FDA 510(k) Applications Received During January, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K173435 11/03/2017 3M Attest Rapid Readout Biological Indicator 3M Company Nadia Battah
K173437 11/03/2017 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H 3M Company Hilary B. Hovde
K173584 11/20/2017 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K173519 11/14/2017 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K170196 01/23/2017 A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor A&D Company, Ltd. Jerry Wang
K173579 11/20/2017 ThoreconÖ Fixation System A&E Medical Corporation Dana Rodriguez
K170183 01/23/2017 Cetus system, Cetus probe A.R.C. Laser GmbH Angela Thyzel
K170160 01/18/2017 Abbott ARCHITECT Free T3 Abbott Laboratories Linda Sohn
K173628 11/24/2017 Acclarent ENT Navigation System Acclarent, Inc James Patrick Garvey
K173430 11/02/2017 SeQure« NF and SeQure« Microcatheters Accurate Medical Therapeutics Ltd. Eran Miller
K170300 01/31/2017 Restrata Wound Matrix Acera Surgical, Inc. Tamas Kovacs
K170007 01/03/2017 Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K170001 01/03/2017 Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini, Jr.
K170214 01/24/2017 Additive Orthopaedics Locking Lattice Plate Additive Orthopaedics, LLC Greg Kowalczyk
K170009 01/03/2017 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC Erik Kulstad
K170039 01/05/2017 STERRAD VELOCITY Biological Indictator and Reader Advanced Sterilization Products (ASP) Sun Choi
K173444 11/06/2017 Quantitative Total Extensible Imaging (QTxI) AIQ Solutions, Inc. Dona Alberti
K170075 01/09/2017 AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) AirXpanders, Inc. Belinda Pinedo
K173550 11/16/2017 Akros FibuLinkÖ Syndesmosis Repair Kit Akros Medical Charles Horrell
K173538 11/15/2017 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K173660 11/29/2017 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K173502 11/13/2017 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. Benjamin Crystal
K173653 11/28/2017 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit Alere Scarborough, Inc. Danielle A. Briggeman
K170178 01/19/2017 Ultravision Visual Field Clearing System Alesi Surgical Ltd. DAVID BRODERICK
K170241 01/26/2017 GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System All Medicus Co., Ltd. Hong-Joo Park
K173522 11/14/2017 Solanas« Posterior Stabilization System Alphatec Spine, Inc Natalia Shirina
K170069 01/09/2017 AmCAD-UV AmCad BioMed Corporation Jack Yang
K173453 11/06/2017 Valeo« C+CSC with Lumen Interbody Fusion Device Amedica Corp. Jason Parberry
K170222 01/25/2017 Rapid Tox Cup II AMERICAN BIO MEDICA CORP. MELISSA WATERHOUSE
K170231 01/25/2017 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á Andon health Co., Ltd Yi Liu
K170258 01/27/2017 SpeedLyser Infusion Catheter AngioDynamics, Inc. Teri Juckett
K170267 01/27/2017 BGM009 Plus Blood Glucose Monitoring System Apex Bio Technology Corp. Hsue-mei Lee
K173658 11/29/2017 Confidence Blood Glucose Monitoring System Applied Biomedical LLC Zakir Murtaza
K170064 01/09/2017 GLUCOCARD W Blood Glucose Monitoring System ARKRAY FACTORY, INC. KAZUYA YORIMITSU
K173542 11/16/2017 Arterys Oncology DL Arterys Inc. John Axerio-Cilies
K170206 01/24/2017 Arthrex FiberTape Cerclage ARTHREX, INC. IVETTE GALMEZ
K173656 11/29/2017 Arthrex FibuLock Nail Arthrex, Inc. Rebecca R. Homan
K170147 01/17/2017 Lucica Glycated Albumin-L ASAHI KASEI PHARMA CORPORATION HIDEJI HIRAOKA
K170223 01/25/2017 Progreat ASHITAKA FACTORY OF TERUMO CORPORATION LAUREN P. NITAHARA
K170049 01/05/2017 AssureTech Panel Dip Test, AssureTech Quick Cup Test ASSURE TECH (HANGZHOU) CO., LTD. SHISHENG LING
K170304 01/31/2017 Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers Astell Scientific Limited Gary Doughty
DEN170004 01/10/2017 Ellipsys Vascular Access System Avenu Medical, Inc Rebecca K. Pine
K173531 11/15/2017 Lockbox for Perfusor Space PCA Infusion Pump B. Braun Medical Inc. Tracy Maddock
K173480 11/13/2017 Crystalsert Lens Delivery System Bausch & Lomb, Inc Gary Rauvola
K170052 01/05/2017 Stellaris Elite vision enhancement system Bausch + Lomb Dan Regan
K170283 01/30/2017 BD Nexiva Diffusics Closed IV Catheter System Becton, Dickinson and Company Amy Honey
K173523 11/14/2017 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company Monica E. Giguere
K170281 01/30/2017 MSA100BT Peak Flow Meter Beijing M&B Electronic Instruments Co., Ltd. Yang Shisheng
K170228 01/25/2017 Belimed Steam Sterilizer MST-H TOP 5000 Belimed AG Christoph Hermens
K173556 11/17/2017 Injection Screw Biedermann Medtech, Inc. Michelle Montesino
K173643 11/27/2017 Trilor Disks, Blocks and Arches Bioloren S.R.L. Ratti Umberto
K173623 11/24/2017 Anchor plate BioMaterials Korea, Inc Jiyea Kim
K170013 01/03/2017 Eztetic BellaTek Encode Healing Abutments BIOMET 3I KRUPAL PATEL
K173411 11/01/2017 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp. Patricia Sandborn Beres
K170143 01/17/2017 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, Bionime Corporation Kay Wu
