERPOINT MEDICAL 510(k) NO: K153307(Special)
ATTN: Edwin Anderson PHONE NO : 503 5178001
825 NE 25th Avenue SE DECISION MADE: 12-FEB-16
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Vacutainer UltraTouch Push Button Blood Collection Set
BECTON, DICKINSON AND COMPANY 510(k) NO: K153309(Special)
ATTN: Pasquale Amato PHONE NO : 201 8474513
1 BECTON DRIVE SE DECISION MADE: 12-FEB-16
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Palisade Pedicular Fixation System
SPINEOLOGY, INC. 510(k) NO: K153323(Traditional)
ATTN: JACQUELINE A HAUGE PHONE NO : 651 2568500
7800 3RD STREET NORTH SE DECISION MADE: 23-FEB-16
SAINT PAUL MN 55128-5455 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FreeStyle Precision Neo H Blood Glucose Monitoring System
Abbott Diabetes Care Inc. 510(k) NO: K153330(Traditional)
ATTN: Arul Sterlin PHONE NO : 510 8644310
1360 South Loop Road SE DECISION MADE: 19-FEB-16
Alameda CA 94202 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Epic Extremity Plate System
Epic Extremity, LLC 510(k) NO: K153340(Traditional)
ATTN: DAN SCHWARTZBAUER PHONE NO : 412 9560320
120 Marguerite Dr, Ste 301 SE DECISION MADE: 09-FEB-16
Cranberry Twp PA 16066 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Relieva Scout Multi-Sinus Dilation System
ACCLARENT, INC. 510(k) NO: K153341(Traditional)
ATTN: JAMES PATRICK GARVEY PHONE NO : 650 6874807
1525-B O’BRIEN DRIVE SE DECISION MADE: 12-FEB-16
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Radiance V3
GMV SOLUCIONES GLOBALES INTERNET S510(k) NO: K153368(Traditional)
ATTN: CARLOS ILLANA PHONE NO : 34 918 072270
CALLE DE ISAAC NEWTON, 11 SE DECISION MADE: 16-FEB-16
MADRID ES 28760 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Caspian OCT/MESA Mini/DENALI Mini Spinal System
K2M, Incorporated 510(k) NO: K153370(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
751 Miller Drive SE SE DECISION MADE: 16-FEB-16
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Low Potassium Dextran Solution with Tris Diluent
United Therapeutics Corporation 510(k) NO: K153384(Traditional)
ATTN: Rita Lee PHONE NO : 919 4858350
55 TW Alexander Drive, PO Box 1418SE DECISION MADE: 19-FEB-16
Research Triangle Park NC 27709 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OS2-C Compression Staple
IN2BONES SAS 510(k) NO: K153395(Traditional)
ATTN: MORGANE GRENIER PHONE NO : 33 4 72292626
28 CHEMIN DU PETIT BOIS SE DECISION MADE: 18-FEB-16
ECULLY FR 63130 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Comprehensive SRS/Nexel Elbow
BIOMET MANUFACTURING CORP. 510(k) NO: K153398(Traditional)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 2676639
56 BELL DRIVE SE DECISION MADE: 03-FEB-16
WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ArcScan Insight 100
ARCSCAN, INC. 510(k) NO: K153416(Special)
ATTN: Andy Levien PHONE NO : 773 3875548
443 PARK POINT DR, SUITE 225 SE DECISION MADE: 02-FEB-16
GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE i7
ALPINION MEDICAL SYSTEMS CO., LTD.510(k) NO: K153424(Traditional)
ATTN: Donghwan KIM PHONE NO : 82 707 4652068
1FL and 6FL Verdi Tower, 72, DigitSE DECISION MADE: 26-FEB-16
SEOUL KR 08393 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K153442(Traditional)
ATTN: Lila Joe PHONE NO : 901 3992309
1800 Pyramid Place SE DECISION MADE: 18-FEB-16
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI Astato XS 40
ASAHI INTECC CO., LTD. 510(k) NO: K153443(Traditional)
ATTN: YOSHIHIKO FUKUI PHONE NO : 81 527 681211
1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 25-FEB-16
NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
BIOCHEMICAL DIAGNOSTICS, INC 510(k) NO: K153474(Traditional)
ATTN: ALLEN PANETZ PHONE NO : 631 5959200
180 HEARTLAND BLVD SE DECISION MADE: 23-FEB-16
EDGEWOOD NY 11717 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
NINEPOINT MEDICAL, INC 510(k) NO: K153479(Traditional)
ATTN: EMAN NAMATI PHONE NO : 617 2507190
12 OAK PARK DRIVE SE DECISION MADE: 16-FEB-16
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
ARROW INTERNATIONAL, INC. (Subsidi510(k) NO: K153487(Special)
ATTN: Elizabeth Duncan PHONE NO : 610 3780131
2400 BERNVILLE ROAD SE DECISION MADE: 04-FEB-16
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Occlusion Perfusion Catheter
Advanced Catheter Therapies, Inc. 510(k) NO: K153488(Traditional)
ATTN: Paul Joseph Fitzpatrick PHONE NO : 1 423 3218964
25 E. Main Street, Suite 205 SE DECISION MADE: 25-FEB-16
Chattanooga TN 37408 510(k) STATEMENT

DEVICE: Cryocare CS Surgical System
Health Tronics 510(k) NO: K153489(Traditional)
ATTN: Maritza Ward PHONE NO : 512 4398361
9825 Spectrum Dr. SE DECISION MADE: 05-FEB-16
Austin TX 78717 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Stryker CMF MEDPOR Customized Implant
Stryker 510(k) NO: K153508(Traditional)
ATTN: Jonathan Schell PHONE NO : 269 3895596
750 Trade Centre Way, Suite 200 SE DECISION MADE: 05-FEB-16
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION Vascular Graft
MAQUET CARDIOVASCULAR, LLC 510(k) NO: K153523(Traditional)
ATTN: Mark Dinger PHONE NO : 973 7097691
45 BARBOUR POND DRIVE SE DECISION MADE: 16-FEB-16
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PacEndo EDTA
PAC-DENT INTERNATIONAL, INC. 510(k) NO: K153528(Traditional)
ATTN: Wenying Zhu PHONE NO : 909 8390888
670 ENDEAVOR CIRCLE SE DECISION MADE: 01-FEB-16
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WS80A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD. 510(k) NO: K153529(Third Party – Traditional)
ATTN: Kyeong-Mi Park PHONE NO : 82 2 21941373
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 02-FEB-16
SEOUL KR 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: Bridge Occlusion Balloon
SPECTRANETICS, INC. 510(k) NO: K153530(Traditional)
ATTN: Christopher McLellan PHONE NO : 719 4472000
9965 FEDERAL DRIVE SE DECISION MADE: 05-FEB-16
COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WHILL Model M
WHILL, INC. 510(k) NO: K153543(Third Party – Traditional)
ATTN: TERESE BOGUCKI PHONE NO : 650 4887799
285 OLD COUNTY RD, SUITE 6 SE DECISION MADE: 12-FEB-16
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
VISIONSENSE LTD 510(k) NO: K153548(Traditional)
ATTN: ALEX CHANIN PHONE NO : 972 3 9244339
20 HAMAGSHIMIM ST SE DECISION MADE: 22-FEB-16
PETACH TIKVA, HAMERKAZ IL 49348 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Axxent Electronic Brachytherapy System Model 110 XP 1200
ICAD INC. 510(k) NO: K153570(Traditional)
ATTN: John DeLucia PHONE NO : 603 5467430
98 SPITBROOK ROAD, SUITE 100 SE DECISION MADE: 25-FEB-16
NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Tyber Medical Trauma Screw
TYBER MEDICAL LLC 510(k) NO: K153575(Traditional)
ATTN: Mark F Schenk PHONE NO : 610 5078255
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 26-FEB-16
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex iBalance TKA System
Arthrex, Inc. 510(k) NO: K153586(Traditional)
ATTN: Leon Brown PHONE NO : 239 6435553 72028
1370 Creekside Boulevard SE DECISION MADE: 19-FEB-16
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EndoChoice Water Bottle Cap System
ENDOCHOICE, INC. 510(k) NO: K153588(Special)
ATTN: Daniel Hoefer PHONE NO : 678 7084743
11810 WILLS RD. SE DECISION MADE: 24-FEB-16
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K153589(Traditional)
ATTN: ANKIT K. SHAH PHONE NO : 901 3963133
1800 PYRAMID PLACE SE DECISION MADE: 10-FEB-16
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CliniscanSM MRI
PICOFEMTO LLC 510(k) NO: K153593(Traditional)
ATTN: Jessica Phillips PHONE NO : 646 8283612
228 EAST 45TH STREET SE DECISION MADE: 17-FEB-16
NEW YORK NY 10017 510(k) STATEMENT

DEVICE: ivWatch Model 400
ivWatch, LLC 510(k) NO: K153605(Special)
ATTN: Jaclyn Lautz PHONE NO : 855 4892824 7023
469 McLaws Circle SE DECISION MADE: 11-FEB-16
Williamsburg VA 23185 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vitoss BiModal Bone Graft Substitute Foam Strip
ORTHOVITA, INC. 510(k) NO: K153608(Special)
ATTN: LYNN LUNDY PHONE NO : 1 610 4075256
45 GREAT VALLEY PARKWAY SE DECISION MADE: 12-FEB-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K153617(Special)
ATTN: Eric Elliott PHONE NO : 510 6241314
47215 LAKEVIEW BLVD SE DECISION MADE: 25-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Single Use Injector NM600/610
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K153625(Traditional)
ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 6422694
2951 ISHIKAWA-CHO SE DECISION MADE: 12-FEB-16
HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Zimmer Virage OCT Spinal Fixation System
Zimmer Spine, Inc 510(k) NO: K153631(Special)
ATTN: Ted Kuhn PHONE NO : 303 5018549
7375 Bush Lake Road SE DECISION MADE: 16-FEB-16
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSolution One w/ACG+ Surgical System
THINK SURGICAL INC. 510(k) NO: K153647(Traditional)
ATTN: IN K. MUN PHONE NO : 510 2492300
47320 MISSION FALLS COURT SE DECISION MADE: 16-FEB-16
FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: The Cellfina System
ULTHERA, INC. 510(k) NO: K153677(Special)
ATTN: Suzon Lommel PHONE NO : 408 6454979
1840 S Stapley Dr, Suite 200 SE DECISION MADE: 25-FEB-16
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PriMatrix Dermal Repair Scaffold
TEI BioSciences Inc. 510(k) NO: K153690(Traditional)
ATTN: David D Cox PHONE NO : 617 2681616
7 Elkins Street SE DECISION MADE: 22-FEB-16
Boston MD 02127 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Spirit Hair Removal laser Family
ACTIVE OPTICAL SYSTEMS , LTD. 510(k) NO: K153718(Third Party – Traditional)
ATTN: GIL Bidas PHONE NO : 972 3 9236610
11 SHOHAM ST. SE DECISION MADE: 12-FEB-16
PETACH-TIKVA IL 49591 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: SIGN Compression Screw System
SIGN FRACTURE CARE INTERNATIONAL 510(k) NO: K153759(Traditional)
ATTN: ROB R. TEETER PHONE NO : 509 3711107
451 Hills Street, Suite B SE DECISION MADE: 25-FEB-16
Richland WA 99354 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TraumaCad Mobile Release 2.0
Voyant Health Ltd 510(k) NO: K160001(Special)
ATTN: Yael Guttentag PHONE NO : 972 392 90929
35 Efal Street SE DECISION MADE: 12-FEB-16
Petach-Tikva IL 4951132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Sniper (R) Spine System
SPINE WAVE, INC. 510(k) NO: K160003(Traditional)
ATTN: KELLY Barbieri PHONE NO : 203 9449494
3 ENTERPRISE DRIVE SUITE 210 SE DECISION MADE: 26-FEB-16
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: iHealth Track Blood Pressure Monitor
Andon Health Co., Ltd 510(k) NO: K160014(Special)
ATTN: Liu Yi PHONE NO : 86 22 60526161 8060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 02-FEB-16
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Image1 SPIES System
KARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K160044(Special)
ATTN: SUSIE S. CHEN PHONE NO : 424 2188201
2151 E. GRAND AVE SE DECISION MADE: 01-FEB-16
EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: McLaren Proton Therapy System
McLaren Health Care Corporation 510(k) NO: K160063(Traditional)
ATTN: Ryan Vlcko PHONE NO : 810 3421174
G-3235 Beecher Rd., Suite B SE DECISION MADE: 25-FEB-16
Flint MI 48532 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FilmArray Respiratory Panel (RP) for use with FilmArray Torch
BioFire Diagnostics, LLC 510(k) NO: K160068(Special)
ATTN: KRISTEN J. KANACK PHONE NO : 801 7366354 330
390 Wakara Way SE DECISION MADE: 08-FEB-16
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Digital Electrocardiograph
SHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K160092(Special)
ATTN: Hongbo Zhong PHONE NO : 86 755 36615333
#A735,Shenzhen Mingyou Industrial SE DECISION MADE: 12-FEB-16
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: InZone Detachment System
STRYKER NEUROVASCULAR 510(k) NO: K160096(Special)
ATTN: KATE TAYLOR PHONE NO : 510 4132175
47900 BAYSIDE PARKWAY SE DECISION MADE: 19-FEB-16
FREMONT CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Synapse PACS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K160108(Traditional)
ATTN: Jyh-Shyan Lin PHONE NO : 301 2511092
419 WEST AVENUE SE DECISION MADE: 03-FEB-16
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK hsE2 Calibrator Set
TOSOH BIOSCIENCE, INC. 510(k) NO: K160113(Traditional)
ATTN: ROBERT L WICK PHONE NO : 650 6368117
6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 17-FEB-16
SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Becton, Dickinson & Co. 510(k) NO: K160161(Special)
ATTN: Gregory P. Payne PHONE NO : 858 7957890
10865 Road to the Cure, Suite 200 SE DECISION MADE: 24-FEB-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
Becton, Dickinson & Co. 510(k) NO: K160164(Special)
ATTN: Gregory P. Payne PHONE NO : 858 7957890
10865 Road to the Cure, Suite 200 SE DECISION MADE: 25-FEB-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Illuminated Mediastinal Access Port
Aegis Surgical Ltd 510(k) NO: K160171(Special)
ATTN: William Starling PHONE NO : 919 2519755
4020 Stirrup Creek Drive Suite 115SE DECISION MADE: 26-FEB-16
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Boston Scientific Corporation 510(k) NO: K160173(Special)
ATTN: Eric Elliott PHONE NO : 510 6241314
47215 Lakeview Boulevard SE DECISION MADE: 26-FEB-16
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ S7 Expert
GE Healthcare 510(k) NO: K160182(Special)
ATTN: Bryan Behn PHONE NO : 414 7214214
9900 Innovation Dr. SE DECISION MADE: 26-FEB-16
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Voluson S6, Voluson S8, Voluson S10
GE HEALTHCARE 510(k) NO: K160184(Traditional)
ATTN: TRACEY ORTIZ PHONE NO : 262 6766120
9900 W. INNOVATION DRIVE SE DECISION MADE: 25-FEB-16
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fujifilm Video Colonoscope Model EC-600WL V2
FUJIFILM Medical Systems U.S.A., I510(k) NO: K160196(Special)
ATTN: Shraddha More PHONE NO : 973 6862627
10 High Point Drive SE DECISION MADE: 23-FEB-16
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UreTron MultiProbe Lithotripter System
Med-Sonics Corp 510(k) NO: K160198(Special)
ATTN: Jennifer Rautine PHONE NO : 814 8996500
4960 Pittsburgh Avenue Suite A SE DECISION MADE: 23-FEB-16
Erie PA 16509 510(k) STATEMENT

DEVICE: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
EIZO Corporation 510(k) NO: K160247(Traditional)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 23-FEB-16
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Optimus ALIF System
Amendia, Inc. 510(k) NO: K160291(Special)
ATTN: Kristen Allen PHONE NO : 877 7553329
1755 West Oak Parkway SE DECISION MADE: 18-FEB-16
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I4 (Integrated Intelligent Imaging Informatics) system
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K160315(Third Party – Traditional)
ATTN: Ilana Ben Moshe PHONE NO : 972 525 233496
VEENPLUIS 4-6 SE DECISION MADE: 19-FEB-16
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: syngo.via MI Workflows
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K160317(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
2501 N. BARRINGTON RD SE DECISION MADE: 29-FEB-16
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
JVC KENWOOD Corporation 510(k) NO: K160326(Traditional)
ATTN: Tsukasa Tashiro PHONE NO : 81 258 246611
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 23-FEB-16
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIVA ZSP2105CMI with QUBYX PerfectLum bundle
THE LINDEN GROUP CORP. 510(k) NO: K160328(Traditional)
ATTN: ROBERT COLAIZZO PHONE NO : 973 9838809
2B WING DR SE DECISION MADE: 25-FEB-16
CEDAR KNOLLS NJ 079271020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Novilase Laser Therapy System, Model LTS-2
NOVIAN HEALTH, INC. 510(k) NO: K160392(Special)
ATTN: WILLIAM GRAVEMAN PHONE NO : 312 2667200
430 W. ERIE ST., SUITE 500 SE DECISION MADE: 26-FEB-16
CHICAGO IL 60654 510(k) SUMMARY AVAILABLE FROM FDA

The post FDA releases February 2016 510(k) clearances appeared first on MassDevice.

