FDA 510(k) Decisions During January, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K173584 01/22/2018 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K171634 01/17/2018 Ortho System 3Shape A/S Antje Marquardsen
K173159 01/08/2018 Cervical Spinal Truss System (CSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K171411 01/12/2018 IRRIS (Infra-Red-Red Intubation System) A.R Guide In Medical Ltd. Ariel Shrem
K173795 01/12/2018 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K171761 01/16/2018 ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. James Patrick Garvey II
K173430 01/26/2018 SeQure« NF and SeQure« Microcatheters Accurate Medical Therapeutics Ltd. Eran Miller
K163451 01/12/2018 Action Trackstander models TR1816, TR1820, TR2016, and TR2020 Action Manufacturing Inc. Alan Macht
K171148 01/12/2018 Aleo BME Liquid Bandage Aleo BME Inc. Chao Liu
K173932 01/26/2018 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K172193 01/09/2018 Modified Alma Lasers Soprano XLÖ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules Alma Lasers Inc. Rekha Anand
K172701 01/04/2018 BIO-C SEALER Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
K173542 01/25/2018 Arterys Oncology DL Arterys Inc. John Axerio-Cilies
K173240 01/16/2018 Arthrex PushLock Arthrex Inc. David L. Rogers
K180010 01/31/2018 AtriClip FLEX-V AtriCure, Inc. Brittany Lowe
K172029 01/05/2018 EnsoETM Attune Medical Erik Kulstad
K171528 01/24/2018 Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) Avantsonic Technology Co., Ltd. Cuiling Wu
K172575 01/18/2018 BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap BAROnova, Inc. Lian Cunningham
K173252 01/05/2018 BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) Becton, Dickinson, and Company Laura Stewart
K172804 01/11/2018 Besmed Peak Flow Meter Besmed Health Business Corp. Lawrence Wu
K172942 01/08/2018 Pristeen (Latex SurgeonÆs Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein Beta Healthcare Products Pvt.Ltd. Boney Moolayil
K171517 01/11/2018 Digital Electrocardiograph Biocare Bio-Medical Equipment Co., Ltd. Hongbo Zhong
K173278 01/05/2018 ToggleLoc System Biomet Inc. Kyle Ponce
K172502 01/03/2018 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp Patricia Sandborn Beres
K171297 01/31/2018 AR_N Type Implant System Biotem Co., Ltd. Hong Koo Yeo
K172929 01/10/2018 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath Boston Scientific Corporation Daniel FitzDaniel
K173820 01/17/2018 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K171410 01/04/2018 ePatch Braemar Manufacturing, LLC Kent Sayler
K163684 01/23/2018 C2 CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K171099 01/05/2018 EON Portable Reverse Osmosis Water Purification System Cantel Mike Halliday
K173547 01/12/2018 ImagenUniversal Cardiovascular Imaging Technologies James A. Case
K173478 01/19/2018 OnSight 3D Extremity System Carestream Health, Inc. Victoria A. Wheeler
K173263 01/09/2018 Xpert Carba-R Cepheid Yi-Ping Lin
K173215 01/19/2018 Choice Spine LaminoplastyÖ Fixation System Choice Spine, LP Kim Finch
K172816 01/26/2018 TiGer SharkÖ System Choice Spine, LP. Kim Finch
K171835 01/30/2018 Irradiation Aesthetic Device Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K171954 01/25/2018 ClearLine IV ClearLine MD Rick Romeo
K171328 01/08/2018 cNeuro cMRI Combinostics Oy Lennart Thurfjell
K172791 01/18/2018 Lumilisse IPL Hair Remover Conair Corporation Mike Cantrell
