FDA 510(k) Decisions During March, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K163629 03/10/2017 Audit MicroControls Linearity FD Tumor Markers II Aalto Scientific, Ltd. Robert Burda
K170009 03/30/2017 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC Erik Kulstad
K161918 03/03/2017 SREE MRI Transport Incubator ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS RAVI SRINIVASAN
K162070 03/16/2017 JOINIX CANNULAR SYSTEM AJU Pharm Co.,Ltd. Kim Jung Gil
K170520 03/22/2017 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ Alcon Research, Ltd. Karen Mudd
K162529 03/03/2017 DigiX FDX Allengers Medical Systems Limited Manmohan Singh
K170512 03/10/2017 Altus Spine Titanium Interbody Fusion System Altus Partners, LLC Claudia Hill
K162589 03/10/2017 Adscope 658 Electronic Stethoscope AMERICAN DIAGNOSTIC CORP. Michael Falco
K170743 03/30/2017 AngioDynamics Total Abscession Biliary Drainage Catheter AngioDynamics, Inc. Teri Juckett
K170267 03/09/2017 BGM009 Plus Blood Glucose Monitoring System Apex Bio Technology Corp. Hsue-mei Lee
K161077 03/17/2017 RnD TE and RnD SE Apex Dental Materials, Inc Scott Lamerand
K160581 03/24/2017 K3PRO Konus Additional Abutments and Implants ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG RICHARD DONACA
K162820 03/31/2017 AC3 Series IABP System ARROW INTERNATIONAL, INC. Alifiya Jagmag
K170350 03/03/2017 ToeMATE« Hammertoe Correction System Arthrosurface, Inc. Phani Puppala
K161257 03/31/2017 MultiPulse HoPLUS ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K170635 03/30/2017 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K163529 03/29/2017 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) AVERY DENNISON CORPORATION LISA BARTAKOVICS
K170539 03/20/2017 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm Avitus Orthopaedics, Inc Maxim Budyansky
K161880 03/14/2017 NIVR58-T kit Barco N.V. Lieven De Wandel
K170476 03/28/2017 Nio Color 5.8MP (MDNC-6121) Barco NV Helena Soenen
K162342 03/24/2017 Stellaris Elite Vision Enhancement System Bausch + Lomb Ken Nehmer
K162562 03/17/2017 OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY BCG MEDICAL, LLC LISA GIAP
K162740 03/21/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) BECKMAN COULTER, INC. SHANNON POPSON
K163637 03/21/2017 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) BECTON, DICKINSON & COMPANY MONICA E. GIGUERE
K170336 03/10/2017 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector Becton, Dickinson and Company Kimberly Geisler
K161898 03/08/2017 Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set BEIJING FERT TECHNOLOGY CO., LTD MENG ZHANG
K161892 03/02/2017 Slimming Treatment Device BEIJING HONKON TECHNOLOGIES CO., LTD Li Yanzhe
K163563 03/13/2017 VITEK 2 AST-GN Gentamicin (<=1 û >=16 ?g/mL) bioMerieux, Inc Cherece L. Jones
K161816 03/28/2017 BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO bioMerieux, Inc. Jolyn Tenllado
K162559 03/31/2017 Move Forward 3D Motion Simulation Service BIOMET INC. PAUL HARDY
K163608 03/21/2017 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm BioStable Science & Engineering Inc. Julie Thomas
K170628 03/31/2017 BioMonitor 2-AF, BioMonitor 2-S BIOTRONIK, Inc Jon Brumbaugh
K163700 03/29/2017 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. Marc Chaunet
K163248 03/27/2017 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Boston Scientific Corporation Yingying Gao
