FDA 510(k) Decisions During January, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K160127 11/10/2016 iCodeConnect 3B MEDICAL, INC. ALEX LUCIO
K163207 11/28/2016 Filtek One Bulk Fill Restorative 3M Company Scott Erickson
K153034 01/21/2016 aap LOQTEQ VA Radius Set 2.5 AAP IMPLANTATE AG Christian Zietsch
K161696 11/23/2016 aap LOQTEQ« Distal Lateral Humerus Plate 2.7/3.5 AAP IMPLANTATE AG RENI SCHALLER
K161703 11/04/2016 LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer AAP IMPLANTATE AG RENI SCHALLER
K161747 11/22/2016 LOQTEQ« VA Distal Tibia Plate System: LOQTEQ« VA Distal Medial Tibia Plate 3.5; LOQTEQ« VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ« VA Distal Fibula Plate 2.7/3.5 aap Implantate AG Reni Schaller
K162322 11/17/2016 the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model ACCESS SCIENTIFIC, LLC WALTER CORDIGLIA
K150019 01/13/2016 TheraVision Ultrasound Ablation System and ACOUSTx Applicators ACOUSTIC MEDSYSTEMS, INC. Yvonne Schleife
K163092 11/30/2016 TubeClear Control Box and Clearing Stem Actuated Medical, Inc. Thomas L. Cronin
K161011 11/08/2016 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive Adhezion Biomedical, LLC Richard Jones
K162230 11/18/2016 Fully Automatic Electronic Blood Pressure Monitor ADON HEALTH CO., LTD. Liu Yi
K152450 01/15/2016 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC Erik Kulstad
K161913 11/04/2016 AOS Small Fragment Plating System ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) ALEX BHASKARLA
K151725 01/13/2016 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS SUN CHOI
K161834 11/30/2016 One Drop Blood Glucose Monitoring System AgaMatrix, Inc. David Olsen
K161391 11/30/2016 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC. Sherri Lakota
K153642 01/20/2016 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal ALCON LABORATORIES, INC. SHERRI LAKOTA
K153643 01/20/2016 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC. SHERRI LAKOTA
K161288 11/16/2016 LenSX Laser System ALCON LABORATORIES, INC. JAMES ARGANDA
K161457 11/21/2016 XEN Glaucoma Treatment System Allergan, Inc. Barbara A. Niksch
K152509 01/12/2016 CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) ALTATEC GMBH COLLEEN BOSWELL
K143713 01/19/2016 Lustre PRO Light System AMBICARE HEALTH LTD Neil MacGilp
K162160 11/18/2016 Preference Elite Pedicle Screw System AMEDICA CORPORATION Shanna Ryan
K153021 11/22/2016 Fingertip Pulse Oximeter A310 AMEMO INC HUA XIE
K151310 01/06/2016 Amendia Interbody Fusion Devices AMENDIA, INC. BRUCE HOOPER
K160924 11/08/2016 Amendia Interbody Fusion Devices AMENDIA, INC. Bruce Hooper
K152972 01/14/2016 Amendia Stand-Alone Cervical System AMENDIA, INC. KRISTEN ALLEN
K160791 11/15/2016 AmorChem Titanium Porous Fixation Device AmorChem Holdings, Inc. KEVIN MCBRIDE
K162914 11/16/2016 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. Robin Fuller
K162316 11/22/2016 Pirouette 014 ArraVasc Ltd Aoife Donoghue
K153423 01/28/2016 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) JULIE LAWSON
K153669 01/19/2016 MultiFIX S Ultra Knotless Fixation System ArthoCare Corporation Laura Kasperowicz
K161782 11/21/2016 Arthrex Univers Revers Shoulder Prosthesis System ARTHREX, INC. David L Rogers
