FDA 510(k) Applications Received During September, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K162482 09/06/2016 A.B. DENTAL DEVICES Dental Implants System A. B. Dental Device Ltd. Gabi Krauss
K162554 09/13/2016 Gentrix Surgical Matrix Acell, Inc. Salman Elmi
K162579 09/15/2016 VascuCel Admedus Regen Pty Ltd Mary E. Donlin
K162596 09/16/2016 AIR OPTIX COLORS Alcon Laboratories, Inc. Sherri Lakota
K162597 09/19/2016 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Sherri Lakota
K162642 09/22/2016 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit ALERE SCARBOROUGH, INC. SARA HALLOWELL
K162529 09/09/2016 DigiX FDX Allengers Medical Systems Limited Manmohan Singh
K162721 09/29/2016 Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator ALLIQUA BIOMEDICAL, INC. KATHY SIMPSON
K162574 09/15/2016 AmCAD-US AmCad BioMed Corporation Jack Yang
K162589 09/16/2016 Adscope 658 Electronic Stethoscope AMERICAN DIAGNOSTIC CORP. Michael Falco
K162668 09/26/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO.,LTD LIU YI
K162449 09/01/2016 Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) ANGIODYNAMICS, INC KASEY E NEWCOMB
K162676 09/26/2016 Voyant Open Fusion Device Applied Medical Resources Jessica Cho
K162461 09/02/2016 Endoform Plastics and Reconstructive Matrix AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) Yasmin Rai
K162608 09/19/2016 ClariFix Device ARRINEX, INC. VAHID SAADAT
K162513 09/08/2016 Arterys Software v2.0 ARTERYS INC. GOLNAZ MOEINI
K162625 09/20/2016 SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters B. BRAUN INTERVENTIONAL SYSTEMS INC. PETER FLOSDORF
K162562 09/14/2016 OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY BCG MEDICAL, LLC LISA GIAP
K162740 09/30/2016 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) BECKMAN COULTER, INC. SHANNON POPSON
K162516 09/09/2016 BD Pen Needle BECTON, DICKINSON AND COMPANY MERIAM YOUSSEF
K162525 09/09/2016 Oniko nail brace BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI FATMA GULRU ERDOGAN
K162499 09/07/2016 Best Instruminal Applicator BEST MEDICAL INTERNATIONAL, INC. MANNY SUBRAMANIAN
K162689 09/27/2016 Vibrance Pelvic Trainer BIOINFINITY (M) SDN. BHD. NG SHEA KANG
K162737 09/30/2016 VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4?g/mL) bioMerieux, Inc CHERECE L. JONES
K162559 09/14/2016 Move Forward 3D Motion Simulation Service BIOMET INC. PAUL HARDY
K162674 09/26/2016 BioPro Foot Plating Systems BIOPRO, INC. AL LIPPINCOTT
K162569 09/15/2016 YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer BIOTECH LUBRICANTS LTD Sarah Brooks
K162571 09/15/2016 Bioflux Software Biotricity Inc. Tom Elias
K162598 09/19/2016 HAPI Seal BISCO, INC. Ryan Hobson
K162567 09/14/2016 ExactechGPS Total Shoulder Application, Equinoxe Planning Software Blue Ortho Anthony Boyer
K162487 09/07/2016 BSD3543 Digital Flat Panel X-ray Detector BONTECH INC. KWANG S. CHOI
K162523 09/09/2016 The IQool System BRAIN COOL AB MARTIN WALEIJ
K162723 09/29/2016 TransFix/EDTA Vacuum Blood Collection Tubes Caltag Medsystems Ltd. Daniel Harrison
K162503 09/07/2016 Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software Cardiac Insight, Inc. Brad Harlow
K162568 09/14/2016 INTRABEAM 600 CARL ZEISS MEDITEC AG Christian Muenster