K170636 03/22/2017 Fathom-16 Steerable Guidewires Boston Scientific Corporation Keith Neligan
K170204 03/24/2017 FFR Link, FFR Signal Processing Module Boston Scientific Corporation Dan Krause
K163314 03/23/2017 Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter Boston Scientific Corporation Nikki Wahlberg
K162793 03/10/2017 RHYTHMIA HDx Mapping System Boston Scientific Corporation Regina Holmes
K170188 03/08/2017 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie Medical Corporation Rubiela Maldonado
K162186 03/31/2017 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K163267 03/24/2017 NITRILE EXAMINATION GLOVE BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K170058 03/03/2017 TheraView TBI Cablon Medical B.V. Jurjen Weistra
K162383 03/01/2017 Cadwell Sierra Summit, Cadwell Sierra Ascent CADWELL INDUSTRIES, INC. CHRISTOPHER BOLKAN
K162199 03/02/2017 Cascade IOMAX Intraoperative Monitor CADWELL INDUSTRIES, INC. MELISSA KIRKUP
K170332 03/01/2017 DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS Canon, Inc. SHINJI MORI
K162394 03/08/2017 CRC-77tHR Capintec, Inc. Mary Anne Yusko
K162503 03/24/2017 Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software Cardiac Insight, Inc. Brad Harlow
K163157 03/21/2017 SmartGrid Carestream Health Diane Koetter
K162947 03/03/2017 Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler CHONGQING QMI SURGICAL CO., LTD KANG LI
K162870 03/07/2017 CIMLRE F1 and CIMILRE S3 CIMILRE CO., LTD. Ko Bong Jae
K162905 03/15/2017 SleepWeaver 3D Nasal Mask Circadiance, LLC JAMES GIANOUTSOS
K163323 03/20/2017 Dolphix« External Fixation System MR Conditional CITIEFFE s.r.l Stefano Pullega
K163103 03/23/2017 Tranberg CLS Diffusor Laser Fiber Clinical Laserthermia Systems AB Lars-Erik Eriksson
K162405 03/28/2017 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHAN YEW MEN
K162789 03/28/2017 Foresight Intracardiac Echocardiology (ICE) System Conavi Medical Inc. Sam Mostafavi
K170501 03/17/2017 CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K162906 03/07/2017 Flexi-Seal PROTECT Fecal Management System ConvaTec Karen Howes
K170622 03/31/2017 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component Cook Incorporated Naomi Funkhouser
K170243 03/31/2017 LOSPA IS TLIF & DLIF Cages CORENTEC CO., LTD J.S. DANIEL
K162979 03/24/2017 Veloxion System Corinth MedTech, Inc. Sandeep Saboo
K170348 03/02/2017 Signia Four-Bay Smart Charger (to be used with Signia Stapler) Covidien Katherine Y. Choi
K163654 03/08/2017 VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar Covidien llc Gary LeMere
K162506 03/09/2017 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K163552 03/03/2017 iPulse SmoothSkin BARE Hair Removal Device CYDEN LIMITED MIKE KIERNAN
K162967 03/24/2017 nuance UNIVERSAL Den-Mat Holdings, LLC Helen Ragus
K162044 03/03/2017 Dentca Denture Base II DENTCA, Inc. Jason Lee
K163350 03/31/2017 Multibase Abutments EV and ATLANTIS Suprastructures DENTSPLY SIRONA KARL NITTINGER
K162124 03/29/2017 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins DePuy Synthes CHRISTOPHER J. MEDBERRY
K162654 03/13/2017 mollosil plus DETAX GmbH & Co.KG Antje Reeps
K161929 03/29/2017 Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove Dipped Products (Thailand) Limited Nilaksha Pushpakumara
K170391 03/09/2017 ANSiStim-PP DyAnsys Inc Srini Nageshwar
