FDA 510(k) Applications Received During November, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K163207 11/15/2016 Filtek One Bulk Fill Restorative 3M Company Scott Erickson
K163342 11/29/2016 i-STAT Hematocrit test with i-STAT Alinity System Abbott Laboratories Tamara McCaw
K163271 11/21/2016 i-Stat Alinity System with i-Stat Glucose test Abbott Point of Care, Inc. Maria L Figueroa
K163092 11/04/2016 TubeClear Control Box and Clearing Stem Actuated Medical, Inc. Thomas L. Cronin
K163254 11/21/2016 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A Bonafini
K163355 11/30/2016 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation Lisa Theama
K163050 11/01/2016 Advance Medical Designs, Inc. Sterile Ultrasound Gel ADVANCE MEDICAL DESIGNS, INC. DAVID MACKIE
K163062 11/02/2016 PHMB Antimicrobial Foam Wound Dressing Advanced Medical Solutions Ltd. Kay McGrath
K163228 11/17/2016 APVolution System AESTHETIC-PRESS, LLC Jorg Muller
K163274 11/21/2016 AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument Aggredyne, Inc. Philip C. Speros
K163367 11/30/2016 GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. Lois Nakayama
K163057 11/01/2016 Relizorb Alcresta Therapeutics, Inc. Robert Gallotto
K163266 11/21/2016 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument ALERE SCARBOROUGH, INC. Angela Drysdale
K163192 11/15/2016 Comfort EC710 ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K163061 11/01/2016 Altus Spine Cervical Plate System Altus Partners, LLC Claudia Hill
K163238 11/18/2016 Eclipse Kiss Zirconia AMS HYUNA KIM
K163276 11/21/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO.,LTD LIU YI
K163141 11/09/2016 NAMIC ClearaCIL Contrast Injection Lines AngioDynamics, Inc. Teri Juckett
K163356 11/30/2016 Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter ANGIODYNAMICS, INC. ROBIN FULLER
K163107 11/07/2016 Lifestyles Zero Lubricated Latex Male Condom ANSELL HEALTHCARE PRODUCTS, LLC Robert Mahler
K163049 11/01/2016 GOLNIT Non-Absorbable PTFE Surgical Suture Antarma dba Golnit Sutures Armine Badalyan
K163359 11/30/2016 ARK Methotrexate Assay ARK Diagnostics, Inc. Cherry Mun
K163253 11/18/2016 Arterys Cardio DL ARTERYS INC. Golnaz Moeini
K163142 11/09/2016 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader ArthroCare Corporation Laura Kasperowicz
K163261 11/21/2016 AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip ATRICURE INC. Jonathan McElwee
K163231 11/17/2016 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K163264 11/21/2016 Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled Avinger, Inc. Patty Hevey
K163358 11/30/2016 Introcan Safety 3 Closed IV Catheter B.BRAUN MELSUNGEN AG ULRICH JEDELHAUSER
K163245 11/18/2016 Virtual Occupational Therapy Application (VOTA) Barron Associates, Inc. Bruce G. Wilson
K163123 11/08/2016 Q-Switched Nd:YAG Laser Therapy Systems BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. HUAN KONG
K163128 11/08/2016 Epic Pro Biolase, Inc Alicia Mszyca
K163083 11/03/2016 VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) bioMerieux, Inc. Mary Beth Anheuser
K163171 11/14/2016 CeraClean Bisco, Inc. Ryan Hobson
K163126 11/08/2016 Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) Blue Sail Medical Co., Ltd Robin Liu
K163251 11/18/2016 Life Essence Universal Porcelain System BLUE SKY BIO ALBERT ZICKMANN
K163058 11/01/2016 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle BOSTON SCIENTIFIC Jennifer Edouard
K163272 11/21/2016 AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation Kayla Mackey
K163174 11/14/2016 Emerge PTCA Dilatation Catheter Boston Scientific Corporation Jane Horan
K163248 11/18/2016 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Boston Scientific Corporation Yingying Gao
K163314 11/23/2016 Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter Boston Scientific Corporation Nikki Wahlberg
K163200 11/15/2016 Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete BOSTON SCIENTIFIC CORPORATION Ka Zoua Xiong
K163267 11/21/2016 NITRILE EXAMINATION GLOVE BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K163165 11/10/2016 AM-100 BTL INDUSTRIES, INC David Chmel
K163176 11/14/2016 Exilis XP II BTL Industries, Inc. David Chmel
K163216 11/16/2016 Pinpoint GT Needles C.R. Bard, Inc. Silvia De La Barra
K163170 11/14/2016 Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 CAPILLUS, LLC PATRICIA SCHNOOR
K163316 11/23/2016 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System CAREFUSION 303, INC. Erika Fernandez
K163157 11/10/2016 SmartGrid Carestream Health Diane Koetter
K163203 11/15/2016 Carestream DRX-Evolution Carestream Health, Inc. Carolyn L. Wagner
K163255 11/21/2016 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor Caretaker Medical, LLC Jeff Pompeo
K163195 11/15/2016 PRIMUS Carl Zeiss Suzhou Co., Ltd. Huang XiaoDong
K163090 11/04/2016 Plasma Edge System Chirurgie Innovation Guillaume Noury
K163323 11/25/2016 Dolphix« External Fixation System MR Conditional CITIEFFE s.r.l Stefano Pullega
K163313 11/23/2016 ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor CIVCO MEDICAL INSTRUMENTS CO., INC. Kevin Mader
K163138 11/09/2016 Clarius Ultrasound System Clarius Mobile Health Corp. Abhijit Ahir
K163139 11/09/2016 PleuraFlow System with FlowGlide CLEARFLOW, INC. DOV GAL
K163214 11/16/2016 Unicare System, Unicare Manipulator ClearPath Surgical, Inc. Puja Ohlhaver
K163103 11/07/2016 Tranberg CLS Diffusor Laser Fiber Clinical Laserthermia Systems AB Lars-Erik Eriksson
K163258 11/21/2016 CrossFT Knotless Suture Anchor with Disposable Driver ConMed Corporation Nyrobia Freeman
K163167 11/14/2016 CKS Plus Knee System CONSENSUS ORTHOPEDICS, INC. ZAC JOHNSON
K163197 11/15/2016 Cook Holmium Laser Fiber COOK INCORPORATED Colin Jacob
K163353 11/30/2016 Needle's Eye Snare Retrieval Set - 54cm Cook Incorporated Thomas Kardos
K163318 11/23/2016 Soules Intrauterine Insemination Catheter Cook Incorporated Naomi N. Funkhouser
K163169 11/14/2016 Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent COOK IRELAND LTD Charlene Ryan
K163104 11/07/2016 TerraceÖ Anterior Cervical Plate System CoreLink, LLC Stephan Jones
K163102 11/07/2016 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm COVIDIEN KATIE BROWN
K163055 11/01/2016 Reprocessed Kendall SCD Express Foot Cuff COVIDIEN Jennifer Sullivan
K163105 11/07/2016 Emprint Ablation System COVIDIEN LLC PATTI ARNDT
K163098 11/07/2016 Tri-Staple 2.0 Intelligent Cartridge Covidien LLC REBECCA BREWER
K163244 11/18/2016 truFreeze System CSA MEDICAL, INC. Sherrie Coval-Goldsmith
K163067 11/02/2016 CyMedica e-viveÖ System; CY-1000 CyMedica Orthopedics, Inc. Kereshmeh Shahriari
K163155 11/10/2016 MTM Clear Aligner DENTSPLY SIRONA HELEN LEWIS
K163350 11/30/2016 Multibase Abutments EV and ATLANTIS Suprastructures DENTSPLY SIRONA KARL NITTINGER
K163046 11/01/2016 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long DEPUY SYNTHES JOANNA RIEDER
K163137 11/09/2016 NIRA Beauty Skin Laser Dermal Photonics Corporation David Bean
K163150 11/09/2016 ViMove2 DORSAVI LTD DAN RONCHI
K163166 11/14/2016 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only EASYWELL BIOMEDICALS, INC. ARTHUR CHEN
K163335 11/28/2016 6MP Color LCD Monitor, RadiForce RX660, RX660-AR EIZO CORPORATION HIROAKI HASHIMOTO
K163071 11/02/2016 vascuCAP Elucid Bioimaging, Inc. Andrew J. Buckler
K163226 11/17/2016 EPIC Extremely Small Staple Epic Extremely, LLC Dan Schwartzbauer
K163082 11/03/2016 6200 Ultrasound System and 6250 Ultrasound System ESAOTE S.P.A MASSIMO POLIGNANO
K163152 11/10/2016 PROLENE Soft Polypropylene Mesh Ethicon, Inc. Debbie Fazen
K163065 11/02/2016 T3 Software ETIOMETRY, INC. DIMITAR BARONOV
K163209 11/15/2016 Fiagon Navigation System FIAGON GMBH Dirk Mucha
K163125 11/08/2016 gekoÖ T-2 and gekoÖ Plus R-2 Neuromuscular Stimulators FIRSTKIND LIMITED NEIL BUCKLEY
K163300 11/22/2016 ThermoShield HME Filter Flexicare Medical Limited Joel Biddle
K163085 11/03/2016 Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC Irene M. Guzman
K163148 11/09/2016 BePOD« Foot Screws Fournitures Hospitalieres Industrie Patricia Donnard
K163053 11/01/2016 Lumipulse G E2-III Calibrators Fujirebio Diagnostics, Inc. Stacey Dolan
K163302 11/22/2016 Senographe Pristina GE Healthcare Camille Vidal
K163205 11/15/2016 48CH Head Coil GE Healthcare Coils (USA Instruments, Inc.) Mary A. Mayka
K163077 11/03/2016 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE Medical Systems Ultrasound and Primary Care Diagnostics, Bryan Behn
K163213 11/16/2016 Revolution CT GE Medical Systems, L.L.C. Helen Peng
K163331 11/28/2016 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist GE Medical Systems, LLC Mary A. Mayka
K163281 11/21/2016 FastStroke GEf Medical Systems SCS Kristine Schraufnagel
K163140 11/09/2016 SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System GEMSS MEDICAL SYSTEMS CO., LTD Sang Woo Lee
K163144 11/09/2016 gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) GKE-GMBH Ulrich Kaiser
K163361 11/30/2016 ANTHEMÖ Fracture System Globus Medical Inc. Kelly J. Baker
K163096 11/04/2016 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System GPC MEDICAL LIMITED VIKAS NARANG
K163113 11/07/2016 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K163191 11/14/2016 ComfortGuard Surgical Gown, i600, Film Reinforced GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. Martin D. Paugh
K163236 11/17/2016 COOLIEF Cooled Radiofrequency Kit Halyard Health, Inc. Mary Ann B Kinard
K163283 11/21/2016 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON MEDICAL AG Steffen Boden
K163079 11/03/2016 HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System HealthLight, LLC Warren Graber
K163146 11/09/2016 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD Shaozhang Nan
K163168 11/14/2016 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED Liu Wei
K163179 11/14/2016 Onli Intermittent Catheter HOLLISTER INCORPORATED JEANNE LEE
K163052 11/01/2016 Brevera Biopsy System with Corlumina Imaging Technology HOLOGIC, INC. SARAH FAIRFIELD
K163343 11/29/2016 Icare HOME tonometer Icare Finland Oy Matti Tulikoura
K163133 11/08/2016 ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA IMMCO Diagnostics, Inc. Kevin Lawson
K163177 11/14/2016 ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K163260 11/21/2016 SeptiCyte LAB IMMUNEXPRESS, INC. VICTORIA ROTHWELL
K163225 11/17/2016 AFIAS iFOB with AFIAS-50 IMMUNOSTICS, INC. Antoinette Prusik
K163127 11/08/2016 bellavista 1000 IMTMEDICAL AG BEAT KELLER
K163293 11/22/2016 ColinkÖ Plating System IN2BONESUSA, LLC JOE CLIFT
K163290 11/22/2016 INFINITT ULite INFINITT CO., LTD. Heejin Lim
K163345 11/29/2016 TVC Imaging System, TVC Catheter Infraredx, Inc. Stephen Sum
K163190 11/14/2016 InMode RF System INMODE MD LTD. Amit Goren
K163326 11/28/2016 SmartEP INTELLIGENT HEARING SYSTEMS Edward Miskiel
K163056 11/01/2016 RevolutionÖ Spinal Fixation System Intelligent Implant Systems, LLC Michael Nutt
K163256 11/21/2016 Dual Mode Infrared Thermometer Intelliworks LLC Dr. Jessica Leonardi
K163149 11/09/2016 VisualEyes Interacoustics A/S Erik Nielsen
K163270 11/21/2016 ISEN-Goggles with Data Viewer ISENT TECH & TRADING COMPANY,LTD. MARTIN LIU
K163185 11/14/2016 OptiLux LED Illuminator ISOLUX LLC NIKOLAOS ANDREOULAKIS
K163223 11/16/2016 ORCA (tm) - Operational Rescue Containment Apparatus ISOVAC PRODUCTS, LLC PETER M. JENKNER
K163087 11/03/2016 PixoTest Blood Glucose Monitoring System iXensor Company Ltd. JAMIE WU
K163224 11/16/2016 JAZZ SOLO Sensor Jazz Imaging LLC Todd C. Miller
K163308 11/23/2016 SMARTO JEIL MEDICAL CORPORATION JAEHAN PARK
K163094 11/04/2016 TinniLogic Mobile Tinnitus Management Device JIANGSU BETTERLIFE MEDICAL CO., LTD. HONGWEI XU
K163093 11/04/2016 Safety Blood Collection Set Jiangsu Shenli Medical Production Co., Ltd Tina Cai
K163162 11/10/2016 Sterile Hypodermic Safety Syringes for Single Use JiangXi HongDa Medical Equipment Group Ltd. Yang Xiaohua
K163160 11/10/2016 Sterile Single-use Infusion Set JiangXi HongDa Medical Equipment Group Ltd. Xiaohua Yang
K163161 11/10/2016 Sterile Single-use Syringe with Needle JiangXi HongDa Medical Equipment Group Ltd. Yang Xiaohua
K163194 11/15/2016 Neodent Implant System - GM Line JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA Julianne Lechechem
K163364 11/30/2016 MOJAVE Expandable Interbody System K2M Nancy Giezen
K163239 11/18/2016 SMARTmatic Kaltenbach & Voigt GmbH Stefan Trampler
K163317 11/23/2016 ELECTROmatic Kaltenbach & Voigt GmgH Stefan Trampler
K163070 11/02/2016 Kent Camera KENT IMAGING INC. Darrell Barnhart
K163064 11/02/2016 Demi Ultra KERR CORPORATION Mohammad Saad Ansari
K163315 11/23/2016 Internal Distraction - Sterile KLS Martin LP Jennifer Damato
K163117 11/07/2016 Alpha Pure KOROAD AMERICA YEON JAE LEE
K163204 11/15/2016 A08 Power wheelchair Kunshan Aoshida Electric Technology Co., Ltd Shen Wenhua
K163352 11/30/2016 Wheelchair Kunshan Hi-Fortune Health Products Co.,Ltd. HongFa Zhi
K163201 11/15/2016 KYMCO EQ10D Scooter KWANG YANG MOTOR CO., LTD. Wang Ching Yun
K163159 11/10/2016 Dario Blood Glucose Monitoring System LabStyle Innovations, Ltd. Erez Raphael
K163247 11/18/2016 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider LAURIMED LLC Brian R DuBois
K163173 11/14/2016 Handheld Diode Laser for Hair Removal Liaoning Sidey Optoelectronics Technologies Co., Ltd. Li Zhao
K163334 11/28/2016 LiDCOunity v2 Hemodynamic Monitor LiDCO Ltd JI HEE KO
K163153 11/10/2016 Livia LIFECARE LTD. AMNON NAHUM SHARON
K163357 11/30/2016 OneTouch Via On-Demand Insulin Delivery System LifeScan Europe, a division of Cilag GmbH Kirsten Franco
K163298 11/22/2016 Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ?g/mL Liofilchem s. r. l. Fabio Brocco
K163347 11/28/2016 xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc. Tina Ip
K163336 11/28/2016 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc. Jennifer Grimes
K163196 11/15/2016 ACTION II Laser System LUTRONIC CORPORATION Jhung Won Vojir
K163282 11/21/2016 Apex Dental Sensors Masterlink LLC Tom Birney
K163156 11/10/2016 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV Oliver Clemens
K163221 11/16/2016 Mazor X Mazor Robotics Ltd. Ayelet Matia
K163311 11/23/2016 GMK Revision Femoral Distal Augmentation Medacta International SA Stefano Baj
K163119 11/08/2016 NaviSuite SSI Edition MEDCOM GMBH JOHANNES MESSOW
K163091 11/04/2016 VibraPEP Medica Holdings, LLC George Reed
K163106 11/07/2016 CODMAN Integrated Bipolar Cord and Tubing Set Medos International SARL Megan Palumbo
K163158 11/10/2016 MEDSYNAPSE Zero Footprint Viewer MEDSYNAPTIC PRIVATE LTD. Ashish Dhawad
K163268 11/21/2016 FlexCath Select Steerable Shealth and Dilator Medtronic CryoCath LP Natalie Sadeghi
K163182 11/14/2016 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories Medtronic Powered Surgical Solutions Deep Pal
K163301 11/22/2016 CD HORIZON« Spinal System Medtronic Sofamor Danek USA, Inc. Justin O'Connor
K163181 11/14/2016 TRANSLACEÖ Spinal Tethering System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K163279 11/21/2016 Medtronic Transportation/Sterilization Cassettes Medtronic Sofamor Danek, USA, Inc. Julie Bassett
K163076 11/03/2016 Segment CMR MEDVISO AB Einar Heiberg
K163280 11/21/2016 RP Lite 760R Mego Afek AC Ltd. Ilan Sharon
K163273 11/21/2016 TRU Legionella MERIDIAN BIOSCIENCE, INC. Lauren Davis
K163084 11/03/2016 Merit Coronary Control Syringe Merit Medical Systems, Inc. Cory Marsh
K163101 11/07/2016 CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set MICROGENICS CORPORATION MINOTI PATEL
K163154 11/10/2016 Traxcess 7 Mini XSoft Guidewire MicroVention, Inc. Sapna Singh
K163337 11/28/2016 Midmark and Ritter M9 and M11 UltraClave« Automatic Sterilizers and Ritter M9D AutoClave« Automatic Sterilizer Midmark Corporation ADAM CLUTTER
K163349 11/29/2016 MIS V3 Conical Connection Dental Implant System¡ MIS Implants Technologies Ltd. Arbel Shezaf
K163233 11/17/2016 MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter MIVI NEUROSCIENCE, INC Randy LaBounty
K163249 11/18/2016 GoSpiro MONITORED THERAPEUTICS, INC. William Zimlich
K163131 11/08/2016 A-dec NLZ Electric Motor System NAKANISHI, INC. KIMIHIKO SATOH
K163183 11/14/2016 Yooeehouse Breast Pump Nantong Poly Technology Co., Ltd. Rongmin Lin
K163163 11/10/2016 XLTEK EMU40EX EEG Headbox Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K163118 11/08/2016 FLEX Microwave Ablation System and Accessories NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K163188 11/14/2016 Next Science Wound Gel (Rx) Next Science, LLC Matthew Myntti
K163136 11/08/2016 Youha electric breast pump NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. Huang Yun Jun
K163122 11/08/2016 NobelClinician, DTX Studio implant NOBEL BIOCARE AB CHALEMAGNE CHUA
K163324 11/25/2016 nordicBrainEx NordicNeurolab AS CHANDANA GURUNG BHANDARI
K163310 11/23/2016 NovaBone IRM NovaBone Products, LLC Gregory Pomrink
K163230 11/17/2016 NuVasive Modulus XLIF Interbody System NUVASIVE INCORPORATED Cynthia Adams
K163069 11/02/2016 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K163332 11/28/2016 Apex Revision Knee System OMNIlife science Christina Rovaldi
K163338 11/28/2016 OMNIBotics Knee System OMNllife Science Inc. Daniel Decruppe
K163235 11/17/2016 HEM-9210T Omron Healthcare, Inc. Renee Thornborough
K163180 11/14/2016 Hubble II Orbbo Surgical, LLC Eric Garofano
K163265 11/21/2016 Kepler II Orbbo Surgical, LLC Eric Garofano
K163114 11/07/2016 Sapphire II PRO OrbusNeich Medical Inc. John Pazienza
K163048 11/01/2016 Smart Stitching Software System, Image Processing, Radiological OSKO, INC. Richard Jeon
K163054 11/01/2016 DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System OSPREY MEDICAL, INC. MELANIE HESS
K163088 11/04/2016 TSIII BA Fixture OSSTEM IMPLANT Co., Ltd. Hee Kwon
K163303 11/22/2016 OsteoMed ExtremiFix Mid and Large Screw System OsteoMed LLC Ellen Hong
K163109 11/07/2016 OxyHeal 4000 Multiplace Hyperbaric Chamber Family OXYHEAL MEDICAL SYSTEMS, INC. EDWARD J. CHOMAS
K163210 11/15/2016 Philips CombiDiagnost R90 Philips Medical Systems DMC GmbH Ming Xiao
K163116 11/07/2016 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland B.V. Ruojuan Zhang
K163250 11/18/2016 Longitudinal Brain Imaging (LoBI) application Philips Medical Systems Nederland B.V. Yoram Levy
K163120 11/08/2016 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Peng Cui
K163328 11/28/2016 Planmed Clarity Planmed Oy Lars Moring
K163327 11/28/2016 Precifit Medical Kirschner Wires PRECIFIT MEDICAL LTD ZHEN YU(ERIC) WU
K163329 11/28/2016 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 PULSADERM LLC Gloria Avendano
K163068 11/02/2016 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent Q UROLOGICAL CORPORATION SCOTT EPSTEIN
K163066 11/02/2016 TxRx Knee 15 Flare MR Coil 3.0T QUALITY ELECTRODYNAMICS, LLC Kathleen Aras
K163222 11/16/2016 Discovery Pico Family Quanta System Spa Francesco Dell'Antonio
K163295 11/22/2016 Infant Transport Mattress Warmer with Disc RAPID AID CORP. Laureta Prifti
K163277 11/21/2016 SuperNO2VA Device Revolutionary Medical Devices, Inc. David M. Kane
K163184 11/14/2016 cobas« CT/NG v2.0 Test Roche Molecular Systems, Inc. David W. Gates
K163321 11/25/2016 Rocket Indwelling Pleural Catheter (IPC) Insertion Kit ROCKET MEDICAL PLC Tracy Charlton
K163206 11/15/2016 SMD-Sr90-DA Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. Laurence Marsteller
K163115 11/07/2016 GC70 SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K163215 11/16/2016 AnemoCheck SANGUINA, LLC ERIKA TYBURSKI
K163099 11/07/2016 My Dose Coach Sanofi, Inc. Robert Ezzell
K163078 11/03/2016 DC-UIBC-CAL SEKISUI DIAGNOSTICS P.E.I. INC. PENNY WHITE
K163366 11/30/2016 Shanghai Sanyou CARMEN Cervical Fusion System Shanghai Sanyou Medical Co, LTD David Fan
K163135 11/08/2016 Finger Pulse Oximeter SHENZHEN FITFAITH TECHNOLOGY CO.,LTD Yuan Junfeng
K163288 11/22/2016 Pelvifine Pelvic Muscle Trainer Shenzhen Konmed Technology Co., Ltd. Tony Tony
K163306 11/23/2016 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable Shockwave Medical, Inc. Plessy Paul
K163220 11/16/2016 Atellica CH Phencyclidine (Pcp) Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K163286 11/22/2016 ARTIS pheno SIEMENS MEDICAL SOLUTION USA, INC. PATRICIA D. JONES
K163285 11/22/2016 syngo Application Software SIEMENS MEDICAL SOLUTION USA, INC. PATRICIA D. JONES