K162684 09/26/2016 SL 220 Carl Zeiss Meditec AG Christian Muenster
K162456 09/02/2016 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System CEPHEID SCOTT A. CAMPBELL
K162566 09/14/2016 AIK Sterile Acupuncture Needles for Single Use CHANGCHUN AIK MEDICAL DEVICES CO., LTD XINGWANG LI
K162590 09/16/2016 Bashan TDP Heat Lamp Chogqing YUHE Medical Instruments Co., Ltd. Liu Yong
DEN160043 09/20/2016 Sentinel Cerebral Protection System Claret Medical, Inc. Zachary Woodson
K162609 09/19/2016 ClearPath Aligner ClearPath Orthodontics Ltd Waqas Wahab
K162563 09/14/2016 YOGA Microcatheter CODMAN & SHURTLEFF, INC. YOON HEE BEATTY
K162719 09/29/2016 iTotal« Hip Replacement System ConforMIS, Inc. Amita Shah
K162741 09/30/2016 AxoGuard Nerve Connector COOK BIOTECH INCORPORATED PERRY W. GUINN
K162729 09/29/2016 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip COOK INCORPORATED KOTEI AOKI
K162448 09/01/2016 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Cook Incorporated Jessica Swafford
K162717 09/29/2016 Evolution Esophageal Stent System û Partially Covered Cook Ireland Ltd. Jane Kennedy
K162496 09/07/2016 Foundation 3D Interbody CoreLink, LLC Stephan Jones
K162515 09/08/2016 COSMED K5 Wearable Metabolic Technology COSMED S.r.l. Andrea Duca
K162738 09/30/2016 Puritan Bennett 980 Ventilator System Covidien Kelsey Lee
K162584 09/16/2016 VersaOne Bladeless Trocar COVIDIEN TRANG HUYNH
K162734 09/30/2016 CreoDent Solidex Customized Abutment CreoDent Prosthetics, Ltd. Calvin Shim
K162506 09/08/2016 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K162695 09/27/2016 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K162682 09/26/2016 MATISSE Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation Tosan Onosode
K162697 09/27/2016 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal Custom Orthopaedic Solutions, Inc. Keith Grafmeyer
K162512 09/08/2016 truSculpt CUTERA, INC. BRADLEY RENTON
K162727 09/29/2016 SENYINT Remote Consultation System Dalian Senyint Digital Medical System Co., Ltd. Yinghui Miao
K162654 09/23/2016 mollosil plus DETAX GmbH & Co.KG Antje Reeps
K162552 09/13/2016 EVS 3643, EVS 3643G DRTECH Corporation Choul-Woo Shin
K162555 09/13/2016 EVS 4343, EVS 4343G DRTECH CORPORATION CHOUL-WOO SHIN
K162670 09/26/2016 RSM 1824C with RConsole1 DRTECH CORPORATION CHOUL-WOO SHIN
K162509 09/08/2016 Infrared Non-contact Thermometer, Model ACT8100 EASYWELL BIOMEDICALS, INC. Arthur Chen
DEN160044 09/26/2016 Acumen Hypotension Prediction Index (HPI) Feature Software Edwards Lifesciences LLC Lisa Gilman
K162474 09/06/2016 Artemis EIGEN William Mandel
K162497 09/07/2016 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR EIZO CORPORATION Hiroaki Hashimoto
K162490 09/07/2016 Disc-FX System ELLIQUENCE LLC Paul D. Buhrke IV
K162627 09/20/2016 EnsoSleep EnsoData, Inc. Chris Fernandez
K162578 09/15/2016 Zerona Z6 OTC ERCHONIA CORPORATION STEVEN SHANKS
K162744 09/30/2016 Everyway OTC EMS, Model EV-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. PAUL HUNG
K162732 09/29/2016 Exactech« Alteon« HA Femoral Stem EXACTECH INC Thomas McNamara
K162726 09/29/2016 Exactech« Equinoxe« Preserve Stem EXACTECH INC Thomas McNamara
K162508 09/08/2016 KerraCel Ag Gelling Fiber Silver Dressing Exciton Technologies Inc. Melanie Ussyk