K173638 11/24/2017 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus Bionime Corporation Kay Wu
K170138 01/17/2017 NEURONAUTE BIOSERENITY Quang TRAN
K173569 11/20/2017 Ultrasound System 1300 BK Medical ApS Karen Provencher
K170232 01/25/2017 AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer BODITECH MED INC. HYUNG-JU OH
K170204 01/23/2017 FFR Link, FFR Signal Processing Module Boston Scientific Corporation Dan Krause
K170188 01/23/2017 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie Medical Corporation Rubiela Maldonado
K173540 11/15/2017 Brainsway Deep (DTMS) System Brainsway Ltd. Ahava Stein
K170037 01/04/2017 Breathe Technologies Life2000Ö Ventilation System Breathe Technologies Samir Ahmad
K170158 01/18/2017 PowerGlide ST Midline Catheter C. R. Bard, Inc. JACOB LEE
K170278 01/30/2017 OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners C.R. BARD INC. KATHERINE EARLE
K170058 01/06/2017 TheraView TBI Cablon Medical B.V. Jurjen Weistra
K173432 11/02/2017 ENZA-A Titanium ALIF Camber Spine Technologies Damian Heinz
K173487 11/13/2017 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K173652 11/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd. Yael Rubin
K170198 01/23/2017 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) Cardinal Health, Inc. Megan Middaugh
K173547 11/16/2017 ImagenUniversal Cardiovascular Imaging Technologies James A. Case
K173478 11/13/2017 OnSight 3D Extremity System Carestream Health, Inc. Victoria A. Wheeler
K173407 11/01/2017 VT - 100, VT - 200 Carilex Medical, Inc. Henry Kao
K170171 01/19/2017 IOLMaster 700 Carl Zeiss Meditec AG Christian Muenster
K170102 01/11/2017 Pekkton Ivory CENDRES+METAUX SA Uli DIERMANN
K170163 01/18/2017 Erisma« LP Spinal Fixation System CLARIANCE SAS Pascal ROKEGEM
K173501 11/13/2017 Meridian Vaginal Positioning System (VPS) Coloplast Diane Brinza
K173527 11/14/2017 Digitex Delivery Device Coloplast A/S Nikita Basandra
K170226 01/25/2017 iTotal Family Reusable Instrument Tray CONFORMIS, INC Emmanuel O. Nyakako
K173675 11/30/2017 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber ConvaTec Limited Justin Lovelace
K170016 01/03/2017 Biodesign Fistula Plug Cook Biotech Incorporated Perry W Guinn
K170193 01/23/2017 Advance 14LP Low Profile PTA Balloon Dilatation Catheter COOK INCORPORATED DANIEL J. CORBIN
K173414 11/01/2017 Advance Biliary Balloon Catheter Cook Incorporated Colin Jacob
K170298 01/31/2017 Liberator Beacon Tip Locking Stylet Cook Incorporated Steven Lawrie
K170008 01/03/2017 Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set COOK INCORPORATED ERUM B. NASIR
K170020 01/03/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K173657 11/29/2017 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated Samuel Engelman
K170010 01/03/2017 Salle Intraoperative Pyeloplasty Stent Set COOK INCORPORATED MINJIN CHOI
K173654 11/28/2017 Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated Kotei Aoki
K170243 01/26/2017 LOSPA IS TLIF & DLIF Cages CORENTEC CO., LTD J.S. DANIEL
K173678 11/30/2017 Diode Laser Cap Cosmo Far East Technology Limited Bob An
K173559 11/17/2017 Barrx SB RFA Endoscopic Catheter Covidien llc Saket Bhatt
K170170 01/19/2017 Valleylab FT10 Electrosurgical Platform Covidien llc Sharon McDermott
K170166 01/19/2017 CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture CPT Sutures Co., Ltd. Khoa Do
K170294 01/31/2017 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4öx 6ö) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 P CR BARD CHRISTINE LLOYD
K170154 01/18/2017 Creavo Vitalscan Magnetocardiograph Creavo Medical Technologies, Ltd. David Dimambro
K170100 01/11/2017 CreoDent Solidex Customized Abutment and Screw CreoDent Prosthetics, Ltd. Calvin Shim
K170005 01/03/2017 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) DAKO DENMARK A/S LASSE POST MOLLER
K170028 01/03/2017 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) DAKO DENMARK A/S Lasse Post Moller
K173465 11/08/2017 Concentrix MX-AC High-Speed Handpiece DentalEZ, Inc. Dan Laskowitz
K170220 01/25/2017 OneQ-SL s-Clean Implant System DENTIS CO., LTD. SUN CHU SHIN
K173528 11/15/2017 Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System Devon Medical Products (Jiangsu) Ltd. Julian Chu
K173498 11/13/2017 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K170104 01/12/2017 COMPACT S, COMPACT S (LED) DMETEC CO., LTD. Lee Seung Dae
K170122 01/13/2017 Delta III Lithotripter Dornier MedTech America John Hoffer
K173644 11/27/2017 Gazelle Polypropylene Suture and Delivery Device Dura Tap LLC Ann R. Lee
K170031 01/04/2017 Internal Octa Implant System EBI Inc. Mi Sook Kim
K170167 01/19/2017 True 3D Viewer Software EchoPixel Inc. Sergio Aguirre
K173586 11/20/2017 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K173442 11/06/2017 gammaCore-S electroCore, LLC Mike Romaniw
K170107 01/12/2017 Surgi Max Ultra elliquence, LLC Paul D. Buhrke IV
K173587 11/20/2017 Magseed Magnetic Marker Systtem Endomagnetics Ltd. Andrew Shawcross