Medtronic’s Resolute Integrity stent tops Abbott’s Xience in Propel all-comers study

Results from the Propel all-comers trial comparing Medtronic‘s (NYSE:MDT) Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made by rival Abbott (NYSE:ABT).

The 1-year study followed 800 patients from the Propel trial who were treated with the Resolute Integrity device, comparing their results with data from 1,142 Xience patients from the Resolute all-comers study.

For the primary outcome, target lesion failure at 12 months, patients treated with the zotarolimus-eluting Resolute Integrity showed a 4.3% TLF rate, compared with 8.5% for the Xience arm.

All lesions were successfully treated and the procedural success rate was 99%.

“At 12 months, the incidence of clinical events was low in all patients and also across various subgroups,” the researchers found. “The Resolute Integrity stent with the continuous sinusoidal technology had improved deliverability and excellent clinical outcomes.”

The post Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup appeared first on MassDevice.

Sterigenics said yesterday it picked up microbiology testing service provider Nelson Laboratories for an undisclosed amount.

Salt Lake City, Utah-based Nelson Labs provides microbiology testing services for the medical device, pharmaceutical and tissue industries and employs 570 individuals, including 300 scientists and 60 registered specialist microbiologists.

“This is a significant strategic acquisition to help build out Sterigenics’ lab testing and service capabilities on a global scale, enabling us to better serve our multinational customers. We will continue to explore additional expansion opportunities for our lab services to meet our customers’ growing needs,” Sterigenics CEO Michael Mulhern said in prepared remarks.

Nelson Labs operates 85 labs out of 5 corporate buildings at its headquarters and works with more than 3,000 client companies across 57 countries, according to Sterigenics, providing more than 400 microbiological and analytical tests.

“We are incredibly impressed with Nelson Labs’ leadership, culture, customer oriented service and commitment to quality. We believe that the fit is perfect with Sterigenics and look forward to working together on our shared mission of improving global public health,” Mulhern said in a press release.

Nelson Labs operations will remain in Salt Lake City, Sterigenics said, where it will be combined with Sterigenics SteriPro Labs microbiological nad analysitcal testing and consultancy biz. Both businesses will operate under the Nelson Labs brand name and operate as a standalone biz within Sterigenics.

“Sterigenics will be a great partner, and will provide the global access and ongoing investment necessary to ensure long-term growth of the lab services business. They are a global leader in contract sterilization and sterility assurance serving the same markets as Nelson Labs. This is an excellent cultural fit, and I’m excited for the opportunities this will bring for our teams and our customers throughout the world,” newly named Nelson Labs prez Jeffery Nelson said in a prepared statement.

Last August, Sterigenics said it purchased Brazilian sterilization firm Companhia Brasileira de Esterilização. The Latin American company is the largest sterilization and microbial load reduction firm in the region and the first to use gamma sterilization in Brazil, according to Sterigenics.

The acquisition comes on top of the 2014 purchase of Cobalt-60 provider Nordion, as well as Florida-based FTSI and Italy’s Gammarad, Sterigenics said.

This article originally appeared on our sister site, Medical Design & Outsourcing.

The post Sterigenics acquires Nelson Labs appeared first on MassDevice.

Stryker (NYSE:SYK) said today that it closed the $1.28 billion acquisition of automated external defibrillator maker Physio-Control from Bain Capital.

Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012.

The all-cash deal is expected to add slightly to Stryker’s adjusted earnings per share this year, the Kalamazoo, Mich.-based company said when the deal was announced in February. Stryker boosted its earnings outlook for the year to reflect contributions from Physio-Control and recent buy Sage Products, saying it now expects to post adjusted EPS of $5.57 to $5.77, up from guidance for $$5.55 to $5.75. The acquisitions are forecast to contribute 15¢ to 18¢ to adjusted EPS next year, Stryker said.

Redmond, Wash.-based Physio-Control, which put up sales of $503 million during fiscal 2015, is due to be integrated into Stryker’s emergency medical systems portfolio, the company said.

“Physio-Control has achieved global leadership positions with a strong brand and customer-centered solutions that can predict or intervene in life-threatening emergencies,” chairman & CEO Kevin Lobo said at the time. “Physio-Control’s focused strategy and their culture will fit well within the EMS business of our medical division, further leveraging our existing call pattern. We look forward to welcoming the Physio-Control team to Stryker.”

“Joining Stryker is an exciting next step in the evolution of Physio-Control for both our team and our customers,” added Physio-Control president & CEO Brian Webster. “Stryker has a deep understanding of capital equipment and of our core market segments. We will build on the success our team has achieved in partnership with Bain Capital, and further accelerate the execution of our strategy, including continued investment in great product solutions for our customers.”

“It has been a privilege to work collaboratively with Brian and the management team as the company has shown great progress and built even more enduring customer loyalty,” Bain managing director Chris Gordon said. “Physio-Control has added significant operational strength and made substantial investments in R&D to accelerate the development and launch of its next generation product lines. We believe the business is well positioned for further growth, and are confident that Physio-Control will continue to thrive under Stryker’s ownership.”

The post Stryker closes $1.3B Physio-Control deal appeared first on MassDevice.

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup

Results from the Propel all-comers trial comparing Medtronic‘s Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made by rival Abbott. Read more

4. Penumbra launches Lantern peripheral microcatheter

Penumbra said it launched its Lantern peripheral microcatheter and reported Phase IV data from a 100-patient trial of its Indigo peripheral thrombectomy device.

The Lantern device won 510(k) clearance from the FDA in December 2015 for the peripheral and neurovascular delivery of diagnostic agents and therapeutic devices such as occlusion coils. YY-based Penumbra makes the Ruby coil, Penumbra occlusion device and its packing coil. Read more

3. ResMed closes $800m Brightree buy

ResMed said it closed the $800 million acquisition of cloud-based healthcare software company Brightree yesterday.

Atlanta, Ga.-based Brightree develops cloud-based software for home or durable medical equipment for home health and hospice care. Its majority owner was private equity shop Battery, which bought its stake in 2008. Read more

2. Edwards Lifesciences hits all-time high on Sapien 3 study

Shares in Edwards Lifesciences hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend.

Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lancet. The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients. Read more

1. Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device

Boston Scientific reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization.

Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial appendage. One of those patients died from complications related to an infection suffered after the device was retrieved. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 5, 2016 appeared first on MassDevice.

Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.

Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound waves to enhance the image. Lumason was previously approved for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve cardiac imaging.

“Bracco is delighted to obtain FDA approval for the use of Lumason in liver imaging for both adult and pediatric patients. The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients. We are proud to be the first company to obtain FDA approval for this important clinical use of ultrasound contrast both in adults and children. This new indication for Lumason reflects our efforts and investments to expand the range of approved clinical indications for contrast-enhanced ultrasound in the United States. We are very pleased with the collaborative work with the FDA whose review is critical to ensuring the safety and efficacy of any use of imaging products to the healthcare community,” global medical & regulatory affairs senior veep Dr. Alberto Spinazzi said in a prepared statement.

The Monroe Township, N.J.-based company said the Lumason is the 1st ultrasound contrast agent to win FDA approval for liver imaging to improve the sensitivity and specificity of ultrasonography to differentiate between malignant and benign focal hepatic lesions.

“The expanded indication for Lumason now offers healthcare professionals and their patients further benefits of our ultrasound contrast agent. This approval demonstrates Bracco’s leadership and commitment to the imaging community, across imaging modality service lines. We are proud to be a leader in contrast imaging and delivery systems and of our continuous investment in imaging activities to help improve patient care in the U.S.,” CEO Vittorio Puppo said in a press release.

The post Bracco wins FDA nod for liver cancer microspheres appeared first on MassDevice.

Proteus Digital Health yesterday presented interim results from a study of its Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes, claiming use of the system raised patient compliance, lowered blood pressure and reduced low-density lipoprotein-cholesterol.

The Chicago-based company’s Proteus discover operates through the use of an ingestible sensor, the size of a grain of sand, which is activated when it reaches the stomach and communicates with a wearable sensor patch which records time of ingestion and personalized data such as heart rate, physical activity and rest. The data can be seen by a patient through a mobile app, which can be shared with healthcare professionals to optimize patient treatment.

“The promising results from the pilot study demonstrate that this innovative digital approach to therapy optimization is not only patient-centered, but can lead to improved clinical outcomes. The findings suggest that deploying a panel of medicines that reflect the needs of patients and physicians can move the needle in treatment optimization,” chief medical officer George Savage said in prepared remarks.

The12-week, 96 patient study enrolled patients with uncontrolled hypertension and type 2 diabetes who failed at least 2 anti-hypertensive medications plus metformin and/or sulfonylurea. Patients in the trial received treatment with the Proteus Discover for 4 to 12 weeks or usual care based on a cluster randomized study design, the company said.

Primary outcome for the study was a change in systolic blood pressure at week 4, with secondary outcomes including change in diastolic blood pressure and proportion of subjects at the BP target.

Data from the study indicated that 85% of patients treated with Proteus Deliver achieved target blood pressure at 4 weeks, while only 33% of patients receiving usual care hit their targets. Proteus Discover users also reported greater reduction in SBPs than usual care and a greater reduction in DBP and LDL.

The results of the study are slated to be published later this year, Proteus said. The company is also partnering with customers to “generate real-world clinical and economic evidence” of their Proteus Discover.

The company said the new study builds upon evidence from 66 previous studies across diverse patient populations assessing the accuracy, safety and feasibility of the device in patients with hypertension and diabetes.

The post Study: Proteus Discover boosts compliance, lowers BP & LDL | ACC 2016 appeared first on MassDevice.

EnteroMedics (NSDQ:ETRM) today released data from the ReCharge study of its vBloc Neurometabolic Therapy in patients with moderate obesity, touting 74% greater weight loss with vBloc therapy compared to a sham control.

Full results form the St. Paul, Minn.-based company’s trial were published in the journal Obesity Surgery.

“Results observed in the moderately obese population provide strong support for vBloc Therapy’s application within this subgroup of patients, many of whom are not willing to undergo, or not appropriate for, more aggressive surgical interventions. We look forward to further understanding how vBloc performs in this population, as we continue to review long-term data derived from ReCharge and other vBloc studies,” chief medical officer Dr. Scott Shikora said in a press release.

Patients treated with vBloc reported an average weight loss of 33% of excess weight at 12 months, while 75% of patients lost at least 20% of their excess weight and 25% lost at least 50%, EnteroMedics said.

“vBloc Therapy represents a safe and well-tolerated, neuroscience-based approach for the treatment of patients with moderate obesity and related comorbid conditions. Its ability to foster clinically meaningful weight loss safely, without changes in anatomy, establishes vBloc as a much needed anatomy sparing alternative to existing treatment options,” Dr. John Morton of the Stanford University School of Medicine said in prepared remarks.

The ReCharge trial is a prospective, randomized, double-blind, sham-controlled trial of the vBloc Neurometabolic Therapy which enrolled 239 patients with obesity, the company said.

“The moderately obese data from ReCharge, and their publication in Obesity Surgery, highlights an important and meaningful segment of the obesity population for which vBloc Therapy fills a significant unmet need, delivering a safe, effective, durable treatment for obesity and its comorbidities. This population is an important area of focus for our commercial efforts, and one where we believe we can deliver differentiated value to the patient, their physician and payers,” CEO Dan Gladney said in a prepared statement.

In January, EnteroMedics said it closed the 2nd tranche of the $25 million senior amortizing convertible notes offering it announced last November, bringing in $11 million.

At the initial closing in November the company received $1.5 million, with a 3rd tranche of $12.5 million scheduled in 45 days, the St. Paul, Minn.-based company said.

Enteromedics said it will use net proceeds from the offering to continue the commercialization of its Maestro Rechargeable System, for clinical and product development and as working capital,according to an SEC filing posted today.

The post EnteroMedics touts study showing improved weight loss in moderate obesity patients appeared first on MassDevice.

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration and the National Institutes of Health (NIH) have jointly proposed a new template for clinical trial sponsors to use for submitting Investigational Device Exemption (IDE) applications.

The agencies are seeking comment on the new protocol template through April 17, 2016.

The new template is intended to improve and speed up FDA and NIH reviews of IDE applications submitted through a better organized and more consistent medium. The template is based on the International Conference on Harmonisation’s E6 Good Clinical Practice guidance.

Together with Pre-Submission Consulting currently offered by the FDA, a more uniform protocol template for IDE applications could do much to reduce complexities and unnecessary delays for medical device manufacturers in need of clinical trials.

For more information on clinical trial requirements for medical devices in the US, please see our whitepaper on FDA clinical quality assurance requirements.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post FDA, NIH propose new clinical trial protocol template for investigational device exemptions (IDE) appeared first on MassDevice.

Medtronic (NYSE:MDT) remains unfazed by the U.S. Treasury Dept.’s push to rein in so-called “inversion” mergers, which allow American companies to re-organized under foreign jurisdictions, after the agency issued new rules on the deals this week.

The U.S. government has grappled with a wave of inversions in recent years, including last year’s $50 billion union of Medtronic and Covidien, which was domiciled in Ireland. Reincorporating overseas allows American companies to slash their tax bills even though their core operations and management stay here. Several U.S. presidential candidates, including Republican Donald Trump and Democrat Hillary Clinton, have seized on the issue in their campaigns. President Barack Obama, a Democrat, has called repeatedly for action by the Republican-controlled U.S. Congress on inversions, but lawmakers have done little.

The new Treasury rules impose a 3-year limit on foreign companies “bulking up” on U.S. assets to skirt ownership limits ahead of an inversion. They also tackle “earnings stripping” after inversions, a tactic designed to shrink taxable U.S. profits, and restrict related-party debt for U.S. subsidiaries that’s not used to fund new U.S. investments.

