FDA 510(k) Decisions During October, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K160666 10/05/2016 Dentiq3D 3D INDUSTRIAL IMAGING CO.,LTD. Jin Sa Kim
K161697 10/24/2016 Acclarent NavWire Sinus Navigation Guidewire ACCLARENT, INC. ANNA HWANG
K161698 10/24/2016 Relieva UltirraNav Sinus Balloon Catheter ACCLARENT, INC. JAMES PATRICK GARVEY
K162554 10/21/2016 Gentrix Surgical Matrix Acell, Inc. Salman Elmi
K160203 10/19/2016 ADAMANT ZIRCONIA DISC Adamant Co., Ltd. Deborah Lavoie Grayeski
K162579 10/14/2016 VascuCel Admedus Regen Pty Ltd Mary E. Donlin
K161241 10/05/2016 e-fix E35/E36 Alber GmbH MICHAEL VENT
K162596 10/13/2016 AIR OPTIX COLORS Alcon Laboratories, Inc. Sherri Lakota
K162597 10/19/2016 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Sherri Lakota
K161981 10/14/2016 Olive Plus AMA NETWORK INC YONG BAIK KIMM
K161842 10/13/2016 Overwatch Spine System Amendia, Inc. Bruce Hooper
K160782 10/14/2016 BracePaste Adhesive American Orthodontics Trang Adams
K160974 10/28/2016 Gammex Cut-Resistant Glove Liner ANSELL HEALTHCARE PRODUCTS LLC ROBERT MAHLER
K161605 10/27/2016 Smart External Drain (SED) System AQUEDUCT CRITICAL CARE, INC. Thomas Clement
K160062 10/07/2016 AUTION ELEVEN Semi-Automated Urinalysis System ARKRAY, Inc. Tom Speikers (U.S. Agent)
K162513 10/28/2016 Arterys Software v2.0 ARTERYS INC. GOLNAZ MOEINI
K161481 10/21/2016 Ambient HipVac 50 Wand with Integrated Finger Switches ARTHROCARE CORPORATION Ashley M. Johnston
K161351 10/26/2016 NanoBone SBX Putty ARTOSS GMBH Walter Gerike
K161912 10/14/2016 ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K161584 10/06/2016 ASAHI« Peripheral Vascular Guide Wire ASAHI Meister«16 ASAHI INTECC CO.,LTD. Yoshihiko Fukui
K161546 10/14/2016 R2P SlenGuide ASHITAKA FACTORY OF TERUMO CORPORATION PHEBE VARGHESE
K162326 10/18/2016 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled Avinger, Inc Patty Hevey
K161925 10/05/2016 CO2 Laser Therapy Machine Beijing ADSS Development Co., Ltd Gao Yurong
K160268 10/14/2016 Fingertip Pulse Oximeter MD300CG11/MD300CG51 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K161560 10/05/2016 Fingertip Pulse Oximeter MD300CN310 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K161050 10/04/2016 ACTABOND Topical Skin Adhesive BERGEN MEDICAL PRODUCTS, INC. Tom Stephens
K160260 10/25/2016 Tempo Temporary Pacing Lead BIO TRACE MEDICAL, INC. Laura N. Dietch
K161687 10/14/2016 D-10 Hemoglobin A1c Program BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K161109 10/06/2016 iSR'obot MRI-US Fusion BIOBOT SURGICAL PTE LTD Lai Chee LIEW
K152579 10/03/2016 FilmArray Respiratory Panel EZ (RP EZ) BIOFIRE DIAGNOSTICS, LLC KRISTEN J. KANACK
K162076 10/25/2016 chromID MRSA bioMerieux, Inc. Karen Russell
K162424 10/12/2016 Ulna Plating System BIOMET INC Julie Largent
K161701 10/24/2016 CARTO ENT System BIOSENSE WEBSTER MELISSA C. SCHULTZ
K162571 10/13/2016 Bioflux Software Biotricity Inc. Tom Elias
K160985 10/07/2016 Pantera Pro BIOTRONIK, INC Jon Brumbaugh
K161960 10/17/2016 bk2300 BK MEDICAL APS MICHAEL J. DOYLE
K162487 10/14/2016 BSD3543 Digital Flat Panel X-ray Detector BONTECH INC. KWANG S. CHOI
K162404 10/12/2016 Express SD Biliary Monorail Premounted Stent System BOSTON SCIENTIFIC CORPORATION Ka Zoua Xiong
K160992 10/21/2016 HPM-6000 BTL INDUSTRIES, INC. JAN ZARSKY
K162443 10/25/2016 PowerPICC Provena Catheters C.R. BARD, INC. BRYAN STONE