K170240 01/26/2017 Truliant Femoral Components Exactech Inc Patrick Hughes
K173583 11/20/2017 Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners Exactech, Inc. Shing Jen Tai
K173439 11/03/2017 Bloom2 Programmable Electrophysiology Stimulator Fischer Medical Wes Rogers
K173505 11/13/2017 FORA GTel Blood Glucose Monitoring System ForaCare Inc. Anne Kuo
K173608 11/21/2017 Forest Dental Unit Forest Dental Products, Inc. Erin-Kate Barton
K170040 01/05/2017 BePOD Cannulated Arthrodesis Screws Fournitures Hospitalieres Industrie PATRICIA DONNARD
K173651 11/28/2017 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173593 11/21/2017 stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K170084 01/10/2017 InterLock Trocar FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K170038 01/05/2017 FuzeFix Screw System Fusion Orthopedics, LLC Adam Cundiff
K170032 01/04/2017 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP Fysicon BV C.W.A (Eric) Van Antwerpen
K170181 01/19/2017 Prizma G-Medical Innovations Ltd. N. Epstein
K173494 11/13/2017 OrthoSteady G Bone Cement G21 s.r.l. Filippo Foroni
K173645 11/27/2017 JASPER Spinal Fixation System GBS Commonwealth Co., Ltd. Jimmy Kim
K173500 11/13/2017 NMF004A GC America Inc. Mark Heiss
K173555 11/17/2017 LOGIQ E10 GE Healthcare Bryan Behn
K173576 11/20/2017 Pristina Serena GE Healthcare Gregory Pessato
K170199 01/23/2017 Unity Network ID GE Healthcare Robert Casarsa
K173612 11/22/2017 Optima XR646 HD GE Hualun Medical Systems Co., Ltd Kenny Ma
K170155 01/18/2017 EK12 Algorithm GE Medical Systems Information Technologies, Inc. Amy Yang
K173456 11/07/2017 ViewPoint 6 GE Medical Systems Ultrasound and Primary Tracey Ortiz
K173602 11/21/2017 Optima XR240amx, AutoGrid GE Medical Systems, LLC Chris Paulik
K170276 01/30/2017 Safety Blood Collection Device for Single Use Gemtier Medical (Shanghai) Inc. Lenny Cao
K170210 01/24/2017 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging Ltd. Hilla Debby
K170157 01/18/2017 INDEPENDENCE« Spacers Globus Medical Inc. Kelly J. Baker
K170284 01/30/2017 Great Basin Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC. SUZETTE CHANCE
K170229 01/25/2017 Dental High-speed Turbine Handpiece GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. KRISTI YANG
K170236 01/25/2017 Dental Low-speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd. Kristi Yang
K170287 01/30/2017 Dental Implants OKTAGON Bone Level Tapered Design Hager& Meisinger GmbH Melanie May
K170127 01/13/2017 HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 Hardy Diagnostics Rianna Malherbe
K170152 01/17/2017 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) HARTALEGA SDN BHD KUAN KAM HON
K173509 11/13/2017 Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn. Bhd. Kuan Kam Hon
K170180 01/19/2017 Will3D HDX WILL CORP. Seung-Il Chun
K170085 01/10/2017 SONON Ultrasound Imaging System, Model: 300L HEALCERION CO., LTD JAEYEOB JUNG
K170090 01/10/2017 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J Rogers
K173648 11/27/2017 Spectralis HRA + OCT and variants Heidelberg Engineering GmbH Christoph Schoess
K170077 01/09/2017 LUOFUCON Silicone Ag Foam Dressing with Border HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. Guosheng Tan
K170134 01/17/2017 Reperen Surgical Mesh IconLab Inc. Pavel Paul Artemow
K170110 01/12/2017 Diana Medication Transfer Set ICU MEDICAL INC Jason Ma
K173477 11/13/2017 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System ICU Medical, Inc. Catherine E. Kang
K173474 11/09/2017 RetiCapture Ilooda Co., Ltd. Yun-Jung Ha
K170202 01/23/2017 Aquarius 8600 IMAGING DYNAMICS COMPANY LTD. Nicole Wherry
K173541 11/15/2017 EPINAUT Imedicom Co., Ltd. Priscilla Chung
K173663 11/29/2017 Electronic Stethoscope DS3011A IMEDIPLUS INC. Shirley Lai
K170209 01/24/2017 ImPACT IMPACT APPLICATIONS, INC MICHAEL ZAGORSKI
K173616 11/22/2017 DIP Arthrodesis System In2Bones SAS Morgane Grenier
K173491 11/13/2017 RTS Lesser MTP Implant System In2Bones USA, LLC Rebecca Wahl
K173470 11/08/2017 ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K173672 11/30/2017 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter Inari Medical Eben Gordon
K173571 11/20/2017 Element System with IBT Electrodes Infinite Biomedical Technologies, LLC Rahul Kaliki
K173677 11/30/2017 InMode VLaze InMode MD Ltd. Amit Goren
K170211 01/24/2017 Insight Dental System Insight Dental System Matthew Kaupp
K173410 11/01/2017 n!ce for Planmill Institut Straumann AG Shokoufeh Khodabandeh
K173562 11/17/2017 Straumann Jason Membrane Institut Straumann AG Christopher Klaczyk
K170101 01/11/2017 Valiant Curing Light Inter-Med / Vista Dental Products Alex Johnson
K173567 11/20/2017 Sera Interacoustics A/S Amy Yanta
K173516 11/14/2017 NuBorne Infant Warmer International Biomedical Amy Pieper
K170029 01/04/2017 FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile INTERNATIONAL BIOPHYSICS CORPORATION Geoff Marcek
K170112 01/12/2017 IMD's Lumbar Puncture Needle INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) WALTER ZOHMANN