The Treasury Dept. tightened the rules on inversions last November, limiting U.S. acquirers’ ability to set up new foreign parents and “stuff” assets into it to meet existing limits on post-inversion ownership levels. Medtronic, which shrugged off the implications back then, said today that a preliminary review of the newer regulations led it to conclude that they “do not have a material financial impact on any transaction undertaken by the company.

“Medtronic will continue to more fully examine the regulations and will provide appropriate disclosure concerning any potential material impact on the company, if applicable,” the company said. “Medtronic’s acquisition of Covidien, which closed in January 2015, was undertaken for strategic reasons and has created a company that is positively impacting the lives of more patients, in more ways and in more places around the world.”

The new rules have already scuppered 1 mega-deal, the proposed $160 billion combination of Pfizer (NYSE:PFE) and Allergan (NYSE: AGN), triggering a $150 million breakup fee to cover Allergan’s expenses in the deal.

Material from Reuters was used in this report.

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SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker.

The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The 1st-in-human study is slated to enroll 15 patients to examine the safety & usability of the SurVeil device before the design is finalized, SurModics said.

“We are pleased with the progress we made enrolling the first patient in this study of our proprietary SurVeil DCB,” president & CEO Gary Maharaj said in prepared remarks. “We are proud to be on the path to offering highly differentiated whole-products solutions to our medical device customers.”

“First- and 2nd-generation DCBs demonstrated a biologic effect and improved patency in patients with PAD,” added Dr. Kenneth Rosenfield, of the Mass. General Hospital and advisory board chairman for SurModics. “The new generation of DCBs, which includes significant advances in technology, provides a great opportunity to further enhance patient outcomes.”

SurModics in January paid $7 million and put another $7 million in milestones on the table for catheter maker NorMedix. Late last year the company paid $32 million for balloon catheter maker Creagh Medical.

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Edap (NSDQ:EDAP) said today it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer.

The company said the new submission comes following the FDA 510(k) clearance of its Ablatherm Robotic HIFU designed for the ablation of prostate tissue, which it won last November.

“We are pleased to submit our Focal One HIFU device file to the FDA to further our goal of making EDAP’s full range of HIFU products available to both urologists and patients in the U.S. There is a clear, growing demand from the worldwide urology community for non-invasive options for the ablation of prostatic tissue, and we are well positioned to address this market with our complementary Ablatherm and Focal One devices. We believe that HIFU has the potential to become a standard of care tool for prostate ablation. We are extremely excited by the progress of the U.S. commercial launch of Ablatherm Robotic HIFU and look forward to working with the FDA on the clearance process for Focal One,” CEO Marc Oczachowski said in an SEC filing.

Last November, Edap said the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer.

EDAP shares plunged in 2014 after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won 510(k) clearance from the federal safety watchdog earlier in November, uses highhigh-intensity focused ultrasound to ablate prostate tissue.

Shareholders sued in August 2014, accusing Edap of misleading investors by exaggerating Ablatherm’s safety and efficacy and understating adverse events.

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MC10 said today it inked a limited exclusive distribution partnership with Marubun Corp. to distribute its BioStamp products in Japan.

The Lexington, Mass.-based company’s BioStamp sensor products are designed as wearable sensors that collect and transmit biometric data.

“Marubun strives to contribute to the advancement of science and technology by engaging with suppliers who are leaders in their respective fields and providing cutting-edge specialized electronics. Through our relationship with MC10, we are continuing in our mission to deliver the most innovative technology to our customers,” Marubun senior veep Satoshi Fujino said in a press release.

In addition to the distribution deal, Marubun also joined the company’s strategic equity investors, MC10 said.

“MC10 is dedicated to developing technology that enables a better understanding of human health. My past engagements with Marubun have demonstrated the corporation’s superior ability to bring new, emerging technologies to the Japanese market,” MC10 CEO Scott Pomerantz said in prepared remarks.

The deal will allow Marubun to distribute MC10’s recently cleared BioStamp Research Connect system, a flexible, wearable sensor that gathers physiological data.

The BioStamp RC is the 1st product that fully integrates the company’s BioStamp tech, which connects to the company’s cloud-based software, and allows researchers to share data with each other across multiple research sites.  Patches can be used simultaneously on multiple body locations, the company said.

The product allows researches to gather raw kinematic and surface biopotential data through a 3-axis accelerometer and 3-axis gyroscope and integrated electrodes to gather surface electromyography and electro-cardiac activity.

The post MC10 inks Japanese distro deal with Marubun for BioStamp appeared first on MassDevice.

by Charles Ornstein, ProPublica.

The New England Journal of Medicine is arguably the best-known and most venerated medical journal in the world. Studies featured in its pages are cited more often, on average, than those of any of its peers. And the careers of young researchers can take off if their work is deemed worthy of appearing in it.

But following a series of well-publicized feuds with prominent medical researchers and former editors of the Journal, some are questioning whether the publication is slipping in relevancy and reputation. The Journal and its top editor, critics say, have resisted correcting errors and lag behind others in an industry-wide push for more openness in medical research. And dissent has been dismissed with a paternalistic arrogance, they say.

In a widely derided editorial earlier this year, Dr. Jeffrey M. Drazen, the Journal’s editor-in-chief, and a deputy used the term “research parasites” to describe researchers who seek others’ data to analyze or replicate their studies, which many say is a crucial step in the scientific process. And last year, the Journal ran a controversial series saying concerns about conflicts of interest in medicine are oversimplified and overblown.

“They basically have a view that … they don’t need to change or adapt. It’s their way or the highway,” said Dr. Eric Topol, director of the Scripps Translational Science Institute and chief academic officer at Scripps Health in La Jolla, California.

Topol and another cardiologist were called out by Drazen and his co-authors last year after they wrote an opinion piece in The New York Times saying the data behind a groundbreaking study about blood pressure treatment should be made available to doctors right away — not delayed for journal publication.

“Most people are afraid to say anything about the New England Journal because they’re afraid they won’t get something published there,” said Topol, whose last piece appearedin its pages in 2011. “That’s part of this oppression.”

In an interview, Drazen said the recent criticisms are misguided. The goal for the research the Journal publishes is to be accurate, he said, while its editorials are sometimes designed to be “controversial” as a means of triggering discussion.

“If there’s anything that I have a passion for, it’s getting it right,” he said. “We work very hard at that. We’re not arrogant. We’re not dismissive.”

Brooding over the Journal’s future comes at a pivotal moment for medical journals more broadly.

Like the larger publishing world, their traditionally slow pace and often imperious control have been jolted by the freedom and brashness of the Internet. So-called open-access journals, which publish online and don’t charge for subscriptions, are proliferating, as are websites that allow researchers to post their results before they have been externally vetted. Respected academics, including Harvard’s medical school dean Dr. Jeffrey Flier, are calling for fundamental changes in the way research is reviewed and published, even proposing that peer reviewers give up their historic anonymity.

This push for transparency tracks the rise of research watchdogs who hunt for evidence of fraud and misconduct, then publicize their findings, often blasting out viral bombs via social media. There’s even a popular website called Retraction Watch whose main goal is to flag such lapses, which had largely gone unnoticed even a few years ago.

In response, some top journals, including The BMJ, formerly the British Medical Journal, have already begun moving toward more openness in their operations. The BMJ now requires researchers to share the underlying data that forms the basis of their clinical trials and allows comments on all of its articles, upending the strong hand editors previously had to determine which dissent was worthy of airing. It has even had outsiders examine questions raised about controversial studies.

The Journal, in contrast, its critics say, has steadfastly clung to an increasingly antiquated view of medical journals as sole arbiters of what should made be public and whether dissenting views should be heard.

“The BMJ wants to take us forward in the new century and the New England Journal of Medicine is trying to take us backwards,” said Dr. Vinay Prasad, an expert in evidence-based medicine and an assistant professor of medicine at Oregon Health & Science University, who has become an outspoken critic of the Journal.

The publication Drazen inherited was initially launched as a quarterly in January 1812with the less pithy title of the New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science. Today, it is read each week by more than 600,000 people in 177 countries, according to the journal’s website

In 1984, the Journal was at the forefront of a nascent effort to respond to the potential bias arising from financial ties between pharmaceutical and device makers and physicians. Editor Arnold S. Relman established a new policy, calling on doctors and researchers to disclose their funding and commercial interests. Six years later he went a step further, prohibiting authors with ties to companies from writing editorials or reviews of medical literature relating to their products.

Drazen’s own ties to the pharmaceutical industry presented something of an obstacle when he was named editor in May 2000. A well-known pulmonologist, he had received money for consulting or research into asthma and its treatments from nine drug companies. Because of those ties, he recused himself for two years from editing or personally selecting any papers related to asthma or to those companies.

Two years into his editorship, he loosened the Journal’s conflict policy. Drazen wrote that the policy Relman had put in place — and that his successors had affirmed — had “constrained” editors from publishing the best information for doctors. The new policy said authors of editorials and reviews couldn’t have “significant” ties to a company, which are defined as receiving more than $10,000 annually from a single company.

The Journal dug into the topic again last May with a three-part series of articlesquestioning efforts to curb financial conflicts of interest among doctors and researchers.

“Although, by definition, a conflict of interest represents a risk that judgment will be compromised — not a determination that such a lapse has actually occurred — the pharmascolds’ narrative about conflicts of interest often conflates the two,” author Lisa Rosenbaum wrote, using a pejorative word some have used to describe those who lament the influence of industry on medical decisions.

Drazen’s predecessors Jerome P. Kassirer and Marcia Angell, and former senior editor Robert Steinbrook, took to the pages of The BMJ to criticize their former home. “Judges are expected to recuse themselves from hearing a case in which there are concerns that they could benefit financially from the outcome. Journalists are expected not to write stories on topics in which they have a financial conflict of interest,” they wrote. “Yet Rosenbaum and Drazen seem to think it is insulting to physicians and medical researchers to suggest that their judgment can be affected in the same way.

Asked if the Journal had plans to further revise its policy on conflicts of interest, Drazen said, “We always continually evaluate what we do to make sure we’re doing the best job possible.” None of Rosenbaum’s pieces, he added, “mentioned anything about us changing our policy.”

Since 2010, ProPublica has written extensively about conflicts of interest in medicine, and has created a tool called Dollars for Docs that allows users to look up payments to doctors by drug and medical device companies. A second tool, Surgeon Scorecard, that includes complication rates, was criticized by Rosenbaum inperspective piece in the Journal last year.

Rosenbaum, in an email, said the reaction to the series was much as she had hoped. “One of the primary goals of the series was to start a conversation so that we could move beyond what has become a very reflexive (and typically negative) response to physician-industry interactions,” she wrote.

Switched Outcomes

Some researchers and doctors have also decried what they perceive as the Journal’s resistance to becoming more transparent about the research it publishes.

In February, a group of British scientists faulted the Journal, as well as some of its peers, for failing to disclose that the questions being answered in certain studies were not the same as those in the researchers’ original protocols. Changes are normal and sometimes to be expected, but they need to be disclosed, the group believes.

When the group shared its findings in a series of letters to the editor, the Journal’seditors sent dismissive responses, they said, declining to make any changes to the papers or publish the team’s criticisms.

In an interview, Drazen said his staff initially reviewed a couple of the group’s claims, found them without merit and moved on. Through a spokeswoman, he emailed documents that he said rebutted the group’s contentions regarding two of the studies.

“We went through this and it just wasn’t worth our effort because it isn’t helping the people we’re trying to help,” Drazen said. A leader of the group, British researcher and author Ben Goldacre, is “trying to sell his books and he’s trying to tell the world that clinical trials aren’t reliable,” Drazen said.

Drazen also noted that in recent years, the Journal began posting the protocols and statistical analysis plan for all clinical trials it publishes.

Shown the Journal’s rebuttals, Goldacre and his team said it not only failed to rebut their contentions, but showed that the editors may not have fully understood the studies’ findings and metrics.

“There is this whole belief that the scientific literature is rigorous, that things are checked, and that researchers can point out errors post-publication, so the system is self-correcting,” Goldacre said in an email. “What we’ve shown is clear: that doesn’t happen, the system doesn’t work.”

Doubling Down on Studies

The critiques of the Journal have moved onto the pages of competing journals and mainstream news sources, with several recently questioning why it has been slow to correct or clarify studies.

A piece last month in The BMJ reported on mounting concerns over the Journal’s handling of a major 2012 study that compared the risks of two different products — saline and hydroxyethyl starch — that boost blood volume in critically ill patients. Though the results were not conclusive, the study suggested that starch solutions were more dangerous, leading to a warning from the U.S. Food and Drug Administration and a precipitous drop in sales.

The company that manufactured starch solutions wrote a letter skeptical of the study’s methodology and results. The Journal, according to The BMJ article, wouldn’t correct the article or publish the company’s letter. Within days of The BMJ article, the Journal appended a correction to the study about the values in a table, but editors otherwise stood by the findings.

In an interview, Drazen said that when concerns are raised about a study, the authors are asked for a response, which is analyzed by statistical reviewers. “Recently we got another query about the same issue,” Drazen said. “When we went back to requery the author, there, in fact, was an error in the paper that was published.”

Separately, at least one researcher was so troubled at what he viewed as a fundamentally flawed and misleading study in the Journal that he spent five years trying to persuade the Journal to pull it.

Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, spotted problems with the 2006 study soon after it was published. The authors said that annual computerized tomography (CT) screenings to detect lung cancer could prevent 80 percent of lung cancer deaths.

Critics of the study — and investigative journalists — caused it to be corrected or clarified three times. The first noted that the authors received royalties for inventing CT screening methods that had been licensed to GE Healthcare, a maker of scanning equipment, a disclosure missing from the original study. The second disclosed that one of the foundations that supported the study was underwritten by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes. The third said that certain numbers in the study were wrong, but asserted that the errors did not change the findings.

But Bach felt the paper should be further corrected or retracted. He said he communicated his concerns to the Journal’s editors but when they didn’t act, he submitted them for publication in the Journal of the National Cancer Institute, which published his paper in 2011.

Even now, the text of the study continues to contain some incorrect numbers. In order to track the corrections, readers must click on separate links to see the accurate data. If the study is simply printed out, that information is not included. Bach said he fears the study’s bad data may continue to have lingering influence.

“All the journals should aspire to making sure the scientific record is as accurate as possible, and this was clearly an example where I was able to show empirically that the data was impossible,” Bach said.

The study’s primary author has vigorously defended its accuracy.

Journal spokeswoman Jennifer Zeis said in an email that the correction to the data “is prominently and permanently attached to the online article. This correction only resulted in very slight changes to the results and no change to the conclusion and interpretation of the data.” A study funded by the National Institutes of Health subsequently found that CT screening does reduce mortality from lung cancer, she said. (It was to a far lesser degree than the 2006 article posited.)

Ivan Oransky, who co-founded Retraction Watch in 2010 to track retractions in science in response to their hidden nature, said “many journals have come to realize or have long realized that correcting the record even with retractions is a sign of health. The New England Journal of Medicine continues to see retractions and even corrections as a badge of shame, and that’s a problem.”

‘Research Parasites’

The incident that has provoked the biggest storm came in January, when Drazen and a deputy editor wrote an editorial that some interpreted as critical of burgeoning efforts to share data on clinical research so others can assess the findings and perhaps replicate the analyses.

“There is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as ‘research parasites,’” Drazen and deputy editor Dan Longo wrote. They defined such people as those “who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited.”

The criticism was immediate, fierce and widespread — probably more than for anything else the Journal has done in many years. In an editorial in the journal Science, entitled “#IAmAResearchParasite,” editor Marcia McNutt wrote: “No more excuses: Let’s step up to data sharing.”

Barry Marshall, a winner of the Nobel Prize in Physiology or Medicine, wrote on Twitter: “Plenty of Nobel prizes came from a new look at other people’s data.”

And Prasad, of Oregon Health & Science University, said despite Drazen’s contention that he was reflecting the views of others, the phrase “research parasites” had never appeared in published medical literature before the editor used the term.

Drazen quickly published a second editorial in which he appeared to backtrack somewhat (he used the word “clarify”), saying he and the Journal did support data sharing.

The worry he was initially trying to articulate, Drazen said in an interview, is that scientists not involved with original research will swoop in, conduct additional analyses (perhaps without understanding the data) and then take credit from those who spent months or years working on the underlying research.

“The datasets are very, very, very complex,” he said. “You don’t want someone to analyze the dataset not fully understanding it.”

For his part, Drazen said he doesn’t see the controversies that have arisen in recent months as any different from those of other periods of his tenure. He is one of the longest-serving editors of a major medical journal at this point.

“In the 16 years, I can’t say that I think this particular last 12 months has been different by a lot,” he said. “When issues come up we pay attention to them, and there are always issues coming up.”

In the interest of full disclosure, the author of this article served on the board of directors of the Association of Health Care Journalists with Oransky.

The post Amid public feuds, NEJM finds itself under attack appeared first on MassDevice.

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2016

TOTAL 510(k)s THIS PERIOD   279                                     
TOTAL WITH SUMMARIES        265                                     
TOTAL WITH STATEMENTS        14

DEVICE: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
ORION DIAGNOSTICA OY              510(k) NO: K142993(Traditional)
ATTN: ANJA  KONTIO                PHONE NO : 358 509665917 
KIVIHARJUNTIE 11 4B               SE DECISION MADE: 10-MAR-16
OULU  FI 90220                    510(k) STATEMENT
                                                    

DEVICE: Flight 60 Ventilator
FLIGHT MEDICAL INNOVATIONS LTD.   510(k) NO: K143035(Traditional)
ATTN: Yanir  Shaked               PHONE NO : 972 8 9235111 
13 HAMELACHA STREET NORTH INDUSTRISE DECISION MADE: 30-MAR-16
LOD  IL 71520                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QbCheck 
QBTECH AB                         510(k) NO: K143468(Traditional)
ATTN: Hans  Bostrom               PHONE NO : 46 706 339209 
Kungsgatan 29                     SE DECISION MADE: 22-MAR-16
Stockholm  SE 11156               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xevonta dialyzer
B. Braun Avitum AG                510(k) NO: K143482(Traditional)
ATTN: Giuliana  Gavioli           PHONE NO : 39 0535 616757 
Am Buschberg 1                    SE DECISION MADE: 01-MAR-16
Melsungen  DE D-34212             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisuCon-F Low Fibrinogen Control Plasma
AFFINITY BIOLOGICALS INC.         510(k) NO: K150144(Traditional)
ATTN: Denise  Foulon              PHONE NO : 905 3049896 
1395 SANDHILL DRIVE               SE DECISION MADE: 06-MAR-16
ANCASTER  CA L9G 4V5              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oniris
SAS Oniris                        510(k) NO: K150566(Traditional)
ATTN: Thibault   Vincent          PHONE NO : 33 147 505070 
704 Avenue Roger Salengro         SE DECISION MADE: 21-MAR-16
CHAVILLE  FR 92370                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OVA1 Next Generation
VERMILLION, INC.                  510(k) NO: K150588(Traditional)
ATTN: Benjamin A Kimball          PHONE NO : 1 512 5190435 
12117 BEE CAVES RD., BLDG III, SUISE DECISION MADE: 18-MAR-16
AUSTIN TX  78738                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exceed Tx
GREAT LAKES ORTHODONTICS, LTD.    510(k) NO: K150702(Traditional)
ATTN: DAVE  GRAVER                PHONE NO : 716 8711161 250
200 COOPER AVE                    SE DECISION MADE: 24-MAR-16
TONAWANDA NY  14150               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Epidural Catheter
MEDLINE INDUSTRIES, INC.          510(k) NO: K150731(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
ONE MEDLINE PLACE                 SE DECISION MADE: 07-MAR-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINAUT-E, SPINAUT-I
IMEDICOM CO., LTD.                510(k) NO: K150789(Traditional)
ATTN: Bonngu  Ha                  PHONE NO : 82 31479 1156 
#612, 172, LS-ro                  SE DECISION MADE: 01-MAR-16
Gunpo-si  KR 435-824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bead Block 
BIOCOMPATIBLES UK LTD             510(k) NO: K150876(Traditional)
ATTN: PEDRO  GARCIA               PHONE NO : 44 01252 732732 
CHAPMAN HOUSE, WEYDON LANE        SE DECISION MADE: 07-MAR-16
FARNHAM, SURREY   GB GU9 8QL      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINAUT-P
IMEDICOM CO., LTD.                510(k) NO: K150915(Traditional)
ATTN: BONGGU  HA                  PHONE NO : 82 31 4791156 
#612, 172, LS-RO                  SE DECISION MADE: 18-MAR-16
GUNPO-SI  KR 435-824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finger Type Pulse Oximeter
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K151024(Traditional)
ATTN: C. W. CHEN                  PHONE NO : 886 2 66258188 
6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 02-MAR-16
NEW TAIPEI CITY  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Pac-Dent International, Inc.      510(k) NO: K151123(Traditional)
ATTN: Wenying  Zhu                PHONE NO : 909 83908888 
670 Endeavor Circle               SE DECISION MADE: 03-MAR-16
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MODEL 621/624 BIOMAGNETOMETER
TRISTAN TECHNOLOGIES, INC         510(k) NO: K151135(Traditional)
ATTN: KEVIN  PRATT                PHONE NO : 858 5502700 
6191 CORNERSTONE CT., STE 107     SE DECISION MADE: 15-MAR-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HARMONIC HOOK
ETHICON ENDO-SURGERY, LLC         510(k) NO: K151136(Traditional)
ATTN: MARJORIE  MEDINA            PHONE NO : 787 7186654 
475 CALLE C                       SE DECISION MADE: 04-MAR-16
GUAYNABO PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Bennett 840 Series Ventilator System
Covidien LP                       510(k) NO: K151252(Traditional)
ATTN: Kelsey  Lee                 PHONE NO : 303 3052760 
6135 Gunbarrel Ave                SE DECISION MADE: 29-MAR-16
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINAUT-V, SPINAUT-S, SPINAUT-I 
IMEDICOM CO., LTD.                510(k) NO: K151268(Traditional)
ATTN: BONGGU  HA                  PHONE NO : 82 31 4791156 
#612, 172, LS-ro                  SE DECISION MADE: 16-MAR-16
Gunpo-si  KR 435-824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BellaFuse
Hans Biomed Corp.                 510(k) NO: K151271(Traditional)
ATTN: Lucy  Choi                  PHONE NO : 82 2 4662266 
64,Yuseong-Daero 1628Beon-Gil, YusSE DECISION MADE: 11-MAR-16
Daejeon  KR 305-811               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock Anchors
ARTHREX, INC.                     510(k) NO: K151342(Traditional)
ATTN: David L. Rogers             PHONE NO : 239 6435553 71924
1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 24-MAR-16
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
Salter Labs                       510(k) NO: K151421(Traditional)
ATTN: Mara  Caler                 PHONE NO : 760 7957094 
2365 Camino Vida Roble            SE DECISION MADE: 10-MAR-16
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AUDICOR CA300/CC100 Analyzer with SDB
INOVISE MEDICAL, INC.             510(k) NO: K151433(Traditional)
ATTN: Earl  Anderson              PHONE NO : 503 4313800 
8770 SW NIMBUS AVENUE SUITE D     SE DECISION MADE: 18-MAR-16
BEAVERTON OR  97008               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hybernite RT 
PLASTIFLEX GROUP NV               510(k) NO: K151461(Traditional)
ATTN: RAF VAN  ROY                PHONE NO : 32 01143 5800 
BEVERLOOSESTEENWEG 99             SE DECISION MADE: 24-MAR-16
PAAL-BERINGEN  BE 3583            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor
CARETAKER MEDICAL, LLC            510(k) NO: K151499(Traditional)
ATTN: JEFF  POMPEO                PHONE NO : 434 4091945 
3042 BERKMAR DRIVE SUITE A        SE DECISION MADE: 18-MAR-16
CHARLOTTESVILLE VA  22901-1455    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
Salter Labs                       510(k) NO: K151506(Traditional)
ATTN: Mara  Caler                 PHONE NO : 760 7957094 
2365 Camino Vida Roble            SE DECISION MADE: 11-MAR-16
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuLisa Enhanced Centromere Antibody ELISA 
IMMCO DIAGNOSTICS, INC.           510(k) NO: K151559(Traditional)
ATTN: KEVIN  LAWSON               PHONE NO : 716 4915452 
60 PINEVIEW DR.                   SE DECISION MADE: 11-MAR-16
BUFFALO NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann RN Gold Abutment for Bridge
STRAUMANN USA, LLC                510(k) NO: K151590(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 7472575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 04-MAR-16
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Family of Steam Sterilizers B 28 series
CEFLA S.C.                        510(k) NO: K151597(Traditional)
ATTN: SILVIA  SANSAVINI           PHONE NO : 39 542 653438 
VIA SELICE PROVINCIALE 23/A       SE DECISION MADE: 04-MAR-16
IMOLA  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NewTom VGi evo
QR S.r.l.                         510(k) NO: K151612(Traditional)
ATTN: LORENZO  BORTOLOTTI         PHONE NO : 39 0542 643496 
Via Silvestrini 20                SE DECISION MADE: 31-MAR-16
Verona  IT 37135                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUSTAIN Additional Implants
GLOBUS MEDICAL INC.               510(k) NO: K151665(Traditional)
ATTN: KELLY J BAKER               PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 16-MAR-16
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: chromID MRSA
bioMerieux, Inc.                  510(k) NO: K151688(Traditional)
ATTN: Jewell  Coulson             PHONE NO : 314 7317342 
595 Anglum Rd.                    SE DECISION MADE: 11-MAR-16
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MetaNeb 4 System
Hill-Rom Services Pte Ltd         510(k) NO: K151689(Traditional)
ATTN: Huifang  Zhu                PHONE NO : 65 649 97395 
1 Yishun Ave 7                    SE DECISION MADE: 17-MAR-16
Singapore  SG 768923              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gammex PI Hybrid Surgical Gloves
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K151694(Traditional)
ATTN: Vasudev  Dobariya           PHONE NO : 732 3455317 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 09-MAR-16
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEAUTIFIL II Gingiva
SHOFU DENTAL CORPORATION          510(k) NO: K151700(Traditional)
ATTN: MAURO  MALZYNER             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 02-MAR-16
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    

DEVICE: Specular Microscope CEM- 530
NIDEK CO., LTD.                   510(k) NO: K151706(Traditional)
ATTN: YONEJI  MIZUNO              PHONE NO : 011 81 533676611 
34-14 MACHAMA, HIROISHI-CHO       SE DECISION MADE: 17-MAR-16
GAMAGORI  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RECON system - Compression Screws
NORMED MEDIZIN-TECHNIK GMBH       510(k) NO: K151708(Traditional)
ATTN: ARNE  BRIEST                PHONE NO : 49 7461 93430 
ULRICHSTRASSE 7                   SE DECISION MADE: 02-MAR-16
TUTTLINGEN  DE D-78532            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Slim UP ULTRA
AIME MEDICAL INC                  510(k) NO: K151722(Traditional)
ATTN: PAUL  GUILBAUD              PHONE NO : 1 727 2866227 
1258 WEST BAY DRIVE, SUITE F      SE DECISION MADE: 18-MAR-16
LARGO FL  33770                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FULL CARE Disposable PVC Nelaton Catheter
SHAOXING FUQING HEALTH PRODUCTS CO510(k) NO: K151745(Traditional)
ATTN: DEAN  WU                    PHONE NO : 86 575 8867600 830
NO. 599 WUXIE ROAD,  SHAOXING HIGHSE DECISION MADE: 03-MAR-16
SHAOXING  CN 312000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clean & More
3M DEUTSCHLAND GMBH               510(k) NO: K151748(Traditional)
ATTN: DESI W SOEGIARTO            PHONE NO : 49 8152 7001169 
ESPE PLATZ                        SE DECISION MADE: 11-MAR-16
SEEFELD  DE 82234                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
Siemens Medical Solutions USA, Inc510(k) NO: K151749(Traditional)
ATTN: Eve  Davis                  PHONE NO : 610 2197133 
51 Valley Stream Parkway          SE DECISION MADE: 18-MAR-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glide-On Vinyl Examination Gloves
MEDLINE INDUSTRIES, INC.          510(k) NO: K151754(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 22-MAR-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PerioLase Nd:YAG Pulsed Dental Laser System
MILLENNIUM DENTAL TECHNOLOGIES, IN510(k) NO: K151763(Traditional)
ATTN: DAVID M HARRIS              PHONE NO : 562 8602908 
10945 SOUTH ST., SUITE 104-A      SE DECISION MADE: 15-MAR-16
CERRITOS CA  90703                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Perspective
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K151765(Traditional)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 4484912 
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 25-MAR-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
CARDINAL HEALTH 200, INC.         510(k) NO: K151778(Traditional)
ATTN: CAROLINE  MICELI            PHONE NO : 847 8876864 
1500 WAUKEGAN ROAD                SE DECISION MADE: 24-MAR-16
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAAS Workstation
PIE MEDICAL IMAGING B.V.          510(k) NO: K151780(Traditional)
ATTN: FLORIE  DANIELS             PHONE NO : 31 43 3281328 
PHILIPSWEG 1                      SE DECISION MADE: 11-MAR-16
MAASTRICHT  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOCATOR F-Tx Attachment System
ZEST ANCHORS, LLC                 510(k) NO: K151789(Traditional)
ATTN: ANNIE  WRIGHT               PHONE NO : 1 760 7437744 140
2061 WINERIDGE PLACE              SE DECISION MADE: 04-MAR-16
ESCONDIDO CA  92029               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
PHADIA AB                         510(k) NO: K151799(Traditional)
ATTN: CARINA  MAGNUSSON           PHONE NO : 46 18 165000 
RAPSGATAN 7P                      SE DECISION MADE: 25-MAR-16
UPPSALA  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVATECH TALCAIR
NOVATECH S.A.                     510(k) NO: K151832(Traditional)
ATTN: JENNIFER  NEFF              PHONE NO : 33 0 422981563 
Z.I. ATHELIA III - 1058, VOIE ANTISE DECISION MADE: 31-MAR-16
LA CIOTAT CEDEX  FR 13705         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
COOPERSURGICAL, INC.              510(k) NO: K151845(Traditional)
ATTN: ROAIDA  JOHNSON             PHONE NO : 203 6015200 
95 CORPORATE DR.                  SE DECISION MADE: 18-MAR-16
TRUMBULL CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
SMART PERFORMER CORP. LTD.        510(k) NO: K151847(Traditional)
ATTN: JEFFERSION  SHEN            PHONE NO : 886 2 22999699 
NO.13-1, WUQUAN 1ST RD., XINZHUANGSE DECISION MADE: 04-MAR-16
NEW TAIPEI CITY  TW 242           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-Fix Line Additions
VILEX IN TENNESSEE, INC           510(k) NO: K151881(Traditional)
ATTN: SYLVIA  SOUTHARD            PHONE NO : 931 4747550 
111 MOFFITT STREET                SE DECISION MADE: 24-MAR-16
MCMINNVILLE TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3400E series; E5400 series; E6400 series; Sundazzler series
HEARTLAND TANNING, INC.           510(k) NO: K151905(Traditional)
ATTN: Jon  Marcum                 PHONE NO : 816 7951414 
4251 NE Port Dr.                  SE DECISION MADE: 01-MAR-16
Lees Summit MO  64064             510(k) STATEMENT
                                                    

DEVICE: VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
BIOMERIEUX, INC.                  510(k) NO: K151923(Traditional)
ATTN: Cherece L Jones             PHONE NO : 314 7318684 
595 Anglum Road                   SE DECISION MADE: 25-MAR-16
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing 
STRYKER CORPORATION               510(k) NO: K151932(Traditional)
ATTN: SOMI  EKWEALOR              PHONE NO : 408 7542356 
5900 OPTICAL CT                   SE DECISION MADE: 31-MAR-16
SAN JOSE CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thora-3Di, Model T-01
PneumaCare LIMITED                510(k) NO: K151940(Traditional)
ATTN: MARK   HARWOOD              PHONE NO : 44 01223 703151 
ST. JOHNS INNOVATION CENTRE, COWLESE DECISION MADE: 10-MAR-16
CAMBRIDGE  GB CB4 0WS             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vas-Q-Clip
NANOVA BIOMATERIALS INC           510(k) NO: K151943(Traditional)
ATTN: ANDREW  RITTS               PHONE NO : 573 8233114 
3806 MOJAVE CT                    SE DECISION MADE: 25-MAR-16
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentti System
Martz, Inc                        510(k) NO: K151965(Traditional)
ATTN: Andrew  Martz               PHONE NO : 661 3048575 
8421 Blue Heron Drive             SE DECISION MADE: 11-MAR-16
Bakersfield CA  93312             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thommen Milling Abutment for CAD/CAM
THOMMEN MEDICAL AG                510(k) NO: K151984(Traditional)
ATTN: DANIEL  SNETIVY             PHONE NO : 41 61 9659020 
NECKARSULMSTRASSE 28              SE DECISION MADE: 10-MAR-16
GRENCHEN  CH 2540                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
HARTALEGA NGC SDN BHD             510(k) NO: K151997(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 60 362 771733 
NO. 1, PERSIARAN TANJUNG, LOT PT43SE DECISION MADE: 31-MAR-16
SEPANG  MY 64000                  510(k) STATEMENT
                                                    

DEVICE: Pure Tilt
Proactive Comfort, LLC            510(k) NO: K152021(Traditional)
ATTN: Tracy  Augustine            PHONE NO : 703 9957104 
3901 Centerview Drive, Suite L    SE DECISION MADE: 31-MAR-16
Chantilly VA  20151               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pencylcap 
B. BRAUN MELSUNGEN AG             510(k) NO: K152050(Traditional)
ATTN: HANS-ULRICH  GAUDIN         PHONE NO : 49 5661 713712 
CARL-BRAUN STRASSE 1              SE DECISION MADE: 02-MAR-16
MELSUNGEN  DE 34212               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearMet
Mycone Dental Supply Co., t/a Keys510(k) NO: K152051(Traditional)
ATTN: Tracey  Schwear             PHONE NO : 717 3763030 
t/a Keystone Industries, Mizzy & DSE DECISION MADE: 22-MAR-16
Myerstown PA  17067               510(k) STATEMENT
                                                    

DEVICE: IMMULITE 2000 TSI Assay,  IMMULITE 2000 TSI Calibration Verification Material
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K152061(Traditional)
ATTN: SUSAN  BROCCHI              PHONE NO : 914 5242525 
511 BENEDICT AVENUE               SE DECISION MADE: 03-MAR-16
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Steerable Introducer
STERILMED, INC.                   510(k) NO: K152090(Traditional)
ATTN: Patricia   Kaufman          PHONE NO : 763 4883211 
5010 Cheshire Parkway N, Suite 2  SE DECISION MADE: 23-MAR-16
Plymouth  MN  55446               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelZygoma 45°
NOBEL BIOCARE AB                  510(k) NO: K152093(Traditional)
ATTN: JI EUN HWANG                PHONE NO : 714 7824800 5030
BOX 5190, SE-402 26, VASTRA HAMNGASE DECISION MADE: 16-MAR-16
GOTEBORG  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set 
ROCKET MEDICAL PLC                510(k) NO: K152105(Traditional)
ATTN: TRACY   CHARLTON            PHONE NO : 0044 191 4194488 222
2-4 SEDLING RD, WEAR INDUSTRIAL ESSE DECISION MADE: 29-MAR-16
WASHINGTON   GB NE38 9BZ          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimQ Peripheral Nerve Stimulator (PNS) System
STIMQ LLC                         510(k) NO: K152178(Traditional)
ATTN: ELIZABETH  GREENE           PHONE NO : 786 4757228 
901 EAST LAS OLAS BOULEVARD, SUITESE DECISION MADE: 11-MAR-16
FORT LAURDERDALE FL  33301        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RejuvatoneMD
TROPHY SKIN, INC.                 510(k) NO: K152199(Traditional)
ATTN: IMRAN  KARIM                PHONE NO : 469 2331768 
4372 KENMARE TRAIL                SE DECISION MADE: 23-MAR-16
FRISCO TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgTech Interbody System
SURGTECH INC                      510(k) NO: K152200(Traditional)
ATTN: XUEGONG  YU                 PHONE NO : 216 4212613 
24600 CENTER RIDGE ROAD, SUITE 195SE DECISION MADE: 25-MAR-16
WESTLAKE OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiPure XD Reconstructive Tissue Matrix
TISSUE REGENIX GROUP PLC          510(k) NO: K152206(Traditional)
ATTN: MIKE  IZON                  PHONE NO : 011 440 7590048062 
THE BIOCENTRE, INNOVATION WAY, HESSE DECISION MADE: 08-MAR-16
YORK  GB YO20 5NY                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Vantage Total Ankle System
EXACTECH INC                      510(k) NO: K152217(Traditional)
ATTN: SHING  JEN TAI              PHONE NO : 352 3274368 
2320 NW 66TH COURT                SE DECISION MADE: 10-MAR-16
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
SUN CAPSULE, INC.                 510(k) NO: K152238(Traditional)
ATTN: THOMAS  P.  HOLLAND         PHONE NO : 800 2728267 200
1600 OSGOOD STREET, SUITE 2006 NORSE DECISION MADE: 04-MAR-16
ANDOVER MA  01845                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Corsair Armet
ASAHI INTECC CO., LTD.            510(k) NO: K152249(Traditional)
ATTN: YOSHIHIKO  FUKUI            PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 04-MAR-16
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Microfixation RibFix Blu Thoracic Fixation System
BIOMET MICROFIXATION              510(k) NO: K152253(Traditional)
ATTN: LAUREN  JASPER              PHONE NO : 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 24-MAR-16
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T3 Software
ETIOMETRY, INC.                   510(k) NO: K152258(Traditional)
ATTN: DIMITAR  BARONOV            PHONE NO : 857 3669333 
119 BRAINTREE STREET SUITE 210    SE DECISION MADE: 31-MAR-16
BOSTON MA  02134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ventix Knotless Anchors
BIOMET MANUFACTURING CORP.        510(k) NO: K152262(Traditional)
ATTN: JARED  COOPER               PHONE NO : 574 3721941 
56 EAST BELL DR.                  SE DECISION MADE: 08-MAR-16
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MSCB-001
GC AMERICA INC.                   510(k) NO: K152274(Traditional)
ATTN: MARK  HEISS                 PHONE NO : 708 9263090 
3737 W. 127TH STREET              SE DECISION MADE: 25-MAR-16
ALSIP IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPhotas Celluma3
BIOPHOTAS, INC                    510(k) NO: K152280(Traditional)
ATTN: PATRICK  JOHNSON            PHONE NO : 714 8381956 
250 EL CAMINO REAL, #110          SE DECISION MADE: 02-MAR-16
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sungshim Insulin Pen Needle
SUNGSHIM MEDICARE CO., LTD.       510(k) NO: K152334(Traditional)
ATTN: KIM YOUNG KWAN              PHONE NO : 82 32 6767066 
190, MAESIL-RO, SOJEONG-MYEON     SE DECISION MADE: 17-MAR-16
SEJONG-SI  KR 30002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cryoFORM cryoICE cryoablation probe
ATRICURE, INC                     510(k) NO: K152337(Third Party - Traditional)
ATTN: JONATHAN  MCELWEE           PHONE NO : 513 7554100 
6217 CENTRE PARK DR               SE DECISION MADE: 22-MAR-16
WEST CHESTER OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Rapicide PA High-Level Disinfectant Test Strips 
MEDIVATORS INC.                   510(k) NO: K152394(Traditional)
ATTN: MEGAN  DICKEY               PHONE NO : 763 5533300 
14605 28TH AVE NORTH              SE DECISION MADE: 11-MAR-16
MINNEAPOLIS MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
SECURUS,INC                       510(k) NO: K152402(Traditional)
ATTN: William J Gorman            PHONE NO : 978 3170836 
100 Cummings Center Suite 215F    SE DECISION MADE: 04-MAR-16
Beverly MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IS4000 Stapler 30 Instrument and Stapler 30 Reloads
INTUITIVE SURGICAL, INC.          510(k) NO: K152421(Traditional)
ATTN: MANISH  PATEL               PHONE NO : 408 5232185 
1266 KIFER ROAD                   SE DECISION MADE: 04-MAR-16
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SensiCare PI Surgical Gloves
MEDLINE INDUSTRIES, INC.          510(k) NO: K152428(Traditional)
ATTN: JENNIFER  MASON             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 31-MAR-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Single-Site Instrument and Accessories
INTUITIVE SURGICAL, INC.          510(k) NO: K152448(Traditional)
ATTN: Melissa  Gonzalez           PHONE NO : 408 5232100 
1266 KIFER ROAD                   SE DECISION MADE: 09-MAR-16
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Great Basin Staph ID/R Blood Culture Panel
GREAT BASIN SCIENTIFIC, INC.      510(k) NO: K152470(Traditional)
ATTN: Chuck  Owen                 PHONE NO : 801 9901055 
2441 S. 3850 West                 SE DECISION MADE: 25-MAR-16
Salt Lake City UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revitive Medic; Revitive MV; Revitive LV
Actegy, Ltd.                      510(k) NO: K152480(Traditional)
ATTN: Angela  Glover              PHONE NO : 44 013 44636940 
Reflex, Cain Road                 SE DECISION MADE: 31-MAR-16
Bracknell  GB RG12 1HL            510(k) STATEMENT
                                                    

DEVICE: Propeller Sensor Model 2014-R
RECIPROCAL LABS                   510(k) NO: K152482(Traditional)
ATTN: DAVID  HUBANKS              PHONE NO : 608 2510470 
634 W. MAIN STREET, SUITE 102     SE DECISION MADE: 04-MAR-16
MADISON WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves, Powder Free, (White)
SHANDONG FEIYANG PROFESSIONAL GLOV510(k) NO: K152517(Traditional)
ATTN: KEN  LU                     PHONE NO : 86 13 355336830 
338 HUAQING DRIVE, QIXIN CHEMICAL SE DECISION MADE: 18-MAR-16
QINZHOU  CN 255400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UCP Stem
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K152530(Traditional)
ATTN: KAREN  HO                   PHONE NO : 886 3 5773351 2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 14-MAR-16
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DNAP Electrode
Ad-Tech Medical Instrument Corpora510(k) NO: K152547(Traditional)
ATTN: Lisa  Theama                PHONE NO : 262 6341555 
1901 William Street               SE DECISION MADE: 04-MAR-16
Racine WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leksell Stereotactic System, Injection/ Aspiration Needle Kit
ELEKTA INSTRUMENT AB              510(k) NO: K152558(Special)
ATTN: EMMA  WIDMARK               PHONE NO : 46 8 58725400 
KUNGSTENSGATAN 18, P.O. BOX 7593  SE DECISION MADE: 02-MAR-16
STOCKHOLM  SE SE-103 93           510(k) STATEMENT
                                                    

DEVICE: da Vinci Surgical System, Model IS4000
INTUITIVE SURGICAL, INC.          510(k) NO: K152578(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 KIFER ROAD                   SE DECISION MADE: 30-MAR-16
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endo Keeper
NELIS                             510(k) NO: K152598(Traditional)
ATTN: SEO  OU NAM                 PHONE NO : 82 32 6241697 
1005,201-DOUG BUCHEON TECHNO PARL SE DECISION MADE: 17-MAR-16
BUCHEON  KR 421-742               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olea Sphere V3.0
OLEA MEDICAL                      510(k) NO: K152602(Traditional)
ATTN: CAROLINE  LENE              PHONE NO : 011 334 42712420 
93 AVENUE DES SORBIERS, ZONE ATHELSE DECISION MADE: 03-MAR-16
LA CIOTAT  FR 13600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Carba-R
CEPHEID                           510(k) NO: K152614(Traditional)
ATTN: SCOTT A. CAMPBELL           PHONE NO : 847 2283299 
904 CARIBBEAN DRIVE               SE DECISION MADE: 07-MAR-16
SUNNYVALE CA  94089-1189          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MMS Guide Catheter
MicroMedical Solutions, Inc.      510(k) NO: K152625(Traditional)
ATTN: Gregory  Mathison           PHONE NO : 218 3871559 
790 Willard Street #209           SE DECISION MADE: 09-MAR-16
Quincy MA  02169                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPO Total Knee Systems MR Labeling
MICROPORT ORTHOPEDICS, INC.       510(k) NO: K152631(Traditional)
ATTN: USMAN  RASHID               PHONE NO : 901 2905274 
5677 AIRLINE ROAD                 SE DECISION MADE: 23-MAR-16
ARLINGTON TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
FUDAKANG INDUSTRIES CO., LTD      510(k) NO: K152640(Special)
ATTN: BOB  YU                     PHONE NO : 86 769 81098181 
NO.8 YINGHE ROAD, YUANJIANGYUAN  MSE DECISION MADE: 28-MAR-16
DONGGUAN  CN 523560               510(k) STATEMENT
                                                    

DEVICE: SYLK PERSONAL LUBRICANT
TORO MANAGEMENT LLC DBA SYLK      510(k) NO: K152646(Traditional)
ATTN: MARIESSA  MAHFOUZ           PHONE NO : 480 2075270 
7272 EAST INDIAN SCHOOL ROAD SUITESE DECISION MADE: 11-MAR-16
SCOTTSDALE AZ  85251              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S-Wire
Spinal Resources Inc              510(k) NO: K152662(Traditional)
ATTN: Bernard  Bedor              PHONE NO : 904 5409049 
274 E Eau Gallie Blvd Unit 303    SE DECISION MADE: 09-MAR-16
Indian Harbour Beach FL  32937    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse Implant System(R)
SI-BONE, INC.                     510(k) NO: K152681(Traditional)
ATTN: ROXANNE  DUBOIS             PHONE NO : 408 2070700 2236
3055 OLIN AVENUE, SUITE 2200      SE DECISION MADE: 01-MAR-16
SAN JOSE CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONQUEST FN
Smith & Nephew                    510(k) NO: K152686(Traditional)
ATTN: Bradley  Heil               PHONE NO : 901 3996339 
1450 E. Brooks Rd.                SE DECISION MADE: 17-MAR-16
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apollo System
PENUMBRA, INC.                    510(k) NO: K152699(Traditional)
ATTN: MARY  ROSE                  PHONE NO : 510 7483346 
ONE PENUMBRA PLACE                SE DECISION MADE: 17-MAR-16
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
Jiayuan Medical Products Co., Ltd 510(k) NO: K152705(Traditional)
ATTN: Wang  Lihong                PHONE NO : 86 315 4160678 
Xihuan Road, Luannan County       SE DECISION MADE: 17-MAR-16
Tangshan  CN 063500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
MINGHAO MEDICAL PRODUCTS CO.,LTD. 510(k) NO: K152707(Traditional)
ATTN: PANG  CUIRU                 PHONE NO : 86 315 8230716 
WEST INDUSTRIAL PARK, LUANNAN COUNSE DECISION MADE: 17-MAR-16
TANGSHAN  CN 063500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Patient Examination Gloves, Blue Color
Zhonghong Pulin Medical Products C510(k) NO: K152712(Traditional)
ATTN: LI  Jinge                   PHONE NO : 86 315 4165760 
Pachigang Industrial Park, LuannanSE DECISION MADE: 09-MAR-16
Tangshan  CN 063502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV Insite System
PSP Corporation                   510(k) NO: K152716(Traditional)
ATTN: Kenji  Ishida               PHONE NO : 03 5485 1028 
Nishi-azabu 28 Moribldg. Nishi-azaSE DECISION MADE: 24-MAR-16
Minato-ku Tokyo  JP 106-0031      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves
XINFU MEDICAL PRODUCTS CO., LTD.  510(k) NO: K152719(Traditional)
ATTN: XIE  WENXING                PHONE NO : 86 315 4431166 
EAST OF LIPINGTUO, LUANNAN COUNTY SE DECISION MADE: 01-MAR-16
TANGSHAN CITY  CN 063502          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
XINGDA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K152720(Traditional)
ATTN: ZHANG  LIXIA                PHONE NO : 86 315 4160290 
SOUTH OF SHENGZHUANG VILLAGE, LUANSE DECISION MADE: 10-MAR-16
TANGSHAN  CN 063502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Braun Thermoscan PRO 6000 Ear Thermometer
KAZ USA, INC (A SUBSIDIARY OF HELE510(k) NO: K152748(Traditional)
ATTN: RAJ  KASBEKAR               PHONE NO : 508 4907280 
250 TURNPIKE ROAD                 SE DECISION MADE: 01-MAR-16
SOUTHBOROUGH MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CharmFlex 
DENTKIST, INC                     510(k) NO: K152766(Traditional)
ATTN: SHIN HEANG LEE              PHONE NO : 82 31 4582822 
(DANGJEONG-DONG) 3, NONGSIM-RO    SE DECISION MADE: 08-MAR-16
GUNPO-SI  KR 15842                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U&U Insulin Syringe with/without Safety Retractable Device
U&U Medical Technology Co., Ltd   510(k) NO: K152808(Traditional)
ATTN: Black  Wang                 PHONE NO : 0086 139 02471751 
Dongzhou Village, Hengshanqiao    SE DECISION MADE: 25-MAR-16
Changzhou  CN 213119              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Giraffe OmniBed Carestation CS1
Ohmeda Medical, a Division of Date510(k) NO: K152814(Special)
ATTN: Kenny M Bello               PHONE NO : 410 8885393 
8880 Gorman Rooad                 SE DECISION MADE: 17-MAR-16
Laurel MD  20723                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mailuokang Self-adhesive Electrode
SHENZHEN MAILUOKANG TECHNOLOGY CO.510(k) NO: K152815(Traditional)
ATTN: HU  PANDENG                 PHONE NO : 86 755 85258460 
RM 602, 6/F, BUILDING B, NANCHANG SE DECISION MADE: 08-MAR-16
SHENZHEN  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDT PEN NEEDLE
SHANDONG CAREMED MEDICAL PRODUCTS 510(k) NO: K152824(Traditional)
ATTN: LIN  YANYAN                 PHONE NO : 86 530 7397700 
(YANTAI) INDUSTRIAL PARK DING TAO SE DECISION MADE: 07-MAR-16
HEZE  CN 274100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
TECO DIAGNOSTICS, INC.            510(k) NO: K152835(Traditional)
ATTN: YUNYUAN VIVIAN WANG         PHONE NO : 714 4631111 
1268 N. LAKEVIEW AVE.             SE DECISION MADE: 07-MAR-16
ANAHEIM CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allied Biocompat Abutment for Nobel Replace Interface
ALLIED DENTAL SOLUTIONS           510(k) NO: K152845(Traditional)
ATTN: Peter  Zhou                 PHONE NO : 909 5988036 
1170 CENTRE DR #1                 SE DECISION MADE: 14-MAR-16
CITY OF INDUSTRY CA  91789        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquasil Ultra + Smart Wetting Impression Material
DENTPLY INTERNATIONAL INC.        510(k) NO: K152861(Special)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA STREET, SUITSE DECISION MADE: 04-MAR-16
YORK PA  17405                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Propeller System
RECIPROCAL LABS                   510(k) NO: K152882(Traditional)
ATTN: DAVID  HUBANKS              PHONE NO : 1 608 2510470 
634 W. MAIN STREET, SUITE 102     SE DECISION MADE: 08-MAR-16
MADISON WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K152897(Traditional)
ATTN: JENNIFER  SIEGEL            PHONE NO : 1 609 2750500 
311 ENTERPRISE DRIVE              SE DECISION MADE: 04-MAR-16
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI Skirted Heads
OMNILIFE SCIENCE INC.             510(k) NO: K152919(Traditional)
ATTN: Vani  Sindwani              PHONE NO : 508 8242444 
50 O'CONNELL WAY SUITE 10         SE DECISION MADE: 10-MAR-16
EAST TAUNTON MA  02718            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesalius
TELEA ELECTRONIC ENGINEERING SRL  510(k) NO: K152933(Special)
ATTN: Simona  Daidone             PHONE NO : 39 0444 239519 
VIA LEONARDO DA VINCI 13          SE DECISION MADE: 23-MAR-16
SANDRIGO  IT 36066                510(k) STATEMENT
                                                    

DEVICE: LiDCOunity Monitor
LIDCO LTD                         510(k) NO: K152935(Traditional)
ATTN: ERIC  MILLS                 PHONE NO : 44 20 77491500 
16 ORSMAN ROAD                    SE DECISION MADE: 17-MAR-16
LONDON  GB N1 5QJ                 510(k) STATEMENT
                                                    

DEVICE: DBB-06 Hemodialysis Delivery System 
NIKKISO, CO.,LTD.                 510(k) NO: K152938(Traditional)
ATTN: SEIYA  RAIJYU               PHONE NO : 81 3 34433754 
20-3, EBISU 4-CHOME               SE DECISION MADE: 18-MAR-16
SHIBUYA-KU  JP 150-6022           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Great Basin Shiga Toxin Direct Test
GREAT BASIN SCIENTIFIC, INC.      510(k) NO: K152955(Traditional)
ATTN: Chuck   Owen                PHONE NO : 801 9901055 
2441 S. 3850 West                 SE DECISION MADE: 22-MAR-16
Salt Lake City UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiCross Catheter
ROXWOOD MEDICAL, INC.             510(k) NO: K152957(Special)
ATTN: Grace  Li                   PHONE NO : 650 7794559 
400 SEAPORT CT, SUITE #103        SE DECISION MADE: 04-MAR-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
CONMED CORPORATION                510(k) NO: K152969(Traditional)
ATTN: DIONNE  SANDERS             PHONE NO : 727 3995564 
525 FRENCH ROAD                   SE DECISION MADE: 31-MAR-16
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VDT985US Vicks SmartTemp Thermometer
Kaz USA, Inc., a Helen of Troy Com510(k) NO: K152975(Traditional)
ATTN: Raj  Kasbekar               PHONE NO : 508 4907280 
250 Turnpike Road                 SE DECISION MADE: 23-MAR-16
Southborough MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeRoyal Angiography Kits
DEROYAL INDUSTRIES, INC.          510(k) NO: K152978(Traditional)
ATTN: Elizabeth  Wheeler          PHONE NO : 865 3622333 
200 DEBUSK LANE                   SE DECISION MADE: 25-MAR-16
POWELL TN  37849                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorPath 200 System
CORINDUS, INC.                    510(k) NO: K152999(Traditional)
ATTN: Tal  Wenderow               PHONE NO : 508 6533335 
309 Waverley Oaks Road Suite 105  SE DECISION MADE: 18-MAR-16
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
BIO ROTECH, INC.                  510(k) NO: K153019(Traditional)
ATTN: DANIEL  WOO                 PHONE NO : 82 33 7357720 
DONGHWA MEDICAL INSTRUMENT COMPLEXSE DECISION MADE: 21-MAR-16
WONJU-SI  KR 220-801              510(k) STATEMENT
                                                    

DEVICE: Cryotop US
KITAZATO BIOPHARMA CO., LTD.      510(k) NO: K153027(Traditional)
ATTN: FUTOSHI  INOUE              PHONE NO : 81 545 662202 
81 Nakajima                       SE DECISION MADE: 14-MAR-16
FUJI  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K153041(Traditional)
ATTN: Timothy  Connors            PHONE NO : 609 9365531 
311 Enterprise Drive              SE DECISION MADE: 14-MAR-16
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRYPTIK2C-plate Anterior Cervical Plate System
SPINEART                          510(k) NO: K153042(Traditional)
ATTN: Franck  PENNESI             PHONE NO : 41 225 701246 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 28-MAR-16
GENEVA  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentimag System, Sentimark Magnetic Marker Systerm 
ENDOMAGNETICS LTD.                510(k) NO: K153044(Traditional)
ATTN: ANDREW  SHAWCROSS           PHONE NO : 44 0 1223652540 
THE JEFFREYS BUILDING, COWLEY ROADSE DECISION MADE: 02-MAR-16
CAMBRIDGE  GB CB4 OWS             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axeo 3 Patient Monitor
AXEO MEDICAL TECHNOLOGIES, LLC    510(k) NO: K153079(Traditional)
ATTN: Stamatios  Parimeros        PHONE NO : 727 7872936 
971 VIRGINIA AVENUE SUITE A       SE DECISION MADE: 17-MAR-16
PALM HARBOR FL  34683             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Diagnostic Ultrasound Catheter
INNOVATIVE HEALTH, LLC            510(k) NO: K153090(Traditional)
ATTN: RAFAL  CHUDZIK              PHONE NO : 480 5256006 
1435 NORTH HAYDEN ROAD, SUITE 100 SE DECISION MADE: 10-MAR-16
SCOTTSDALE AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, 
SUMMIT INDUSTRIES LLC             510(k) NO: K153119(Traditional)
ATTN: Tom  Boon                   PHONE NO : 773 3534024 
2901 W LAWRENCE AVE               SE DECISION MADE: 14-MAR-16
Chicago IL  60625                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Ear Thermometer
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K153146(Traditional)
ATTN: REN  YUNHUA                 PHONE NO : 86 571 81957767 
BUILDING 2, NO. 202, ZHENZHONG ROASE DECISION MADE: 31-MAR-16
HANGZHOU  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Electrophysiology Catheter
INNOVATIVE HEALTH, LLC            510(k) NO: K153153(Traditional)
ATTN: RAFAL  CHUDZIK              PHONE NO : 480 5256006 
1435 NORTH HAYDEN ROAD, SUITE 100 SE DECISION MADE: 14-MAR-16
SCOTTSDALE AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVIVO Mobile Patient Management (MPM) System
MEDTRONIC, INC.                   510(k) NO: K153160(Special)
ATTN: CHERYL L. SWANSON           PHONE NO : 763 5140088 
8200 CORAL SEA STREET NE          SE DECISION MADE: 30-MAR-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iMESH Tacker
THD LAP                           510(k) NO: K153202(Special)
ATTN: Einat   Duvdevany           PHONE NO : 972 52 6717051 
1 NIRIM ST.                       SE DECISION MADE: 24-MAR-16
TEL AVIV  IL 6706036              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K153206(Traditional)
ATTN: Shraddha   More             PHONE NO : 973 6862627 522627
10 HIGH POINT DRIVE               SE DECISION MADE: 03-MAR-16
WAYNE NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sheathes Ultrasound Probe Covers
Sheathing Technologies, Inc.      510(k) NO: K153212(Traditional)
ATTN: JENNIFER   DOWNING          PHONE NO : 408 7822720 12
18431 TECHNOLOGY DRIVE            SE DECISION MADE: 04-MAR-16
MORGAN HILL CA  95037             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
ZOLL CIRCULATION, INC.            510(k) NO: K153226(Traditional)
ATTN: SAM  NANAVATI               PHONE NO : 408 4192950 
2000 RINGWOOD AVE.                SE DECISION MADE: 24-MAR-16
SAN JOSE CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthAlign Plus System
OrthAlign, Inc.                   510(k) NO: K153237(Traditional)
ATTN: David  Vancelette           PHONE NO : 949 7152424 
120 Columbia, Suite 500           SE DECISION MADE: 01-MAR-16
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dignity Dual Port
Medcomp ( Medical Components)     510(k) NO: K153238(Traditional)
ATTN: Beth Ann Giammaruti         PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 15-MAR-16
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Fusion
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153244(Traditional)
ATTN: DARREN A. DORMAN            PHONE NO : 610 4486483 
40 LIBERTY BOULEVARD 65-1A        SE DECISION MADE: 07-MAR-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Baha 5 Super Power Sound Processor
COCHLEAR AMERICAS                 510(k) NO: K153245(Traditional)
ATTN: TRISTAN  MANUS              PHONE NO : 303 7909010 
13059 E. PEAKVIEW AVE             SE DECISION MADE: 02-MAR-16
CENTENNIAL CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEEK Customized Cranial Implant
STRYKER                           510(k) NO: K153248(Traditional)
ATTN: Jonathan  Schell            PHONE NO : 269 3895596 
750 TRADE CENTRE WAY SUITE 200    SE DECISION MADE: 10-MAR-16
PORTAGE MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
RENOVIS SURGICAL TECHNOLOGIES     510(k) NO: K153250(Traditional)
ATTN: ANTHONY  DEBENEDICTIS       PHONE NO : 909 5572360 
1901 W. LUGONIA                   SE DECISION MADE: 16-MAR-16
REDLANDS CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC Reline II
GC AMERICA, INC.                  510(k) NO: K153253(Traditional)
ATTN: MARK  HEISS                 PHONE NO : 708 9263090 
3737 W. 127TH ST.                 SE DECISION MADE: 03-MAR-16
ALSIP IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruGuard Custom Tongue and Jaw Positioner 
BIONIX DEVELOPMENT CORP.          510(k) NO: K153270(Traditional)
ATTN: JAMES  HUTTNER              PHONE NO : 419 7278421 
5154 ENTERPRISE BLVD.             SE DECISION MADE: 08-MAR-16
TOLEDO OH  43612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrightMatter Guide with Surface Trace Registration
SYNAPTIVE MEDICAL INC.            510(k) NO: K153281(Traditional)
ATTN: Cameron  Piron              PHONE NO : 416 6736679 
MARS CENTER, SOUTH TOWER, 101 COLLSE DECISION MADE: 30-MAR-16
TORONTO  CA M5G1L7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synaptive ImageDrive Pro
SYNAPTIVE MEDICAL INC.            510(k) NO: K153284(Traditional)
ATTN: Cameron   Piron             PHONE NO : 41 667 36679 
MARS CENTER, SOUTH TOWER, 101 COLLSE DECISION MADE: 29-MAR-16
TORONTO  CA M5G1L7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SICAT OPTISLEEP
SICAT GMBH & CO. KG               510(k) NO: K153291(Abbreviated)
ATTN: MANFRED  BREUER             PHONE NO : 49 228 85469782 
BRUNNENALLEE 6                    SE DECISION MADE: 31-MAR-16
BONN  DE 53177                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tenex Health TX System
TENEX HEALTH, INC.                510(k) NO: K153299(Traditional)
ATTN: GLORIA   PENDERGRASS        PHONE NO : 949 4547500 
26902 VISTA TERRACE               SE DECISION MADE: 03-MAR-16
LAKE FOREST CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia 1.5T and Ingenia 1.5T S R5.2
PHILIPS MEDICAL SYSTEMS, NEDERLAND510(k) NO: K153324(Abbreviated)
ATTN: Henrie   Daniels            PHONE NO : 31 402 762192 
VEENPLUIS 4-6                     SE DECISION MADE: 22-MAR-16
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erisma-LP Spinal Fixation System
CLARIANCE, SAS                    510(k) NO: K153326(Special)
ATTN: PASCAL  ROKEGEM             PHONE NO : 33 321 161215 
18, rue Robespierre               SE DECISION MADE: 08-MAR-16
BEAURAINS  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlertWatch: OR
ALERTWATCH LLC                    510(k) NO: K153335(Traditional)
ATTN: Justin   Adams              PHONE NO : 734 9988344 
1600 HURON PARKWAY, BLDG. 520, STESE DECISION MADE: 15-MAR-16
ANN ARBOR MI  48109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corvocet Biopsy System
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K153337(Traditional)
ATTN: Ileana   Davis              PHONE NO : 801 2084187 
1600 WEST MERIT PARKWAY           SE DECISION MADE: 25-MAR-16
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software VD11
Siemens Medical Solutions USA, Inc510(k) NO: K153346(Traditional)
ATTN: Patricia D Jones            PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 04-MAR-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ LOCK
Implanet, S.A.                    510(k) NO: K153348(Traditional)
ATTN: Regis  Le Couedic           PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu AlSE DECISION MADE: 31-MAR-16
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xeleris 4.0 Processing and Review Workstation
GE HEALTHCARE                     510(k) NO: K153355(Traditional)
ATTN: EFRAT  HARTOG-DAVID         PHONE NO : 972 4 8563666 
4 HAYOZMA STREET                  SE DECISION MADE: 16-MAR-16
TIRAT HACARMEL  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonicision Cordless Ultrasonic Dissection Device
COVIDIEN LLC                      510(k) NO: K153371(Traditional)
ATTN: NANCY  SAUER                PHONE NO : 1 303 5816791 
5920 LONGBOW DRIVE                SE DECISION MADE: 28-MAR-16
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
IN LIGHT WELLNESS SYSTEMS, INC.   510(k) NO: K153389(Traditional)
ATTN: JANE  MELONE                PHONE NO : 1 505 4047130 
5601 MIDWAY PARK PLACE NE         SE DECISION MADE: 30-MAR-16
ALBUQUERQUE NM  87109             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERIZONE  VP4  Sterilizer
TS03 INC                          510(k) NO: K153392(Traditional)
ATTN: Nathalie  Racette           PHONE NO : 418 6510003 294
2505, AVENUE DALTON               SE DECISION MADE: 24-MAR-16
QUEBEC  CA G1P 3S5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProLift Expandable System
LIFE SPINE, INC.                  510(k) NO: K153400(Traditional)
ATTN: RANDY   LEWIS               PHONE NO : 847 8846117 
13951 S QUALITY DRIVE             SE DECISION MADE: 07-MAR-16
HUNTLEY IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sleep Profiler
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K153412(Traditional)
ATTN: DANIEL J. LEVENDOWSKI       PHONE NO : 760 7200099 6040
2237 FARADAY AVENUE SUITE 100     SE DECISION MADE: 14-MAR-16
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartView 3D Option
GE HANGWEI MEDICAL SYSTEM CO., LTD510(k) NO: K153429(Traditional)
ATTN: LV  RUI                     PHONE NO : 86 10 58068888 71063
NO.1, YONG CHANG STREET,  BEIJING SE DECISION MADE: 09-MAR-16
BEIJING  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
COOK INCORPORATED                 510(k) NO: K153430(Special)
ATTN: SARAH  REEVES               PHONE NO : 812 3353575 105024
750 DANIELS WAY, P.O. BOX 489     SE DECISION MADE: 07-MAR-16
BLOOMINGTON IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERIMETER C (Titanium) Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K153438(Special)
ATTN: MICHAEL  SCOTT              PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 02-MAR-16
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VibraPEP
Medica Holdings, LLC              510(k) NO: K153441(Traditional)
ATTN: George  Reed                PHONE NO : 503 2235360 
5200 Meadows Road, Suite 150      SE DECISION MADE: 25-MAR-16
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Spectra
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153447(Special)
ATTN: CORDELL L. FIELDS           PHONE NO : 610 4486469 
65 VALLEY STREAM PARKWAY          SE DECISION MADE: 31-MAR-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Passport Series Patient Monitors (Including Passport 8, Passport 12)
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K153448(Traditional)
ATTN: BAI  YANHONG                PHONE NO : 86 755 81888998 
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 03-MAR-16
NANSHAN  CN 518057                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
AVINGER, INC.                     510(k) NO: K153460(Traditional)
ATTN: Patty   Hevey               PHONE NO : 650 2417900 
400 CHESAPEAKE DRIVE              SE DECISION MADE: 01-MAR-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
Assure Tech (Hangzhou) Co., Ltd.  510(k) NO: K153465(Traditional)
ATTN: Shisheng  Ling              PHONE NO : 86 571 88868960 
No. 10, Xiyuansan Rd., Westlake EcSE DECISION MADE: 31-MAR-16
Hangzhou  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENROUTE Transcarotid Neuroprotection System
SILK ROAD MEDICAL, INC.           510(k) NO: K153485(Traditional)
ATTN: KRISTIN  ELLIS              PHONE NO : 408 7209002 
735 NORTH PASTORIA AVENUE         SE DECISION MADE: 10-MAR-16
SUNNYVALE CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
LDR Spine USA                     510(k) NO: K153495(Traditional)
ATTN: Brad  Strasser              PHONE NO : 512 3443333 
13785 Research Boulevard, Suite 20SE DECISION MADE: 31-MAR-16
Austin TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Polychloroprene Examination Glove Green
TERANG NUSA SDN BHD               510(k) NO: K153510(Traditional)
ATTN: ROBERT   HILL               PHONE NO : 006 09 7747171 
1 JALAN 8, PENGKALAN CHEPA 2 INDUSSE DECISION MADE: 21-MAR-16
KOTA BHARU   MY 16100             510(k) STATEMENT
                                                    

DEVICE: Insufflator 50L FM134
W.O.M WORLD OF MEDICINE GMBH      510(k) NO: K153513(Traditional)
ATTN: Soeren  Markworth           PHONE NO : 11 49 3039981594 
SALZUFER 8                        SE DECISION MADE: 04-MAR-16
BERLIN  DE 10587                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DReal
CAREVATURE MEDICAL LTD            510(k) NO: K153519(Traditional)
ATTN: Orly   Maor                 PHONE NO : 972 8 6757073 
42 Tvuot Haarets St.              SE DECISION MADE: 16-MAR-16
Tel Aviv  IL 6954648              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
SYNERON CANDELA CORPORATION       510(k) NO: K153527(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 508 3587400 330
530 BOSTON POST ROAD              SE DECISION MADE: 02-MAR-16
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON Oval V 5.1 MRI System
Hitachi Medical Systems America, I510(k) NO: K153547(Special)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 31-MAR-16
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesis Low Temperature Reusable Rigid Container System
CareFusion 2200 Inc               510(k) NO: K153554(Traditional)
ATTN: Jane  Weber                 PHONE NO : 847 3628094 
75 N. Fairway Drive               SE DECISION MADE: 21-MAR-16
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PURE CRYOGEN
AIR LIQUIDE HEALTHCARE AMERICA COR510(k) NO: K153564(Traditional)
ATTN: STEVE  MILLER               PHONE NO : 713 8962280 
12800 WEST LITTLE YORK ROAD       SE DECISION MADE: 29-MAR-16
HOUSTON TX  77041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoTract UroLift System UL500
NeoTract, Inc.                    510(k) NO: K153584(Traditional)
ATTN: Nancy E Isaac               PHONE NO : 650 2692552 
4473 Willow Road, Suite 100       SE DECISION MADE: 15-MAR-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optetrak Logic Metaphyseal Cones
EXACTECH INC                      510(k) NO: K153595(Traditional)
ATTN: PATRICK  HUGHES             PHONE NO : 352 3274762 
2320 NW 66TH COURT                SE DECISION MADE: 25-MAR-16
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArthrexVIP Web Portal
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.510(k) NO: K153612(Traditional)
ATTN: Keith   Grafmeyer           PHONE NO : 216 4453403 
10000 CEDAR AVENUE                SE DECISION MADE: 15-MAR-16
CLEVELAND OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cerafix Dura Substitute
ACERA SURGICAL, INC.              510(k) NO: K153613(Traditional)
ATTN: MATTHEW  MACEWAN            PHONE NO : 440 4471890 
10880 BAUR BLVD.                  SE DECISION MADE: 16-MAR-16
ST. LOUIS MO  63132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® TLX Interbody System
NUVASIVE INCORPORATED             510(k) NO: K153627(Traditional)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 3204549 
7475 LUSK BOULEVARD               SE DECISION MADE: 17-MAR-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoform Reconstructive Template
Aroa Biosurgery Limited (Formerly 510(k) NO: K153633(Special)
ATTN: Yasmin  Rai                 PHONE NO : 64 9 8693035 
2 Kingsford Smith Place, Airport OSE DECISION MADE: 15-MAR-16
Auckland  NZ 2022                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
SAFECARE BIOTECH (HANGZHOU)CO.,LTD510(k) NO: K153646(Traditional)
ATTN: Alex   Qiu                  PHONE NO : 86 571 89712897 
BUILDING 2/203 NO.18 HAISHU RD.,  SE DECISION MADE: 18-MAR-16
HANGZHOU  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCard STAT! HpSA
Meridian Bioscience, Inc          510(k) NO: K153661(Traditional)
ATTN: Susan  Rolih                PHONE NO : 513 2713700 
3471 River Hills Drive            SE DECISION MADE: 14-MAR-16
Cincinnati OH  45244              510(k) STATEMENT
                                                    

DEVICE: TRUESPAN Meniscal Repair System
Medos International SARL          510(k) NO: K153667(Traditional)
ATTN: Kristine  Christo           PHONE NO : 
Chemin-Blanc 38                   SE DECISION MADE: 24-MAR-16
Le Locle Neuchatel  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Family of CoolGlide Aesthetic Lasers
CUTERA, INC.                      510(k) NO: K153671(Traditional)
ATTN: Julia   Brown               PHONE NO : 415 6575575 
3240 BAYSHORE BLVD.               SE DECISION MADE: 09-MAR-16
BRISBANE CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
Liofilchem s.r.l                  510(k) NO: K153687(Traditional)
ATTN: Fabio  Brocci               PHONE NO : 39 085 8930745 
64026 Roseto Degli                SE DECISION MADE: 31-MAR-16
Abruzzi  IT                       510(k) STATEMENT
                                                    

DEVICE: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
IMMUNALYSIS CORPORATION           510(k) NO: K153693(Traditional)
ATTN: JOSEPH  GINETE              PHONE NO : 909 4820840 
829 TOWNE CENTER DRIVE            SE DECISION MADE: 18-MAR-16
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Black-Orange Powder-Free Nitrile Exam Glove
Halyard Health                    510(k) NO: K153708(Abbreviated)
ATTN: Christine L Macauley        PHONE NO : 470 4485158 
5405 Windward Parkway             SE DECISION MADE: 31-MAR-16
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tuxedo Digital Dental Sensor
LED DENTAL INC                    510(k) NO: K153710(Traditional)
ATTN: Wesley  Newsom              PHONE NO : 404 4322819 
NO.235-5589 BYRNE RD.             SE DECISION MADE: 18-MAR-16
Burnaby  CA V5J 3J1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Versa System
Venus Concept Ltd.                510(k) NO: K153717(Traditional)
ATTN: Tal  Bresler-Stramer        PHONE NO : 416 9070115 
4556 N. Hiatus Road               SE DECISION MADE: 21-MAR-16
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iTotal Cruciate Retaining (CR) Knee Replacement System
CONFORMIS, INC.                   510(k) NO: K153721(Traditional)
ATTN: Amita  Shah                 PHONE NO : 781 3459164 
28 Crosby Dr.                     SE DECISION MADE: 25-MAR-16
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin TaperFit Hip Stem
CORIN USA LIMITED                 510(k) NO: K153725(Traditional)
ATTN: DIANA L. NADER-MARTONE      PHONE NO : 813 9774469 
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 25-MAR-16
TAMPA FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
HANGZHOU CLONGENE BIOTECH CO., LTD510(k) NO: K153741(Traditional)
ATTN: ZHENG  SHUJIAN              PHONE NO : 86 571 88262120 
BUILDING 4, NO.20 LONGQUAN ROAD  YSE DECISION MADE: 18-MAR-16
HANGZHOU  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dunamis Force DFX Tensile Tape
Dunamis LLC                       510(k) NO: K153746(Traditional)
ATTN: Prithvi Raj Chavan          PHONE NO : 731 2172533 
693 Sherling Lake Rd. Apt. 122    SE DECISION MADE: 03-MAR-16
Greenville AL  36037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroMatrix
ACELL, INC                        510(k) NO: K153754(Special)
ATTN: THOMAS  GILBERT             PHONE NO : 410 9538509 
6640 ELI WHITNEY DRIVE            SE DECISION MADE: 14-MAR-16
COLUMBIA MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Bone Level Tapered Implants
INSTITUT STRAUMANN AG             510(k) NO: K153758(Traditional)
ATTN: Christopher   Klaczyk       PHONE NO : 41 61 9651260 
PETER MERIAN-WEG 12               SE DECISION MADE: 23-MAR-16
BASEL  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-cera Zirconia Blanks
SHENZHEN XIANGTONG PHOTOELECTRICIT510(k) NO: K153767(Third Party - Traditional)
ATTN: YONGQING  CHEN              PHONE NO : 0086 755 86001804 
2~4TH FLOOR, 1ST BUILDING, SOUTH ISE DECISION MADE: 29-MAR-16
SHENZHEN  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OS2(R)-VP Varisation Staple
IN2BONES SAS                      510(k) NO: K153770(Traditional)
ATTN: MORGANE  GRENIER            PHONE NO : 33 47 2292626 
28 CHEMIN DU PETIT BOIS           SE DECISION MADE: 21-MAR-16
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin TriFit TS Hip
CORIN USA LIMITED                 510(k) NO: K153772(Traditional)
ATTN: Diana L. Nader-Martone      PHONE NO : 813 9774469 
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 31-MAR-16
TAMPA FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optetrak One Logic Femoral Components
Exactech Inc                      510(k) NO: K153776(Special)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 NW 66th CT                   SE DECISION MADE: 10-MAR-16
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Abutment for Bridges
ALTATEC GmbH                      510(k) NO: K153779(Traditional)
ATTN: Colleen  Boswell            PHONE NO : 49 7044 94450 
Maybachstrasse 5                  SE DECISION MADE: 31-MAR-16
Wimsheim  DE D-71299              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Lumbar Interbody Implants
NUVASIVE, INCORPORATED            510(k) NO: K153782(Traditional)
ATTN: MARTIN  YAHIRO              PHONE NO : 858 3206157 
7475 LUSK BLVD.                   SE DECISION MADE: 24-MAR-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Composite(R) Distal Volar Radius Plate System
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K160002(Special)
ATTN: Yael  Rubin                 PHONE NO : 972 995 11511 
11 HA'HOSHLIM STREET              SE DECISION MADE: 09-MAR-16
HERZELIYA  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
Captiva Spine                     510(k) NO: K160020(Special)
ATTN: Tamala J. Wampler           PHONE NO : 877 7725571 
967 N. Alternate A1A Ste 1        SE DECISION MADE: 02-MAR-16
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
CONFORMIS, INC.                   510(k) NO: K160025(Special)
ATTN: Amita   Shah                PHONE NO : 781 3459164 
28 Crosby Dr.                     SE DECISION MADE: 07-MAR-16
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cobbra RF Tissue Dissector
ELLIQUENCE LLC.                   510(k) NO: K160041(Traditional)
ATTN: PAUL D. BUHRKE              PHONE NO : 516 2779010 
2455 Grand Avenue                 SE DECISION MADE: 07-MAR-16
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Variable Pitch Compression Screw System
Biomet Inc                        510(k) NO: K160058(Traditional)
ATTN: Julie  Largent              PHONE NO : 305 2696391 
56 East Bell Drive                SE DECISION MADE: 09-MAR-16
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
INFOBIONIC, INC.                  510(k) NO: K160064(Abbreviated)
ATTN: NANCY  BRIEFS               PHONE NO : 978 6748304 
600 SUFFOLK STREET                SE DECISION MADE: 11-MAR-16
LOWELL MA  01854                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonoma Fibula Repair System
Sonoma Orthopedics Products, Inc  510(k) NO: K160069(Traditional)
ATTN: Rick  Epstein               PHONE NO : 
1388 Busch Parkway                SE DECISION MADE: 10-MAR-16
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid T8
GE Medical Systems Ultrasound and 510(k) NO: K160078(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 10-MAR-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
ZIMMER GMBH                       510(k) NO: K160085(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 588 548264 
SULZERALLEE 8                     SE DECISION MADE: 08-MAR-16
WINTERTHUR  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle NA-U401SX
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K160098(Traditional)
ATTN: TOSHIYUKI  NAKAJIMA         PHONE NO : 81 42 6422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 22-MAR-16
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xspan Laminoplasty Fixation System
X-SPINE SYSTEMS, INC.             510(k) NO: K160114(Traditional)
ATTN: Kriss   Anderson            PHONE NO : 937 8478400 
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 15-MAR-16
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-SPECT Processing and Reviewing Workstation
SPECTRUM DYNAMICS LTD.            510(k) NO: K160120(Traditional)
ATTN: YORAM  LEVY                 PHONE NO : 972 73 7374500 
22 BAREKET STREET                 SE DECISION MADE: 21-MAR-16
CAESAREA  IL 30889                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRII Cranial Drill and Accessories
MRI INTERVENTIONS, INC.           510(k) NO: K160129(Special)
ATTN: PETER  PIFERI               PHONE NO : 949 9006833 
5 MUSICK                          SE DECISION MADE: 26-MAR-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd.           510(k) NO: K160145(Traditional)
ATTN: Sarah  Su                   PHONE NO : 886 2 82271300 1201
9F, No. 186, Jian Yi Road         SE DECISION MADE: 13-MAR-16
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea CT Colon Analysis
Vital Images, Inc.                510(k) NO: K160150(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 952 4879774 
5850 Opus Parkway, Suite 300      SE DECISION MADE: 16-MAR-16
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist 3 
ASPECT IMAGING LTD                510(k) NO: K160185(Third Party - Traditional)
ATTN: ISRAEL  CITRON              PHONE NO : 972 732 239000 
27 SHAKED STREET                  SE DECISION MADE: 01-MAR-16
INDUSTRIAL AREA HEVEL MODI'IN  IL 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Align Anterior Ankle Fusion Plate
Extremity Medical, LLC            510(k) NO: K160191(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway, Suite 410  SE DECISION MADE: 25-MAR-16
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NILE Alternative Fixation Spinal System
K2M, Inc.                         510(k) NO: K160208(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
751 MILLER DRIVE SE               SE DECISION MADE: 18-MAR-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUVUE (senofilcon C) Soft Contact Lens
Johnson & Johnson Vision Care, Inc510(k) NO: K160212(Traditional)
ATTN: Ramona  Haile               PHONE NO : 904 4431191 
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 28-MAR-16
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
Cook Ireland Ltd.                 510(k) NO: K160229(Traditional)
ATTN: Lynsey  Shine               PHONE NO : 011 353 61334440 2657
O' Halloran Road, National TechnolSE DECISION MADE: 21-MAR-16
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
COVIDIEN                          510(k) NO: K160230(Special)
ATTN: TRANG  HUYNH                PHONE NO : 203 4927473 
60 Middletown Avenue              SE DECISION MADE: 01-MAR-16
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OVENT
OVENTUS MANUFACTURING PTY LTD     510(k) NO: K160234(Third Party - Traditional)
ATTN: Neil  Anderson              PHONE NO : 61 7 32102913 
Suite 8, Level 17 - 141 Queen StreSE DECISION MADE: 17-MAR-16
Brisbane  AU 4000                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Cefaly
CEFALY TECHNOLOGY                 510(k) NO: K160237(Special)
ATTN: JEAN-YVES  MIGNOLET         PHONE NO : 32 436 76722 
ZI DES HAUTS SARTS, 4EME AVENUE 5 SE DECISION MADE: 04-MAR-16
HERSTAL  BE 4040                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K160241(Special)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 02-MAR-16
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROTEK Duo 31 Fr. Veno-Venous Cannula Set
CARDIAC ASSIST, INC.              510(k) NO: K160257(Special)
ATTN: GREG  JOHNSON               PHONE NO : 412 9637770 
240 ALPHA DRIVE                   SE DECISION MADE: 04-MAR-16
PITTSBURGH  PA  15238             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ AESTHETICS, INC.           510(k) NO: K160259(Traditional)
ATTN: SHRUTI  JAYAKUMAR           PHONE NO : 925 4742516 
4698 WILLOW ROAD                  SE DECISION MADE: 23-MAR-16
PLEASANTON CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE Trauma Nail System
Ellipse Technologies, Incorporated510(k) NO: K160267(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 8373600 
101 Enterprise, Suite 100         SE DECISION MADE: 31-MAR-16
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endophys Pressure Sensing Sheath Kit
Endophys, Inc.                    510(k) NO: K160272(Special)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
Thanksgiving Tower, Suite 1930 160SE DECISION MADE: 04-MAR-16
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA MEDIAL, INC.                  510(k) NO: K160273(Traditional)
ATTN: Sherrie  Coval-Goldsmith    PHONE NO : 781 5384720 
91 HARTWELL AVENUE                SE DECISION MADE: 25-MAR-16
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
INSTRUMENTATION LABORATORY CO.    510(k) NO: K160276(Special)
ATTN: NIKITA  MALLADI             PHONE NO : 781 6743245 
180 HARTWELL ROAD                 SE DECISION MADE: 03-MAR-16
BEDFORD MA  01730-2441            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
GE Medical Systems Ultrasound and 510(k) NO: K160277(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 25-MAR-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Platinum dRF Imaging System
Apelem-DMS Group                  510(k) NO: K160301(Special)
ATTN: Krishna  Mahadea            PHONE NO : 33 046 7504900 
Parc Scientifique Georges Passe 17SE DECISION MADE: 04-MAR-16
Nimes 30005  FR                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd.           510(k) NO: K160336(Traditional)
ATTN: Sarah  Su                   PHONE NO : 886 2 82271300 1201
9F, No. 186, Jian Yi Road         SE DECISION MADE: 29-MAR-16
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
QINGDAO HISENSE MEDICAL EQUIPMENT 510(k) NO: K160347(Traditional)
ATTN: Liu   zhitang               PHONE NO : 86 532 55753811 
Software outsourcing center 3rd flSE DECISION MADE: 03-MAR-16
Qing dao  CN  266101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Span Plate System
Zavation, LLC                     510(k) NO: K160362(Traditional)
ATTN: Frankie  Cummins            PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 22-MAR-16
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GuideWire
FIAGON GMBH                       510(k) NO: K160369(Special)
ATTN: Dirk  Mucha                 PHONE NO : 49 330 22012110 
NEUENDORFSTR. 23 B                SE DECISION MADE: 10-MAR-16
HENNIGSDORF  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 20G x 1.25" NovaCath Secure IV Catheter System, 24G x 0.56" NovaCath Secure IV Catheter System
TANGENT MEDICAL TECHNOLOGIES, INC.510(k) NO: K160374(Special)
ATTN: GREG  LAST                  PHONE NO : 734 5274051 
8170 JACKSON ROAD, STE A          SE DECISION MADE: 11-MAR-16
ANN ARBOR MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TE7 Diagnostic Ultrasound System
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K160381(Special)
ATTN: WU  ZICUI                   PHONE NO : 86 755 81885658 
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 09-MAR-16
SHENZHEN  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReadeR, VieweR, QuickScan PSP 
TRIDENT S.R.L                     510(k) NO: K160386(Traditional)
ATTN: GIORGIO  RIZZO              PHONE NO : 39 02 87072380 
VIA VERDI 20                      SE DECISION MADE: 10-MAR-16
ASSAGO  IT 20090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaCross Microcatheter
Nitiloop Ltd.                     510(k) NO: K160389(Special)
ATTN: Chanan  Schneider           PHONE NO : 972 54 6645494 
4 Haomanut Street                 SE DECISION MADE: 11-MAR-16
Netanya  IL 4250438               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM FC1 Ultrasound System
FUJIFILM SonoSite, Inc.           510(k) NO: K160406(Third Party - Traditional)
ATTN: Scott  Paulson              PHONE NO : 425 9516926 
21919 30th Drive SE               SE DECISION MADE: 16-MAR-16
Bothell WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AOS Anterolateral Proximal Humeral Plate
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K160409(Special)
ATTN: KAZU  MIYAHARA              PHONE NO : 310 5339966 
3203 KASHIWA STREET               SE DECISION MADE: 15-MAR-16
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rezum System
NxThera, Inc.                     510(k) NO: K160417(Special)
ATTN: J. Robert Paulson           PHONE NO : 763 5150404 
7351 Kirkwood Lane N, Suite 138   SE DECISION MADE: 17-MAR-16
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERIMETER Interbody Fusion Device
Medtronic Sofamor Danek USA, Inc  510(k) NO: K160418(Special)
ATTN: Ankit K. Shah               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 07-MAR-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeqT
Signostics Limited                510(k) NO: K160420(Third Party - Traditional)
ATTN: Stewart  Bartlett           PHONE NO : 61 874 240600 
1284 South Road                   SE DECISION MADE: 21-MAR-16
Clovelly Park  AU 5042            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: syngo.via MI Workflows
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K160426(Special)
ATTN: Veronica   Padharia         PHONE NO : 630 8775761 
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 04-MAR-16
HOFFMAN ESTATES IL  60192         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint System
MRI INTERVENTIONS, INC.           510(k) NO: K160434(Special)
ATTN: Peter   Piferi              PHONE NO : 949 9006833 
5 MUSICK                          SE DECISION MADE: 17-MAR-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL Silica Clotting Time
INSTRUMENTATION LABORATORY CO.    510(k) NO: K160445(Special)
ATTN: Heather  L  Harvey          PHONE NO : 781 8614549 
180 HARTWELL ROAD                 SE DECISION MADE: 16-MAR-16
BEDFORD MA  01730-2442            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
ATRICURE, INC.                    510(k) NO: K160454(Special)
ATTN: JONATHAN  MCELWEE           PHONE NO : 513 7554100 
6217 CENTRE PARK DRIVE            SE DECISION MADE: 18-MAR-16
WEST CHESTER OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
BIOFIRE DIAGNOSTICS, LLC          510(k) NO: K160457(Special)
ATTN: Kristen J. Kanack           PHONE NO : 801 7366354 330
390 WAKARA WAY                    SE DECISION MADE: 15-MAR-16
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
BIOFIRE DIAGNOSTICS, LLC          510(k) NO: K160462(Special)
ATTN: Kristen J. Kanack           PHONE NO : 801 7366354 330
390 WAKARA WAY                    SE DECISION MADE: 17-MAR-16
SALT LAKE CITY UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Response 5.5 Spine System
ORTHOPEDIATRICS  CORP.            510(k) NO: K160466(Traditional)
ATTN: Mark  Fox                   PHONE NO : 574 2686379 
2850 FRONTIER DRIVE               SE DECISION MADE: 23-MAR-16
WARSAW IL  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PointerShell Universal, PointerShell LS 
FIAGON GMBH                       510(k) NO: K160479(Special)
ATTN: DIRK  MUCHA                 PHONE NO : 49 330 22012110 
NEUENDORFSTR. 23 B                SE DECISION MADE: 23-MAR-16
HENNIGSDORF  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optetrak Advanced Patella
EXACTECH INC                      510(k) NO: K160484(Special)
ATTN: PATRICK  HUGHES             PHONE NO : 352 3274762 
2320 NW 66TH CT                   SE DECISION MADE: 18-MAR-16
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quanta System Surgical Laser fibers
QUANTA SYSTEM SPA                 510(k) NO: K160513(Special)
ATTN: FRANCESCO  DELL'ANTONIO     PHONE NO : 39 0331 376797 
VIA IV NOVEMBRE, 116              SE DECISION MADE: 18-MAR-16
SOLBIATE OLONA (VA)  IT 21058     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
ETHICON ENDO-SURGERY, LLC         510(k) NO: K160521(Special)
ATTN: Marjorie  Medina            PHONE NO : 787 7837070 
475 CALLE C                       SE DECISION MADE: 22-MAR-16
GUAYNABO PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibroScan 530 Compact
ECHOSENS                          510(k) NO: K160524(Special)
ATTN: KARINE  BONENFANT           PHONE NO : 33 144 827856 
30 Place d'Italie                 SE DECISION MADE: 18-MAR-16
PARIS  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANATOMIC PEEK PTC Cervical Fusion System
MEDTRONIC SOFAMOR DANEK, USA, INC.510(k) NO: K160528(Traditional)
ATTN: LEE  GRANT                  PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 28-MAR-16
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cascadia Interbody System
K2M                               510(k) NO: K160547(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
751 MILLER DR SE                  SE DECISION MADE: 24-MAR-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMV Scientific Schanz Screws
SMV SCIENTIFIC                    510(k) NO: K160603(Traditional)
ATTN: NEPHI  ZUFELT               PHONE NO : 512 7508622 
111 SANDRA MURAIDA WAY UNIT 18A   SE DECISION MADE: 28-MAR-16
AUSTIN TX  78703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
VISARIS D.O.O. BELGRADE           510(k) NO: K160620(Traditional)
ATTN: MILAN  RATKOVIC             PHONE NO : 381 11 2017656 
BATAJNICKI DRUM 10 DEO 1B         SE DECISION MADE: 30-MAR-16
ZEMUN  RS 11080                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNAPioneer
GE HEALTHCARE                     510(k) NO: K160621(Special)
ATTN: GLEN  SABIN                 PHONE NO : 262 5216848 
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 29-MAR-16
WAUKESHA WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotatable Snares
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K160637(Special)
ATTN: Michael   Secondini         PHONE NO : 508 6836503 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 30-MAR-16
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surefire Infusion System
SUREFIRE MEDICAL, INC             510(k) NO: K160662(Third Party - Special)
ATTN: Lynne   Aronson             PHONE NO : 720 3059877 
6272 W. 91st Avenue               SE DECISION MADE: 11-MAR-16
Westminster CO  80031             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Proxis Ureteral Access Sheath
C.R. Bard, Inc.                   510(k) NO: K160861(Third Party - Traditional)
ATTN: Beatrice  Wan               PHONE NO : 770 7846414 
8195 Industrial Blvd              SE DECISION MADE: 31-MAR-16
Covington GA  30014               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

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