K171360 01/22/2018 CONTECÖ Electrocardiograph Contec Medical Systems Co., LTD. Xueyong Li
K171445 01/10/2018 Amplatz Support Wire Guide with Apex Curve Cook Incorporated Jennifer Allman
K172051 01/10/2018 GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter Cook Incorporated Naomi Funkhouser
K171948 01/05/2018 Roadrunner Extra Support Wire Guide Cook Incorporated Jennifer Allman
K171264 01/25/2018 Royal Flush Catheter Cook Incorporated Jessica Swafford
K173884 01/17/2018 Unity Total Knee System Corin USA Limited Lorraine Mander
K173559 01/18/2018 Barrx SB RFA Endoscopic Catheter Covidien llc Saket Bhatt
K171819 01/04/2018 Attain Assist CS Access Catheter Creganna Medical also doing business as Ceganna Tactx Medica Olivia Odhiambo
K172212 01/09/2018 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKÖ CTL Medical Corporation Tosan Onosode
K172702 01/04/2018 Tec 820, Tec 850 Datex-Ohmeda, Inc. Trishia Mercier
K173814 01/29/2018 DeGen Medical E3 MIS Pedicle Screw System Degen Medical Craig Black
K171622 01/11/2018 Dentium Ti-Base Dentium Co., Ltd. Sangpil Yoon
K171122 01/11/2018 CEREC Ortho Software Dentsply Sirona Karl J. Nittinger
K170748 01/11/2018 GLOBAL UNITE Platform Shoulder System DePuy Ireland UC Carol Sandberg Ming
K172992 01/11/2018 Diazyme EZ Vitamin D Assay Diazyme Laboratories Abhijit Datta
K171772 01/31/2018 Ecosite Bulk Fill DMG USA Inc. Gordon Craig
K173876 01/24/2018 Cybird LED Curing Light DXM Co., Ltd Seung Hyun Kim
K173234 01/10/2018 Swiss LithoClast Trilogy E.M.S Electro Medical Systems SA Sonia Callegaro
K171836 01/04/2018 EarlySense Bed Sensing Unit EarlySense Ltd. Dalia Argaman
K171942 01/24/2018 Electrocardiograph Edan Instruments, Inc. Alice Yang
K173843 01/26/2018 illumiflow 148 Laser Cap EGlobal, LLC Wayne De Stefano
K173442 01/23/2018 gammaCore-S electroCore, LLC Mike Romaniw
K171799 01/15/2018 Elos Accurate Customized Abutment, Elos Prosthetic Screw Elos Medtech Pinol A/S Tina Friis Poulsen
K171860 01/05/2018 Sureclear aligners Emergo Global Consulting, LLC Stuart R. Goldman
K172935 01/26/2018 Embrace Empatica Srl Simone Tognetti
K172858 01/08/2018 PreOp Epilog Gregor Strobbe
K171247 01/17/2018 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test Epocal Inc. Jennifer Armstrong
K173291 01/12/2018 6440 Ultrasound System Esaote S.p.A Massimo Polignano
K171056 01/04/2018 WAVE Clinical Platform Excel Medical Electronics, LLC Lance Burton
K172205 01/11/2018 ExoToe Staple ExoToe LLC Avi Roop
K173060 01/25/2018 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version Fisher and Paykel Healthcare Limited Ashley Nguyen
K171789 01/23/2018 ARROW Reverse Porous Glenoid Fournitures Hospitalieres Industrie Patricia Donnard
K173363 01/24/2018 Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K171291 01/19/2018 FUJIFILM Bronchoscope Model EB-530P FUJIFILM Medical Systems U.S.A., Inc. Shraddha S. More
K171207 01/11/2018 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan
K171673 01/19/2018 Focus Cap GCE Medical Corporation Stanley Chang
K173456 01/05/2018 ViewPoint 6 GE Medical Systems Ultrasound and Primary Tracey Ortiz
K173602 01/12/2018 Optima XR240amx, AutoGrid GE Medical Systems, LLC Chris Paulik
K172438 01/12/2018 ARBOR External Fixation System Globus Medical Inc. Kelly J. Baker
K173955 01/26/2018 Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc. David M Lee
K170421 01/11/2018 ET Hybrid Abutment Hiossen Inc. David Kim