K162693 09/27/2016 VertebraLINK Fusion Platform FACETLINK DBA LINKSPINE MASSIMO CALAFIORE
K162767 09/30/2016 Sentinel BreastScan II System First Sense Medical, LLC Alan Alan Klevens
K162582 09/15/2016 HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit FISHER & PAYKEL HEALTHCARE Tina O'Brien
K162450 09/01/2016 ESPADA Acne-Clearing Blue Light Pen FOREO INC. Davor Soldo
K162462 09/02/2016 AMICUS Separator System, AMICUS Separator System; Refurbished FRESENIUS KABI USA LLC KIM FORCH
K162488 09/07/2016 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K162716 09/29/2016 bibag FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC Denise Oppermann
K162622 09/20/2016 Fujifilm Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc. Shraddha More
K162749 09/30/2016 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR FUJIFILM Medical Systems U.S.A., Inc. Shraddha S. More
K162455 09/02/2016 Humelock Reversed Shoulder FX SOLUTIONS Jean-Jacques Martin
K162599 09/19/2016 IcePearl 2.1 CX L, IceForce 2.1 CX L GALIL MEDICAL LTD. LYNNE DAVIES
K162743 09/30/2016 ViewPoint 6 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K162722 09/29/2016 HyperSense GE MEDICAL SYSTEMS, LLC GLEN SABIN
K162463 09/02/2016 Matrix Data Management System GLOBAL INSTRUMENTATION, LLC JASON DEMASO
K162618 09/20/2016 CONCORD Plus Radiopaque Bone Cement GLOBUS MEDICAL, INC. KELLY J. BAKER
K162707 09/28/2016 Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload Golden Stapler Surgical Co., Ltd. Hao Chao
K162747 09/30/2016 Proture Double Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd. Jun Deng
K162471 09/06/2016 Hach CM130 Chlorine Monitoring System HACH COMPANY Jeff Ryberg
K162646 09/22/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K162491 09/07/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN. BHD. KUAN KAM HON
K162683 09/26/2016 RehaStim 2 HASOMED GmbH Matthias Ueltzen
K162583 09/15/2016 ALOKA LISENDO 880 HITACHI, LTD. ANGELA VAN ARSDALE
K162673 09/26/2016 Aptima Herpes Simplex Viruses 1 & 2 Assay HOLOGIC, INC. Ron Domingo
K162764 09/30/2016 JAZZ FRAME SYSTEM IMPLANET S.A. REGIS LE COUEDIC
K162633 09/21/2016 Custom Bars IMPLANT DIRECT SYBRON MANUFACTURING, LLC Reina Choi
K162753 09/30/2016 RTC 26-C Inline Aerosol Adapter INSTRUMENTATION INDUSTRIES, INC. Doris Walter
K162768 09/30/2016 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables INTEGRAL PROCESS SAS Virginie S Grondin
K162624 09/20/2016 Pre-Formed Penile Silicone Block INTERNATIONAL MEDICAL DEVICES, INC. JAMES ELIST
K162621 09/20/2016 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair Invacare Corporation Elijah N. Wreh
K162696 09/27/2016 Kuschall Advance Manual Wheelchair INVACARE CORPORATION ELIJAH N. WREH
K162686 09/27/2016 Kuschall Champion Manual Wheelchair Invacare Corporation Elijah N. Wreh
K162692 09/27/2016 Kuschall K-Series Attract Manual Wheelchair INVACARE CORPORATION Elijah N. Wreh
K162679 09/26/2016 IOB Temperature Management System IOB MEDICAL INC JIULIN XIA
K162629 09/21/2016 IQM Integral Quality Monitor (also IQM) IRT SYSTEMS Juergen Oellig
K162478 09/06/2016 ivWatch ivWatch, LLC Jaclyn Lautz
K162600 09/19/2016 Jewel Precision Reusable Rigid Sterilization Container System JEWEL PRECISION SHEET METAL & MACHINE, INC. GARY SCHNEBERGER