K153186 01/28/2016 Adjustable Fixation Device ARTHROCARE CORP. Katherine Marcaccio
K153675 01/15/2016 Paragon T2 Wand with Integrated Cable ARTHROCARE CORPORATION KRYSTLE DANUZ
K152447 01/22/2016 ASAHI Caravel ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K160682 11/17/2016 CONTOUR NEXT ONE Blood Glucose Monitoring System ASCENSIA DIABETES CARE Roger Sonnenburg
K152512 01/28/2016 Half Dome Posterior Lumbar Interbody System Astura Medical Thomas Astura
K153459 01/28/2016 TACVAC ATHENA GTX SEAN MAHONEY
K153500 01/27/2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip Atricure, Inc. Jonathan McElwee
K161623 11/10/2016 Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL B. Braun Medical Inc. Nancy Skocypec
K161819 11/25/2016 NNR06 Multi-Purpose Solution Bausch & Lomb Incorporated Glenn Davies
K161323 11/30/2016 Solution Set for Epidural Use BAXTER HEALTHCARE CORPORATION Tiffany Lin
K162414 11/29/2016 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System BECKMAN COULTER, INC. NANCY NADLER
K151320 01/15/2016 BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml BECTON, DICKINSON AND COMPANY MONICA E. GIGUERE
K161692 11/16/2016 Diode Laser Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD GAO YURONG
K160508 11/21/2016 Electronic Pulse Stimulator BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Lei Chen
K160558 11/18/2016 RAPIDO HOLLOW-FIBRE DIALYZERS BELLCO Srl Giuseppe Tomasini
K162431 11/17/2016 Luna 3D Interbody Fusion System Benvenue Medical, Inc. Jeff Emery
K162232 11/17/2016 MOSS 100 Pedicle Screw System Biedermann Motech GmbH & Co. KG Gerd Federle
K161974 11/01/2016 SLENDERTONE« Connect Abs, Type 570 Bio-Medical Research Ltd. Anne-Marie Keenan
K152589 01/12/2016 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc Janet Krevolin
K151621 01/13/2016 BioHorizons CAD/CAM Abutments BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K163007 11/23/2016 Biomet Microfixation SternaLock 360 Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K153695 01/21/2016 Biomet Spine Fusion System Biomet Spine LLC. Kyle Hoefling
K161592 11/03/2016 Persona Partial Knee System BIOMET, INC. Nicole J. Meredith
K160446 11/07/2016 MCP Bone Putty BioStructures, LLC John Brunelle
K161670 11/02/2016 Lucid Q-PTP / HWA 55 BISON MEDICAL CO., LTD SUN WO
K151354 01/27/2016 Cervello STIM BLACKROCK NEUROMED SHANNA RYAN
K161628 11/10/2016 JAS Pulse(TM) Ultrasonic Therapy Bonutti Research, Inc. Patrick G. Balsmann
K162350 11/04/2016 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Boston Scientific Corporation Ka Zoua Xiong
K152777 01/15/2016 Bovie Disposable Bipolar Ablator BOVIE MEDICAL CORPORATION BRIAN KUNST
K151048 01/22/2016 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set BRACCO INJENEERING MAUD GIORGI
K150498 01/26/2016 Discovery 24 BRAINMASTER TECHNOLOGIES, INC. Mr. Tom Collura
K160481 11/09/2016 Vivo 60 BREAS MEDICAL AB Albert Cefalo
K161277 11/22/2016 ConvertX Nephroureteral Stent System BRIGHTWATER MEDICAL BOB SMOUSE
K152613 01/19/2016 True Flow Valvuloplasty Perfusion Catheter C. R. BARD, INC. AARON CONOVALOFF
K153190 01/05/2016 Zenysis Short-Term Dialysis Catheter C.R BARD INC. SILVIA DE LA BARRA