K173577 11/20/2017 Guarded Luer Connector International Medical Industries Inc. Brandon Hunt
K170120 01/13/2017 EndoRotor Interscope, Inc Jeffrey Ryan
K173585 11/20/2017 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K173415 11/01/2017 EndoWrist 5mm Thoracic Grasper Intuitive Surgical, Inc. Gayle Perry
K170207 01/24/2017 Obturys Itena Clinical Charles Peyre
K173573 11/20/2017 Tetric CAD Ivoclar Vivadent AG Sandra Cakebread
K170275 01/30/2017 Tri Auto ZX2 J. MORITA USA, INC. KEISUKE MORI
K170105 01/12/2017 Jac-Cell Medic testers JAC-CELL MEDIC MARK MELTZER
K170054 01/06/2017 iSurg JACO, LLC dba Macan Manufacturing and BNA Burz North America John Marsillo
K170080 01/10/2017 Neodent Implant System - CM Pro PEEK Abutment JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lechechem
K173565 11/17/2017 Sunrise 6200, Sunrise 7200 JK-Holding GmbH Juergen Gerstenmeier
K173553 11/16/2017 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K173434 11/02/2017 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 JVC KENWOOD Corporation Masafumi Yugami
K170262 01/27/2017 Digital Thermometer K-Jump Health Co., Ltd. JM Lin
K170055 01/06/2017 CAPRI Corpectomy Cage System K2M Nancy Giezen
K173508 11/13/2017 Everest Spinal System K2M Nancy Giezen
K170247 01/27/2017 Lacriflow CL KANEKA PHARMA AMERICA LLC Masaaki Fukunishi
K173426 11/02/2017 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System KCI USA, INC. Margaret Marsh
K173447 11/06/2017 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit KCI USA, Inc. Melanie Avila
K173572 11/20/2017 DSM Biomedical Calcium Phosphate Cement with Microspheres Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K170245 01/26/2017 DSM Biomedical Dental Bone Graft Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K173669 11/30/2017 K-D Balance King-Devick Technologies, Inc. Lori Grover
K170124 01/13/2017 Level One Hand Plating System KLS MARTIN LP Jennifer Damato
K170203 01/23/2017 System, Applicator, Radionuclide, Remote Controlled Kobold, LLC Deanna Hughes
K170286 01/30/2017 Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K170239 01/26/2017 Leica FL560 LEICA MICROSYSTEMS (SCHWEIZ) AG GRAINNE GRIFFIN
K173443 11/06/2017 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
K170299 01/31/2017 Ion PGM Dx System LIFE TECHNOLOGIES CORPORATION EMILY FINNEGAN
K170073 01/09/2017 LightMed Dental Laser System LIGHTMED DENTALTECHNOLOGY CORP. APRIL CHENG
K170046 01/05/2017 Lilium a-200E Lilium Otsuka Co., Ltd. Hiroaki Takahashi
K173484 11/13/2017 CorticaLINK Spinal Fusion Platform LinkSPINE Inc Nickolas Kriska
K170270 01/27/2017 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline LS Scientific Inc. D.B.A. KSE Scientific Jordan Reynolds
K173436 11/03/2017 Luma Light System Luma Therapeutics Tiffini Wittwer
K170179 01/19/2017 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity Lumenis Ltd. Amaya De Levie
K170121 01/13/2017 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Lumenis Ltd. Yehudit Kraizer
K170060 01/06/2017 M22 and ResurFx Systems LUMENIS, LTD. Naama Jacoby
K170175 01/19/2017 ENDOSEAL MTA MARUCHI Jang Sung Wook
K170168 01/19/2017 Masimo Rad-97 and Accessories MASIMO CORPORATION MARGUERITE THOMLINSON
K173445 11/06/2017 Materialise TKA Guide System Materialise NV Oliver Clemens
K173619 11/22/2017 Mimics inPrint Materialise NV Oliver Clemens
K170272 01/30/2017 TruMatch CMF Titanium 3D Printed Implant System Materialise NV Lina Ramirez
K173510 11/13/2017 BioStamp nPoint MC10 Inc. Rakesh Lal
K170149 01/17/2017 3DMetal Tibial Cones Medacta International SA Stefano Baj
K170106 01/12/2017 MyKnee PPS-Pin Positioners Medacta International SA Stefano Baj
K173472 11/09/2017 MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments Medacta International SA Stefano Baj
K170088 01/10/2017 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film MEDELA, AG Markus Butler
K170103 01/12/2017 Laparoscope Lens Shield Device (LENS) Medeon Biodesign, Inc Greta Chang
K173605 11/21/2017 iQMR Medic Vision - Imaging Solutions Ltd Eyal Aharon
K173667 11/30/2017 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia Medical Components, Inc. (Dba Medcomp) Courtney Nix
K170172 01/19/2017 UNiD Spine Analyzer MEDICREA INTERNATIONAL David Ryan
K173506 11/13/2017 LigaPASS Medicrea International S.A. David Ryan
K170095 01/11/2017 Vial2Bag Direct Connect Medimop Medical Project Ltd. Ilanit Goldgraber
K173581 11/20/2017 Gallant PTCA Dilatation Catheter Medinol, Ltd. Marina Tikhonov Demishtein
K170078 01/09/2017 Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley MEDISONO, LLC JORGE MILLAN
K170002 01/03/2017 Medline Blood Collection Set Medline Industries, Inc. Matt Clausen
K173537 11/15/2017 CONCORDE LIFTÖ Medos International, SARL Karen Sylvia
K173526 11/14/2017 SENTIO MMG Gen 2 Medos International, SARL Karen Sylvia
K170296 01/31/2017 CoreCath 2.7S Medtronic Advanced Energy Lydia Sakakeeny
K173664 11/29/2017 Medtronic O-arm O2 Imaging System Medtronic Inc. Dean Honkonen
K170011 01/03/2017 StealthStation S8 Spine Software v1.0.0 MEDTRONIC NAVIGATION JOHN CONNOR