K162509 03/10/2017 Infrared Non-contact Thermometer, Model ACT8100 EASYWELL BIOMEDICALS, INC. Arthur Chen
K170167 03/03/2017 True 3D Viewer Software EchoPixel Inc. Sergio Aguirre
K163497 03/02/2017 EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt ENCORE MEDICAL, L.P. Teffany Hutto
K162627 03/31/2017 EnsoSleep EnsoData, Inc. Chris Fernandez
K163082 03/16/2017 6200 Ultrasound System and 6250 Ultrasound System ESAOTE S.P.A MASSIMO POLIGNANO
K162811 03/02/2017 MR Conditional CGA 870 Essex Industries, Inc. Russ Jacobsmeyer
K163152 03/11/2017 PROLENE Soft Polypropylene Mesh Ethicon, Inc. Debbie Fazen
K162167 03/31/2017 Caphosol Artifical Saliva Tablets EUSA Pharma (UK) Limited Paul Davisson
K162325 03/06/2017 Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw Exactech Inc Zach Sharrah
K162693 03/29/2017 VertebraLINK Fusion Platform FACETLINK DBA LINKSPINE MASSIMO CALAFIORE
K163300 03/22/2017 ThermoShield HME Filter Flexicare Medical Limited Joel Biddle
K170701 03/24/2017 GEN_2 and GEN_3 Mechanical Wheelchairs Free Wheelchair Mission Don Schoendorfer
K160139 03/20/2017 Luggie Chair FREERIDER CORPORATION Arthur Wang
K170451 03/16/2017 FDX Console (DR-ID300CL) Software FUJIFILM Medical Systems U.S.A., Inc. Peter Altman
K162836 03/13/2017 FUJIFILM Surgical System FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K170084 03/10/2017 InterLock Trocar FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K163331 03/17/2017 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
K162023 03/24/2017 CardioDay V2.5 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K163017 03/22/2017 Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs GMP MEDICARE SDN BHD EVA VINONI BT MUSTAFA
K163096 03/31/2017 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System GPC MEDICAL LIMITED VIKAS NARANG
K170284 03/31/2017 Great Basin Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC. SUZETTE CHANCE
K163436 03/06/2017 Greiner Vacuette Urine Count and Culture, Mannitol tube GREINER BIO-ONE NA INC. MANFRED ABEL
K162850 03/24/2017 GuideMia Ortho+ GUIDEMIA TECHNOLOGIES, LLC FEI GAO
K153600 03/17/2017 Consult Station TS H4D SAS MARTA RIVAS
K162471 03/30/2017 Hach CM130 Chlorine Monitoring System HACH COMPANY Jeff Ryberg
K170127 03/14/2017 HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 Hardy Diagnostics Rianna Malherbe
K162646 03/03/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K163378 03/17/2017 Monarch Airway Clearance System HILL-ROM SERVICES PTE LTD Huifang Zhu
K163528 03/03/2017 HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. Doug Thistlethwaite
K162412 03/09/2017 Hoggan Scientific« microFET2Ö Hoggan Scientific, LLC Spencer Walker
K163052 03/29/2017 Brevera Biopsy System with Corlumina Imaging Technology HOLOGIC, INC. SARAH FAIRFIELD
K162784 03/25/2017 Silk'n HST Home Skinovations Ltd. Amit Goren
K161469 03/28/2017 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module Hospira, Inc Keith Dunn
K170077 03/30/2017 LUOFUCON Silicone Ag Foam Dressing with Border HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. Guosheng Tan
K163343 03/21/2017 Icare HOME tonometer Icare Finland Oy Matti Tulikoura
K153538 03/02/2017 Dextramer CMV Kit Immudex Aps Liselotte Brix
K163290 03/24/2017 INFINITT ULite INFINITT CO., LTD. Heejin Lim
K170420 03/02/2017 n!ce Glass Ceramic Blocks for Amann Girrbach Institut Straumann AG Christopher Klaczyk