K163252 11/18/2016 Mammomat Fusion with Stereotactic Biopsy SIEMENS MEDICAL SOLUTIONS USA, INC Denise Adams
K163234 11/17/2016 Biograph mMR with syngo MR E11P system software Siemens Medical Solutions USA, Inc. Cordell L. Fields
K163312 11/23/2016 MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Siemens Medical Solutions USA, Inc. Cordell L Fields
K163211 11/16/2016 MAGNETOM Sempra with syngo MR E11S Siemens Medical Solutions USA, Inc. Cordell L Fields
K163297 11/22/2016 Scan&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K163296 11/22/2016 SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc. Kimberly Mangum
K163284 11/22/2016 syngo. CT Neuro Perfusion SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K163341 11/29/2016 syngo.CT Extended Functionality SIEMENS MEDICAL SOLUTIONS USA, Inc. Kimberly Mangum
K163294 11/22/2016 syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K163289 11/22/2016 syngo. CT Single Source Dual Energy (twin beam) SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI Kimberly Mangum
K163081 11/03/2016 40-42mm BiPolar Head and 22mm Femoral Head SIGNATURE ORTHOPAEDICS PTY LTD. Declan Brazil
K163257 11/14/2016 VitreOx Anti-fog Solution SiO2 Nanotech, LLC CLARIZZA WATSON
K163086 11/03/2016 VLP MINI-MOD 2.0mm Column Plates SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K163172 11/14/2016 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit SMITHS MEDICAL ASD, INC. Bruce Backlund
K163212 11/16/2016 Parietene DS Composite Mesh Sofradim Production Benjamin Rochette
K163073 11/02/2016 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder Sol-Millennium Medical, Inc. Jim Barley
K163063 11/02/2016 UC-5000 Mobile X-Ray SOURCE-RAY, INC. RAY MANEZ
K163060 11/01/2016 Deep Conical (DC) Implants and Accessories SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K163292 11/22/2016 Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford SPECTRA MEDICAL DEVICES SCOTT HENDERSON
K163339 11/28/2016 SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 SPECTRALMD, INC. J. MICHAEL DIMAIO
K163246 11/18/2016 Leva Anterior Expandable Spacer System SPINE WAVE, INC. AMY NOCCIOLI
K163259 11/21/2016 AXS Offset Delivery Assist Catheter STRYKER NEUROVASCULAR Shazia Hakim
K163363 11/30/2016 SurgTech Thoracolumbosacral (TLS) Posterior Fixation System SurgTech Inc. Xuegong Yu
K163175 11/14/2016 Bel-Cypher Pro Takara Belmont Corporation Toshinori Kiyomatsu
K163121 11/08/2016 SmartUs EXT-1M/3M TELEMED YURY SOKOLOV
K163269 11/21/2016 Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device TITAN SPINE, LLC JANE RODD
K163095 11/04/2016 Lyme B. burgdorferi (IgG) MarStripe Test Trinity Biotech Kevin Lawson
K163322 11/25/2016 TZ SKULL PIN Adult TZ MEDICAL INC JOHN LUBISICH
K163193 11/15/2016 UTF Stem, reduced, #0, #00 UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K163307 11/23/2016 Expro Elite Snare, Sympro Elite Snare Vascular Solutions, Inc. Jake Schultz
K163346 11/29/2016 MAZIC Duro VERICOM CO., LTD. Myung-Hwan Oh
K163232 11/17/2016 Vitrea View Vital Images, Inc Fei Li
K163217 11/16/2016 GORE BIO-A Tissue Reinforcement W. L. GORE & ASSOCIATES, INC. Barbara L Smith
K163320 11/23/2016 LAP-Pump PP110 W.O.M. WORLD OF MEDICINE GMBH Soeren Markworth
K163051 11/01/2016 ClearLumen II Peripheral Thrombectomy System Walk Vascular, LLC David Look
K163368 11/30/2016 FITBONE TAA WITTENSTEIN intens GmbH Hartmut Kampa


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