FDA 510(k) Decisions During February, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K170330 02/06/2017 3M Protemp Cement Temporary Dental Cement 3M Company Gretchen Keenan
K162916 02/24/2017 3NT endoscopy system 3NT Medical Ltd. Ehud Bendory
K163709 02/28/2017 FIRMap Catheter ABBOTT ELECTROPHYSIOLOGY DENNIS POZZO
K170160 02/15/2017 Abbott ARCHITECT Free T3 Abbott Laboratories Linda Sohn
DEN160032 02/23/2017 Accelerate Pheno system, Accelerate Phenotest BC Kit ACCELERATE DIAGNOTICS MAUREEN MENDE
K172388 12/22/2017 VPOD ITPR Advanced Circulatory System, a wholly owned subsidiary of Anja Metzger
K172931 12/01/2017 DUS-6000 Digital Ultrasonic Diagnostic Imaging System Advanced Instrumentations, Inc. Jorge Millan
K172966 12/08/2017 CMS-2000 Central Monitoring System Advanced Instumentations, Inc. Jorge Millan
K162007 02/16/2017 STERRAD NX Sterilizer Advanced Sterilization Products Nazanin Yacobi
DEN170075 12/19/2017 ContainOR Advanced Surgical Concepts Ltd. Edward Hyland
K172529 12/05/2017 Vivaer ARC Stylus Aerin Medical, Inc. Shannon Scott
K161853 02/27/2017 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System AESCULAP INC. KATHY A. RACOSKY
K173550 12/14/2017 Akros FibuLinkÖ Syndesmosis Repair Kit Akros Medical Charles Horrell
K173538 12/04/2017 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K163551 02/03/2017 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K173502 12/13/2017 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. Benjamin Crystal
K171581 12/22/2017 Neuro Omega System Alpha Omega Engineering Ltd, Maysana Mousa
K172732 12/14/2017 E-CUBE 8 ALPINION MEDICAL SYSTEMS Co., Ltd. Boyeon CHO
K163061 02/06/2017 Altus Spine Cervical Plate System Altus Partners, LLC Claudia Hill
K170553 12/01/2017 Altus Spine Interbody Fusion System Altus Partners, LLC Mark Melton
K161996 02/16/2017 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE Amend Surgical, Inc. Robert Lane
K172908 12/07/2017 Q-Switched Nd:YAG Laser System AMI Inc. Hae Youn Lee
K171037 12/27/2017 PoreStar Patient Specific Implant Anatomics Pty Ltd Joanne Flatley
K153561 02/16/2017 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System ANDON HEALTH CO., LTD Yi Liu
K162915 02/08/2017 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K162668 02/14/2017 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO.,LTD LIU YI
K162144 02/01/2017 iHealth Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD Liu Yi
K170258 02/21/2017 SpeedLyser Infusion Catheter AngioDynamics, Inc. Teri Juckett
K172494 12/15/2017 PROTEUS PTA Balloon Catheter with Embolic Capture Feature Angioslide, Ltd. Eran Vickus
K173017 12/15/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K173008 12/26/2017 SCS 17-01 Anika Therapeutics, Inc. Steven Chartier
K171737 12/29/2017 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products LLC Robert Mahler
K161413 02/09/2017 Low Profile Balloon Feeding Device APPLIED MEDICAL TECHNOLOGY, INC. Michelle Scott
K160857 02/24/2017 HF 718BD X-Ray System ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION GUIDO ARQUILLA
K162608 02/14/2017 ClariFix Device ARRINEX, INC. VAHID SAADAT
K163513 02/24/2017 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (subsidiary of Teleflex Inc.) Fallon Young
K162032 02/21/2017 Arrowhead Mini-Rail Fixator Arrowhead DE, LLC Thomas J. Twardzik
K172052 12/13/2017 Arthrex DynaNite Nitinol Staple Arthrex Inc. Rebecca R. Homan
K170414 12/14/2017 Arthrex Univers Revers Apex Humeral Stems Arthrex Inc. David L. Rogers
K162391 02/21/2017 AlignMATEÖ Lapidus Arthrodesis System ARTHROSURFACE, INC. PHANI PUPPALA
K172383 12/22/2017 Arthrosurface Bone Screws Arthrosurface, Inc. Dawn J. wilson