K162311 03/07/2017 Straumann PrefGel INSTITUT STRAUMANN AG CHRISTOPHER KLACZYK
K170314 03/03/2017 ACL AcuStar INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K162364 03/02/2017 Intellijoint HIP Generation 2A System INTELLIJOINT SURGICAL INC. BRANDON GINGRICH
K162037 03/23/2017 Eclipse with VEMP INTERACOUSTICS A/S Erik Nielsen
K163488 03/20/2017 Flex-Thread Clavicle Pin System INTRAFUSE LLC Robert Hoy
K170508 03/10/2017 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads Intuitive Surgical, Inc. Cheryl Wu
K161865 03/07/2017 iSage Rx (iSage Rx Basal Insulin Titration) iSag Rx, Inc. RYAN SYSKO
K162960 03/14/2017 TotalC-Ram ITENA CLINICAL Charles Peyre
K161991 03/03/2017 Curasite IZUN PHARMACEUTICALS JACK TALLEY
K163224 03/09/2017 JAZZ SOLO Sensor Jazz Imaging LLC Todd C. Miller
K163093 03/14/2017 Safety Blood Collection Set Jiangsu Shenli Medical Production Co., Ltd Tina Cai
K163162 03/20/2017 Sterile Hypodermic Safety Syringes for Single Use JiangXi HongDa Medical Equipment Group Ltd. Yang Xiaohua
K163161 03/20/2017 Sterile Single-use Syringe with Needle JiangXi HongDa Medical Equipment Group Ltd. Yang Xiaohua
K161979 03/22/2017 ENFit enteral syringe JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K162868 03/17/2017 Exam Vue PACS JPI Healthcare Solutions, Inc Jang Won Lee
K163364 03/15/2017 MOJAVE Expandable Interbody System K2M Nancy Giezen
K160721 03/07/2017 Vado Steerable Sheath KALILA MEDICAL, INC. Carrie Neuberger
K163471 03/16/2017 Kalitec Direct InSePtionÖ MIS Fixation System KALITEC DIRECT, LLC KEITH CANNAN
K163239 03/17/2017 SMARTmatic Kaltenbach & Voigt GmbH Stefan Trampler
K162410 03/02/2017 TIPCAM 1S 3D System KARL STORZ Endoscopy America, Inc Winkie Wong
K162880 03/16/2017 TIPCAM 1S 3D System KARL STORZ Endoscopy America, Inc Winkie Wong
K161554 03/02/2017 ENDOFLATOR 40, ENDOFLATOR 50 KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K163405 03/21/2017 360KS Implant Positioning System Kico Knee Innovation Company PTY Limited Karl Rentsch
K170124 03/09/2017 Level One Hand Plating System KLS MARTIN LP Jennifer Damato
K163201 03/16/2017 KYMCO EQ10D Scooter KWANG YANG MOTOR CO., LTD. Wang Ching Yun
K162235 03/24/2017 LUVENA VAGINAL MOISTURIZER & LUBRICANT LACLEDE, INC. MICHAEL PELLICO
K163247 03/09/2017 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider LAURIMED LLC Brian R DuBois
K163517 03/14/2017 Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ?g/mL LIOFILCHEM S.R.L. FABIO BROCCO
K163572 03/15/2017 LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source LV Liberty Vision Corp. Paul T. Finger
K162935 03/10/2017 Rapid2 Therapy System MAGSTIM COMPANY LTD. Kevyn Beard
K163522 03/14/2017 FilmArray Warrior Control Panel M290 Maine Molecular Quality Controls, Inc. Joan Gordon
K163498 03/16/2017 VALIDATE Heparin Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY, LLC JAMES CHAMPLIN
K153688 03/02/2017 Edi Catheter ENFit MAQUET CRITICAL CARE AB MIRVA BOOTHE
K160665 03/29/2017 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 MAQUET CRITICAL CARE AB CARINA LUNDBERG
K161635 03/31/2017 AMIStem-H Proximal Coating MEDACTA INTERNATIONAL SA STEFANO BAJ
K162035 03/06/2017 GMK Sphere Medacta International SA Stefano Baj
K170455 03/16/2017 MectaLIF Anterior Stand Alone Medacta International SA Stefano Baj
K161680 03/24/2017 MEDICON Spinal Spreading Systems MEDICON EG Joachim Schmid
K170095 03/08/2017 Vial2Bag Direct Connect Medimop Medical Project Ltd. Ilanit Goldgraber