K172110 01/11/2018 ECHELON OVAL V6.0A MRI System Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K173196 01/24/2018 SUNTOUCH Dental Dressing Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang
K173616 01/19/2018 DIP Arthrodesis System In2Bones SAS Morgane Grenier
K173709 01/26/2018 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm InNeuroCo, Inc Marc Litzenberg
K172798 01/03/2018 Straumann CARES Abutments CoCr Institut Straumann AG Shokoufeh Khodabandeh
K170438 01/30/2018 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K172643 01/31/2018 da Vinci Xi Surgical System; da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K173085 01/08/2018 invendoscopy E210 System invendo medical GmbH Oliver v. Ruepprecht
K173508 01/09/2018 Everest Spinal System K2M Nancy Giezen
K171556 01/16/2018 K2M Navigation Instruments K2M Nancy Giezen
K173730 01/17/2018 Kinsa QuickCare Thermometer KINSA, Inc. David Gal
K171731 01/19/2018 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. Brian Deis
K172662 01/09/2018 reVive Perioral LED Technologies, Inc. Lloyd Nelson
K172456 01/04/2018 Bone Screws 6.5mm LimaCorporate S.p.A. Michela Zanotto
K171113 01/04/2018 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module LiNA Medical ApS Natalia Szychulska
K171971 01/25/2018 Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer Lite-On Technology Corp. H.S.P.B. John Lo
K173436 01/30/2018 Luma Light System Luma Therapeutics Tiffini Wittwer
K172159 01/30/2018 Getinge GSS67N Series Steam Sterilizer Maquet GmbH Holger Ullrich
K172890 01/26/2018 SedLine Sedation Monitor Masimo Corporation Matthew Tiacharoen
K171958 01/12/2018 PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE Mectron SPA Franco Zunino
K173170 01/10/2018 Epicardia Anywhere Medicomp, Inc. Sean Marcus
K173581 01/25/2018 Gallant PTCA Dilatation Catheter Medinol, Ltd. Marina Tikhonov Demishtein
K173113 01/17/2018 Medline Disposable Electronic Thermometer Probe Cover Medline Industries, Inc. Dinah Rincones
K171237 01/18/2018 FMS VUE II Fluid Management and Tissue Debridement System Medos International SARL Tatyana Korsunsky
K172796 01/18/2018 Flex Robotic System and Flex Transabdominal Drive MEDROBOTICS CORPORATION Linda J Varroso
K173338 01/18/2018 Navigated INFINITYÖ Instruments Medtronic Sofamor Danek USA, Inc. Tejas Patel
K173601 01/31/2018 Merit Syringe Merit Medical Systems, Inc. Cory Marsh
K172655 01/11/2018 Automated ankle brachial pressure index measuring device Mesi D.O.O.; Mesi, Development of medical devices, Ltd. Jakob Susteric
K171498 01/12/2018 MSD CRP Assay Kit and MESO SECTOR S 700 Instrument Meso Scale Diagnostics, LLC Lillian Quintero
K162665 01/26/2018 MiCor A100 Wearable ECG Recorder MITAC INTERNATIONAL CORP. YIHAO HUANG
K172240 01/31/2018 SPI Dental Implant System MSI France Gerard Bouna
K171354 01/13/2018 MR4 Laser Multi Radiance Medical Andrey Godes
K172977 01/16/2018 Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel Nanova Biomaterials Inc Andrew C. Ritts
K171312 01/22/2018 FortiCore« Nanovis LLC Matthew Hedrick
K172962 01/18/2018 Nurture Rest Neonatal Loving Kare, Inc. Nicole Sawyers
K173641 01/16/2018 Activ Ankle Newclip Technics Gaelle Lussori
K171372 01/04/2018 Alians Elbow Locking Plating System Newclip Technics Gaelle Lussori
K172224 01/11/2018 DTX Studio diagnose Nobel Biocare AB Charlemagne Chua
K163600 01/22/2018 Kit Boxes and Kit Plates Nobel Biocare AB Charlemagne Chua