K172228 12/15/2017 pioli IOL Delivery System AST Products, Inc. William Lee
K162918 02/09/2017 Atlas Spine Expandable Interbody System Atlas Spine, Inc. Thomas Smith
K161587 02/01/2017 Memodyn Staple AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT AL AUSTIN
K171584 12/22/2017 B. Braun Tear-Away Introducer Needle B. Braun Medical Inc. Kimberly Smith
DEN150035 02/03/2017 SEEKER System Baebies, Inc. Vamsee Pamula
K172922 12/21/2017 MMPC-4127F1 Barco N.V. Lieven De Wandel
K163245 02/28/2017 Virtual Occupational Therapy Application (VOTA) Barron Associates, Inc. Bruce G. Wilson
K173480 12/11/2017 Crystalsert Lens Delivery System Bausch & Lomb, Inc Gary Rauvola
K172912 12/07/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ?g/mL) Beckman Coulter Inc. Shannon Popson
K172255 12/01/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Beckman Coulter, Inc Shannon Popson
K172337 12/15/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Beckman Coulter, Inc. Teresa S. Wong
K161810 02/09/2017 BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial BECTON DICKINSON Ashanti C. Brown
K161552 02/02/2017 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton Dickinson and Company John Blewitt
K163591 02/27/2017 BD PosiFlush Heparin Lock Flush Syringe Becton Dickinson and Company Aakash Jain
K173354 12/15/2017 BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. Henry Boland
K170283 02/28/2017 BD Nexiva Diffusics Closed IV Catheter System Becton, Dickinson and Company Amy Honey
K161926 02/22/2017 ND YAG Q-switch Laser Therapy Machine Beijing ADSS Development Co., Ltd Gao Yurong
K162089 02/10/2017 Blood Pressure Monitor BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K163123 02/02/2017 Q-Switched Nd:YAG Laser Therapy Systems BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. HUAN KONG
K151834 02/22/2017 BEMER Classic Set, BEMER Pro-Set BEMER Int. AG Sven Bieler
K171061 12/28/2017 MRSASelect II Bio-Rad Sylvie Fernez
K152432 02/03/2017 ActiPatch(R) BIOELECTRONICS CORPORATION ANDREW WHELAN
K163395 02/10/2017 Astroglide Diamond Silicone Gel Personal Lubricant BioFilm, Inc. Richard Hines
DEN160048 02/14/2017 FilmArray NGDS Warrior Panel BioFire Defense, LLC Cynthia Phillips
K162827 02/23/2017 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc John Albright
K161510 02/13/2017 VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) BIOMERIEUX, INC CHERECE L. JONES
K161437 02/16/2017 VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) BIOMERIEUX, INC. KAREN RUSSELL
K172731 12/08/2017 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) bioMerieux, Inc. Esther Hernandez
K172944 12/19/2017 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ?g/mL bioMerieux, Inc. Cherece L. Jones
K163083 02/01/2017 VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) bioMerieux, Inc. Mary Beth Anheuser
K173374 12/13/2017 TSV BellaTek Encode Healing Abutments Biomet 3i Nichole OÆNeil
K163651 02/17/2017 ExpressBraid Graft Manipulation Biomet Manufacturing Corp. Vinay Bhal
K170138 12/26/2017 NEURONAUTE BIOSERENITY Quang TRAN
K171185 12/01/2017 IR Type Implant System Biotem Co., Ltd. Hong Koo Yeo
K172311 12/15/2017 BioFlux Device Biotricity Inc. Spencer LaDow
K162860 02/13/2017 MCS Bone Graft BIOVENTUS LLC John Brunelle
K163126 02/22/2017 Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) Blue Sail Medical Co., Ltd Robin Liu
K162014 02/06/2017 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) BLUEPOINT MEDICAL GMBH & CO. KG BERND LINDNER
K172330 12/21/2017 Blustone Synergy Silica System Blustone Synergy Lisa Peterson
K172565 12/20/2017 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device Boston Scientific Corporation Anand Patel