K162769 11/04/2016 Pinpoint GT Introducer Needle C.R. BARD, INC. Jamie Howell
K162894 11/15/2016 AccuCath Intravascular Catheter C.R.BARD, INC. JACOB LEE
K153541 01/07/2016 Coldplay CryoBalloon« Ablation System C2 THERAPEUTICS, INC. THERESA BRANDNER-ALLEN
K161027 11/08/2016 Cadwell AmpliScan Cadwell Industries, Inc. John Cadwell
K153618 01/19/2016 Capillus202 CAPILLUS, LLC PATRICIA SCHNOOR
K162994 11/18/2016 Capillus302, Capillus312, Capillus352 CAPILLUS, LLC PATRICIA SCHNOOR
K153536 01/06/2016 Piccolo Composite« Nailing System CARBOFIX ORTHOPEDICS, LTD. YAEL RUBIN
K162214 11/30/2016 Protek Solo 24 Fr Venous Cannula Set CARDIAC ASSIST, INC. GREG JOHNSON
K151081 01/15/2016 MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge Cardica, Inc. Vee Arya
K162440 11/04/2016 CardioInsight Cardiac Mapping System CARDIOINSIGHT TECHNOLOGIES, INC LAURIE LEWANDOWSKI
K160746 11/02/2016 CARDIOLINE touchECG CARDIOLINE S.p.A Emanuele Ercoli
K152503 01/25/2016 ImagenSPECT CARDIOVASCULAR IMAGING TECHNOLOGIES JAMES CASE
K151303 01/21/2016 AirLife Infant Heated Wire Circuit CAREFUSION ERIKA FERNANDEZ
K160437 11/03/2016 PleurX Peritoneal Catheter System CareFusion Tamara Brey
K151959 01/20/2016 AirLife Infant Single Limb Heated Wire Circuit CAREFUSION INC ERIKA FERNANDEZ
K152473 01/20/2016 CAS-One IR CAScination AG Matthias Peterehans
K161408 11/22/2016 Compass Cast and MAP CENTURION MEDICAL PRODUCTS CORPORATION MATTHEW K. PRICE
K162444 11/23/2016 Xpert MRSA NxG CEPHEID SCOTT A. CAMPBELL
K161905 11/17/2016 Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. Boping Ma
K162103 11/23/2016 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) CHOICE SPINE, LP KIM FINCH
K163138 11/30/2016 Clarius Ultrasound System Clarius Mobile Health Corp. Abhijit Ahir
K153681 01/20/2016 PleuraFlow System CLEARFLOW, INC. DOV GAL
K163139 11/30/2016 PleuraFlow System with FlowGlide CLEARFLOW, INC. DOV GAL
K161515 11/15/2016 eUnity Client Outlook Inc. Christie Eby
K153591 01/14/2016 ebb Complete Tamponade System CLINICAL INNOVATIONS, LLC TOM HAUETER
K160800 11/16/2016 DuoCem COLTENE/WHALEDENT AG Silke Wallaschek
K153729 01/27/2016 8F FlowGate2 Balloon Guide Catheter CONCENTRIC MEDICAL SHAZIA HAKIM
K153217 01/07/2016 ConforMIS iTotal Posterior Stabilized Knee Replacement System ConforMIS, Inc. Amita Shah
K153197 01/11/2016 Fortress Introducer Sheath SYstem CONTRACT MEDICAL INTERNATIONAL GMBH JAN KLOBOUCNIK
K152926 01/21/2016 AQUACEL Ag Surgical SP Dressing CONVATEC LIMITED AARON SIBLEY
K160884 11/22/2016 CXI Support Catheter COOK INCORPORATED Daniel J. Corbin
K151018 01/08/2016 Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette COOK INCORPORATED Naomi Funkhouser
K151051 01/11/2016 Universa Soft Ureteral Stents and Stent Sets COOK INCORPORATED Jamie Ridner
K153381 01/21/2016 Corin Metafix Hip Stem Corin USA Limited Rachel King
K160656 11/21/2016 CorSens CorSens Medical Ltd. Yoram Levy
K162941 11/14/2016 Ligasure Blunt Tip, Sealer/Divider, Nano-coated COVIDIEN CELSO DURAN
K163102 11/30/2016 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm COVIDIEN KATIE BROWN
K152149 01/22/2016 VersaOne Bladed Trocar 5mm COVIDIEN Trang Huynh
K160718 11/14/2016 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform COVIDIEN Timothy Holwick
K160921 11/03/2016 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant CS Medical LLC Kendall Ashe
K162231 11/16/2016 iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert CYDEN LIMITED MIKE KIERNAN
K160180 11/03/2016 Intermittent Pneumatic Compression system DaeSung Maref Co., Ltd Jae-wha Lee
K151570 01/21/2016 Carestation 620/650/650C DATEX-OHMEDA, INC. JAMES RASKOB
K160166 11/15/2016 X-MIND trium DE GOTZEN S.R.L. Olivier Balouka
K152188 01/28/2016 QUAD Dental Implants and Prostheses Dentack Impants Ltd David Salton
K152215 01/19/2016 DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR DENTALPLUS GMBH RALF GERSCHUETZ RUETH
K163043 11/30/2016 Zeramex P6 Dental Implant System DENTALPOINT AG Viktor Lienhard
K151039 01/14/2016 ATLANTIS Abutment for NobelActive 3.0 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K152247 01/29/2016 ATLANTIS Crown DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K152810 01/21/2016 DeVilbiss DV6WM Wireless Modem DeVilbiss Healthcare, LLC Betty Miller
K151487 01/14/2016 Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method Diatron US, Inc. Frank Matusazak
K160762 11/21/2016 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K143470 01/31/2016 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set DIAZYME LABORATORIES Abhijit Datta
K161646 11/04/2016 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K153394 11/18/2016 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator Diazyme Laboratories Abhijit Datta
K152977 01/25/2016 DG PACS DICOM GRID, INC. LAUREN STILL
K162220 11/21/2016 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage DIO MEDICAL CO., LTD SUNG HEE-LEE
K160761 11/22/2016 DW-1C DONGWON MEDICAL CO., LTD. Gil Haeng Lee
K150672 01/27/2016 VistaCam iX Proof Durr Dental AG Oliver Lange
K152522 01/15/2016 ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes ECOLAB, INC. Jennifer Willner
K151787 01/27/2016 Holter System EDAN INSTRUMENTS, INC. QUEENA CHEN
K153475 01/29/2016 SD5 & SD6 Ultrasonic Tabletop Doppler EDAN INSTRUMENTS, INC. QUEENA CHEN
K153069 01/07/2016 Edwards Balloon Catheter EDWARDS LIFESCIENCES CHRIS KENNELLY
K161962 11/28/2016 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences LLC Jennifer Wilbur
K152980 01/19/2016 Flo Trac sensor, Volume View sensor Edwards Lifesciences, LLC Andrew S Mazurkiewicz
K153354 01/12/2016 3MP Color LCD Monitor, RadiForce RX350 EIZO CORPORATION Hiroaki Hashimoto
K151594 01/25/2016 Ellipse Supplemental Instrument Trays Ellipse Technologies, Incorporated Cora Sim
K151228 01/15/2016 PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm EMERSON & CO. S.R.L. Stefano Costigliolo
K162024 11/21/2016 AltiVate Anatomic Shoulder System ENCORE MEDICAL, L.P DESIREE WELLS
K161610 11/09/2016 EXPRT Revision Hip System Encore Medical, L.P. TEFFANY HUTTO
K143169 01/08/2016 MyGlucoHealth Wireless System ENTRA HEALTH SYSTEMS RICHARD STROBRIDGE
K153333 01/19/2016 Epic Extremity Cannulated Screw System Epic Extremity, LLC Dan Schwartzbauer
K153052 01/04/2016 Erchonia PL Touch ERCHONIA CORPORATION Steven Shanks
K153039 01/08/2016 MRI Dynamic Analysis Plus Esaote S.p.A. DONATELLA RAGGHIANTI
K161472 11/18/2016 Walk-O2-Bout ESSEX INDUSTRIES, INC. RUSS JACOBSMEYER
K160447 11/10/2016 Calprest NG EUROSPITAL S.P.A. Claudia Brandolin
K160663 11/16/2016 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) EVOLUTION SPINE, LLC Ashton Kouzbari
K152746 01/03/2016 Ez3D Plus EWOO SOFT CO., LTD. YOUNG SEOK KIM
K151491 01/15/2016 Falck Medical Multifunction Tonometer, FAT1 FALCK MEDICAL, INC FRANCIS FALCK
K161373 11/03/2016 Nunchaku FCI (FRANCE CHIRURGIE INSTRUMENTATION) THIERRY FETICK
K151083 01/08/2016 BioBridge Collagen Matrix Fibralign Corporation Greg King
K153166 01/25/2016 Fusion Bx FOCAL HEALTCARE INC. MAHAM ANSARI
K161131 11/03/2016 FONA Pan/Ceph FONA SRL ELISA GUSBERTI
K162450 11/30/2016 ESPADA Acne-Clearing Blue Light Pen FOREO INC. Davor Soldo
K153259 01/06/2016 VasoStat Hemostasis Device FORGE MEDICAL, INC. Timothy Clark
K162781 11/09/2016 Magma Spark Formatk Systems Ltd. Ahava Stein
K151662 01/06/2016 iRestore Freedom Laser Therapy, Inc. Craig Nabat
K162462 11/23/2016 AMICUS Separator System, AMICUS Separator System; Refurbished FRESENIUS KABI USA LLC KIM FORCH
K153242 01/13/2016 Frontier Medical Devices In-Line Orthopedic Cable Cerclage System FRONTIER MEDICAL DEVICES, INC. ALLISON K. ROGERS
K152676 01/22/2016 FD TENS 2090, FD TENS 2095 FUJI DYNAMICS LTD MAN CHUNG MAN
K152374 01/13/2016 LL TENS 160A, LL TENS 160B Fuji Dynamics Ltd Man Man Chung
K153626 01/20/2016 SonoSite Edge II Ultrasound System FUJIFILM SONOSITE,INC. Patricia Liau
K160933 11/18/2016 Discovery NM 750b Bopsy GE Healthcare Efrat Hartog-David
K153402 01/21/2016 Discovery NM/CT 670 CZT GE HEALTHCARE GEORGE MASHOUR
K162268 11/03/2016 Senographe Pristina GE HEALTHCARE Gregory Pessato
K152993 01/12/2016 MUSE Cardiology Information System GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. AMY YANG
K152584 01/20/2016 Stroke VCAR GE MEDICAL SYSTEMS SCS Peter Uhlir
K153037 01/04/2016 LOGIQ V1/ LOGIQ V2 GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC Tracey Ortiz
K162743 11/22/2016 ViewPoint 6 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K163077 11/17/2016 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE Medical Systems Ultrasound and Primary Care Diagnostics, Bryan Behn
K162403 11/18/2016 HyperBand GE Medical Systems, LLC Jason Ma
K162990 11/15/2016 Optima XR240amx GE Medical Systems, LLC Chris Paulik
K152352 01/20/2016 Stereo 3D option for Vision Applications GE MEDICAL SYSTEMS, SCS NING WEN
K161438 11/08/2016 Genesys Spine Apache« Anterior Lumbar Interbody Fusion System GENESYS SPINE BRIAN BERGERON
K151846 01/14/2016 Rainbow LS Pressing GENOSS BYUNGSUN KIM
K151842 01/14/2016 Rainbow Shine GENOSS BYUNGSUN KIM
K160079 11/10/2016 rainbow Shine GENOSS Co. Ltd. Byungsun Kim
K153466 01/14/2016 PillCam COLON 2 Capsule Endoscopy System GIVEN IMAGING LTD. HILLA DEBBY
K160872 11/23/2016 PolyPlex Wound Dressing GLOBAL HEALTH SOLUTIONS, LLC Bradley Burnam
K151939 01/29/2016 COALITION Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K150032 01/14/2016 GluStitch Twist Tissue Adhesive GLUSTITCH, INC. DON BLACKLOCK
K160564 11/17/2016 TroClose1200 GORDIAN SURGICAL LTD. ZVI PEER
K160532 11/03/2016 Greiner Holdex GREINER BIO-ONE NA INC. MANFRED ABEL
K160349 11/03/2016 Electronic Sphygmomanometer Guangdong Biolight Meditech Co., Ltd. Liang Jin
K151287 01/06/2016 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jin Liang
K152531 01/15/2016 InstaClear Lens Cleaner GYRUS ACMI, INC. DOLAN MILLS
K160132 11/21/2016 Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC HAGER & MEISINGER GMBH Melanie May
K150893 01/29/2016 IntelliCuff HAMILTON MEDICAL AG STEFFEN BODEN
K160512 11/15/2016 HardyCHROM ESBL HARDY DIAGNOSTICS ANDRE HSIUNG
K153214 01/07/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K153289 01/15/2016 HEALTHMYNE HEALTHMYNE, INC SIGRID SCHOEPEL
K152733 01/13/2016 FFRct HEARTFLOW, INC. WINDI HARY
K160049 11/15/2016 Charisma Heraeus Kulzer, LLC (Mitsui Chemicals Group) Jamie Cleveland
K153421 01/21/2016 HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS HITACHI ALOKA MEDICAL AMERICA, INC. ANGELA VAN ARSDALE
K162583 11/17/2016 ALOKA LISENDO 880 HITACHI, LTD. ANGELA VAN ARSDALE
K151969 01/19/2016 Hospira Extension Sets Hospira, Inc. Charles Neitzel
K162085 11/10/2016 i-CAT FLX V series / KaVo 3D eXam+ V series IMAGING SCIENCES INTERNATIONAL Ruth Pui
K151771 01/05/2016 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K161831 11/15/2016 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems Ltd Mick Henderson
K162970 11/22/2016 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator Inari Medical Eben Gordon
K151273 01/04/2016 InMode FRF Applicator Inmode MD Ltd. Ahava Stein
K152520 01/25/2016 Magicore System INNOBIOSURG CO., LTD BO-REUM YOO
K161013 11/29/2016 InnoSEAL Hemostatic Pad InnoTherapy Inc. Moon Sue Lee
K160421 11/02/2016 Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K151794 01/15/2016 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K151450 01/12/2016 Endoscope Sterilization Tray INTUITIVE SURGICAL, INC. Kunal Gunjal
K152536 01/05/2016 MyOn HC Manual Wheelchair INVACARE CORPORATION Elijah N. Wreh
K162863 11/07/2016 dS Small Extremity 16CH 1.5T Coil INVIVO THERAPEUTICS CORPORATION Ken Revennaugh
K163185 11/21/2016 OptiLux LED Illuminator ISOLUX LLC NIKOLAOS ANDREOULAKIS
K162265 11/15/2016 CushionCast Moldable Cushions IZI Medical Products LLC Qiang Cao
K151468 01/14/2016 ARIX Wrist System Jeil Medical Corporation Jiwon Kang
K161378 11/02/2016 joimax Electrosurgical Instruments JOIMAX GMBH WOLFGANG RIES
K161768 11/09/2016 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K152872 01/05/2016 K2M Fenestrated Tap System K2M NANCY GIEZEN
K152887 01/22/2016 Crosperio RX PTA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K152873 01/22/2016 Crosstella RX Balloon Dilatation Catheter KANEKA CORPORATION TOSHIHIKO MOTOMINE
K150969 01/08/2016 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces KARL STORZ ENDOSCOPY AMERICA, INC. Jennifer Michelle Chambers
K162257 11/07/2016 P1145 Dental Restorative Kerr Corporation Mohammad Saad Ansari
K160895 11/01/2016 Initia Total Hip System & BIOCERAM AZUL(R) HEAD KYOCERA Medical Corporation Cheryl Hastings
K162801 11/03/2016 CastleLoc Spinal Fixation System L&K BIOMED CO., LTD. Yerim An
K153656 11/14/2016 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Yerim An
K162136 11/03/2016 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System L&K BIOMED CO.,LTD. Yerim An
K161673 11/18/2016 LacriPro Punctum Plug LACRIMEDICS, INC. REBECCA C. DUTTON
K152137 01/25/2016 FacetBRIDGE System LDR SPINE USA James Wilson
K152833 01/21/2016 Pruitt F3-S Polyurethane Carotid Shunt LEMAITRE VASCULAR, INC. ANNA KASSERIS
K161776 11/29/2016 Lenstec LC Injection system LENSTEC INC. JIMMY CHACKO
K152361 01/14/2016 OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System Liebel-Flarsheim Company LLC Craig Buehler
K151269 01/15/2016 ECG Mini System Continuous ECG Monitor and Arrhythmia Detector LifeWatch Technologies Ltd. Asher Kassel
K152672 01/21/2016 Cajun Commando 4x4 LIL CRITTER, LLC BRENDA BRANT
K161636 11/04/2016 Lipogems System Lipogems International SpA CARLO RUSSO
K162210 11/16/2016 touchTymp MAICO DIAGNOSTICS GMBH UWE LEDWORUSKI
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K151312 01/13/2016 VerteLP Interbody Fusion Device VGI, LLC Tov Vestgaarten
K162252 11/14/2016 FasTouch Fixation System VIA SURGICAL LTD. OFEK LEVIN
K162175 11/21/2016 Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less Viet Glove Corporation PHAM NGOC THANH
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K161157 11/03/2016 Vitrea CT Dual Energy Image View VITAL IMAGES, INC. Alexis Erazo
K161433 11/09/2016 Insulia Diabetes Management Companion VOLUNTIS S.A. RAFFI KRIKORIAN
K161957 11/23/2016 W&H Implantmed SI-1015 incl. Accessories W&H DENTALWERK BURMOOS GMBH ANJA LINDNER
K151084 01/07/2016 Well Lead Ureteral Access Sheath WELL LEAD MEDICAL CO. LTD HUANG KAI GEN
K160801 11/29/2016 Well Lead Extraction Bag WELL LEAD MEDICAL CO., LTD. HAN GUANG YUAN
K162225 11/22/2016 WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System WellDoc, Inc Michele Livingston
K153290 01/27/2016 Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium WILLIAM A. COOK AUSTRALIA PTY LTD Gordana Pozvek
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K153635 01/13/2016 SALVATION(R) External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K152906 11/22/2016 Disposable High Pressure Injector Syringe WUXI YUSHOU MEDICAL APPLICANCES CO., LTD Wu Feng
K162944 11/07/2016 Irix-C Cervical Integrated Fusion System X-SPINE SYSTEMS, INC. KRISS ANDERSSON
K160959 11/17/2016 Xsert Lumbar Expandable Interbody System X-SPINE SYSTEMS, INC. KRISS ANDERSON
K153159 01/26/2016 Vinyl patient examination glove, Powder Free XINGYUAN PLASTIC PRODUCTS CO., LTD. QIWEI XING
K160705 11/23/2016 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, Y. JACOBS MEDICAL, INC HUI JUN PARK
K162095 11/02/2016 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) YTY INDUSTRY (MANJUNG) SDN. BHD., Punitha Samy
K162002 11/01/2016 Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay ZDi, Solutions, LLC Zachary A. Dutton
K162050 11/21/2016 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc Shruti Jayakumar
K161620 11/01/2016 Anatomical Shoulder Domelock Dome centric ZIMMER GMBH ROBERTO TOMMASINI
K161862 11/14/2016 ThermoPro Zimmer MedizinSysteme GmbH Armin Petraschka
K151716 01/28/2016 Cable-Ready Cable Grip System: Cable-Ready Bone Plate System ZIMMER, INC. Patrick McCullagh
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