K170018 01/03/2017 StealthStationTM S8 ENT Software Medtronic Navigation, Inc. K. Elizabeth Waite
K173515 11/14/2017 Admiral Xtreme Medtronic Vascular Maddalena Pinsi
K170191 01/23/2017 SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System MEDTRONIC VASCULAR, INC. AARON HAGE
K173460 11/07/2017 NeuroEEG MemoryMD Inc. Abdus-Salaam Muwwakkil
K173475 11/09/2017 Merge PACS Merge Healthcare Incorporated Carol Nakagawa
K173621 11/22/2017 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K173548 11/16/2017 Merit Pursue Microcatheter Merit Medical Systems, Inc. Niloufar Samimi
K173601 11/21/2017 Merit Syringe Merit Medical Systems, Inc. Cory Marsh
K170108 01/12/2017 Xultan 5.5 Pedicle Screw System Met One Technologies Dan Gerbec
K170050 01/05/2017 Z-CAD smile Metoxit AG Dipl.-Ing Stefan Leyen
K170219 01/25/2017 Microlife Digital Infrared Ear Thermometer MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K170288 01/30/2017 BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell MicroPort Orthopedics, Inc. Grace Johnson-Bann
K173420 11/01/2017 Radiomics App v1.0 Microsoft Corp. Ivan Tarapov
K170165 01/19/2017 Osteo-P Bone Graft Substitute Molecular Matrix, Inc. Charles Lee
K173492 11/13/2017 MRDx BCR-ABL Test, MRDx BCR-ABL Test Software MolecularMD Corporation Kevin Hawkins
K173512 11/13/2017 MFI-Cardiac MultiFunctional Imaging, LLC Dan Kadrmas
K170132 01/17/2017 MyoCycle Home, MyoCycle Pro MYOLYN, LLC Matthew Bellman
K173423 11/01/2017 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4Imaging GmbH Christoph R. Manegold
K173544 11/16/2017 Phoenix Wound Matrix Nanofiber Solutions, Inc. Ronald L. Bracken
K170285 01/30/2017 AED Sinuscope National Advanced Endoscopy Devices, Inc. Gayle Butler
K173486 11/13/2017 NTU-USB Ultrasound USB Box National Taiwan University Pai-Chi Li
K173580 11/20/2017 Vinyl Patient Examination Glove (Yellow) Nature Medical Products Co.,Ltd. Chao Kevin
K173450 11/06/2017 PRESS DUO elite, PRESS DUO elite AG Nemoto Kyorindo Co., Ltd. Jim Knipfer
K173409 11/01/2017 Wireless Audio System NeoCoil, LLC Michael Leigh
K173452 11/06/2017 EmboTrap ll Revascularization Device Neuravi Ltd. Mairsil Claffey
K170238 01/26/2017 BodyTom Elite NeuroLogica Corporation, a Subsidiary of Samsung Electronics Ninad Gujar
K170161 01/18/2017 New Deantronics E GreenÖ Electrosurgical Monopolar Pencils New Deantronics Taiwan, LTD Jane Liu
K173641 11/24/2017 Activ Ankle Newclip Technics Gaelle Lussori
K170012 01/03/2017 Foot and Hand Motion NEWCLIP TECHNICS Celine CHEVRIER
K170297 01/31/2017 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K170302 01/31/2017 YELLOW LASER PHOTOCOAGULATOR YLC-500 NIDEK CO., LTD. Yoneji Mizuno
K170135 01/17/2017 TREFOIL System Nobel Biocare AB Charlemagne Chua
K170030 01/04/2017 NOVATECH TALCAIR NOVATECH S.A. JENNIFER NEFF
K173479 11/13/2017 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Novo Nordisk Inc. Devraj Chakravarty
K173631 11/24/2017 Intelli-C NRT X-ray A/S Jan Malling
K170169 01/19/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. Cora Sim
K170271 01/27/2017 NuVasive(r) Monolith Corpectomy System NuVasive, Incorporated Cynthia Adams
K170126 01/13/2017 NuVasive« Reline« 4.5-5.0 System NUVASIVE, INCORPORATED Olga Lewis
K170074 01/09/2017 nvc Nvision Biomedical Technologies, LLC Diana L Langham
K173459 11/07/2017 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp. Toshiyuki Nakajima
K170260 01/27/2017 BC-001+ Acne Purifier Oriental Inspiration Limited Andy Wu
K170269 01/27/2017 Hee HR Mini Oriental Inspiration Limited Andy Wu
K173624 11/24/2017 ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) Origio a/s Tove Kjaer
K173440 11/06/2017 Carriere SLX 3D Clear Ortho Organizers, Inc. Colleen Boswell
K170093 01/11/2017 AcceleDent Optima OrthoAccel Technology Inc. Jouana Harris-Livings
K170146 01/17/2017 Galaxy UNYCO System Orthofix Srl Gianluca Ricadona
K173458 11/07/2017 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl Gianluca Ricadona
K173525 11/14/2017 NovoGro OsteoNovus, Inc. Brian M. Schlossberg
K173575 11/20/2017 OsteoReady Dental Implant System OsteoReady LLC Robert Gottlander
K170305 01/31/2017 Spinal Manometer NRFit; Spinal Manometer LUER PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K173646 11/27/2017 FS Ergo PaloDEx Group Oy Anni Lundholm
K173466 11/08/2017 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K173615 11/22/2017 Stryker Universal Select Sterilization Tray System Paragon Medical Rebecca Walker
K173530 11/15/2017 Indego(R) Parker-Hannifin Corporation Achilleas Dorotheou
K170215 01/24/2017 LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock Patient Pocket LLC Allen D. Seftel
K173554 11/17/2017 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope PENTAX of America, Inc. James W. Monroe
K173614 11/22/2017 Penumbra Coil 400, Ruby Coil System, POD System Penumbra, Inc. Aditi Kolla
K173507 11/13/2017 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K170144 01/17/2017 StentBoost Live Philips Medical Stystems Nederland BV Elaine Alan