K163272 02/18/2017 AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation Kayla Mackey
K173251 12/19/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation Lindsay Forys
K171271 12/15/2017 Polyform Synthetic Mesh Boston Scientific Corporation Michelle Berry
K162771 02/24/2017 EkoSonic Control Unit 4.0 BTG International, Inc. CURTIS JENSEN
K163165 02/16/2017 AM-100 BTL INDUSTRIES, INC David Chmel
K172932 12/13/2017 True Flow Valvuloplasty Perfusion Catheter C. R. Bard, Inc. Aaron Conovaloff
K163380 02/13/2017 Serranator Alto PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K173652 12/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd. Yael Rubin
K161607 02/23/2017 VISULUX CARL ZEISS MEDITEC AG Christian Muenster
K161415 02/10/2017 SteriTite Containers System & MediTray Products CASE MEDICAL, INC. TANIA LUPU
K161848 02/23/2017 Family of Steam sterilizers B17 B22 Series CEFLA S.C. Silvia Sansavini
DEN160016 02/06/2017 Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) YON YU
K162456 02/13/2017 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
K171552 12/19/2017 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Cepheid Yi-Ping Lin
K162331 02/09/2017 Xpert Xpress Flu/RSV, 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
K171186 12/08/2017 Cerebrotech CMS-5000 Cerebrotech Medical Systems Dawnel Scott
K171956 12/12/2017 Sterile Endoscope Biopsy Sampling Needle Changzhou Detain Medical Devices Co., Ltd. Zhengrong Ding
K172561 12/05/2017 Disposable Circular Stapler Changzhou Kangdi Medical Stapler Co., Ltd. Eve Zhou
K162590 02/14/2017 Bashan TDP Heat Lamp Chogqing YUHE Medical Instruments Co., Ltd. Liu Yong
K171877 12/21/2017 SLM-1ER, SLM-2ER, SLM-3ER Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You
K161764 02/16/2017 SLIT LAMP, Model: YF-100 CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD BING HU
K170163 02/14/2017 Erisma« LP Spinal Fixation System CLARIANCE SAS Pascal ROKEGEM
K172465 12/15/2017 IdysÖ TLIF 3DTi Cages CLARIANCE, SAS Pascal Rokegem
K171677 12/08/2017 Clear Guide SCENERGY Clear Guide Medical Jack Kent
K163214 02/07/2017 Unicare System, Unicare Manipulator ClearPath Surgical, Inc. Puja Ohlhaver
K173148 12/01/2017 ACIF coLigne, AG Robert Lange
K162158 02/09/2017 Porcine Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. Peggy Hansen
K171043 12/21/2017 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters Coloplast Corp Cori Ragan
K172986 12/19/2017 Zmachine Synergy Consolidated Research of Richmond, Inc. dba General Sleep Co Richard Kaplan
K170193 02/13/2017 Advance 14LP Low Profile PTA Balloon Dilatation Catheter COOK INCORPORATED DANIEL J. CORBIN
K172217 12/13/2017 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath Cook Incorporated Andrew Breidenbach
K160200 02/17/2017 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set COOK INCORPORATED Kotei Aoki
K171275 12/20/2017 Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design Cook Incorporated Daniel J. Corbin
K170008 02/28/2017 Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set COOK INCORPORATED ERUM B. NASIR
K173685 12/20/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K172321 12/21/2017 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters Cook Incorporated Naomi Funkhouser
K173687 12/15/2017 Strange Bile Duct Stone Exploration Set Cook Incorporated Colin Jacob
K170898 12/12/2017 Wittich Nitinol Stone Basket Cook Incorporated Erum B. Nasir
K163169 02/07/2017 Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent COOK IRELAND LTD Charlene Ryan
K172707 12/05/2017 Renamel Microfill Cosmedent, Inc Mary Nowak