K163401 03/21/2017 Nix Ultra Lice Treatment Kit MEDTECH PRODUCTS INC. JEAN BOYKO
K170296 03/20/2017 CoreCath 2.7S Medtronic Advanced Energy Lydia Sakakeeny
K162309 03/31/2017 StealthStation S8 System Platforms and StealthStation Cranial Software MEDTRONIC NAVIGATION, INC. Tia Fushimi-Bain
K163182 03/23/2017 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
K163565 03/28/2017 MR8 Drill System MEDTRONIC POWERED SURGICAL SOLUTIONS Deep Pal
K170583 03/17/2017 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface Medtronic, Inc. Gayatri Ghadge
K163575 03/03/2017 Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K162898 03/17/2017 Olecranon Plating System MIAMI DEVICE SOLUTIONS, LLC Michelle Montesino
K160641 03/08/2017 Solitaire Platinum Revascularization Device, 6x40 mm Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K162026 03/01/2017 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions MicroPort Orthopedics, Inc. Byron Ledbetter
K162524 03/03/2017 AZUR CX Detachable 18 Peripheral Coil System MicroVention, Inc Laraine Pangelina
K162999 03/29/2017 V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System MICROVENTION, INC Laraine Pangelina
K163376 03/10/2017 Mikro-Cath Pressure Catheter Millar, Inc. Jacqueline Jean-Baptiste
K170449 03/31/2017 Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection Millennium Medical Technologies, Inc. Jim Barley
K170329 03/24/2017 Basic, Dominant Flex Modela AG Markus Butler
K163249 03/24/2017 GoSpiro MONITORED THERAPEUTICS, INC. William Zimlich
K160287 03/14/2017 Rapid Barostat Bag (RBB) Pump and Catheter MUI SCIENTIFIC TAMMY MUI
K161737 03/02/2017 RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed MYCO MEDICAL Sanjiv Kumar
K161835 03/24/2017 iovera system Myoscience, Inc Tracey Henry
K163425 03/24/2017 NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System NARANG MEDICAL USA CORPORATION Reginald Swift
K161430 03/02/2017 Myoject Luer Lock Needle Electrode Natus Manufacturing Limited Michael Galvin
K161304 03/02/2017 EndoPur Filter Nephros Inc. Hollie Johnson
K163118 03/09/2017 FLEX Microwave Ablation System and Accessories NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K170161 03/29/2017 New Deantronics E GreenÖ Electrosurgical Monopolar Pencils New Deantronics Taiwan, LTD Jane Liu
K170310 03/30/2017 Alians Clavicle range Newclip Technics Gaelle Lussori
K163188 03/06/2017 Next Science Wound Gel (Rx) Next Science, LLC Matthew Myntti
K161681 03/08/2017 Nipro SafeTouch IV Catheter NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K161416 03/16/2017 Multi-unit Abutment Plus NOBEL BIOCARE AB Charlemagne Chua
K161598 03/14/2017 NobelZygoma 0? Nobel Biocare AB Charlemagne Chua
K162308 03/17/2017 Noris Medical MBI-2mm Dental Implant System Noris Medical Ltd Simha Sibony
K170030 03/13/2017 NOVATECH TALCAIR NOVATECH S.A. JENNIFER NEFF
K163230 03/16/2017 NuVasive Modulus XLIF Interbody System NUVASIVE INCORPORATED Cynthia Adams
K162313 03/16/2017 NuVasive Next Generation NVM5 System NUVASIVE INCORPORATED MARY ADAMS
K170346 03/07/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. Lance Justice
K163491 03/24/2017 NuVasive CoRoent Small Interbody System NuVasive, Incorporated Martin Yahiro
K170271 03/30/2017 NuVasive(r) Monolith Corpectomy System NuVasive, Incorporated Cynthia Adams
K170126 03/09/2017 NuVasive« Reline« 4.5-5.0 System NUVASIVE, INCORPORATED Olga Lewis