K170086 01/10/2017 Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc. Michelle Godin
K170113 01/12/2017 pixium 4343RCE Philips Medical Systems DMC GmbH Ming Xiao
K173433 11/02/2017 ProxiDiagnost N90 Philips Medical Systems DMC GmbH Ming Xiao
K173467 11/08/2017 Advanced Diffusion Analysis (ADA) application Philips Medical Systems Nederland B.V. Yoram Levy
K173451 11/06/2017 Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K170130 01/13/2017 Dynamic Coronary Roadmap Philips Medical Systems Nederland BV Elaine Alan
K173588 11/20/2017 Illumeo System Philips Medical Systems Technologies, Ltd. Yoram Levy
K170133 01/17/2017 FFR V2.5 Philips Volcano Elaine Alan
K173533 11/15/2017 Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter Poiesis Medical, LLC Greg Wiita
K173503 11/13/2017 Pollogen Legend System Pollogen Ltd. Einat Shammai
K170213 01/24/2017 SupraSDRM Biodegradable Matrix Wound Dressing PolyMedics Innovations GmbH Kenneth K. Kleinhenz
K170061 01/06/2017 ProMISÖ Fixation System Premia Spine Ltd. Kobi Arbus
K170261 01/27/2017 Premium Plus Prophy Air Motor PREMIUM PLUS INTERNATIONAL LIMITED JESSICA MAO
K170044 01/05/2017 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System PRISMATIK DENTALCRAFT, INC. MARIA E. WAGNER
K170306 01/31/2017 FIBERGRAFT BG Putty Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K170111 01/12/2017 Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 Pulsaderm LLC Gloria Avendano
K173469 11/08/2017 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC Eric Yeh
K173446 11/06/2017 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K170067 01/09/2017 Easyret Quantel Medical Bruno Pages
K170195 01/23/2017 QuantX Quantitative Insights, Inc. Robert Tomek
K173496 11/13/2017 Sofia 2 Lyme FIA, Sofia Lyme Control Set Quidel Corporation Jennifer S. Rial
K173504 11/13/2017 K-Y Silicone Reckitt Benckiser LLC Elizabeth Viguerie
K173662 11/29/2017 speX Support Catheter ReFlow Medical, Inc. Rebecca K Pine
K173661 11/29/2017 Wingman 35 Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K170150 01/17/2017 Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags S.A.L.F. spa Carmelo Gagliano
K173513 11/13/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K170182 01/23/2017 CARDIOVIT FT-1 SCHILLER AG ZHENRONG YU
K173521 11/14/2017 SeaSpine Cabo ACP (Anterior Cervical Plate) System SeaSpine Orthopedics Corporation Gina Flores
K173606 11/21/2017 SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device SeaSpine Orthopedics Corporation Gina Flores
K173425 11/02/2017 SRT-100+ Sensus Healthcare, Inc. Nicolas Soro
K170136 01/17/2017 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD KEN LU
K170025 01/03/2017 Angiography Syringe SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Xu Jianhai
K170014 01/03/2017 High Pressure Tubing SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Xu Jianhai
K170027 01/03/2017 Inflation Device SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Xu Jianhai
K170024 01/03/2017 Y-Connector Kit SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Xu Jianhai
K170290 01/30/2017 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr Shen Wei USA Inc. Cheryl Reep
K173454 11/06/2017 Multi-parameter Patient Monitor, models C30 Shenzhen Comen Medical Instruments Co.,Ltd. Hongbo Yan
K170047 01/05/2017 All-in-One Health Monitor, PC-303 Shenzhen Creative Industry Co., Ltd. Jia Wang
K173462 11/08/2017 Wireless Pain Relieve Device Model: LT5018C Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K170145 01/17/2017 Digital TENS Unit SHENZHEN EAPPLY TECHNOLOGY CO., LTD LISA HUANG
K170205 01/23/2017 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K170277 01/30/2017 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
K173471 11/08/2017 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD Yang Zhaohui
K170151 01/17/2017 Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co., Ltd. Xiaoyun Yang
K173517 11/14/2017 RADspeed fit SHIMADZU corporation Toshio Kadowaki
K170293 01/31/2017 Emit II Plus Cocaine Metabolite Assay SIEMENS HEALTHCARE DIAGNOSTICS INC. ALAN HALEY
K170065 01/09/2017 ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc. Julie Warren
K170221 01/25/2017 syngo.CT Cardiac Planning Siemens Healthcare GmbH Martin Knoppik
K170263 01/27/2017 AcuNav Diagnostic Ultrasound Catheter 8F,10F Siemens Medical Solutions USA, Inc. Shelly Pearce
K173618 11/22/2017 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc. HyunJung Lee
K173578 11/20/2017 Biograph mCT Family of PET/CT Systems Siemens Medical Solutions USA, Inc. Tabitha Estes
K173592 11/21/2017 MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173600 11/21/2017 MAGNETOM Amira Siemens Medical Solutions USA, Inc. Martin Rajchel
K173617 11/22/2017 MAGNETOM Vida with Compressed Sensing GRASP-VIBE Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173597 11/21/2017 Scenium VE20 Software Siemens Medical Solutions USA, Inc. Veronica Padharia
K173607 11/21/2017 SOMATOM Edge Plus Siemens Medical Solutions USA, Inc. Alaine Medio