K163480 02/24/2017 Renamel NANO +plus Cosmedent, Inc Hiren Patel
K172482 12/15/2017 The Nellcor pulse oximetry monitor interface cable Covidien Mia M. Ware
K170170 02/16/2017 Valleylab FT10 Electrosurgical Platform Covidien llc Sharon McDermott
K172432 12/12/2017 SporView Rapid Read Biological Indicator Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K172085 12/04/2017 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K162388 02/03/2017 CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) CURASEAL, INC. HAROLD F. CARRISON
K162697 02/10/2017 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal Custom Orthopaedic Solutions, Inc. Keith Grafmeyer
K171909 12/17/2017 HAL for Medical Use (Lower Limb Type) CYBERDYNE Inc. Yohei Suzuki
K170005 12/21/2017 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) DAKO DENMARK A/S LASSE POST MOLLER
K170028 12/21/2017 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) DAKO DENMARK A/S Lasse Post Moller
K171530 12/21/2017 Deltaven XiV Max, Deltaven XiV Max FF Delta Med SpA Raschi Olga
K162888 02/24/2017 Cercon Dentsply Sirona Karl Nittinger
K163155 02/03/2017 MTM Clear Aligner DENTSPLY SIRONA HELEN LEWIS
K161213 02/10/2017 XSmart iQ DENTSPLY SIRONA HELEN LEWIS
K163046 02/09/2017 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long DEPUY SYNTHES JOANNA RIEDER
K161987 02/21/2017 UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure DIO CORPORATION SANGIN PARK
K162849 02/16/2017 Huvex Interspinous Fixation System DIO MEDICAL CO., LTD. LEE SUNG-HEE
K170104 12/27/2017 COMPACT S, COMPACT S (LED) DMETEC CO., LTD. Lee Seung Dae
K163535 02/22/2017 my Patch sl DMS-SERVICE LLC LYNDA COLE
K162283 02/06/2017 DCM Kyphoplasty System Dragon Crown Medical Co., Ltd. Zhi Yong Song
K171729 12/13/2017 Fixtemp C&B Dreve Dentamid GmbH Reiner Altmann
K162670 02/23/2017 RSM 1824C with RConsole1 DRTECH CORPORATION CHOUL-WOO SHIN
K171174 12/18/2017 PERIO-FLOW nozzle E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy
K160876 02/15/2017 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K161056 02/03/2017 Telemetry Transmitter Edan Instruments, Inc. Queena Chen
K162071 02/24/2017 IllumiFlow Laser Cap EGLOBAL, LLC WAYNE DESTEFANO
K172888 12/15/2017 EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages EIT Emerging Implant Technologies GmbH Barbara Wirth
K172270 12/07/2017 gammaCore-2 eletroCore, LLC Mike Romaniw
K173073 12/26/2017 AltiVate Anatomic to Reverse Conversion Module Encore Medical, L.P. Teffany Hutto
K172651 12/13/2017 FMP Extended Liners Encore Medical, L.P. Teffany Hutto
K161715 02/07/2017 EndyGel EndyMed Medical Ltd. Yoram Levy
K163038 02/28/2017 EPIC Extremity Snap-Off Screw EPIC EXTREMITY, LLC DAN SCHWARTZBAUER
K163548 02/14/2017 ENSEAL X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC Marjorie Medina
K172722 12/10/2017 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) EUROIMMUN US, Inc. Michael A. Locke
K172357 12/29/2017 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow EVER GROWTH (VIETNAM) CO., LTD Che-Min Lee
K171781 12/13/2017 eVox System Evoke Neuroscience, Inc. David Hagedorn
K173375 12/21/2017 Anterior Cervical Plate System Evolution Spine, LLC Douglas Davis
K162903 02/27/2017 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies Exactech Inc Thomas McNamara
K162726 02/01/2017 Exactech« Equinoxe« Preserve Stem EXACTECH INC Thomas McNamara
K170240 02/23/2017 Truliant Femoral Components Exactech Inc Patrick Hughes
K162508 02/13/2017 KerraCel Ag Gelling Fiber Silver Dressing Exciton Technologies Inc. Melanie Ussyk
K172960 12/21/2017 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use Ezisurg Medical Co., Ltd. Sheng Tian