K173479 01/17/2018 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Novo Nordisk Inc. Devraj Chakravarty
K171396 01/31/2018 ODFS Pace XL Odstock Medical Ltd Steven Crook
K172845 01/31/2018 Symetri Clear Ormco Corporation Tara Bonny
K180025 01/22/2018 Centurion POCT System Orthofix Inc. Jacki Koch
K172696 01/19/2018 FORZA« XP Expandable Spacer System Orthofix Inc. Natalia Volosen
K172183 01/09/2018 Guided Growth Plate System Plus Orthofix Srl Gianluca Ricadona
K173466 01/26/2018 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K173530 01/31/2018 Indego(R) Parker-Hannifin Corporation Achilleas Dorotheou
K173554 01/19/2018 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope PENTAX of America, Inc. James W. Monroe
K163026 01/09/2018 Ultra/Phonic Scanning Gel Pharmaceutical Innovations Inc. Shirley J. Bergman
K163023 01/08/2018 Other-Sonic Transmission Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K163024 01/08/2018 Ultra/Phonic Conductivity Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K163027 01/09/2018 Ultra/Phonic Free Conductivity Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K172920 01/22/2018 3D APT Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K173588 01/12/2018 Illumeo System Philips Medical Systems Technologies, Ltd. Yoram Levy
K173878 01/19/2018 PreXion3D Excelsior PreXion Corporation Katsumi Hayashi
K172358 01/10/2018 Instalief Privi Medical Pte Ltd Prusothman M Sinha Raja
K172164 01/17/2018 PROPEL Device Propel Orthodontics LLC Bryce Way
K173020 01/17/2018 OBA-MCP, Orthodontic Bracket Adhesive with MCP Pulpdent Corporation Kenneth J. Berk
K172169 01/05/2018 Pulpdent (Activa) Pit and Fissure Sealant with MCP Pulpdent Corporation Kenneth J. Berk
K172259 01/18/2018 PulsioFlex Monitoring System PULSION Medical Systems SE Marc Bergenthal
K172287 01/12/2018 ipsogen JAK2 RGQ PCR Kit QIAGEN, Inc. Lindsey Howard
K173469 01/09/2018 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC Eric Yeh
K173504 01/12/2018 K-Y Silicone Reckitt Benckiser LLC Elizabeth Viguerie
K173283 01/19/2018 Reliance Lumbar IBF System Reliance Medical Systems, LLC Bret M. Berry
K173768 01/10/2018 Tempus Pro Patient Monitor Remote Diagnostic Technologies Ltd. James Hamlyn
K170924 01/03/2018 AirFit F20 ResMed Ltd Johanna Wright
K171235 01/04/2018 OmniCap Respirion, Inc. Ed Fadel
K173389 01/30/2018 Rex Medical Aspiration Pump Rex Medical, L.P. Erich Bressler
K172913 01/12/2018 cobas Factor II and Factor V Test Roche Molecular Systems, Inc. Pooja Shah
K171436 01/05/2018 STRONG Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K173828 01/12/2018 GU60A & GU60A-65 Samsung Electronics Co.,Ltd. Noh Jaesang
K171367 01/26/2018 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) Sanrea Healthcare Products Pvt Ltd Jose Paul M
K173235 01/22/2018 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile Scientia Vascular LLC David Sabodski
K173285 01/29/2018 JOULE SYSTEM Sciton, Inc Jay M. Patel
K171529 01/02/2018 Snorer's Friend Scope Healthcare Technologies Pty Ltd Ben Olsen
K173521 01/24/2018 SeaSpine Cabo ACP (Anterior Cervical Plate) System SeaSpine Orthopedics Corporation Gina Flores
K172195 01/11/2018 HYDRASHIFT 2/4 daratumumab, daratumumab Control Sebia Karen Anderson
K173299 01/26/2018 DRAGON X SPSL4HC, DRAGON X SPSL8HC Sedecal SA MaLuisa Gomez de Aguero
K173953 01/26/2018 uDR 780i Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K172969 01/26/2018 Essence 55S Large Monitor System Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing
K171833 01/10/2018 Digital Blood Pressure Monitor-Wrist Style Shenzhen Combei Technology CO., LTD Huaguang Meng
K172933 01/26/2018 Mini TENS DEVICE (Model: KRES102), TENS &EMS DEVICE (Model: KRES100B) Shenzhen Conree Technology Co.,Ltd Rihua Meng
K172896 01/26/2018 Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 Shenzhen Jiacom Technology Co ., Ltd Luo Tianfeng
K171721 01/05/2018 Electrodes with silver conductive Shenzhen Konmed Technology Co., Ltd Tony Tony
K171722 01/10/2018 Electrodes with snap / Electrodes with pigtail Shenzhen Konmed Technology Co., Ltd Tony Tony
K163288 01/18/2018 Pelvifine Pelvic Muscle Trainer Shenzhen Konmed Technology Co., Ltd. Tony Tony
K173471 01/08/2018 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD Yang Zhaohui
K172860 01/02/2018 Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Ma Chao
K171311 01/12/2018 A5 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai
K171292 01/12/2018 A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai
K163712 01/02/2018 Clover 50/Clover60/Clover70 Diagnostic Ultrasound System SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. JIANG XIAOSAN
K173635 01/12/2018 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Kimberly Mangum
K163081 01/29/2018 40-42mm BiPolar Head and 22mm Femoral Head SIGNATURE ORTHOPAEDICS PTY LTD. Declan Brazil
K171421 01/10/2018 VERTICALE« Posterior Spinal Fixation System/VERTICALE« System Silony Medical GmbH Bircan Yilmaz
K172452 01/11/2018 Bruxor Sleep Specialties, LLC James S. Fallon
K171827 01/19/2018 ReddyPort NIV Access Elbow SMD Manufacturing, LLC Rian Wendling
K171674 01/19/2018 Angel Align System Smile Development Corp Ian Kitching
K173293 01/08/2018 EVOS Small Fragment Upper Extremity Plates Smith & Nephew, Inc. Samantha Staubach
K172336 01/10/2018 Smith & Nephew Patient Matched Cutting Blocks Smith & Nephew, Inc. Brad Sheals
K171968 01/25/2018 EchoGlo Needle Smiths Medical ASD, Inc. Michael R. Johnson
K173759 01/08/2018 Thermage CPT System and Accessories Solta Medical Ken Nehmer
K173702 01/03/2018 Juliet Ti LL SPINEART Franck Pennesi
K172518 01/05/2018 Spineology Navigation Instruments Spineology Inc. Jacqueline Hauge
K171228 01/19/2018 Fiji Anchor SportWelding GmbH Joerg Mayer
K173875 01/19/2018 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert StelKast, Inc. Dave Stumpo
K172319 01/18/2018 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K173448 01/25/2018 CliniCloud Stethoscope StethoCloud Pty.Ltd (CliniCloud) Andrew Lin
K171784 01/19/2018 Straumann Dental Implant System Straumann USA, LLC Jennifer M. Jackson
K171391 01/26/2018 Stryker 90-S Max SERFAS Energy Probe Stryker Ben Krebs
K173866 01/18/2018 Stryker AIM Light Source and SafeLight cable Stryker Jay Nayar
K173476 01/18/2018 Tritanium« TL Curved Posterior Lumbar Cage Stryker Nikin Desai
K172116 01/25/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation Kristi Ashton
K172774 01/12/2018 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma Gmbh Heike Gustke
K171628 01/12/2018 HBS2 Headless Bone Screw Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock
K172384 01/16/2018 Quickie(r) Q700-UP M Sunrise Medical (US) LLC Nancy J. Gertlar
K173021 01/09/2018 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems Supersonic Imagine Laurence Hermitte
K173560 01/12/2018 Microcatheter Surmodics, Inc. Sherri Mellingen
K171665 01/11/2018 Microcatheter and guide-wire system Suzhou Hengrui Disheng Medical Co.,Ltd. Jingwen Li
K173301 01/19/2018 BioSphere MIS Putty (BioSphere MIS) Synergy Biomedical, Llc Mark Borden
K173558 01/26/2018 SyMRI SyntheticMR AB Maria Almesaker
K173219 01/22/2018 CAMPYLOBACTER CHEK Techlab, Inc. Donna T. Link
K173217 01/22/2018 CAMPYLOBACTER QUIK CHEK Techlab, Inc. Donna T. Link
K173596 01/29/2018 Rusch Intermittent Urethral Catheters Teleflex Medical Amanda Webb
K171213 01/12/2018 One Touch Condom with Benzocaine Thai Nippon Rubber Industry Public Company Limited Pisut Chanwatarungkull (Pete)
K171775 01/09/2018 Theradome LH80 PRO Theradome Inc. Tamim Hamid
K173582 01/17/2018 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes ThermiGen, L.L.C Suzanne Cheang
K171313 01/19/2018 EM-4000 Specular Microscope Tomey Corporation Tomoko Watanabe
K173119 01/19/2018 DRI OCT Triton Topcon Corporation Charles Reisman
K173090 01/11/2018 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Toshiba Medical Systems Corporation Paul Biggins
K173382 01/26/2018 Vantage Galan 3T, V4.6 Toshiba Medical Systems Corporation Paul Biggins
K173088 01/31/2018 Vitrea Software Toshiba Package VSTP-001A Toshiba Medical Systems Corporation Paul Biggins
K173622 01/16/2018 CS Imaging Trophy Marie-Pierre Labat-camy
K172304 01/23/2018 TruAbutment DS TruAbutment Inc. Brandon Kim
K172189 01/16/2018 Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt Truemed Group LLC Nina Galeana Rodriguez
K173563 01/10/2018 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE TZ Medical Inc John Lubisich
K173198 01/03/2018 Facet Screw Fixation System U&i Corporation Yeon-Jung Choi
K173054 01/16/2018 Navigo Workstation Version 2.0 UC-Care Ltd. Hadas Sheynise
K171295 01/09/2018 ULab Systems Treatment Planning Software ULab Systems, Inc. Charlie Wen
K173650 01/05/2018 AquaShield System CO2- Fujifilm United States Endoscopy Group, Inc. Carroll Martin
K171500 01/30/2018 Uro-V Cystoscope UroViu Corporation Thomas Lawson
K173062 01/25/2018 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) V&Q Manufacturing Corporation Jacky Jin
K172716 01/26/2018 V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108 Length V2K Medical Inc. Jake Wolenberg
K173838 01/17/2018 ARIA Radiation Therapy Management Varian Medical Systems, Inc. Peter J. Coronado
K173891 01/19/2018 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. Lisa Gallatin
K172567 01/31/2018 GORE Molding and Occlusion Balloon Catheter W.L Gore And Associates Inc Jeremiah Andrews
K171273 01/19/2018 LINK« BiMobile(TM) Dual Mobility System Waldemar Link Gmbh & Co. KG Stefanie Reimers
K171625 01/12/2018 Single Lumen Ovum Aspiration Needles Willian A. Cook Australia Pty Ltd Gordana Pozvek
K172548 01/12/2018 Wiltrom Spinal Fixation System Wiltrom Corporation Limited Yi-Chun Su
K172968 01/05/2018 Hair Up Y&J BIO Co., Ltd. Kwang Sic Kim
K172683 01/16/2018 Yamahachi Pink CAD/CAM Disk Yamahachi Dental Mfg., Co. Shogo Muramatsu
K173306 01/22/2018 EZ Plate Zavation Medical Products Llc Matt Jones
K170234 01/17/2018 Endotracheal tube; Reinforced Endotracheal tube Zhanjiang Star Enterprise Co., Ltd Rongsheng Tang
K171518 01/05/2018 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Zhejiang kindly Medical Devices Co., Ltd Zenghua Zhang
K173417 01/30/2018 Zimmer Persona Personalized Knee System Zimmer, Inc. Nicole Meredith


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