K162517 09/09/2016 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 JKH Health Co., Ltd. Pu Jiang
K162664 09/26/2016 Pyrenees Cervical Plate System K2M, Inc. NANCY GIEZEN
K162759 09/30/2016 KeraStat(R) Gel KeraNetics, LLC. Luke Burnett
K162536 09/12/2016 GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord KERR CORPORATION MOHAMMAD SAAD ANSARI
K162667 09/26/2016 Kitazato IUI Catheter Kitazato Corporation Mari Yazaki
K162504 09/07/2016 SKR 3000 KONICA MINOLTA, INC TSUTOMU FUKUO
K162511 09/08/2016 LELO RESPECT HEX Natural Rubber Latex Condom LELO INC. PAVLE SEDIC
K162652 09/23/2016 Smart Photon Micro-current Device, Model: EP-300 LI-TEK ELECTRONIC TECHNOLOGY CORPORATION Barry Yuan
K162685 09/26/2016 2-Piece Hammertoe Correction System Life Spine, Inc. Randy Lewis
K162752 09/30/2016 ARTIA Reconstructive Tissue Matrix Perforated LIFECELL CORPORATION ANUJA YARDI
K162705 09/28/2016 VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY LLC JAMES CHAMPLIN
K162603 09/19/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION MARGUERITE THOMLINSON
K162675 09/26/2016 Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter MASIMO CORPORATION MARGUERITE THOMLINSON
K162577 09/15/2016 Dosimetry Check Version 5 Release 1 MATH RESOLUTIONS, LLC WENDEL DEAN RENNER
K162469 09/02/2016 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps Medos International SARL Jennifer Siu
K162604 09/19/2016 Cranial Reducing Tubes MEDTRONIC NAVIGATION, INC. Christopher Perman
K162655 09/23/2016 StealthConnect Remote Viewing, Planning and Collaboration System MEDTRONIC NAVIGATION, INC. MONICA R. MONTANEZ
K162494 09/07/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Justin O'Connor
K162680 09/26/2016 SOVEREIGN« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. KANESHA HINES
K162550 09/13/2016 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K162687 09/27/2016 Paragon 2 MERIDIAN MEDICAL SYSTEMS, LLC Larry Cornell
K162635 09/21/2016 Distal Radius Plating System Miami Device Solutions, LLC Michelle Montesino
K162704 09/28/2016 Axium Prime Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Joyce Zhong
K162539 09/12/2016 Solitaire 2 Revascularization Device MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR JENNIFER CORREA
K162466 09/02/2016 LuminScan (TM) Imaging System MICRO-TECH (NANJING) CO.,LTD. Becky Li
K162459 09/02/2016 AccuPoint Electrode MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON Martin Bak
K162524 09/09/2016 AZUR CX Detachable 18 Peripheral Coil System MicroVention, Inc Laraine Pangelina
K162630 09/21/2016 CP Relief Wand-OTC Mid-America Medical Innovations LLC Norm Schroeder
K162748 09/30/2016 MindMotionPRO MindMaze SA SYLVAIN BOURRIQUET
K162570 09/15/2016 Miromatrix Biological Mesh TW Miromatrix Medical Inc. Jeff Ross
K162665 09/26/2016 MiCor A100 Wearable ECG Recorder MITAC INTERNATIONAL CORP. YIHAO HUANG
K162588 09/16/2016 M÷ller Medical Biopsy Needles and Systems Moller Medical GmbH Christoph Traxler
K162762 09/30/2016 NeuroBlate System Monteris Medical, Inc. David H. Mueller
K162651 09/23/2016 Breast BI 7 MR Coil Mammavention 3T MORAS MRI products GmbH Zahed Sedighiani
K162754 09/30/2016 FREND Vitamin D Test System NanoEnTek USA, Inc. Jimmy Chen
K162595 09/15/2016 Trex_HD Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K162681 09/26/2016 Enobio Wireless EEG Neuroelectrics Barcelona S.L.U. Anna Maiques
K162610 09/19/2016 NEXA Negative Pressure Wound Therapy System Nexa Medical Ltd. Keith Heaton
K162617 09/20/2016 NobleStitch EL NOBLES MEDICAL TECHNOLOGIES II, INC. FAYE DUNN
K162602 09/19/2016 NovoPen Echo Novo Nordisk Inc. Elizabeth D'Amato
K162647 09/22/2016 NuVasive NuvaLine Mobile App NUVASIVE, INCORPORATED Olga Lewis
K162746 09/30/2016 Ontex and other proprietary names ONTEX BVBA Henri Lesage
K162638 09/22/2016 CETRA Anterior Cervical Plate System Orthofix Inc. Jacki Koch
K162446 09/01/2016 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System ORTHOFIX INC. JACKI KOCH
K162576 09/15/2016 FORTEZZA Spinal Stabilization System OSSO SURGICAL Basheer Hassan
K162542 09/12/2016 OsteoMed PINNACLE Driver OSTEOMED KATHRYN A. JAYNE
K162544 09/12/2016 OsteoMed PINNACLE Driver OSTEOMED KATHRYN A. JAYNE
K162662 09/26/2016 GingiDent Gingival Retraction Paste PAC-DENT INTERNATIONAL, INC. JIAQING WU
K162453 09/01/2016 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) Pan Medical Ltd. Jennie Budding
K162447 09/01/2016 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner PENTAX of America, Inc. Krishna Govindarajan
K162756 09/30/2016 PHAKOS Disposable Retinal Cryo Probe PHAKOS OLIVER AUMAITRE
K162549 09/13/2016 Lumify Ultrasound System Philips Healthcare Chuck Morreale
K162484 09/07/2016 Lung Nodule Assessment and Comparison Option (LNA) Philips Medical Systems Nederland B.V. Yoram Levy
K162537 09/12/2016 CAD/CAMouflage Milling Block PRISMATIK DENTALCRAFT, INC. ALIVA DAS
K162623 09/20/2016 16ch T/R Hand Wrist Coil QUALITY ELECTRODYNAMICS, LLC KATHLEEN ARAS
K162451 09/01/2016 Solana HSV 1+2/VZV Assay QUIDEL CORPORATION Ronald H. Lollar
K162468 09/02/2016 ClearCheck RADFORMATION KURT SYSOCK
K162519 09/09/2016 1717WCC / 1717WGC RAYENCE CO., LTD KEVIN KIM
K162518 09/09/2016 1012WCC, 1012WGC RAYENCE CO., LTD. KEVIN KIM
K162481 09/06/2016 RF1400 Active Compression Wrap RECOVERY FORCE LLC Jeff Schwegman
K162620 09/20/2016 Remel Spectra ESBL REMEL, INC. CYNTHIA KNAPP
K162613 09/19/2016 Integrated Catch-up Freedom Syringe Driver Infusion System Repro-Med Systems, Inc., DBA RMS Medical Products Fred Ma
K162640 09/22/2016 iVitri EZ REPROBITECH CORP. Huai L. Feng
K162470 09/06/2016 RT300 FES cycle ergometer Restorative Therapies, Inc. Andrew Barriskill
K162677 09/26/2016 L- OVC Rhondium, Ltd Greer Fricker
K162526 09/09/2016 Creatine Kinase-MB ROCHE DIAGNOSTICS NOEL B. MENCIAS
K162678 09/26/2016 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl ROCHE DIAGNOSTICS Kelli Turner
K162606 09/19/2016 Elecsys TSH assay, cobas e 801 Immunoassay analyzer ROCHE DIAGNOSTICS ANGELO PEREIRA
K162593 09/16/2016 HDL-Cholesterol Gen.4 Roche Diagnostics Operations (RDO) Barbara McWhorter
K162457 09/02/2016 Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Rocket Medical Plc Tracy Charlton
K162531 09/09/2016 STERISPINE CC SAFE ORTHOPAEDICS SOPHIE REHAULT
K162543 09/12/2016 Reverse Pull Adjustable Facemask SAWBROS INDUSTRIES PVT.LTD. DHRUV SAWHNEY
K162715 09/29/2016 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene SeaSpine Orthopedics Corporation Gina Flores
K162565 09/14/2016 VIA 17 Microcatheter SEQUENT MEDICAL, INC. BETHANY BARRETT
K162659 09/26/2016 Diode Laser Hair Removal System SHANDONG HUAMEI TECHNOLOGY CO.,LTD. Xu QingHua
K162527 09/09/2016 8MP Color LCD Monitor (C81W+) Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K162479 09/06/2016 Smart Pain Reliever, Model LT5019 SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. TRUMAN SHEN
K162607 09/19/2016 BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai
K162698 09/27/2016 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD Jie Rao
K162718 09/29/2016 Foot Drop System (Model XFT-2001D) SHENZHEN XFT Medical Limited JIANG XIAOYING
K162601 09/19/2016 Infusion Set for Single Use SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD. Xiaolei Tian
K162733 09/29/2016 iFuse Implant System« - iFuse-3D implant SI-BONE, INC. ROXANNE DUBOIS
K162538 09/12/2016 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator SIEMENS HEALTHCARE DIAGNOSTICS SUSAN FERRIN
K162540 09/12/2016 INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH ROSE T MARINELLI
K162688 09/27/2016 Sysmex CS-2100i Siemens Healthcare Diagnostics Products GmbH Donna Noeh
K162541 09/12/2016 syngo Application Software SIEMENS MEDICAL SOLUTIONS USA, INC PATRICIA D. JONES
K162736 09/30/2016 Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT Siemens Medical Solutions USA, Inc. ALAINE MEDIO
K162483 09/06/2016 Symbia Intevo Bold SIEMENS MEDICAL SOLUTIONS, USA, INC. Cynthia Busch
K162587 09/16/2016 ROCCIA« ACIF SILONY MEDICAL GMBH Bircan YILMAZ
K162641 09/22/2016 Smith & Nephew, Inc. R3Ö Constrained Liner Smith & Nephew, Inc. Natalie P. Williams
K162573 09/15/2016 Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source SOURCE PRODUCTION AND EQUIPMENT CO., INC. KELLEY RICHARDT
K162561 09/14/2016 Turbo-Power (2.0mm) Laser Atherectomy Catheters SPECTRANETICS, INC. PRISCILA TAPIA
K162750 09/30/2016 Libra Pedicle Screw System Spinal Balance, Inc. Anand Agarwal
K162639 09/22/2016 ProficientÖ Posterior Cervical Spine System Spine Wave, Inc. Sanja Jahr
K162760 09/30/2016 Spine Wave Anterior Cervical Spine System SPINE WAVE, INC. Amnon Talmor
K162694 09/27/2016 Ayers Rock Cervical interbody fusion system Spineway Nicolas Roth
K162611 09/19/2016 PeriFLEX SPIRATION, INC. Aadarsh S Viswanathan
K162500 09/07/2016 Ostial Sprit Cannulae SPYDER MEDICAL MICHAEL WEBB
K162643 09/22/2016 MediGuide Technology System ST. JUDE MEDICAL MARLENE PETERSON
K162701 09/28/2016 VERIFY Assert Self-Contained Biological Indicator STERIS CORPORATION ANTHONY PIOTRKOWSKI
K162758 09/30/2016 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack STERIS Corporation Anthony Piotrkowski
K162631 09/21/2016 VERIFY STEAM Integrating Indicator - Short STERIS CORPORATION TRICIA CREGGER
K162702 09/28/2016 Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table STL International, Inc. Rylie Teeter Leier
K162585 09/16/2016 SuniIQ Digital Radiography System Suni Medical Imaging, Inc Al Bettencourt
K162751 09/30/2016 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider Surgical Instrument Services and Savings, Inc Brandi J Panteleon
K162778 09/30/2016 Portable Slit Lamp Microscope SUZHOU KANGJIE MEDICAL INC Hong Zhu
K162454 09/01/2016 PicoWay Laser System SYNERON CANDELA CORPORATION Ruthie Amir
K162594 09/16/2016 Craniomaxillofacial Distraction System (CMFD) SYNTHES USA PRODUCTS, LLC NICHOLAS FOUNTOULAKIS
K162580 09/15/2016 Guardian Angel GA1000 Digital Vital Sign Monitoring System TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. ALAN TANG
K162636 09/21/2016 Marco Ultra M3, Marco Ultra M4 TAKAGI SEIKO CO.LTD. HAGIWARA TORU
K162530 09/09/2016 Multichem IA Plus TECHNO-PATH MANUFACTURING BERND HASS
K162514 09/08/2016 Multichem A1c Technopath Manufacturing Bernd Hass
K162522 09/09/2016 UltraCath Continuous Nerve block Catheter TELEFLEX MEDICAL , INC. James A. Cochie
K162710 09/28/2016 Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload TGS Medical Co., Ltd. Hua Cao
K162564 09/14/2016 Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 Tianjin Empecs Medical Device Co.,Ltd. Chae Chung Lyuel
K162648 09/22/2016 U-Blade Veress Needle TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. TAO FAN
K162626 09/20/2016 THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE TOP QUALITY GLOVE SDN. BHD HUE KON FAH
K162614 09/19/2016 Infinix, INFX-8000V, V6.35 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162475 09/06/2016 mi-eye 2, mi-eye 2 monitor Trice Medical Tiffini Diage
K162619 09/20/2016 I View and Imagen Sensor TRIDENT S.R.L. GIORGIO RIZZO
K162507 09/08/2016 Arzzt 3.5 / 4.5 Small & Large Fragments System TRUEMED GROUP, LLC Jorge Castillo
K162656 09/23/2016 ESU-1 Electrosurgical Generator TVA Medical, Inc. Katherine Kumar
K162661 09/26/2016 SavDenTM MTA Root Canal Filling Materials tYDS Biotech Incorporation Liang-Yu Chang
K162510 09/08/2016 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue UG GLOBAL RESOURCES SDN. BHD. WONG SEE KEONG
K162533 09/09/2016 Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc Peter J. Coronado
K162615 09/19/2016 Mould Applicator Set Varian Medical Systems, Inc Peter J. Coronado
K162472 09/06/2016 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. Peter J. Coronado
K162476 09/06/2016 Varian High Energy Linear Accelerator Varian Medical Systems, Inc. Peter J. Coronado
K162467 09/02/2016 Twin-Pass Torque VASCULAR SOLUTIONS, INC. LISA GALLATIN
K162660 09/26/2016 Green Smart (Model: PHT-35LHS) VATECH CO., LTD Daniel Kim
K162765 09/30/2016 Venus Velocity Diode Laser System Venus Concept Ltd. Tal Bresler-Stramer
K162572 09/15/2016 NextDent Denture, E-Denture VERTEX-DENTAL BV O. F. Beckeringh van Loenen
K162763 09/30/2016 Vevazz LED Heat Lamp Vevazz, LLC Jamie Fettig
K162556 09/14/2016 LIGHTFUSION LED SYSTEM VITAGE LED LTD SUE D'ARCY
K162547 09/12/2016 Viveve System Viveve Inc. Jim Talbot
K162460 09/02/2016 WAViÖ Headset and WAViÖ eSocÖ Single Use Electrode Contacts WAVI, CO ALEXIS VERACRUZ
K162663 09/26/2016 WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A WELL-LIFE HEALTHCARE LIMITED CHIN-CHIH HSIEH
K162532 09/09/2016 WellDoc BlueStar, WellDoc BlueStar Rx WELLDOC, INC DANIELLE DORFMAN
K162755 09/30/2016 Picocare WON TECH CO., LTD. James Hoon Lim
K162616 09/20/2016 Wrist Type Blood Pressure Monitor Xuzhou Yongkang Electronic Science Technology Co., Ltd YanLi Li
K162575 09/15/2016 Z-LINKPC System ZAVATION, LLC FRANKIE CUMMINS
K162489 09/07/2016 RED Light Device Zhongshan Bisen Plastic Electronic Products Co.,Ltd. FengPing Li


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