K161773 10/21/2016 CapsoCam Plus (SV-3) Capsule Endoscope System CapsoVision, Inc Azimun Jamal
K160450 10/31/2016 Pleurx Pleural Catheter System CAREFUSION JOY GREIDANUS
K161410 10/13/2016 VT?One, VT?One 60days CARILEX MEDICAL, INC. Henry Kao
K161194 10/26/2016 PLEX Elite 9000 SS-OCT CARL ZEISS MEDITEC, INC. CHRISTINE DUNBAR
K160081 10/19/2016 TENS Electrodes CATHAY MANUFACTURING CORP. Ren Ren
K160731 10/04/2016 LumFix Spinal Fixation Sytem CG BIO CO., LTD. YUNA JEONG
K162367 10/27/2016 Erisma« LP MIS CLARIANCE SAS Pascal ROKEGEM
DEN150059 10/06/2016 APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG Lusia Guthrie
K162437 10/28/2016 Codman EDS3 CSF External Drainage System Codman & Shurtleff, Inc. Christopher Garete
K161471 10/06/2016 MR Syringe Dual Pack for Solaris Injectors Coeur, Inc. Priscilla Clinner
K160181 10/20/2016 COLORADO THERAPEUTICS XENOGRAFT IMPLANT Colorado Therapeutics LLC WILLIAM JACKSON
K162741 10/31/2016 AxoGuard Nerve Connector COOK BIOTECH INCORPORATED PERRY W. GUINN
K161822 10/27/2016 Torcon NB Advantage Catheters Cook Incorporated Jennifer Allman
K161496 10/07/2016 Turbo-Flo PICC Sets COOK INCORPORATED Steven Lawrie
K160217 10/06/2016 uVue HSG/SHG Catheter COOK INCORPORATED Kara Kanorr
K160121 10/27/2016 CorPath GRX System Corindus, Inc. Michael Douglas
K161537 10/13/2016 OTC TENS Device, Model PTS-IV COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD WENDY POON
K162584 10/18/2016 VersaOne Bladeless Trocar COVIDIEN TRANG HUYNH
K162695 10/25/2016 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K161937 10/06/2016 CuattroDR Cuattro, LLC Matthew Taylor
K160488 10/28/2016 Cutera enlighten III Laser System Cutera, Inc. Bradley Renton
K161674 10/20/2016 QuantumCam DDD-DIAGNOSTIC A/S Niels Sorensen
K153760 10/03/2016 Volumetric Infusion Controller DEKA RESEARCH & DEVELOPMENT Julie Perkins
K161330 10/06/2016 Pour Acrylic Dentsply Sirona Helen Lewis
K160199 10/19/2016 Advocate Insulin Pen Needles Diabetic Supply of Suncoast, Inc. Victoria Thuss
K161497 10/28/2016 Dental Implants and Abutments Ditron Precision Ltd Moshe Orlev
K160060 10/03/2016 DMi Dental Implant System DMi Innovative Medical Technology Ltd. Yaniv Haim Buchacho
K152970 10/03/2016 Dynarex Xeroform Petrolatum Dressing DYNAREX CORPORATION JAMES HURLMAN
K160279 10/14/2016 ANYVIEW-500R Fluoroscopic Mobile X-Ray System ECOTRON CO.,LTD Sang Bong Lee
K162474 10/21/2016 Artemis EIGEN William Mandel
K161973 10/25/2016 G-scan Brio, S-scan Esaote S.p.A. Maria Marzapane
K162290 10/14/2016 MyLabSix CrystaLine ESAOTE S.P.A. MASSIMO POLIGNANO
K153784 10/21/2016 NOSOGARD FILTERS Evoqua Water Technologies, LLC Robert Dudek
K162150 10/31/2016 BreathID Hp Lab System Exalenz Bioscience Ltd. Raffi Werner
K161727 10/04/2016 Eyenez Ophthalmic Camera EYENEZ LLC DR. KISLINGER
K161676 10/20/2016 Q13 SPIROLYSER« FIM MEDICAL LIZA PERRAT
K162622 10/18/2016 Fujifilm Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc. Shraddha More
K161449 10/11/2016 HammerTech Fixation System Fusion Orthopedics, LLC Adam Cundiff
K162599 10/11/2016 IcePearl 2.1 CX L, IceForce 2.1 CX L GALIL MEDICAL LTD. LYNNE DAVIES
K160116 10/07/2016 SpiroScout GANSHORN MEDIZIN ELECTRONIC GMBH Stefan Ponto
K162269 10/03/2016 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
DEN160001 10/28/2016 BD MAX Vaginal Panel, BD MAX Instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) MANON RICHARD
K161815 10/12/2016 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Genesee BioMedical, Inc. Woodrow G. Mathison
K161886 10/14/2016 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD ADA ZHANG
K153016 10/20/2016 aoni Natural Rubber Latex Condom Guangzhou Daming United Rubber Products Ltd. Yongbing Xie
K161038 10/07/2016 PK Morcellator GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K162117 10/25/2016 NIRO-200NX DP Hamamatsu Photonics K.K. Susumu Suzuki
K160562 10/13/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SND. BHD. KUAN KAM HON
K152533 10/28/2016 Xonrid Gel Helsinn Healthcare SA Valentina Tombolini Bossi
K153332 10/27/2016 ETIII SA Fixture System (O3.2mm) HIOSSEN INC. PATRICK LIM
K160559 10/18/2016 NOBLUSÖ Ultrasound Diagnostic System HITACHI MEDICAL CORPORATION ANGELA VAN ARSDALE
K161569 10/14/2016 Trident« II Tritanium« Acetabular Shells and 6.5 mm Low Profile Hex Screws Howmedica Osteonics Corp. aka Stryker Orthopaedics Valerie Giambanco
K160312 10/28/2016 FRAXIS DUO ILOODA CO., LTD YUN JUNG HA
K161714 10/14/2016 Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K160174 10/06/2016 I.B.S. 2.0 Osteosynthesis screw In2Bones SAS Morgane Grenier
K161426 10/24/2016 NeoSpan Compression Staple Impant w/instruments IN2BONESUSA, LLC JOE CLIFT
K161458 10/03/2016 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care Indiba USA Inc. Carles Janer
K161010 10/20/2016 HICP200 Patient/Monitor Interconnect Cable InnerSpace Neuro Solutions, Inc. Gary G. Frugard
K161393 10/26/2016 Reprocessed Orbiter ST Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K161677 10/07/2016 Straumann Sterile Healing Solution Institut Straumann AG Christopher Klaczyk
K160885 10/27/2016 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K161882 10/14/2016 CUSA Clarity Ultrasonic Surgical Aspirator System INTEGRA LIFESCIENCES CORPORATION RESHAM RAMSAY
K162629 10/20/2016 IQM Integral Quality Monitor (also IQM) IRT SYSTEMS Juergen Oellig
K162169 10/27/2016 EdgeOne CO2 Laser Jeisys Medical Inc. Erica Seo
K160143 10/28/2016 ClearVision ExamVue Flat Panel Detector JPI HEALTHCARE, INC JANG WON LEE
K162664 10/07/2016 Pyrenees Cervical Plate System K2M, Inc. NANCY GIEZEN
K161555 10/21/2016 KARL STORZ NAV1 Electromagnetic Navigation System KARL STORZ Endoscopy America, Inc. Leigh Spotten
K162386 10/25/2016 KATOR Suture Anchor KATOR LLC Robert Hoy
K161897 10/04/2016 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K160864 10/07/2016 Cryotop Vitrification Kit and Cryotop Thawing Kit KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K151970 10/21/2016 KJ Mini Implant System KJ MEDITECH CO., LTD. GOONG-SAN NAM
K162504 10/03/2016 SKR 3000 KONICA MINOLTA, INC TSUTOMU FUKUO
K162065 10/19/2016 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Tsutomu Fukui
K161042 10/25/2016 CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack Kuraray Noritake Dental, Inc. Michio Takigawa
K160643 10/18/2016 ENROUTE 0.014 Guidewire LAKE REGION MEDICAL MICHAEL DUNNING
K162445 10/20/2016 LiVac Retractor System Livac Pty Ltd Anabela Correia
K153769 10/05/2016 R:GEN Laser System Lutronic Corporation Jhung Won Vojir
K160316 10/27/2016 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
K161718 10/27/2016 MaxBlend 2, MaxBlend Lite Maxtec, LLC Bruce Brierley
K162061 10/21/2016 M.U.S.T. Pedicle Screw System MEDACTA INTERNATIONAL SA Stefano Baj
K161725 10/28/2016 Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail MEDELA, INC ROBERT SOKOLOWSKI
K151139 10/18/2016 EasyMap MAP Catheter MedFact Engineering GmbH Joerg Reinhardt
K161282 10/30/2016 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W MEDICO ELECTRODES INTERNATIONAL LTD. AMIT SETH
K161473 10/19/2016 Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) MEDLINE, INDUSTRIES, INC. Jennifer Mason
K162469 10/26/2016 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps Medos International SARL Jennifer Siu
K162494 10/04/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Justin O'Connor
K162027 10/21/2016 TRAcelet Compression Device MEDTRONIC VASCULAR COLLEEN MULLINS
K161361 10/14/2016 HawkOne Directional Atherectomy System Medtronic Vascular, Inc. Rupali Gupta
K162550 10/12/2016 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K162054 10/18/2016 Medtronic Temporary External Pacemaker 53401 MEDTRONIC, INC. SYED SUMRAN MOHIUDDIN
K162687 10/21/2016 Paragon 2 MERIDIAN MEDICAL SYSTEMS, LLC Larry Cornell
K162777 10/31/2016 Squirt Fluid Delivery System Merit Medical Systems, Inc. Angela Brady
K162635 10/21/2016 Distal Radius Plating System Miami Device Solutions, LLC Michelle Montesino
K161152 10/12/2016 Navien Intracranial Support Catheter MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR Ingrid Takeuchi
K160706 10/19/2016 ReNew V Handpiece Laparoscopic Instruments MICROLINE SURGICAL, INC. ANU GAUR
K162419 10/28/2016 FIREFLY« Pedicle Screw Navigation Guide MIGHTY OAK MEDICAL INC. Mark A. Wylie
K160141 10/31/2016 miraDry System Miramar Labs, Inc. Kathy O'Shaughnessy
K161797 10/19/2016 Avance Tubing, Avance Y-Connector, Avance ViewPad MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K162762 10/26/2016 NeuroBlate System Monteris Medical, Inc. David H. Mueller
K160909 10/04/2016 ATTO Mobility Scooter Moving Life Ltd Nino A. Ransenberg
K153577 10/14/2016 FREND Testosterone Test System NanoEnTek USA Inc. Jimmy Chen
K162250 10/26/2016 FortiBridge Anterior Cervical Plate System NANOVIS SPINE LLC MATTHEW HEDRICK
K160442 10/21/2016 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers NEURAL ANALYTICS, INC. JAY YONEMOTO
K162060 10/24/2016 Ahmed Glaucoma Valve NEW WORLD MEDICAL, INC. SUHAIL ABDULLAH
K161448 10/31/2016 Footmotion Plating System NEWCLIP TECHNICS Gaelle Lussori
K151995 10/05/2016 Painmaster MCT Patch NEWMARK, INC. Francis Powell
K160371 10/14/2016 NovaPACS NOVARAD CORPORATION DOUG MERRILL
K162602 10/18/2016 NovoPen Echo Novo Nordisk Inc. Elizabeth D'Amato
K161941 10/19/2016 Pulsaderm Acne Device NUTRA LUXE MD, LLC GLORIA AVENDANO
K160352 10/21/2016 MAGEC« Spinal Bracing and Distraction System NuVasive Specialized Orthopedics, Inc. LANCE JUSTICE
K162138 10/26/2016 NuVasive CoRoent Small Ti-C System NUVASIVE, INCORPORATED MICHELLE CHEUNG
K161828 10/03/2016 kneeEOS ONEFIT Medical Julien Simon
K161520 10/28/2016 ELEOS Limb Salvage System Onkos Surgical, Inc. Jan Triani
K162209 10/06/2016 Sapphire NC Plus OrbusNeich Medical, Inc John D. Pazienza
K160495 10/18/2016 VITROS« Automation Solutions Ortho-Clinical Diagnostics, Inc. Darlene J Phillips
K161447 10/06/2016 HydroSet XT ORTHOVITA, INC. TINA MORNAK
K160519 10/28/2016 Link Abutment for CEREC Osstem Implant Co., Ltd Hee Kwon
K161604 10/17/2016 OSSTEM Implant System OSSTEM IMPLANT CO., LTD. Hee Kwon
K160363 10/20/2016 OPTIMUS CMF SYSTEM OSTEONIC Co., Ltd. Jisun Lee
K160076 10/13/2016 XCageÖ Interbody Fusion System Ouroboros Medical, Inc. John To
K153550 10/12/2016 FTRD System Set OVESCO ENDOSCOPY AG MARC O. SCHURR
K160295 10/27/2016 SPROTTE NRFit, Quincke NRFit PAJUNK GmbH Medizintechnologie Christian G. H. Quass
K160294 10/21/2016 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G.H. QUASS
K160296 10/27/2016 SPROTTE SPECIAL NRFit PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G.H. QUASS
K160297 10/28/2016 Tuohy NRFit PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K162549 10/03/2016 Lumify Ultrasound System Philips Healthcare Chuck Morreale
K162025 10/18/2016 IntelliSpace Portal Platform PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. Ilana Ben Moshe
K161931 10/12/2016 Toricolors (hioxifilcon D) Soft Contact Lenses POLYDEV LTD. JOHN MULVIHILL
K161580 10/18/2016 Premier Sealant PREMIER DENTAL COMPANY PRODUCTS VINCENT D'ALESSANDRO
K160100 10/07/2016 Prestige Ameritech Pediatric/ChildÆs Face mask Prestige Ameritech RODNEY GREGORY
K161881 10/03/2016 PreXion3D Excelsior PreXion Corporation Shumpeita Torii
K161642 10/07/2016 CAVUXÖ Cervical Cage PROVIDENCE MEDICAL TECHNOLOGY, INC Margaret Wong
K161295 10/21/2016 MiniBox + PULMONE ADVANCED MEDICAL DEVICES, LTD Avi Lazar
K162029 10/18/2016 16ch T/R Knee Coil Quality Electrodynamics, LLC Kathleen Aras
K162276 10/01/2016 SeraQuest Herpes Type 1 Specific IgG QUEST INTERNATIONAL, INC DAVID J. KIEFER
K162274 10/25/2016 Solana Strep Complete Assay Quidel Corporation Ronald H Lollar
K161480 10/05/2016 R2 Dermal Cooling System R2 Dermatology Kristine Tatsutani
K162519 10/06/2016 1717WCC / 1717WGC RAYENCE CO., LTD KEVIN KIM
K162518 10/06/2016 1012WCC, 1012WGC RAYENCE CO., LTD. KEVIN KIM
K161684 10/06/2016 Quantum LB Reliance Orthodontic Products Inc. Paula Wendland
K162593 10/19/2016 HDL-Cholesterol Gen.4 Roche Diagnostics Operations (RDO) Barbara McWhorter
K160847 10/20/2016 Rockwell Medical CitraPure Acid Concetrate ROCKWELL MEDICAL ROBERT CHIOINI
K153539 10/03/2016 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. Kyeong-Mi Park
K151399 10/24/2016 Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow SCHUTZ DENTAL GMBH ANTJE MAURER
K162715 10/28/2016 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene SeaSpine Orthopedics Corporation Gina Flores
K153521 10/14/2016 IH Implant System Sewon Medix Inc. Bum-keun Park
K161851 10/31/2016 Glass Ionomer Cement (Luting) SHANDONG HUGE DENTAL MATERIAL CORPORATION STEVEN SONG
K153188 10/24/2016 Caremed patient cable and leadwires SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. XINLIN XIAO
K161893 10/18/2016 Neuromonitoring Kit SI-BONE, INC. ROXANNE DUBOIS
K161964 10/13/2016 ADVIA Centaur HAV IgM Assay Siemens Healthcare Diagnostics, Inc. Philip Liu
K162736 10/25/2016 Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT Siemens Medical Solutions USA, Inc. ALAINE MEDIO
K162370 10/25/2016 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Kimberly Mangum
K162011 10/14/2016 MedDream SOFTNETA UAB LAURA BARONIENE
K162750 10/27/2016 Libra Pedicle Screw System Spinal Balance, Inc. Anand Agarwal
K160074 10/18/2016 Rampart D Lumbar Interbody Fusion Device Spineology Inc. Karen Roche
K160187 10/21/2016 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 ST. JUDE MEDICAL MELISSA FRANK
K160186 10/07/2016 EnSite Velocity Surface Electrode Kit ST. JUDE MEDICAL YUMI WACKERFUSS
K162317 10/21/2016 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens ST. SHINE OPTICAL CO., LTD. ELLA LEE
K161720 10/24/2016 Standard Clamp STANDARD BARIATRICS Alison Sathe
K160912 10/07/2016 Sterilization Tray STERIS CORPORATION ANTHONY PIOTRKOWSKI
K161483 10/31/2016 Unger Quad Injector STRADIS HEALTHCARE Joseph Trznadel
K162341 10/12/2016 Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co. KG N/A N/A
K153685 10/13/2016 Sunmed Haemostatic Valves SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. James Qi Zhang
K161065 10/27/2016 ColpoWaveÖ Colpotomizer and CerviGripÖ Uterine Manipulator Surgitools Pty Ltd. Jai Singh
K160103 10/12/2016 Spetzler Malis Dual Illuminating Bipolar Forceps SYNERGETICS DAN REGAN
K160541 10/21/2016 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control SYSMEX AMERICA, INC. Michelle Parker
K162080 10/25/2016 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. Michael Sarrasin
K162514 10/26/2016 Multichem A1c Technopath Manufacturing Bernd Hass
K161075 10/04/2016 Arrow Epidural Catheter Kit TELEFLEX MEDICAL, INC. ANGELA BOUSE
K161854 10/04/2016 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS THE BINDING SITE GROUP LTD ANDREA THOMAS
K161184 10/14/2016 iNSitu Total Hip System Theken Companies, LLC Dale Davison
K162614 10/17/2016 Infinix, INFX-8000V, V6.35 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162256 10/27/2016 Klassic Femur, Porous, Klassic Tibial Baseplate, Porous TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K162422 10/28/2016 Klassic Knee System Total Joint Orthopedics, Inc. Chris Weaber
K161073 10/19/2016 Klassic HD Hip System Total Joint Othopedics, Inc. Chris Weaber
K161846 10/24/2016 Automatic Arm Bluetooth Blood Pressure Monitor TRULY INSTRUMENT LIMITED YANG JIAN-HO
K160401 10/19/2016 Tyto Stethoscope Tyto Care Ltd. Yoni Iger
K161885 10/05/2016 The Cellfina System ULTHERA, INC. SUZON LOMMEL
K161540 10/20/2016 Advanced Breast Template System VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K161576 10/02/2016 Esophagus Bougie Set Varian Medical Systems, Inc. Peter J. Coronado
K162272 10/20/2016 Fluent inflation device VASCULAR SOLUTIONS, INC. BEKA VITE
K162660 10/20/2016 Green Smart (Model: PHT-35LHS) VATECH CO., LTD Daniel Kim
K160882 10/28/2016 PaX-i3D Green Premium (Model: PCT-90LH) VATECH CO., LTD Daniel Kim
K162145 10/25/2016 vRad PACS with Mammography Virtual Radiologic Corporation Melinda Sewell
K160245 10/24/2016 Visco (olifilcon A) soft contact lens Visco Vision Inc Evan Huang
K160327 10/05/2016 ALADDIN HW3.0 VISIA IMAGING S.R.L Silvia Fantechi
K162547 10/06/2016 Viveve System Viveve Inc. Jim Talbot
K160583 10/26/2016 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip VOLCANO CORPORATION BRIAN PARK
K161786 10/18/2016 ClearLumen II Thrombectomy System Walk Vascular, LLC David Look
K161110 10/12/2016 ClearPetra Suction-Evacuation Sheath WELL LEAD MEDICAL CO., LTD. Han Guang Yuan
K161422 10/20/2016 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WRP ASIA PACIFIC SDN. BHD. SARALA DEVI JAYARAMAN
K160246 10/06/2016 SimulCare II(TM) XANACARE TECHNOLOGIES, LLC THOMAS C SIIROLA
K160313 10/21/2016 Xenco Medical Cervical Interbody System XENCO MEDICAL, LLC GUSTAVO PRADO
K161016 10/19/2016 Z-Clamp ISP System Zavation, LLC James M Philips
K152472 10/31/2016 Disposable Pressure Transducer ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Junbin Hu
K161976 10/06/2016 Ziehm Solo FD ZIEHM IMAGING GMBH RICHARD L. WESTRICH
K161830 10/26/2016 Zimmer M/L Taper Hip Prosthesis ZIMMER, INC. RHONDA MYER


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