K173630 11/24/2017 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173632 11/24/2017 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173625 11/24/2017 syngo.CT Clinical Extensions Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173637 11/24/2017 syngo.CT Coronary Analysis; syngo.CT Vascular Analysis Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173635 11/24/2017 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173639 11/24/2017 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medical Solutions, Inc Denise Adams
K173408 11/01/2017 Mammomat Revelation Siemens Medical Solutions, Inc. Denise Adams
K173611 11/22/2017 syngo Application Software Siemens Medical Solutions, USA Inc. Patricia D. Jones
K170264 01/27/2017 Gold AQ Blood Glucose Monitoring System Sinocare Meditech, Inc. Qian Zhou
K170071 01/09/2017 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer Sleep Group Solutions Rani Ben-David
K173461 11/07/2017 ECG recorder and Arrhythmia Detector Smart Solutions Technologies SL Daniel Llorca
K170250 01/27/2017 SmartTarget SmartTarget, Ltd. Dean Barratt
K170282 01/30/2017 Smith & Nephew VISIONAIRE Adaptive Guides Smith & Nephew, Inc Brad Sheals
K170280 01/30/2017 Smith & Nephew SURESHOT Distal Targeting System V4.0 Smith & Nephew, Inc. Allison Chan
K170021 01/03/2017 SMV Scientific Cannulated Screws SMV Scientific Nephi Zufelt
K170022 01/03/2017 Klockner Vega TiBase for CEREC SOADCO S.L. MARIA MITJANETA
K170303 01/31/2017 E5 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K170291 01/31/2017 IontoDC SOTERIX MEDICAL,INC. ABHISHEK DATTA
K170059 01/06/2017 Spectranetics Turbo-Elite Laser Atherectomy Catheters Spectranetics, Inc. Rebecca Spelich
K173591 11/21/2017 Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Spectrum Medical Ltd Mark Drain
K170235 01/25/2017 Lucent« Spinal Elements Inc. Julie Lamothe
K170045 01/05/2017 SwedgeÖ Pedicle Screw Fixation System Spinal Resources, Inc. Bernard Bedor
K170268 01/27/2017 FortressÖ Pedicular Fixation System Spineology Inc. Jacqueline Hauge
K170266 01/27/2017 PalisadeÖ Pedicular Fixation System Spineology Inc. Jacqueline Hauge
K170251 01/27/2017 ThresholdÖ Pedicular Fixation System SPINEOLOGY INC. JACQUELINE HAUGE
K170255 01/27/2017 ThresholdÖ V2 Pedicular Fixation System SPINEOLOGY INC. JACQUELINE HAUGE
K173574 11/20/2017 DenSeeMammo Statlife Stephane Ragusa
K173493 11/13/2017 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation Anthony Piotrkowski
K173481 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173485 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173490 11/13/2017 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation Anthony Piotrkowski
K173488 11/13/2017 CELERITY 20 HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K173634 11/24/2017 CELERITY 20 Steam Biological Indicator STERIS Corporation Anthony Piotrkowski
K173670 11/30/2017 CELERITY 20 Steam Incubator STERIS Corporation Anthony Piotrkowski
K173626 11/24/2017 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation Anthony Piotrkowski
K173629 11/24/2017 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation Anthony Piotrkowski
K173633 11/24/2017 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporation Jennifer Nalepka
K170070 01/09/2017 VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles STERIS Corporation Anthony Piotrkowski
K173428 11/02/2017 VERIFY Chemical Indicator for S40 Sterilant STERIS Corporation Marcia L. Benedict
K173448 11/06/2017 CliniCloud Stethoscope StethoCloud Pty.Ltd (CliniCloud) Andrew Lin
K170141 01/17/2017 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated Elizabeth Greene
K170091 01/10/2017 UA-Cellular Complete Streck Deborah Kipp
K170098 01/11/2017 ICONIX TT All Suture Anchor Stryker Taylor White
K173476 11/09/2017 Tritanium« TL Curved Posterior Lumbar Cage Stryker Nikin Desai
K170242 01/26/2017 MultiGenÖ 2 RF Generator System STRYKER CORPORATION BECKY DITTY
K173499 11/13/2017 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Stryker Orthopaedics Kirsten Lehmuller
K173627 11/24/2017 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K173455 11/07/2017 SurgTech Bipolar Head System SurgTech, Inc., Xuegong Yu
K173560 11/17/2017 Microcatheter Surmodics, Inc. Sherri Mellingen
K173558 11/17/2017 SyMRI SyntheticMR AB Maria Almesaker
K173536 11/15/2017 T2Candida 1.1 Panel T2 Biosystems, Inc. Anne Marie Whalen
K170216 01/24/2017 Flexitouch System Tactile Systems Technology, Inc (dba Tactile Medical) Thomas A. Dold
K173511 11/13/2017 ActiveCare TD-4121 Blood Glucose Monitoring System TaiDoc Technology Corporation Sheena Song
K170131 01/17/2017 TAV Medical Dental Implants System Tav Medical Ltd. Revital Shabtai
K170118 01/13/2017 Scanostics UTI Check Application Test System Teco Diagnostics Ling Koh
K170200 01/23/2017 Carbon Dioxide Reagent Set Teco Diagnostics, Inc. Hyun Bin Song
K173441 11/06/2017 Neurosoft TMS (also CloudTMS) TeleEMG, LLC Joe F. Jabre
K173596 11/21/2017 Rusch Intermittent Urethral Catheters Teleflex Medical Amanda Webb
K173545 11/16/2017 TEMED Gas Diffuser TEMED Katie Evans