K162217 03/23/2017 LOYON Oculus Innovative Sciences Brian W. Martin
K162746 03/03/2017 Ontex and other proprietary names ONTEX BVBA Henri Lesage
K161547 03/09/2017 Transem and EchoGen Embryo Transfer Catheters ORIGIO A/S TOVE KJAER
K163379 03/02/2017 KneeAlign 2 System OrthAlign, Inc. David Vancelette
K162995 03/30/2017 Ibis« Pedicle Screw System Ortho Development Corporation Lindsay Martin
K163489 03/08/2017 OrthoSolutions 'System26' Bone Screws Ortho SOlutions UK Limited Craig Bluett
K162921 03/13/2017 Navigated Instrument System ORTHOFIX INC. JACKI KOCH
K163054 03/08/2017 DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System OSPREY MEDICAL, INC. MELANIE HESS
K163109 03/22/2017 OxyHeal 4000 Multiplace Hyperbaric Chamber Family OXYHEAL MEDICAL SYSTEMS, INC. EDWARD J. CHOMAS
K170327 03/30/2017 Parcus SLiK Anchors Parcus Medical Paul Vagts
K161731 03/27/2017 Cleveland Multiport Ventricular Catheter Set Parker Hannifin Corp. George Austria
K163003 03/16/2017 Y3 Proximal Femoral Plate System PEGA MEDICAL INC. ARIEL R. DUJOVNE
K161141 03/22/2017 ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT PENTAFERTE ITALIA S.R.L. ROSA DI GIOIA
K163649 03/31/2017 SureSigns VS3; SureSigns VS4 Philips Medical Systems Greg Li
K161812 03/27/2017 Freedom Syringe Procedure Products, Inc. Doug Rowley
K163474 03/10/2017 CAVUX CervicalCage-L SA System PROVIDENCE MEDICAL TECHNOLOGY, INC. EDWARD LIOU
K161667 03/27/2017 Sapphire Infusion Pump Q Core Medical Ltd. Shimon Vaknin
DEN160028 03/27/2017 ipsogen JAK2 RGQ PCR Kit QIAGEN INC LINDSEY HOWARD
K170331 03/03/2017 Cyber Ho quanta system spa Francesco Dell'Antonio
K162804 03/08/2017 Q2 Low Pressure Power Injection Extension Set QUEST MEDICAL, INC. Amy Clendening-Wheeler
K161691 03/20/2017 Direct LDL Cholesterol (LDL) RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K170355 03/02/2017 RayStation 6 RaySearch Laboratories AB (publ) David Hedfors
K160067 03/07/2017 RenovoCath RenovoRx, Inc. Kamran Najmabadi
K163569 03/17/2017 Elecsys CMV IgM Roche Diagnostics Angelo Pereira
K170403 03/07/2017 CenterCross Ultra LV Catheter Roxwood Medical, Inc. Mehrdad Farhangnia
K170528 03/09/2017 SterispineÖ PS SAFE ORTHOPAEDICS Pierre Dumouchel
K170493 03/28/2017 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Jiyeon Cho
K163099 03/22/2017 My Dose Coach Sanofi, Inc. Robert Ezzell
K163604 03/09/2017 SeaSpine« Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K160345 03/03/2017 Glass Ionomer Cement SHANDONG HUGE DENTAL MATERIAL CORPORATION Steven Song
K163655 03/17/2017 Sparkling Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Amy Lee
K161428 03/23/2017 PerfectSmooth SHEN ZHEN COSBEAUTY CO.,LTD. Nicole Hu
K161530 03/31/2017 Bluetooth blood pressure monitor SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. Dacheng Gong
K170277 03/23/2017 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K162733 03/10/2017 iFuse Implant System« - iFuse-3D implant SI-BONE, INC. ROXANNE DUBOIS
K161954 03/09/2017 Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) Siemens Healthcare Diagnostics Justin DiValentino
K162298 03/16/2017 LOCI Total Vitamin D Total Assay, LOCI VITD CAL SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN DRAY-LYONS
K170065 03/09/2017 ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc. Julie Warren
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