K171193 12/18/2017 Certa Catheter Ferrosan Medical Devices SP. Z O.O. Elzbieta Porebska-Guillemant
K163416 02/16/2017 Fiagon Navigation û PointerTube Straight and PointerTube Keat FIAGON GMBH DIRK MUCHA
K163440 02/01/2017 Stealth Staple System FIRST RAY LLC ROBERT HOY
K162987 02/14/2017 FA100 SCCD (Sequential Continuous Contraction Device) FlowAid Medical Technologies, Corp Jacob Brezel
K163085 02/14/2017 Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC Irene M. Guzman
K172819 12/01/2017 LightWalker Laser System Family Fotona d.o.o. Marko Berdajs
K172238 12/14/2017 CAREline Airless Hemodialysis Blood Tubing Sets Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K172713 12/10/2017 Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set Fujirebio Diagnostics, Inc. Stacey Dolan
K161980 02/07/2017 Fuselier Intraoral Nighttime Device (FIND) FUSELIER ENTERPRISES, LLC BRIAN FUSELIER
K171834 12/19/2017 G Surgical OCT Spinal System G Surgical LLC Donald Grafton
K173287 12/21/2017 Elite HV Radial Galt Medical Corp. David Derrick
K173555 12/20/2017 LOGIQ E10 GE Healthcare Bryan Behn
K163596 02/10/2017 LOGIQ P9 and LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K173612 12/11/2017 Optima XR646 HD GE Hualun Medical Systems Co., Ltd Kenny Ma
K163619 02/14/2017 SIGNA PET/MR GE Medical Systems, LLC Janice M. Sich
K172010 12/07/2017 gel-e Bandage gel-e, Inc. (formerly Remedium Technologies, Inc.) Matthew Dowling
K170276 12/11/2017 Safety Blood Collection Device for Single Use Gemtier Medical (Shanghai) Inc. Lenny Cao
K172714 12/08/2017 LipiVage Genesis Biosystems, Inc. Jim Lafferty
K161316 02/23/2017 George King Coumadin Plasma GEORGE KING BIO-MEDICAL, INC. BARBARA YOUNG
K171108 12/29/2017 AUTOBAHN Nailing System Globus Medical Inc. Kelly J. Baker
K173115 12/20/2017 COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS Globus Medical Inc. Kelly J. Baker
K171848 12/21/2017 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Globus Medical Inc. Lori Burns
K152022 02/22/2017 SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K172445 12/08/2017 RoyalGuard Surgical Gown, i600, Breathable GRI Medical & electrical Technology Co., Ltd Martin D. Paugh
K163191 02/27/2017 ComfortGuard Surgical Gown, i600, Film Reinforced GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. Martin D. Paugh
K163550 12/20/2017 Pobling MIITY 2 HABALAN MED & BEAUTY CO.,LTD RAY JEON
K162073 02/24/2017 Dental Implants OKTAGON Tissue Level and Bone Level HAGER & MEISINGER GMBH MELANIE MAY
K172861 12/19/2017 Digital thermometer(with disposable thermometer cover) Hangzhou Hua'an medical&health instruments Co.,Ltd Ahneo Yang
K162923 02/06/2017 NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DR HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K173137 12/12/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn. Bhd. Kuan Kam Hon
K162491 02/08/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN. BHD. KUAN KAM HON
K162683 02/03/2017 RehaStim 2 HASOMED GmbH Matthias Ueltzen
K163146 02/13/2017 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD Shaozhang Nan
K163168 02/23/2017 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED Liu Wei
K171336 12/07/2017 Cystoscope 4.0mm autoclavable 0? WL 302mm; Hysteroscope 4.0mm autoclavable 0? WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath Henke-Sass, Wolf GmbH Anna Reifschneider
K171049 12/26/2017 Real Time Image Gating System for Proton Beam Therapy Systems Hitachi, Ltd. Healthcare Tomoyuki Seino
K172629 12/04/2017 Panther Fusion AdV/hMPV/RV Assay Hologic, Inc. Anila K Tarte
K170988 12/12/2017 DropSafe Safety Pen Needle HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska
K173131 12/08/2017 Rexious Spinal Fixation System Huvexel Co., Ltd Sung Hee-Lee
K171480 12/13/2017 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
DEN160062 12/19/2017 IlluminOss Bone Stabilization System IllminOss Medical, Inc. Fred Tobia
K173038 12/01/2017 CuRAS Nd:YAG Laser Ilooda Co., Ltd. Yun-Jung HA
K170202 02/22/2017 Aquarius 8600 IMAGING DYNAMICS COMPANY LTD. Nicole Wherry
K163260 02/17/2017 SeptiCyte LAB IMMUNEXPRESS, INC. VICTORIA ROTHWELL
K170209 02/23/2017 ImPACT IMPACT APPLICATIONS, INC MICHAEL ZAGORSKI
K172507 12/22/2017 SOZO ImpediMed Limited Catherine Kingsford
K173470 12/04/2017 ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K163549 02/16/2017 ClotTriever Thrombectomy System Inari Medical, Inc. Eben Gordon
K170881 12/14/2017 ISP Safety Huber Needle Infusion Set Infusion Safety Products, Inc. Alan P. Reid
K173126 12/05/2017 ArisstosÖ Spinal System Ingenium Spine David Brumfield
K172302 12/08/2017 InMode PLUS System InMode MD Ltd. Amit Goren
K172468 12/06/2017 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm InNeuroCo, Inc Marc Litzenberg
K162099 02/15/2017 IBS Implant System II InnoBioSurg Co., Ltd. Bo-reum Yoo
K161258 02/03/2017 NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit INOVA DIAGNOSTICS, INC. Gabriella Lakos
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K172989 12/20/2017 Electric Breast Pump Joytech Healthcare Co., Ltd. Ren Yunhua
K160918 02/13/2017 JUVORA Dental Disc, Ceramill PEEK by JUVORA JUVORA SELINA SALTHOUSE
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K172918 12/18/2017 DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) KaVo Dental Technologies, LLC Frank Ray
K162536 02/03/2017 GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord KERR CORPORATION MOHAMMAD SAAD ANSARI
K171748 12/14/2017 Vitrification Kit and Thawing Kit Kitazato Corporation Futoshi Inoue
K160610 02/13/2017 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set KOBOLD, LLC Brian Stoddart
K173696 12/19/2017 TBL-ABI System LD Technology LLC Albert Maarek
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K162106 02/03/2017 Micro-current Wrinkle Reduction Facial service, model EP-400 Li-Tek Electronic Technology Corporation Barry Yuan
K163173 02/08/2017 Handheld Diode Laser for Hair Removal Liaoning Sidey Optoelectronics Technologies Co., Ltd. Li Zhao
K173286 12/14/2017 Cannulated Screw Internal Fixation System Life Spine Inc. Randy Lewis
K172973 12/21/2017 Life Spine Foot and Ankle Plating System Life Spine Inc. Randy Lewis
K161279 02/01/2017 Life Spine Metatarsal Hemi Implant LIFE SPINE INC. RANDY LEWIS
K173182 12/20/2017 ProLift« Expandable System Life Spine Inc. Randy Lewis
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K173484 12/11/2017 CorticaLINK Spinal Fusion Platform LinkSPINE Inc Nickolas Kriska
K163298 02/22/2017 Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 ?g/mL Liofilchem s. r. l. Fabio Brocco
K173307 12/19/2017 Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ?g/mL Liofilchem s. r. l. Fabio Brocco
K162852 02/08/2017 Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG Robert Hill
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K163282 02/28/2017 Apex Dental Sensors Masterlink LLC Tom Birney
K172844 12/15/2017 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
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K171058 12/13/2017 Medacta Shoulder System: Threaded Glenoid Baseplate Medacta International SA Stefano Baj
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K162484 02/23/2017 Lung Nodule Assessment and Comparison Option (LNA) Philips Medical Systems Nederland B.V. Yoram Levy
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K173002 12/13/2017 2940 nm Er:Yag Laser Handpiece Quanta System S.p.A. Francesco DellÆAntonio
K162911 02/22/2017 Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation Edward C. Brehm
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K170960 12/25/2017 CoaguChek Vantus System Roche Diagnostics Justin Davis
K162840 02/08/2017 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics Linda McCammack
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K172926 12/21/2017 SeaSpine Vu cPOD, Zuma-C, Complete Cervical SeaSpine Orthopedics Corporation Gina Flores
K162281 02/17/2017 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) SEBIA KAREN ANDERSON
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K170913 12/15/2017 Composite Removable Sinus Stent System STS Medical Lena Shlossberg
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K170818 12/07/2017 Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC Nicholas Fountoulakis
K161616 02/16/2017 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannu Synthes USA Products, LLC Nina Rudolph
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K162710 02/09/2017 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
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K173349 12/20/2017 Operio Toul Meditech AB Tomas Hansson
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K172185 12/21/2017 Tyber Medical PT Interbody Spacer System Tyber Medical LLC Mark F. Schenk
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K160835 02/02/2017 Titan 3W TZORA ACTIVE SYSTEMS LTD. Adi Shemer
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K160934 02/06/2017 UC-CARE NaviGo Workstation UC-CARE LTD. TOMER SCHATZBERGER
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K163607 12/15/2017 ECG Acquisition Systems VALES & HILLS BIOMEDICAL TECH. LTD. Jianfang Liu
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K171447 12/05/2017 OxyPure Color Silicone Hydrogel Soft Contact Lenses Visco Vision Inc Evan Huang
K171553 12/08/2017 W&H Assistina Twin W & H Dentalwerk Buermoos GmbH Mag. Anja Lindner
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K163217 02/10/2017 GORE BIO-A Tissue Reinforcement W. L. GORE & ASSOCIATES, INC. Barbara L Smith
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K163511 02/02/2017 NovaGuard SA Pro Safety System WEST PHARMACEUTICAL SERVICES, INC. Ana Ladino
K170797 12/06/2017 wettrust D2care Wettrust Korea Co., Ltd. Sungho Lee
K172578 12/07/2017 Equipment Pouch WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Haobin Li
K171611 12/15/2017 Double Lumen Ovum Aspiration Needles William A. Cook Australia Pty Ltd Gordana Pozvek
K170257 02/24/2017 Sydney IVF Culture Oil William A. Cook Australia Pty Ltd Gordana Pozvek
K171513 12/07/2017 Lunderquist Extra Stiff Wire Guide William Cook Europe ApS Henriette Stordal Christiansen
K171573 12/29/2017 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. Sierra Lowe
K173013 12/14/2017 WishBone K-Wire System WishBone Medical, Inc. Gary Barnett
K170265 02/23/2017 GRAVITYTM PEEK-OPTIMA Suture Anchor Wright Medical Technology, Inc. Tara Conrad
K162795 02/22/2017 PROPHECY INVISION Preoperative Navigation Alignment System Wright Medical Technology, Inc. Tara Conrad
K172706 12/22/2017 GammaPod - Model A Xcision Medical Systems, LLC Daniel R. Plonski
K161907 02/23/2017 Pressure Therapy System XIAMEN SENYANG CO., LTD. XINJIE SHAO
K161859 02/24/2017 MagnetOs XPAND BIOTECHNOLOGY BV YVONNE P. BOVELL
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K163543 02/28/2017 Biomet Fusion System Zimmer Biomet Spine Inc. Megan Fessenden
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