K170053 01/05/2017 Meridian PM The Center for Craniofacial & Dental Sleep Medicine Samuel Cress
K170082 01/10/2017 Test of Variables of Attention (T.O.V.A.) Version 9.0 THE TOVA COMPANY CHRIS HOLDER
K170116 01/13/2017 Thermi Injectable RF Electrodes Thermi Suzanne Cheang
K173582 11/20/2017 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes ThermiGen, L.L.C Suzanne Cheang
K170185 01/23/2017 tremoFlo C-100 Airwave Oscillometry System THORASYS Thoracic Medical Systems, Inc. Sebastien Jutras
K170056 01/06/2017 IRENE Cannulated Screw System TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD WANG QI
K173535 11/15/2017 Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device Titan Spine, LLC Jane Rodd
K173620 11/22/2017 Mag Vita TMS Therapy System w/Theta Burst Stimulation Tonica Elektronik A/S Sanne Barsballe Jessen
K170114 01/12/2017 MagVita TMS Therapy - w/MagPro R20 TONICA ELEKTRONIK A/S LISE TERKELSEN
K170164 01/18/2017 3D OCT-1 Maestro Topcon Corporation James Lorkowski
K170019 01/03/2017 Aquilion Lightning, TSX-036A/1, V8.4 Toshiba Medical Systems Corporation Paul Biggins
K170177 01/19/2017 Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Toshiba Medical Systems Corporation Paul Biggins
K173468 11/08/2017 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshiba Medical Systems Corporation Paul Biggins
K173622 11/24/2017 CS Imaging Trophy Marie-Pierre Labat-camy
K170259 01/27/2017 TruAbutment DS TRUABUTMENT BRANDON KIM
K170079 01/10/2017 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System TYSON BIORESEARCH, INC. WEN-HAI TSAI
K173563 11/17/2017 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE TZ Medical Inc John Lubisich
K173524 11/14/2017 ANAX 5.5Ö Spinal System U&I Corporation Jee Ae Bang
K170279 01/30/2017 Disposable High Pressure Syringe Union Medical Shenzhen Co., Ltd. Wenguo Zhang
K170089 01/10/2017 U-Motion II Acetabular Systemù Additional sizes United Orthopedic Corporation Gimpel Chien
K173650 11/28/2017 AquaShield System CO2- Fujifilm United States Endoscopy Group, Inc. Carroll Martin
K170187 01/23/2017 Photodynamic Therapy Device UVBIOTEK, LLC Dave Oberhelman
K173549 11/16/2017 BIAFINE Valeant Pharmaceuticals Melissa Thomas
DEN170001 01/03/2017 Precision Flow« HVNI VAPOTHERM, INC. SOM KOVVURI
K173636 11/24/2017 Velocity Varian Medical Systems, Inc. Peter J. Coronado
K173532 11/15/2017 Raider Guidewire Vascular Solutions, Inc. Beka Vite
K170066 01/09/2017 Green16/Green18 (Model: PHT-65LHS) VATECH CO., LTD. Daniel Kim
K170023 01/03/2017 SPiN Thoracic Navigation System Veran Medical Technologies, Inc. Scott Wrightstone
K170162 01/18/2017 Vesco Medical Nasoenteric Feeding Tubes Vesco Medical, LLC Chris O'Keefe
K170218 01/25/2017 Vesco Medical NRFit Tip Syringes Vesco Medical, LLC Chris O'Keefe
K170094 01/11/2017 POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED Viet Glove Corporation Pham Ngoc Thanh
K170026 01/03/2017 Radiopaque Tissue Marker Viscus Biologics, LLC Leslie Rebecca Clark
K173489 11/13/2017 GYN-Pump PH304 W.O.M. World of Medicine GmbH Soeren Markworth
K170068 01/09/2017 Softcure 96 WELLRAY MEDICAL LASER, INC. Richard O DeRoberts
K170257 01/27/2017 Sydney IVF Culture Oil William A. Cook Australia Pty Ltd Gordana Pozvek
K173431 11/02/2017 Towako Transmyometrial Embryo Transfer Set William A. Cook Australia PTY LTD Gordana Pozvek
K173673 11/30/2017 AcuSnare Polypectomy Snare Wilson-Cook Medical, Inc Theresa de Prat
K173659 11/29/2017 Howell D.A.S.H Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc Tiffanny A. Thomas
K170292 01/31/2017 Tri-Ex Extraction Balloon With Multiple Sizing WILSON-COOK MEDICAL, INC TIFFANNY A. THOMAS
K170265 01/27/2017 GRAVITYTM PEEK-OPTIMA Suture Anchor Wright Medical Technology, Inc. Tara Conrad
K170249 01/27/2017 GRAVITYÖ Syndesmosis LP WRIGHT MEDICAL TECHNOLOGY, INC. MICHAEL MULLINS
K173595 11/21/2017 Shear Wave Quantificational Ultrasound Diagnostic System Wuxi Hisky Medical Technologies Co., Ltd. Jinhua Shao
K170119 01/13/2017 Calix Lumbar Spinal Implant System X-Spine Systems, Inc. Charlene Brumbaugh
K170224 01/25/2017 Spider Cervical Plating System X-SPINE SYSTEMS, INC. KRISS ANDERSON
K170041 01/05/2017 XableCath Support Catheter XABLECATH, INC. RICK GAYKOWSKI
K173483 11/13/2017 Pure Flow External Counter-Pulsation Device Xtreem Pulse, LLC Andrew Barile
K173561 11/17/2017 Vinyl Patient Examination Glove (Yellow) Yurun Glove Co., Ltd. Chao Kevin
K170273 01/30/2017 Z-DOSE29 ZETTA MEDICAL TECHNOLOGIES, LLC. MAIN M. GHAZAL
K170233 01/25/2017 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) Zhanjiang Star Enterprise Co., Ltd Rongsheng Tang
K170234 01/25/2017 Endotracheal tube; Reinforced Endotracheal tube Zhanjiang Star Enterprise Co., Ltd Rongsheng Tang
K170072 01/09/2017 Fitmore« Hip Stem Zimmer GmbH Thomas Lincoln
K173417 11/01/2017 Zimmer Persona Personalized Knee System Zimmer, Inc. Nicole Meredith
K170003 01/03/2017 Zip 4 Skin Closure Device ZipLine Medical, Inc. Trish Howell


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact