FDA 510(k) Applications Received During February, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K160546 02/26/2016 3M Attest Rapid Readout Biological Indicator 3M COMPANY Matt Mortensen
K163689 12/28/2016 3M Clear Tray Aligner 3M Unitek Corporation Yanine Garcia-Quezada
K163677 12/27/2016 Ortho System 3Shape A/S Hanne Nielsen
K163683 12/28/2016 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor A&D COMPANY, LTD JERRY WANG
K163629 12/22/2016 Audit MicroControls Linearity FD Tumor Markers II Aalto Scientific, Ltd. Robert Burda
K163709 12/30/2016 FIRMap Catheter ABBOTT ELECTROPHYSIOLOGY DENNIS POZZO
K160236 02/01/2016 Dual Pump Pack Abbott Medical Optics Inc. Priya Viswanathan
K160390 02/11/2016 Map-it Diagnostic Mapping Catheters ACCESS POINT TECHNOLOGIES EP, INC. SEAN CARROLL
K163406 12/05/2016 Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System ACON LABORATORIES INC. QIYI XIE
K163451 12/08/2016 Action Trackstander models TR1816, TR1820, TR2016, and TR2020 Action Manufacturing Inc. Alan Macht
K160264 02/02/2016 Additive Orthopaedics Hammertoe Correction System Additive Orthopaedics, LLC Greg Kowalczyk
K163593 12/21/2016 Additive Orthopaedics Bunion System Additive Orthopaedics, LLC. Gregory Kowalczyk
K163485 12/12/2016 SmartTouch Adherium (NZ) Ltd CHRIS MANDER
K160409 02/16/2016 AOS Anterolateral Proximal Humeral Plate ADVANCED ORTHOPAEDIC SOLUTIONS, INC KAZU MIYAHARA
K163598 12/21/2016 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator ADVANCED STERILIZATION PRODUCTS NAZANIN YACOBI
K160393 02/11/2016 AdTec AESCULAP, INC. Jessica Stigliano
K160239 02/01/2016 TAP 3, TAP 1 Airway Management, Inc. Dale Siebenmorgen
K160364 02/09/2016 VersaWrap Tendon Protector Alafair Biosciences Inc Ben Walthall
K163551 12/19/2016 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K163699 12/29/2016 ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook ALN Implants Chirurgicaux Alain Nigon
K163664 12/27/2016 Health-e-Connect System with IDA ALR TECHNOLOGIES SIDNEY CHAN
K160291 02/03/2016 Optimus ALIF System Amendia, Inc. Kristen Allen
K163580 12/20/2016 ASD Oral Appliances AMERICAN SLEEP DENTISTRY RYAN GREGERSON
K160563 02/29/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD LIU YI
K160565 02/29/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD LIU YI
K160399 02/12/2016 Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC Robert Mahler
K160432 02/16/2016 Anzai Respiratory Gating System ANZAI MEDICAL CO, LTD. NAOYA IWASAKI
K160301 02/04/2016 Platinum dRF Imaging System Apelem-DMS Group Krishna Mahadea
K160248 02/01/2016 ArgenIS Titanium Abutments Argen Corporation Paul Cascone
K163513 12/15/2016 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (subsidiary of Teleflex Inc.) Fallon Young
K160461 02/19/2016 Arthrex iBalance BiCompartmental Arthroplasty System Arthrex, Inc. Courtney Smith
K160319 02/05/2016 FiberTak DR ARTHREX, INC. IVETTE GALMEZ
K163426 12/06/2016 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K160430 02/16/2016 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. Jennifer L. Gregory
K163481 12/12/2016 HALF DOME Posterior Lumbar Interbody System Astura Medical Troy Taylor
K163408 12/05/2016 Isolator Multifunctional Linear Pen AtriCure Inc. Melissa Smallwood
K160454 02/18/2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC. JONATHAN MCELWEE
K160356 02/08/2016 Third Eye Panoramic Auxiliary Endoscopy System - Resposable AVANTIS MEDICAL SYSTEMS, INC. Louis Fries
K163529 12/16/2016 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) AVERY DENNISON CORPORATION LISA BARTAKOVICS
K163446 12/08/2016 AxoGen Nerve Cap AxoGen Corporation Mark L. Friedman
K163430 12/07/2016 Prontosan Wound Gel B. Braun Medical, Inc. Nancy Skocypec
K160337 02/08/2016 Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns BAM CORPORATION LIMITED MARY MEJAES
K163420 12/06/2016 UltraScore Focused Force PTA Balloon BARD PERIPHERAL VASCULAR, INC. TIMOTHY WADE
K163530 12/16/2016 PrisMax Control Unit BAXTER HEALTHCARE CORP Chris Scavotto
K163591 12/20/2016 BD PosiFlush Heparin Lock Flush Syringe Becton Dickinson and Company Aakash Jain
K163637 12/23/2016 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) BECTON, DICKINSON & COMPANY MONICA E. GIGUERE
K160268 02/02/2016 Fingertip Pulse Oximeter MD300CG11/MD300CG51 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K160508 02/24/2016 Electronic Pulse Stimulator BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Lei Chen
K160343 02/08/2016 SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD JUNE LI
K163429 12/07/2016 B6 Beijing East Whale Imaging Technology Co., Ltd Sharon Fan
K160558 02/29/2016 RAPIDO HOLLOW-FIBRE DIALYZERS BELLCO Srl Giuseppe Tomasini
K160260 02/01/2016 Tempo Temporary Pacing Lead BIO TRACE MEDICAL, INC. Laura N. Dietch
K163638 12/23/2016 Dental 5 Multi Diode laser BIO-MED USA INC YOUNG CHI
K163502 12/14/2016 iSR'obot Biopsy Kit Biobot Surgical Pte Ltd Lai Chee LIEW
K163467 12/12/2016 C-Line Orthodontic Ceramic Bracket BIOCETEC CO., LTD DAVE KIM
K163395 12/05/2016 Astroglide Diamond Silicone Gel Personal Lubricant BioFilm, Inc. Richard Hines
K160457 02/19/2016 FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC Kristen J. Kanack
K160459 02/19/2016 FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC Kristen J. Kanack
K160462 02/19/2016 FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC Kristen J. Kanack
K163563 12/19/2016 VITEK 2 AST-GN Gentamicin (<=1 û >=16 ?g/mL) bioMerieux, Inc Cherece L. Jones
K163651 12/23/2016 ExpressBraid Graft Manipulation Biomet Manufacturing Corp. Vinay Bhal
K163627 12/22/2016 Shotel Ankle Arthrodesis Nail System BioPro, Inc. Dave Mrak
K163608 12/21/2016 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm BioStable Science & Engineering Inc. Julie Thomas
K160446 02/17/2016 MCP Bone Putty BioStructures, LLC John Brunelle
K163660 12/27/2016 Pantera LEO BIOTRONIK, INC. Jon Brumbaugh
K160274 02/02/2016 Hi bebe plus BISTOS CO., LTD. Jenny Cho
K160537 02/26/2016 Navio Blue Belt Technologies, Inc. Richard G. Confer
K163464 12/09/2016 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) BMC MEDICAL.,LTD. Jiang Huiqi
K163622 12/22/2016 Lung Vision BODY VISION MEDICAL LTD. DORIAN AVERBUCH
K163700 12/29/2016 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. Marc Chaunet
K163701 12/29/2016 Direxion and Direxion HI-FLO Torqueable Microcatheters BOSTON SCIENTIFIC CORPORATION LIZ JOHNSTON
K160514 02/24/2016 OptiCross 18, 30 MHz Peripheral Imaging Catheter BOSTON SCIENTIFIC CORPORATION Eric Elliott
K163399 12/05/2016 Tria Firm Ureteral Stent Boston Scientific Corporation Christine Shoemaker
K160481 02/22/2016 Vivo 60 BREAS MEDICAL AB Albert Cefalo
K160378 02/10/2016 BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) BRH Medical Ltd. Kevin Bentley
K160256 02/01/2016 Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd. Tina Yin
K163536 12/16/2016 MALDI Biotyper CA (MBT-CA) System, MBT smart CA System BRUKER DALTONIK GMBH MARKUS KOSTRZEWA
K163510 12/15/2016 Poseidon Ultrasound System BUTTERFLY NETWORK, INC. BRIAN SAWIN
K163437 12/07/2016 hypodermic PinpointÖ GT Needle C. R. Bard, Inc. Jamie Howell
K163458 12/09/2016 Zenysis Short-Term Dialysis Catheter C.R BARD. INC. SILVIA DE LA BARRA
K163698 12/29/2016 OptiFix Open Absorbable Fixation System - 20 absorbable fasteners C.R. BARD INC, KATHERINE EARLE
K163684 12/28/2016 C2 CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K163380 12/01/2016 Serranator Alto PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K160413 02/16/2016 Sterling 5W Diode Laser CAO Group, Inc. Robert K Larsen
K160285 02/03/2016 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 CAPILLUS, LLC PATRICIA SCHNOOR
K160257 02/01/2016 PROTEK Duo 31 Fr. Veno-Venous Cannula Set CARDIAC ASSIST, INC. GREG JOHNSON
K160339 02/08/2016 Cardinal Health Isolation Gown Cardinal Health 200, LLC Caroline Miceli
K160411 02/16/2016 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating CARDINAL HEALTH, INC. Megan Middaugh
K160437 02/17/2016 PleurX Peritoneal Catheter System CareFusion Tamara Brey
K160450 02/18/2016 Pleurx Pleural Catheter System CAREFUSION JOY GREIDANUS
K163615 12/22/2016 Snowden-Pencer MicroLap 3mm Laparoscopic Instruments CareFusion 2200 Inc Jane Weber
K163570 12/19/2016 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) Carolina Liquid Chemistries Corporation Mica A. Welsh
K160237 02/01/2016 Cefaly CEFALY TECHNOLOGY JEAN-YVES MIGNOLET
K163519 12/15/2016 RX DC CEFLA SC BORTOLOTTI LORENZO
K163439 12/08/2016 NaviENT ClaroNav Inc. Ahmad Kolahi
K160515 02/24/2016 PS2 Knee System CONSENSUS ORTHOPEDICS, INC. JUSTIN CREEL
K160542 02/26/2016 5.0 Fr Arndt Endobronchial Blocker Set COOK INCORPORATED Kotei Aoki
K160567 02/29/2016 Barone Jejunostomy Catheter Set COOK INCORPORATED Erum B. Nasir
K160509 02/24/2016 Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube COOK INCORPORATED Erum B. Nasir
K160229 02/01/2016 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle Cook Ireland Ltd. Lynsey Shine
K163468 12/12/2016 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered Cook Ireland Ltd. Jacinta Kilmartin
K160423 02/16/2016 Perineologic Access Needle Corbin Clinical Resources, LLC Kenneth K. Kleinhenz
K160414 02/16/2016 Precision Point Biopsy Needle Guide Corbin Clinical Resources, LLC Kenneth K Kleinhenz
K163385 12/02/2016 Cortex Dental Implant System Cortex Dental Implants Industries Ltd. Michal Yeger
K163480 12/12/2016 Renamel NANO +plus Cosmedent, Inc Hiren Patel
K163556 12/19/2016 MediClear PreOp COVALON TECHNOLOGIES, INC. KIM CROOKS
K160539 02/26/2016 BiZact Open Sealer/Divider COVIDIEN Sharon McDermott
K160331 02/08/2016 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp Covidien Hong Zhu
K160419 02/16/2016 Monoject Enteral Feeding Syringe with ENFit Connector COVIDIEN Sona Manickam
K163620 12/22/2016 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Covidien Nicole Genco
K160230 02/01/2016 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm COVIDIEN TRANG HUYNH
K163537 12/16/2016 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga Covidien llc LeeAnne Swiridow
K160360 02/09/2016 Barrx FLEX RFA Energy Generator Covidien llc Timothy Thomas
K160290 02/03/2016 Valleylab REM Polyhesive Infant Patient Return Electrode Covidien LLC Nancy Sauer
K163654 12/23/2016 VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar Covidien llc Gary LeMere
K160436 02/17/2016 CreoDent Solidex Custom Abutment CreoDent Prosthetics, Ltd. Calvin Shim
K160300 02/04/2016 MotoBand(TM) CP Implant System CrossRoads Extremity Systems, LLC Vernon Hartdegen
K160385 02/11/2016 Precision Screw CRYPTYCH PTY LTD GREG ROGER
K160273 02/02/2016 truFreeze System CSA MEDIAL, INC. Sherrie Coval-Goldsmith
K160566 02/29/2016 Cerasorb Ortho Foam CURASAN AG Wolf-Dietrich Hubner
K160488 02/22/2016 Cutera enlighten III Laser System Cutera, Inc. Bradley Renton
K163552 12/19/2016 iPulse SmoothSkin BARE Hair Removal Device CYDEN LIMITED MIKE KIERNAN
K160480 02/22/2016 PicoSure Workstation Cynosure, Inc Amy Tannenbaum
K160470 02/19/2016 SculpSure CYNOSURE, INC. Aastha Kohli
K163542 12/16/2016 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp. Helder A. Sousa
K163714 12/30/2016 OSSIX BONE Datum Dental Ltd Arie Goldlust
K160281 02/02/2016 OSSIX PLUS Datum Dental Ltd. Arie Goldlust
K160410 02/16/2016 WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head Dental Savings Club Chadi Saade
K160498 02/23/2016 Dentivera Milling Disc Dental Solutions, LLC Kendra Shoulders
K160483 02/22/2016 Burn-out Cylinder and Angled Screw Abutments Dentium Co., Ltd Sangpil Yoon
K163605 12/21/2016 LEDEX WL070+ DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K160232 02/01/2016 Disposable Barrier Sleeves and Covers DENTSPLY International Inc. Helen Lewis
K163398 12/05/2016 ATLANTIS suprastructures Dentsply Sirona Karl Nittinger
K163418 12/06/2016 Diazyme DZ-Lite Total beta-hCG Test System Diazyme Laboratories Abhijit Datta
K160323 02/05/2016 FlowKeepers DK ELECTRONICS, LLC AVERY HUFF
K160443 02/17/2016 TempoCem Clear DMG USA, INC. Gordon Craig
K163535 12/16/2016 my Patch sl DMS-SERVICE LLC LYNDA COLE
K163668 12/27/2016 SUITESTENSA EBIT srl Marco Fruscione
K160524 02/25/2016 FibroScan 530 Compact ECHOSENS KARINE BONENFANT
K160279 02/02/2016 ANYVIEW-500R Fluoroscopic Mobile X-Ray System ECOTRON CO.,LTD Sang Bong Lee
K163693 12/28/2016 IntraClude Intra-Aortic Occlusion Device Edwards Lifesciences LLC Lisa G. Hessabi
K160552 02/29/2016 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform EDWARDS LIFESCIENCES, LLC Tara Viviani
K163381 12/01/2016 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC Chirag Shah
K160247 02/01/2016 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR EIZO Corporation Hiroaki Hashimoto
K160440 02/17/2016 Leksell Gamma Knife Icon Elekta Instrument AB Alf Laurell
K160325 02/05/2016 PRECICE Intramedullary Limb Lengthening System ELLIPSE TECHNOLOGIES, INC. Cora Sim
K160267 02/02/2016 PRECICE Trauma Nail System Ellipse Technologies, Incorporated Cora Sim
K163617 12/22/2016 REMbrandt Embla Systems Shane T Sawall
K160342 02/08/2016 EMPOWR PS Knee System Encore Medical, L.P. Teffany Hutto
K163497 12/13/2016 EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt ENCORE MEDICAL, L.P. Teffany Hutto
K160275 02/02/2016 Fuse Endoscopic System with FuseBox Processor EndoChoice Inc. Daniel Hoefer
K160403 02/12/2016 SmartStart Air/Water and Suction Valves ENDOCHOICE, INC. DANIEL HOEFER
K163541 12/16/2016 Magseed Magnetic Marker System ENDOMAGNETICS LTD ANDREW SHAWCROSS
K160272 02/02/2016 Endophys Pressure Sensing Sheath Kit Endophys, Inc. Rebecca K Pine
K163435 12/07/2016 Entellus Medical Reinforced Anesthesia Needle Entellus Medical Inc. Megan Bernier
K163509 12/15/2016 XprESS ENT Dilation System Entellus Medical, Inc. Karen E. Peterson
K163523 12/15/2016 ECHELON CIRCULAR Powered Stapler Ethicon Endo-Surgery, LLC Carmen Ortiz
K163454 12/09/2016 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm ETHICON ENDO-SURGERY, LLC Carmen Ortiz
K160521 02/25/2016 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm ETHICON ENDO-SURGERY, LLC Marjorie Medina
K160554 02/29/2016 Enseal X1 Large Jaw Tissue Sealer ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K163548 12/16/2016 ENSEAL X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC Marjorie Medina
K163645 12/23/2016 DERMABOND PRINEO Skin Closure System Ethicon, LLC Joice Pappan
K160447 02/17/2016 Calprest NG EUROSPITAL S.P.A. Claudia Brandolin
K160324 02/05/2016 Cervical Interbody Fusion System EVOLUTION SPINE, LLC ASHTON KOUZBARI
K163539 12/16/2016 Ez3D-i / E3 EWOO SOFT Co., Ltd. Young Seok Kim
K163533 12/16/2016 EzDent-i; E2; ProraView EWOO SOFT CO., LTD. YOUNG SEOK KIM
K160484 02/22/2016 Optetrak Advanced Patella EXACTECH INC PATRICK HUGHES
K163524 12/15/2016 Vessel Dilator Fetzer Medical GmbH & Co. KG Harald Jung
K163416 12/05/2016 Fiagon Navigation û PointerTube Straight and PointerTube Keat FIAGON GMBH DIRK MUCHA
K160369 02/10/2016 GuideWire FIAGON GMBH Dirk Mucha
K160479 02/22/2016 PointerShell Universal, PointerShell LS FIAGON GMBH DIRK MUCHA
K160531 02/25/2016 Noiselezz FIRMA INGEMARSSON Natashia Ingemarsson-Matzen
K163440 12/08/2016 Stealth Staple System FIRST RAY LLC ROBERT HOY
K160573 02/29/2016 FirstSense Breast Exam First Sense Medical, LLC Paul G. Angott
K160299 02/04/2016 geko(TM) Plus R-2 Neuromuscular Stimulator FIRSTKIND LIMITED NEIL BUCKLEY
K160540 02/26/2016 FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM FLEXICARE MEDICAL LIMITED JOEL BIDDLE
K163710 12/30/2016 BePOD« EZ Weil Screws Fournitures Hospitalieres Industrie Patricia Donnard
K160308 02/04/2016 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) Fudakang Industrial Co., Ltd Bob Yu
K163675 12/27/2016 Processor VP-7000, Light Source BL-7000 FUJIFILM Medical System U.S.A., Inc. Shraddha S More
K163624 12/22/2016 Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) FUJIFILM Medical Systems U.S.A., Inc. Dharaben Desai
K160406 02/16/2016 FUJIFILM FC1 Ultrasound System FUJIFILM SonoSite, Inc. Scott Paulson
K163521 12/15/2016 Lumipulse G LH Calibrators FUJIREBIO DIAGNOSTICS, INC DIANA DICKSON
K163534 12/16/2016 Lumipulse G FSH-N Calibrators Fujirebio Diagnostics, Inc. Diana Dickerson
K163546 12/16/2016 Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics, Inc. Stacey Dolan
K163544 12/16/2016 Lumipulse G Prolactin FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN
K163669 12/27/2016 Humeris Shoulder Fx Solutions Jean-Jacques Martin
K160338 02/08/2016 Triton System GAUSS SURGICAL INC. ARTIE KAUSHIK
K163507 12/14/2016 Triton Sponge System Gauss Surgical, Inc. Artie Kaushik
K163596 12/21/2016 LOGIQ P9 and LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K160277 02/02/2016 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K163619 12/22/2016 SIGNA PET/MR GE Medical Systems, LLC Janice M. Sich
K163652 12/23/2016 ePlex Instrument GenMark Diagnostics, Incorporated Alan Maderazo
K163636 12/22/2016 ePlex Respiratory Pathogen Panel GENMARK DIAGNOSTICS, INCORPORATED ALAN MADERAZO
K163412 12/05/2016 Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) Girgis Scope LLC Madgy S. Girgis
K160564 02/29/2016 TroClose1200 GORDIAN SURGICAL LTD. ZVI PEER
K160469 02/19/2016 AGNES GOWOONSESANG COSMETICS CO., LTD Kyeong Tai Ko
K163648 12/23/2016 Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series Grandway Technology (Shenzhen) Limited Patrick Chow
K163679 12/27/2016 Digital Automatic Blood Pressure Monitor MD3600 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K163571 12/19/2016 Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. Suzette Chance
K163383 12/01/2016 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System GREENS SURGICALS PVT. LTD. Vinay Kumar
K160532 02/26/2016 Greiner Holdex GREINER BIO-ONE NA INC. MANFRED ABEL
K163436 12/07/2016 Greiner Vacuette Urine Count and Culture, Mannitol tube GREINER BIO-ONE NA INC. MANFRED ABEL
K160349 02/08/2016 Electronic Sphygmomanometer Guangdong Biolight Meditech Co., Ltd. Liang Jin
K160306 02/04/2016 Cloud Smart Thermometer GUANGZHOU BOSMA TECHNOLOGY CO LTD Guoxing Dai
K163603 12/21/2016 Digital Thermometer Guangzhou Jinxinbao Electronic Co., Ltd Mowu Zhu
K163611 12/22/2016 Pain Therapy Device Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K163373 12/01/2016 PK AIM Gyrus ACMI Inc. Graham A.L. Baillie
K163550 12/19/2016 Pobling MIITY 2 HABALAN MED & BEAUTY CO.,LTD RAY JEON
K160502 02/23/2016 TEG 6s Hemostasis System Haemonetics Corporation Paige Sweeney
K163461 12/09/2016 Coolief* Cooled RF Probe Halyard Health, Inc. Monica King
K160512 02/24/2016 HardyCHROM ESBL HARDY DIAGNOSTICS ANDRE HSIUNG
K160560 02/29/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN BHD KUAN KAM HON
K160562 02/29/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SND. BHD. KUAN KAM HON
K160255 02/01/2016 HBOTC Muscle and Nerve Stimulator HB MEDICAL, INC. RYAN HEANEY
K163704 12/29/2016 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC Jianqiu Fang
K160336 02/08/2016 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. Sarah Su
K160557 02/29/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO.,LTD. SARAH SU
K163667 12/27/2016 RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) HEALTH BEACONS, INC. NANCY CONFREY
K160448 02/18/2016 ARTLINE HEALTH LINE INTERNATIONAL CORPORATION JOEL FAULKNER
K163553 12/19/2016 Powder Free Nitrile Patient Examination Gloves, Blue HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD. Shaozhang Nan
K163394 12/05/2016 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K163687 12/28/2016 OLINDA EXM Hermes Medical Solutions AB Joakim Arwidson
K163393 12/02/2016 Hi-Dow Wireless TENS/EMS System (Model HD-SN) Hi-Dow International, Inc. Eric Chen
K163378 12/01/2016 Monarch Airway Clearance System HILL-ROM SERVICES PTE LTD Huifang Zhu
K160559 02/29/2016 NOBLUSÖ Ultrasound Diagnostic System HITACHI MEDICAL CORPORATION ANGELA VAN ARSDALE
K163528 12/16/2016 HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. Doug Thistlethwaite
K163505 12/14/2016 ARIETTA PRECISION HITACHI, LTD ANGELA VAN ARSDALE
K163486 12/12/2016 DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates HNM Total Recon, LLC Noah Roitman
K163623 12/22/2016 Quantra HOLOGIC, INC. Neil Kelly
K160492 02/22/2016 Hospira Sapphire Sets Hospira, Inc David Blonski
K163449 12/08/2016 HyPHo Laser System Hyper Photonics SRL Isabella Carrer
K163659 12/27/2016 Crystal Vision I.C MEDICAL, INC. ELENA S. BUIGA
K160266 02/02/2016 ICONACY(TM) I-Hip(TM) ICONACY ORTHOPEDIC IMPLANTS, LLC Thomas R. Allen
K163390 12/02/2016 iC-GPC Assay TM for use on the iC-SystemTM iCubate, Inc Carter Wells
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K160312 02/05/2016 FRAXIS DUO ILOODA CO., LTD YUN JUNG HA
K160265 02/02/2016 Image Navigator by Immuno Concepts Immuno Concepts, NA, Ltd. Eric S. Hoy
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K163465 12/12/2016 hemochroma PLUS System IMMUNOSTICS, INC. ANTOINETTE PRUSIK
K163577 12/20/2016 Ecofit« Hip System Implantcast GmbH Juliane Hoeppner
K163549 12/16/2016 ClotTriever Thrombectomy System Inari Medical, Inc. Eben Gordon
K160365 02/09/2016 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System Infopia Co., Ltd. NA YUN KIM
K160329 02/05/2016 InMode System MiniFX Handpiece InMode MD Ltd. Amit Goren
K160242 02/01/2016 Reprocessed Livewire Steerable Diagnostic EP Catheter INNOVATIVE HEALTH, LLC RAFAL CHUDZIK
K163560 12/19/2016 Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative Health, LLC. Rafal Chudzik
K160421 02/16/2016 Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K160496 02/22/2016 Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K160303 02/04/2016 Reprocessed Polaris X Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K163525 12/15/2016 QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls Inova Diagnostics, Inc. Peter Martis
K163538 12/16/2016 QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls INOVA DIAGNOSTICS, INC. ROGER ALBESA
K160468 02/19/2016 Synthetic Vinyl Examination Gloves, Powder-Free, Yellow INPRO TECHNOLOGY DEVICE FACTORY WANG YANMEI
K160262 02/02/2016 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG Christopher Klaczyk
K160276 02/02/2016 ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K160415 02/12/2016 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Instrumentation Laboratory Co. Carol Marble
K160412 02/12/2016 GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) Instrumentation Laboratory Co. Carol Marble
K160402 02/12/2016 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) Instrumentation Laboratory Co. Carol Murble
K160445 02/17/2016 HemosIL Silica Clotting Time INSTRUMENTATION LABORATORY CO. Heather L Harvey
K160252 02/01/2016 OmniPod Insulin Management System INSULET CORPORATION MATTHEW KING
K163456 12/09/2016 DuraGen Secure Dural Regeneration Matrix INTEGRA LIFESCIENCES CORPORATION YARA HAMID
K163457 12/09/2016 NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation Gabriella Green
K160238 02/01/2016 Airborne Phototherapy Light INTERNATIONAL BIOMEDICAL Amy Pieper
K163443 12/08/2016 Interson USB Ultrasound System Interson Corporation David Asarnow
K160464 02/19/2016 Opticage(R) Expandable Interbody Fusion Device INTERVENTIONAL SPINE, INC. JANE METCALF
K163488 12/12/2016 Flex-Thread Clavicle Pin System INTRAFUSE LLC Robert Hoy
K163500 12/13/2016 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A. Anne-Sophie Grell
K163512 12/15/2016 Zio AT ECG Monitoring System IRHYTHM TECHNOLOGIES, INC. RICH LAGUNA
K163613 12/22/2016 Bluephase Style 20i IVOCLAR VIVADENT, AG SANDRA CAKEBREAD
K163628 12/22/2016 Idylla Respiratory (IFV-RSV) Panel JANSSEN PHARMACEUTICA NV SARAH PARSONS
K160284 02/03/2016 JointPoint JOINTPOINT, INC. Noah D. Wollowick
K163518 12/15/2016 Digital Thermometer JOYTECH HEALTHCARE CO., LTD Ren Yunhua
K160326 02/05/2016 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) JVC KENWOOD Corporation Tsukasa Tashiro
K160547 02/26/2016 Cascadia Interbody System K2M NANCY GIEZEN
K163471 12/12/2016 Kalitec Direct InSePtionÖ MIS Fixation System KALITEC DIRECT, LLC KEITH CANNAN
K163479 12/12/2016 R2P Metacross RX KANEKA CORPORATION TOSHIHIKO MOTOMINE
K163372 12/01/2016 RX Takeru Balloon Dilatation Catheter KANEKA CORPORATION Toshihiko Motomine
K163632 12/22/2016 Katalyst Cyclophotocoagulation Probe Katalyst Surgical, LLC Meryl Koch
K163516 12/15/2016 Braun No Touch + Forehead NTF3000 Thermometer Kaz USA, Inc., a Helen of Troy Company Rajesh Kasbekar
K160487 02/22/2016 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System KCI USA, Inc. Kristen Weniger Hopewell
K160451 02/18/2016 V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... KCI USA, INC. (KINETIC CONCEPTS, INC.) MELANIE AVILA
K160474 02/19/2016 DSM Biomedical Porcine Pericardium Dental Membrane Kensey Nash Corporation dba DSM Biomedical Brianna Schehr
K163386 12/02/2016 Keos Lumbar IBFD Keos Mark F Schenk
K160334 02/08/2016 Advanced Medical Imaging Software Suite (KSWVWR) KEOSYS SAS Laurence BOY-MACHEFER
K160441 02/17/2016 Identic and KromaFaze Alginate Dental Impression Materials KERR CORPORATION Mohammad Saad Ansari
K163405 12/05/2016 360KS Implant Positioning System Kico Knee Innovation Company PTY Limited Karl Rentsch
K163579 12/20/2016 KLS Martin Individual Patient Solutions KLS Martin LP Jennifer Damato
K160357 02/08/2016 TRINITY KOELIS LAETITIA GERVAIS
K160467 02/19/2016 Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Kossan International Sdn. Bhd. Cho Sow Fong
K163482 12/12/2016 Orthodontic Acrylic 2 Lang Dental Manufacturing Co., Inc. Dave Lang
K160518 02/24/2016 LEONI ORION System LEONI CIA CABLE SYSTEM AURELIE GENHO
K163647 12/23/2016 Revolve Envi 600 Advanced Adipose System LifeCell Corporation Anuja Yardi
K163397 12/05/2016 SMR Hybrid Glenoid System Limacorporate S.p.A. Michela Zanotto
K163517 12/15/2016 Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ?g/mL LIOFILCHEM S.R.L. FABIO BROCCO
K163639 12/23/2016 LS-5 ePTFE Suture LSI SOLUTIONS Kevin Bentley
K160529 02/25/2016 Pledgeted COR-SUTURE QUICK LOAD LSI SOULTIONS KEVIN BENTLEY
K160477 02/19/2016 The Luco Hybrid OSA Appliance LUCO HYBRID OSA APPLIANCE INC. Ken Luco
K163626 12/22/2016 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation Kate Linak
K160517 02/24/2016 ARIES System LUMINEX CORPORATION Wendy Ricker
K160380 02/10/2016 LT-300 HD Lutech Industries, Inc. Ronald Vachula
K163572 12/19/2016 LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source LV Liberty Vision Corp. Paul T. Finger
K160316 02/05/2016 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles M.D.L. S.r.l. Marcello Dell'Oca
K163522 12/15/2016 FilmArray Warrior Control Panel M290 Maine Molecular Quality Controls, Inc. Joan Gordon
K163498 12/13/2016 VALIDATE Heparin Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY, LLC JAMES CHAMPLIN
K160318 02/05/2016 PlasmaFlow MANAMED, INC Trevor Theriot
K160526 02/25/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION MARGUERITE THOMLINSON
K163643 12/23/2016 SIRIO H3 MASMEC SPA Domenico Marino
K160416 02/16/2016 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes MAUNA KEA TECHNOLOGIES VERONIQUE DENTAN
K160289 02/03/2016 MasterLoc Stem MEDACTA INTERNATIONAL MICHAEL G. LOITERMAN
K160358 02/09/2016 DT-100 Mediana Co., Ltd. Min-hye Kim
K160431 02/16/2016 ActiveCare Home MEDICAL COMPRESSION SYSTEMS (DBN) LTD. YAKI BARAK
K163595 12/21/2016 IMPIX 3D Print Cages MEDICREA INTERNATIONAL S.A. David Ryan
K160536 02/26/2016 Chaorum Implant System MEDIMECCA CO., LTD. PARK YOUNG WAN
K160503 02/24/2016 Vented Vial Adapter Transfer Device - 13mm MEDIMOP MEDICAL PROJECTS LTD. Ilanit Goldgraber
K163688 12/28/2016 Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 MEDISONO, LLC JORGE MILLAN
K160471 02/19/2016 Medline Non-Surgical Isolation Gown- MEDLINE INDUSTRIES, INC. PAULINE MARALIT
K163401 12/05/2016 Nix Ultra Lice Treatment Kit MEDTECH PRODUCTS INC. JEAN BOYKO
K163565 12/19/2016 MR8 Drill System MEDTRONIC POWERED SURGICAL SOLUTIONS Deep Pal
K163581 12/20/2016 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments MEDTRONIC SOFAMOR DANEK USA, INC LAVEEDA LEFLORE
K160418 02/16/2016 PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc Ankit K. Shah
K163375 12/01/2016 INFINITYÖ OCT System Medtronic Sofamor Danek USA, Inc. Tejas Patel
K160528 02/25/2016 ANATOMIC PEEK PTC Cervical Fusion System MEDTRONIC SOFAMOR DANEK, USA, INC. LEE GRANT
K163460 12/09/2016 Reveal LINQ Insertable Cardiac Monitor MEDTRONIC,INC. Laura Danielson
K160548 02/29/2016 MC-Subtalar(TM) II MERETE MEDICAL GMBH PAUL MUNCH
K163575 12/19/2016 Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K163597 12/21/2016 VacLok AT Vacuum Syringe Merit Medical Systems, Inc. Angela Brady
K163578 12/20/2016 EasyTouch Safety Pen Needle MHC Medical Products, LLC. John Edmiston
K163376 12/01/2016 Mikro-Cath Pressure Catheter Millar, Inc. Jacqueline Jean-Baptiste
K160429 02/16/2016 BC-5390 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Min Zheng
K160400 02/12/2016 Miromatrix Biological Mesh MIROMATRIX MEDICAL INC. JEFF ROSS
K163442 12/08/2016 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) Modern Medical Equipment Manufacturing Limited Thomas Tsz Fung Chan
K160379 02/10/2016 Exufiber Ag+ MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K160434 02/16/2016 ClearPoint System MRI INTERVENTIONS, INC. Peter Piferi
K160287 02/03/2016 Rapid Barostat Bag (RBB) Pump and Catheter MUI SCIENTIFIC TAMMY MUI
K160427 02/16/2016 dynaMX(TM) Nitinol Compression Screw MX ORTHOPEDICS CORP. HOWARD L. SCHRAYER
K163696 12/29/2016 SleepImage System MyCardio, LLC dba SleepImage. Robert Schueppert
K163402 12/05/2016 NLZ Motor System NAKANISHI INC. Kimihiko Satoh
K163483 12/12/2016 PANA SPRAY Plus NAKANISHI, INC. Kimihiko Satoh
K163414 12/05/2016 Ultrasonic scaler NANNING VV DENTAL CO., LTD. Liang chaojun
K163672 12/27/2016 Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor NANOVA BIOMATERIALS, INC. ANDREW RITTS
K163425 12/06/2016 NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System NARANG MEDICAL USA CORPORATION Reginald Swift
K160305 02/04/2016 neoBLUE« LED Phototherapy System Natus Medical Incorporated Judy Buckham
K163452 12/09/2016 PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. Robin Fuller
K160511 02/24/2016 Naya Breast Pump System NAYA HEALTH INC. Janica B. Alvarez
K160500 02/23/2016 Elite SPK, Compasso, Elite SPK Kit NCS Lab Srl Matteo Mantovani
K163674 12/27/2016 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry NEO COSMETIQUE NATHALIE VERNIN
K160350 02/08/2016 ECG CT Gating Device NEOCOIL, LLC MICHAEL LEIGH
K163526 12/16/2016 BilicocoonÖ Phototherapy System NEOMEDLIGHT Pierre Saint Girons
K160442 02/17/2016 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers NEURAL ANALYTICS, INC. JAY YONEMOTO
K163547 12/16/2016 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 NEUROVIRTUAL USA, INC. Eduardo Faria
K163564 12/19/2016 SLIT LAMP SL-2000 NIDEK CO., LTD. Yoneji Mizuno
K163644 12/23/2016 Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation Tom Bento
K163459 12/09/2016 Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation Tom Bento
K160444 02/17/2016 FB-U Hemodialyzer NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K160367 02/09/2016 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Nissin-Metec China Co., Ltd. Xiwei Shen
K160389 02/11/2016 NovaCross Microcatheter Nitiloop Ltd. Chanan Schneider
K163600 12/21/2016 Kit Boxes and Kit Plates Nobel Biocare AB Charlemagne Chua
K160231 02/01/2016 Model X-100C CO-MetÖ Oximetry System NONIN MEDICAL, INC. KIM E. AVES
K163490 12/12/2016 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K160371 02/10/2016 NovaPACS NOVARAD CORPORATION DOUG MERRILL
K160392 02/11/2016 Novilase Laser Therapy System, Model LTS-2 NOVIAN HEALTH, INC. WILLIAM GRAVEMAN
K160501 02/23/2016 Noxilizer Surgical Ruler Noxilizer,Inc. Mary Dadone
K160352 02/08/2016 MAGEC« Spinal Bracing and Distraction System NuVasive Specialized Orthopedics, Inc. LANCE JUSTICE
K163491 12/12/2016 NuVasive CoRoent Small Interbody System NuVasive, Incorporated Martin Yahiro
K163707 12/29/2016 NuVasive CoRoent Ti-C System NuVasive, Incorporated Cynthia Adams
K160510 02/24/2016 MAKO 7 nVision Medical Corporation Surbhi Sarna
K160417 02/16/2016 Rezum System NxThera, Inc. J. Robert Paulson
K160241 02/01/2016 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K163469 12/12/2016 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K160249 02/01/2016 ULTRA Telescopes Olympus Winter & Ibe GmbH Katharina Campbell
K160407 02/16/2016 spineEOS ONEFIT MEDICAL JULIEN SIMON
K163475 12/12/2016 iVue Optovue, Inc. Edward J. Sinclair
K163566 12/19/2016 Hubble I System Orbbo Surgical, LLC. Eric Garofano
K163602 12/21/2016 Kepler I Cervical Plate System Orbbo Surgical, LLC. Eric Garofano
K163379 12/01/2016 KneeAlign 2 System OrthAlign, Inc. David Vancelette
K163433 12/07/2016 VITROS Chemistry Products GLU Slides Ortho Clinical Diagnostics Darlene J. Phillips
K163489 12/12/2016 OrthoSolutions 'System26' Bone Screws Ortho SOlutions UK Limited Craig Bluett
K160495 02/22/2016 VITROS« Automation Solutions Ortho-Clinical Diagnostics, Inc. Darlene J Phillips
K160466 02/19/2016 Response 5.5 Spine System ORTHOPEDIATRICS CORP. Mark Fox
K163621 12/22/2016 Vitoss Bioactive (BA) Injectable Orthovita, Inc. John Rossman
K160522 02/25/2016 White Pearl Preferred Angle Anterior Cervical Plate OSSEUS FUSION SYSTEMS, LLC Robert Pace
K160519 02/25/2016 Link Abutment for CEREC Osstem Implant Co., Ltd Hee Kwon
K163557 12/19/2016 SS SA Fixture OSSTEM IMPLANT Co., Ltd. Mr. HeeKwon
K160363 02/09/2016 OPTIMUS CMF SYSTEM OSTEONIC Co., Ltd. Jisun Lee
K160234 02/01/2016 OVENT OVENTUS MANUFACTURING PTY LTD Neil Anderson
K163382 12/01/2016 Oxitone 1000 Oxitone Medical Ltd. Leon Eisen
K160295 02/03/2016 SPROTTE NRFit, Quincke NRFit PAJUNK GmbH Medizintechnologie Christian G. H. Quass
K160294 02/03/2016 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G.H. QUASS
K160296 02/03/2016 SPROTTE SPECIAL NRFit PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G.H. QUASS
K160297 02/03/2016 Tuohy NRFit PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K163609 12/22/2016 Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) PALL INTERNATIONAL SARL Karen Peterson-Doyle
K163423 12/06/2016 Orthopantomograph OP300 PaloDEx Group Oy Eric Schwandt
K163484 12/12/2016 Paxman Scalp Cooler Paxman Coolers Limited Richard PAXMAN
K163432 12/07/2016 Stellar LEAP PDG Product Design Group, Inc Torr Brown
K160545 02/26/2016 GAP ENDO-EXO MEDULLARY SYSTEM PEGA MEDICAL INC. Ariel R. Dujovne
K163614 12/22/2016 PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX Medical Kanchana Iyer
K163618 12/22/2016 INDIGO Aspiration System PENUMBRA, INC. RICHARD KIMURA
K160533 02/18/2016 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) PENUMBRA, INC. RICHARD KIMURA
K160449 02/18/2016 Penumbra System, Penumbra Pump MAX PENUMBRA, INC. RICHARD KIMURA
K160240 02/01/2016 Perimeter OtisÖ 1.0 Optical Coherence Tomography System PERIMETER MEDICAL IMAGING, INC. ELIZABETH MUNRO
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K160304 02/04/2016 OsteoBullet Compression Screw Phalanx Innovations Daniel Lanois
K163410 12/05/2016 DigitalDiagnost C50 PHILIPS HEALTHCARE (SUZHOU) CO., LTD. ALINA ZHOU
K163584 12/20/2016 M3290B Philips IntelliVue Information Center iX Philips Medical Systems Theresa Poole
K163649 12/23/2016 SureSigns VS3; SureSigns VS4 Philips Medical Systems Greg Li
K163711 12/30/2016 IQon Spectral CT Philips Medical Systems (Cleveland), Inc. Steven Goldberg
DEN160056 12/01/2016 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. Esther Abels
K163715 12/30/2016 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K160455 02/18/2016 AneurysmFlow PHILIPS MEDICAL SYSTEMS NEDERLAND BV Jeanette Becker
K160315 02/05/2016 I4 (Integrated Intelligent Imaging Informatics) system PHILIPS MEDICAL SYSTEMS NEDERLAND BV Ilana Ben Moshe
K160506 02/24/2016 Planmeca ProMax 3D Max, Planmeca Maximity PLANMECA OY LARS MORING
K160569 02/29/2016 NeuGuide POP Medical Solutions Guy Ohad
K163473 12/12/2016 Upper Arm Blood Pressure Monitor Portal 724, LLC George Oneid
K160568 02/29/2016 Precision Spine Interspinous Plate System Precision Spine, Inc. Michael C. Dawson
K163447 12/08/2016 Premium Plus Disposable Barrier Sleeve PREMIUM PLUS INTERNATIONAL LIMITED JESSICA MAO
K160361 02/09/2016 PRIMAGARD Isolation Gown (AAMI PB70 Level 3) PRIMED MEDICAL PRODUCTS INC. RICHARD R ROY
K160425 02/16/2016 CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. ARMIN ZEHTABCHI
K163374 12/01/2016 ALLYÖ Facet Screws PROVIDENCE MEDICAL TECHNOLOGY, INC. MARGARET WONG
K163474 12/12/2016 CAVUX CervicalCage-L SA System PROVIDENCE MEDICAL TECHNOLOGY, INC. EDWARD LIOU
K163590 12/20/2016 Psychemedics Microplate EIA for Benzodiazepines in Hair Psychemedics Corporation Virginia Hill
K160405 02/16/2016 OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN Sandor-Csaba Ats
K160347 02/08/2016 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD Liu zhitang
K163708 12/29/2016 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K160368 02/09/2016 EVO platform Quanta System SpA FRANCESCO DELL'ANTONIO
K160513 02/24/2016 Quanta System Surgical Laser fibers QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K163713 12/30/2016 Sofia Lyme FIA, Sofia Lyme Control Set Quidel Corporation Jennifer S Rial
K160561 02/29/2016 Boosting Catheter QXMEDICAL, LLC FERNANDO DI CAPRIO
K163462 12/09/2016 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical ApS Per Pape Thomsen
K160458 02/19/2016 BI IMAGE-X EVOLUTION RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. Marcelo Mojica
K163661 12/27/2016 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil RAPID Biomedical GmbH Christian Zimmermann
K160525 02/25/2016 RCT700 RAY CO.,LTD Changhwan Lee
K160463 02/19/2016 Reliance Lumbar IBF System Reliance Medical Systems, LLC Bret M Berry
K163666 12/27/2016 neuro inspire Rensihaw plc Roberto Liddi
K160504 02/24/2016 RI Witness Embryology Heated Plate RESEARCH INSTRUMENTS LIMITED Wendy Hassan
K163585 12/20/2016 Responsive Orthopedics Total Hip Arthroplasty System Responsive Orthopedics, LLC Kathy Remsen
K160382 02/10/2016 OT EQUATOR RHEIN'83 SRL CLAUDIA NARDI
K160475 02/19/2016 Ritter Dental Implant System Ritter Implants GmbH & Co. KG Werner Schmitz
K163569 12/19/2016 Elecsys CMV IgM Roche Diagnostics Angelo Pereira
K163633 12/22/2016 cobas HbA1c Test, cobas b 101 system Roche Diagnostics Operations Patty Bates
K160571 02/29/2016 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (RDO) David Tribbett
K160570 02/29/2016 Creatine Kinase Roche Diagnostics Operations (RDO) Noel B. Mencias
K163694 12/28/2016 Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs Ltd. Sue Chuang
K163673 12/27/2016 FortilinkÖ-C with TETRAfuseÖ 3D Technology RTI Surgical, Inc. Diana Taylor
K160493 02/22/2016 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm Salvin Dental Specialties Jennifer Singer
K163691 12/28/2016 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Emily Woo
K160271 02/02/2016 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 SAN-M PACKAGE CO., LTD. Shogo Nagao
K160269 02/02/2016 Surgical Face Masks (Ear loops and Tie-on) SAN-M PACKAGE CO., LTD. Shogo Nagao
K163610 12/22/2016 PIEZOTOME M+, PIEZOTOME M+ Handpiece SATALEC-ACTEON GROUP PHILIPPE GIRARD
K160282 02/02/2016 SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System SD BIOSENSOR Sunok Go
K163604 12/21/2016 SeaSpine« Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K160345 02/08/2016 Glass Ionomer Cement SHANDONG HUGE DENTAL MATERIAL CORPORATION Steven Song
K160320 02/05/2016 Premier Shandong Weigao Orthopaedic Device Co., Ltd Han Wang
K163422 12/06/2016 Shanghai Sanyou PEEK Cage System SHANGHAI SANYOU MEDICAL CO, LTD David Fan
K163655 12/23/2016 Sparkling Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Amy Lee
K163606 12/21/2016 Digital Blood Pressure Monitor-Automatic Upper Arm Style Shenzhen Combei Technology CO., LTD Huaguang Meng
K160530 02/25/2016 Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. Mina Cheng
K160370 02/10/2016 BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Zeng Zhe
K160381 02/10/2016 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD WU ZICUI
K163690 12/28/2016 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yang Zhaohui
K163470 12/12/2016 Galvanic Spa, Model: SKB-1405 ShenZhen Siken 3D Technology Development Co., Ltd. Kimi Xue
K163712 12/30/2016 Clover 50/Clover60/Clover70 Diagnostic Ultrasound System SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. JIANG XIAOSAN
K163568 12/19/2016 SHOFU RESIN GLAZE Shofu Dental Corporation Mauro Malzyner
K163658 12/23/2016 ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Siemens Healthcare Diagnostics Inc. Darius Daruwala
K163478 12/12/2016 AcuNav Volume ICE Catheter Siemens Medical Solutions USA, Inc. Shelly Pearce
K163396 12/05/2016 ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc. Shelly Pearce
K160317 02/05/2016 syngo.via MI Workflows SIEMENS MEDICAL SOLUTIONS USA, INC. Veronica Padharia
K160426 02/16/2016 syngo.via MI Workflows SIEMENS MEDICAL SOLUTIONS USA, INC. Veronica Padharia
K163421 12/06/2016 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K163635 12/22/2016 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K163589 12/20/2016 SIGN IM Nail SIGN FRACTURE CARE INTERNATIONAL Robert Schmitt
K163625 12/22/2016 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K160420 02/16/2016 SpeqT Signostics Limited Stewart Bartlett
K163676 12/27/2016 Silhouette InstaLift SILHOUETTE LIFT, INC. DOUG ABEL
K163653 12/23/2016 NOVOS-NAIL Limb Lengthening System (LLS) Smith & Nephew Allison Chan
K163387 12/02/2016 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K160235 02/01/2016 ViaValve Safety I.V. Catheter SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K160472 02/19/2016 Hidrocor, Hidrocharme, and Natural Colors SOLOTICA Gilberto Zablith
K160283 02/03/2016 S45 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K163427 12/06/2016 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K160258 02/01/2016 X5 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K163634 12/22/2016 External Hex Implants SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K163657 12/23/2016 Quantum Workstation Spectrum Medical Ltd Mark Drain
K160278 02/02/2016 VSTAAR AdjusteR SPINAL ACOUSTICS, LLC ALBERT A. TORRENCE
K160465 02/19/2016 Spinal Elements' Spinous Process Plate System Spinal Elements Inc. Julie Lamothe
K163428 12/06/2016 HA Minuteman G3-R MIS Fusion Plate Spinal Simplicity Douglas B Snell
K163670 12/27/2016 Rampart One Lumbar Interbody Fusion Device SPINEOLOGY INC. Jacqueline A. Hauge
K163409 12/05/2016 Rampart(TM) T Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K160335 02/08/2016 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D St. Jude Medical Tamara Stanczak
K163407 12/05/2016 Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. Jennifer Dunham
K163450 12/08/2016 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K160433 02/16/2016 V-PRO« 1 Plus and V-PRO« maX Low Temperature STERIS CORPORATION BILL BRODBECK
K163587 12/20/2016 VERIFY Incubator for Assert Self Contained Biological Indicators STERIS Corporation Anthony Piotrkowski
K160485 02/22/2016 VERIFY VH2O2 Indicator Tape STERIS CORPORATION Anthony Piotrkowski
K160332 02/08/2016 Stryker SDC3 HD Information Management System with Wireless Device Control Capability Stryker Endoscopy Angela Wong
K163656 12/23/2016 Hoffmann LRF System Stryker GmbH Paul Nelson
K163494 12/13/2016 Summit Spine Channel Cervical Interbody Fusion System Summit Spine Eric Buescher
K163448 12/08/2016 GrindCare System SUNSTAR SUISSE S.A. Olivier Ducamp
K160439 02/17/2016 SunTech CT40 Spot-check Vital Signs Device SUNTECH MEDICAL CHUCK SETZER
K160333 02/08/2016 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K163455 12/09/2016 SurgiCube SURGICUBE INTERNATIONAL B.V. GER VIJFVINKEL
K163558 12/19/2016 Synapsys Ulmer Video Nystagmograph Synapsys SA Laetitia Baconnier
K160523 02/25/2016 BrightMatter Guide with BrightMatter Pointer SYNAPTIVE MEDICAL INC. Cameron Piron
K163415 12/05/2016 SlimShape System Syneron Medical Ltd. Ruthie Amir
K160553 02/29/2016 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws û MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) û MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System ûMR Conditional, DePuy Synthes Small Fragment Dynamic Compressi SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC ELIZABETH JACOBS
K160541 02/26/2016 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control SYSMEX AMERICA, INC. Michelle Parker
K160538 02/26/2016 Sysmex XN-L Automated Hematology Analyzer SYSMEX AMERICA, INC. SHARITA BROOKS
K160482 02/22/2016 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. Michael Sarrasin
K160374 02/10/2016 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System TANGENT MEDICAL TECHNOLOGIES, INC. GREG LAST
K160372 02/10/2016 URITEK TC-201 URINE CHEMISTRY TEST SYSTEM TECO DIAGNOSTICS, INC. AQUIL MERCHANT
K160309 02/04/2016 Neurosoft TMS TeleEMG, LLC Joe F Jabre
K163646 12/23/2016 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene SA Maria Victoria Quiroga
K163531 12/16/2016 Advanced Perfusion System 1 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BRYAN HANN
K160328 02/05/2016 DIVA ZSP2105CMI with QUBYX PerfectLum bundle THE LINDEN GROUP CORP. ROBERT COLAIZZO
K160376 02/10/2016 EndoSize Therenva SAS Cemil Goksu
K160244 02/01/2016 VARIOunite Thommen Medical AG Daniel Snetivy
K160280 02/02/2016 MagPro R20 TONICA ELEKTRONIK A/S Lise Terkelsen
K160366 02/09/2016 Electrosurgical disposable grounding pads TOP-RANK Health Care Co., Ltd Liubo Shen
K160555 02/29/2016 BLUEPRINT Patient Specific Instrumentation TORNIER SAS AYMEN AZAIEZ
K163702 12/29/2016 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K160386 02/11/2016 ReadeR, VieweR, QuickScan PSP TRIDENT S.R.L GIORGIO RIZZO
K163640 12/23/2016 QZA and RS Dental Implant Systems TRINON Titanium GmbH Katja Lvova
K163586 12/20/2016 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector TrovRx, Inc. dba Trovita Health Science William Brown
DEN160006 02/03/2016 everlinQ endoAVF System TVA Medical, Inc. Noah Bartsch
K160401 02/12/2016 Tyto Stethoscope Tyto Care Ltd. Yoni Iger
K160551 02/29/2016 VALO Grand ULTRADENT PRODUCTS, INC. Marie Hess
K163441 12/08/2016 Locking Cage, Full XPE Cup UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K163424 12/06/2016 AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON United State Endoscopy Group, Inc. Ganga Kolli
K163495 12/13/2016 AdvanCE capsule endoscope delivery device United States Endoscopy Group, Inc. Carroll Martin
K163492 12/13/2016 Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear United states Endoscopy Group, Inc. Carroll Martin
K163607 12/21/2016 ECG Acquisition Systems VALES & HILLS BIOMEDICAL TECH. LTD. Jianfang Liu
K160516 02/24/2016 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths Varian Medical Systems, Inc Peter J. Coronado
K163444 12/08/2016 Spectre guidewire Vascular Solutions, Inc. Beka Vite
K163705 12/29/2016 EzRay Air W Vatech Co., Ltd Daniel Kim
K163508 12/14/2016 PIVO Velano Vascular Tiffini Diage
K160377 02/10/2016 V-varnish Premium Vericom Co., Ltd. Myung-Hwan Oh
K163506 12/14/2016 CoalesceÖ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System Vertera, Inc. Wei Allen Chang
K163703 12/29/2016 VIVIX-S 1417N VIEWORKS CO., LTD. JORDIN KIM
K163487 12/12/2016 Ultima HA Coated Half Pins and Wire Vilex in Tennessee, Inc Sylvia Southard
K163472 12/12/2016 Intra.Ox Handheld Tissue Oximeter VIOPTIX, INC. MARK LONSINGER
K163504 12/14/2016 Borrelia B31 ViraChip IgG Test Kit VIRAMED BIOTECH AG MARTIN KINTRUP+
K163695 12/28/2016 Borrelia B31 ViraChip IgM Test Kit Viramed Biotech AG Martin Kintrup
K160344 02/08/2016 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 Visco Vision Inc Evan Huang
K160245 02/01/2016 Visco (olifilcon A) soft contact lens Visco Vision Inc Evan Huang
K160327 02/05/2016 ALADDIN HW3.0 VISIA IMAGING S.R.L Silvia Fantechi
K163453 12/09/2016 VitalPatch« VitalConnect Platform VITAL CONNECT, INC. KEVIN POTGIETER
K163574 12/19/2016 Multi Modality Viewer Vital Images, Inc. Susan Atwood
K160253 02/01/2016 Vitalograph Model 6300 micro VITALOGRAPH (IRELAND) LTD. TOM J HEALY
K163576 12/19/2016 GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc. Michael J. Titus
K160254 02/01/2016 GORE DrySeal Flex Introducer Sheath W.L. GORE & ASSOCIATES, INC. Mary Townsend
K160499 02/23/2016 Apnea Risk Evaluation System (ARES), Model 620 Watermark Medical Frank Katarow
K163511 12/15/2016 NovaGuard SA Pro Safety System WEST PHARMACEUTICAL SERVICES, INC. Ana Ladino
K160355 02/08/2016 CX20N(CX20PUX) WIDE Corporation YeoJin Yun
K160348 02/08/2016 CX30N (CX30PQX) WIDE CORPORATION YEOJIN YUN
K160351 02/08/2016 CX50N, CX50YQS WIDE Corporation YeoJin Yun
K160346 02/08/2016 MX30N(MX30TQS) WIDE Corporation YeoJin Yun
K160353 02/08/2016 MX50N(MX50YQS) WIDE Corporation YeoJin Yun
K160354 02/08/2016 MX50T(MX50TQS) WIDE CORPORATION YeoJin Yun
K163377 12/01/2016 Captura Disposable Bronchoscope Biopsy Forceps Wilson-Cook Medical Inc. Ashley Howard
K160544 02/26/2016 Withings Thermo (Model SCT01) WITHINGS Xavier Debreuil
K163650 12/23/2016 ORTHOLOC« 3Di Ankle Fusion Plating System Line Extension Wright Medical Technology, Inc. Rachel Roberts
K160549 02/29/2016 MEDICAL DIODE LASER SYSTEMS WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD NIE XINXING
K160428 02/16/2016 Certex Spinal Fixation System X-spine Systems, Inc. David Kirschman
K160246 02/01/2016 SimulCare II(TM) XANACARE TECHNOLOGIES, LLC THOMAS C SIIROLA
K160313 02/05/2016 Xenco Medical Cervical Interbody System XENCO MEDICAL, LLC GUSTAVO PRADO
K163388 12/02/2016 XPress BCD Breast Compression Device XPress BCD, LLC Peter Kremers
K160341 02/08/2016 Colposcope System XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD JING WANG
K163476 12/12/2016 Lubricity You First Services, Incorporated Jeffrey Eberhard
K163400 12/05/2016 Orbit Inserter YPSOMED AG STEPHAN AFFOLTER
K160362 02/09/2016 Z-Span Plate System Zavation, LLC Frankie Cummins
K160259 02/01/2016 ZELTIQ CoolSculpting System ZELTIQ AESTHETICS, INC. SHRUTI JAYAKUMAR
K163665 12/27/2016 MATRx plus Zephyr Sleep Technologies Sabina Bruehlmann
K163543 12/16/2016 Biomet Fusion System Zimmer Biomet Spine Inc. Megan Fessenden
K160398 02/12/2016 MRI Compatibility for Existing Zimmer Dental Implant Systems Zimmer Dental, Inc. Alex Eastes


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