FDA 510(k) Decisions During May, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K153410 05/15/2017 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M COMPANY Melissa Forth
K163683 05/03/2017 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor A&D COMPANY, LTD JERRY WANG
K170196 05/17/2017 A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor A&D Company, Ltd. Jerry Wang
DEN170019 05/18/2017 Vitamin D 200M Assay for the Topaz System AB SCIEX LLC Shilpa Sharma
K170322 05/19/2017 Catalys Precision Laser System Abbott Medical Optics Inc. Audrey Munnerlyn
K162348 05/10/2017 ABCcolla Collagen Matrix ACRO BIOMEDICAL CO., LTD DAR-JEN HSIEH
K170007 05/31/2017 Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K170178 05/26/2017 Ultravision Visual Field Clearing System Alesi Surgical Ltd. DAVID BRODERICK
K170626 05/31/2017 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers Inc. Rekha Anand
K162574 05/30/2017 AmCAD-US AmCad BioMed Corporation Jack Yang
K163238 05/04/2017 Eclipse Kiss Zirconia AMS HYUNA KIM
K163276 05/11/2017 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO.,LTD LIU YI
K162449 05/05/2017 Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) ANGIODYNAMICS, INC KASEY E NEWCOMB
K163356 05/30/2017 Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter ANGIODYNAMICS, INC. ROBIN FULLER
K170695 05/30/2017 VenaCure EVLT NeverTouch Direct Introducer Sheath AngioDynamics, Inc. Robin Fuller
K160667 05/11/2017 Anybattery C2 Rechargeable Battery Anybattery, Inc. Ed Speegle
DEN160033 05/05/2017 ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC Kenneth C. Kasper
K170382 05/11/2017 Arthrex Compression Screws Arthrex Inc. David L. Rogers
K171020 05/16/2017 Arthrex Knotless SutureTak Anchor Arthrex Inc. David L Rogers
K171141 05/04/2017 Arthrex SwiveLock Anchors Arthrex Inc. David L. Rogers
K171296 05/26/2017 SutureTape Arthrex, Inc. Ivette Galmez
K170440 05/03/2017 KISSloc Suture System Arthrosurface, Inc Dawn J. Wilson
K162248 05/03/2017 Asahi ViE-U Series Dialyzer ASAHI KASEI MEDICAL CO., LTD. Masaharu Aritomi
K170049 05/02/2017 AssureTech Panel Dip Test, AssureTech Quick Cup Test ASSURE TECH (HANGZHOU) CO., LTD. SHISHENG LING
K163481 05/03/2017 HALF DOME Posterior Lumbar Interbody System Astura Medical Troy Taylor
K163261 05/19/2017 AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip ATRICURE INC. Jonathan McElwee
K162392 05/12/2017 Avazzia AVAZZIA, INC. TAMMY LAHUTSKY
K163430 05/23/2017 Prontosan Wound Gel B. Braun Medical, Inc. Nancy Skocypec
K171338 05/31/2017 B R A H M S PCT sensitive KRYPTOR B.R.A.H.M.S GmbH Sascha Johannes
K170989 05/22/2017 Dymaxeon Spine System Back 2 Basics Direct, LLC Mitchell Bass
K163530 05/03/2017 PrisMax Control Unit BAXTER HEALTHCARE CORP Chris Scavotto
K170308 05/02/2017 BD MAX Extended Enteric Bacterial Panel, BD MAX System BECTON, DICKINSON AND COMPANY LAURA STEWART
K162380 05/02/2017 Locking Plate System BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. CINDY NIE
K170228 05/12/2017 Belimed Steam Sterilizer MST-H TOP 5000 Belimed AG Christoph Hermens
K170944 05/25/2017 LCD Monitor (MD310C, MD310G, MD210G) BenQ Corporation Calvin KT Chang
K163638 05/15/2017 Dental 5 Multi Diode laser BIO-MED USA INC YOUNG CHI
K170413 05/11/2017 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set Bio-Rad Laboratories Juang Wang
K170509 05/19/2017 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set Bio-Rad Laboratories Arlene Carillo
K163502 05/16/2017 iSR'obot Biopsy Kit Biobot Surgical Pte Ltd Lai Chee LIEW
K170604 05/30/2017 FilmArray Respiratory Panel 2 (RP2) BioFire Diagnostics, LLC Kristen J. Kanack
K170670 05/31/2017 Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) bioMerieux, Inc. Cherece L. Jones
K161790 05/02/2017 iGlucose Blood Glucose Monitoring System BIONIME CORPORATION Tino Lee
K162598 05/23/2017 HAPI Seal BISCO, INC. Ryan Hobson
K170360 05/02/2017 NAVIO Blue Belt Technologies, Inc. Richard G. Confer
K163622 05/11/2017 Lung Vision BODY VISION MEDICAL LTD. DORIAN AVERBUCH
K163701 05/16/2017 Direxion and Direxion HI-FLO Torqueable Microcatheters BOSTON SCIENTIFIC CORPORATION LIZ JOHNSTON
K170777 05/01/2017 Bovie J-Plasma Precise FLEX Handpiece Bovie Medical Corporation Rubiela Maldonado
K162523 05/03/2017 The IQool System BRAIN COOL AB MARTIN WALEIJ
K171139 05/18/2017 LaparoLight Veress Needle Buffalo Filter, LLC Kyrylo Shvetsov
K170278 05/31/2017 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
K171348 05/22/2017 Pinpoint GT Needle Guide Kits C.R. Bard, Inc. Christopher M. Phillips
K171194 05/24/2017 AS-10, CXDI-401RF Canon, Inc. Shinji Mori
K170401 05/12/2017 Piccolo Composite« Plate System CarboFix Orthopedics Ltd. Yael Rubin
K153748 05/17/2017 AirLife Misty Finity Nebulizer CareFusion Erika Fernandez
K163615 05/04/2017 Snowden-Pencer MicroLap 3mm Laparoscopic Instruments CareFusion 2200 Inc Jane Weber
K161833 05/23/2017 LATEX EXAMINATION GLOVE POWDER FREE CAREGLOVE GLOBAL SDN BHD LIM KWEE SHYAN
K162684 05/31/2017 SL 220 Carl Zeiss Meditec AG Christian Muenster
K162254 05/04/2017 Cedic Enteral ENFit Transition Connectors CEDIC S.R.L. TIZIANA MELIS
K170363 05/08/2017 Ceribell Pocket EEG Device Ceribell, Inc. Josef Parvizi
K162566 05/11/2017 AIK Sterile Acupuncture Needles for Single Use CHANGCHUN AIK MEDICAL DEVICES CO., LTD XINGWANG LI
K162952 05/03/2017 C.T.M. Mobility Scooter CHIEN TI ENTERPRISE CO., LTD. VIVIAN LO
K163090 05/23/2017 Plasma Edge System Chirurgie Innovation Guillaume Noury
K170954 05/30/2017 Portable ECG Monitor CONTEC Medical Systems Co.,Ltd Xueyong Li
K162041 05/02/2017 Airworks Nebulizer pe1200m Convexity Scientific LLC Paul Reiferson
K160567 05/18/2017 Barone Jejunostomy Catheter Set COOK INCORPORATED Erum B. Nasir
K163197 05/24/2017 Cook Holmium Laser Fiber COOK INCORPORATED Colin Jacob
K170603 05/24/2017 Tao Brush I.U.M.C. Endometrial Sampler Cook Incorporated Ian Herman
K160509 05/18/2017 Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube COOK INCORPORATED Erum B. Nasir
K162448 05/26/2017 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Cook Incorporated Jessica Swafford
K163468 05/04/2017 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered Cook Ireland Ltd. Jacinta Kilmartin
K162496 05/04/2017 Foundation 3D Interbody CoreLink, LLC Stephan Jones
K163002 05/16/2017 Kangaroo Feeding Tube with IRIS Technology Covidien (dba Medtronic) Alexis Erazo
K170294 05/01/2017 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
K162734 05/08/2017 CreoDent Solidex Customized Abutment CreoDent Prosthetics, Ltd. Calvin Shim
K163244 05/24/2017 truFreeze System CSA MEDICAL, INC. Sherrie Coval-Goldsmith
K170789 05/05/2017 In Reach CurveBeam, LLC Stuti Singh
K170734 05/08/2017 Venus Silk.expert Cyden Limited Mike Kiernan
K170500 05/16/2017 SIROLaser Advance+ Dentsply Sirona Karl J. Nittinger
K171137 05/15/2017 EVS 2430W, EVS 2430GW DRTECH Corporation Choul-Woo Shin
K170733 05/01/2017 ScanX Intraoral View Duerr Dental AG Oliver Lange
K170874 05/19/2017 Eko Model E5 System (EME5), Eko DUO Eko Devices, Inc. Connor Landgraf
K171306 05/30/2017 gammaCore-S electroCore, LLC Mike Romaniw
K171387 05/31/2017 EMS100 Tri-Wave Combination Stimulator Elite Medical Supply of New York, LLC John McGrady
K170107 05/03/2017 Surgi Max Ultra elliquence, LLC Paul D. Buhrke IV
K163071 05/24/2017 vascuCAP Elucid Bioimaging, Inc. Andrew J. Buckler
K170573 05/31/2017 Empowr CR Knee Tibial Insert Encore Medical, L.P. Desiree Wells
K163226 05/16/2017 EPIC Extremely Small Staple Epic Extremely, LLC Dan Schwartzbauer
K170831 05/09/2017 EpiAccess System EpiEP, INc Pamela Bunes
K163065 05/26/2017 T3 Software ETIOMETRY, INC. DIMITAR BARONOV
K170575 05/16/2017 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow Ever Global (Vietnam) Enterprise Corp Jerry Lin
K162716 05/18/2017 bibag FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC Denise Oppermann
K171096 05/09/2017 Fujifilm Diathermic Slitter (FlushKnife) FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan
K163669 05/17/2017 Humeris Shoulder Fx Solutions Jean-Jacques Martin
K170199 05/12/2017 Unity Network ID GE Healthcare Robert Casarsa
K163140 05/26/2017 SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System GEMSS MEDICAL SYSTEMS CO., LTD Sang Woo Lee
K161261 05/12/2017 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase Genea Biomedx Pty Ltd Kea Dent
K162409 05/24/2017 Gems Vitrification Set, Gems Warming Set GENEA BIOMEDX PTY LTD Kea Dent
K170557 05/25/2017 GenePOC GBS LB GenePOC Inc. Guy Sevigny
K170558 05/25/2017 revogene GenePOC Inc. Guy Sevigny
K170839 05/26/2017 RAPID Web Given Imaging Ltd. Hilla Debby
K162463 05/24/2017 Matrix Data Management System GLOBAL INSTRUMENTATION, LLC JASON DEMASO
K162825 05/01/2017 CAPTIVATEÖ Compression Screws GLOBUS MEDICAL, INC. Kelly J. Baker
K162207 05/04/2017 Restore Moisturizing Vaginal Lubricant Good Clean Love Wendy Strgar
K170514 05/24/2017 Central Monitoring System Guangdong Biolight Meditech Co., Ltd. Jin Liang
K162333 05/14/2017 Wondfo One Step Fecal Occult Blood (FOB) Test GUANGZHOU WONDFO BIOTECH CO., LTD. Bin Chen
K170908 05/19/2017 PK AIM Gyrus ACMI Inc. Graham A. L. Baillie
K170287 05/24/2017 Dental Implants OKTAGON Bone Level Tapered Design Hager& Meisinger GmbH Melanie May
K170481 05/16/2017 Strep B Carrot Broth Kit Hardy Diagnostics Rianna Malherbe
K170586 05/22/2017 Strep B Carrot Broth One-Step Hardy Diagnostics Christopher Massey
K170152 05/05/2017 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) HARTALEGA SDN BHD KUAN KAM HON
K170180 05/08/2017 Will3D HDX WILL CORP. Seung-Il Chun
K163553 05/22/2017 Powder Free Nitrile Patient Examination Gloves, Blue HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD. Shaozhang Nan
K163394 05/22/2017 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K163505 05/30/2017 ARIETTA PRECISION HITACHI, LTD ANGELA VAN ARSDALE
K161601 05/17/2017 Dynamika IMAGE ANALYSIS LIMITED Mark Hinton
K170594 05/10/2017 I.B.S. osteosynthesis screws In2Bones SAS Morgane Grenier
K163293 05/05/2017 ColinkÖ Plating System IN2BONESUSA, LLC JOE CLIFT
K171294 05/26/2017 da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K171388 05/31/2017 EndoWrist Stapler 45 System and Stapler 45 Reloads Intuitive Surgical, Inc. Doreen Nakamura
K170659 05/26/2017 IQ Technologies IQ Technologies Inc. Elli Josef
K170718 05/03/2017 Iridex TruFocus LIO Premiere Iridex Corporation Gloria Dy
K171083 05/12/2017 iChemVELOCITY Automated Urine Chemistry System Iris Diagnostics, a Division of Iris International Inc Nancy Nadler
K170828 05/17/2017 Cardiac Trigger Monitor Ivy Biomedical Systems, Inc. Nicole Bush
K170364 05/02/2017 Collagen Meniscus Implant XL Ivy Sports Medicine, LLC John Dichiara
K163094 05/17/2017 TinniLogic Mobile Tinnitus Management Device JIANGSU BETTERLIFE MEDICAL CO., LTD. HONGWEI XU
K171097 05/10/2017 MOJAVE Expandable Interbody System K2M, Inc. Nancy Giezen
K170342 05/09/2017 Ocata Anterior Cervical System Kalitec Direct, LLC Scott Winn
K171238 05/25/2017 KARL STORZ ICG Imaging System Karl Storz Endoscopy- America, Inc. Winkie Wong
K170462 05/16/2017 KARL STORZ ShuntScope KARL STORZ Endoscopy-America, Inc. Susie S. Chen
K170245 05/16/2017 DSM Biomedical Dental Bone Graft Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K163070 05/05/2017 Kent Camera KENT IMAGING INC. Darrell Barnhart
K162667 05/11/2017 Kitazato IUI Catheter Kitazato Corporation Mari Yazaki
K163315 05/05/2017 Internal Distraction - Sterile KLS Martin LP Jennifer Damato
K170521 05/30/2017 TRINITY/3D PROSTATE SUITE KOELIS Laetitia GERVAIS
K163117 05/09/2017 Alpha Pure KOROAD AMERICA YEON JAE LEE
K163204 05/05/2017 A08 Power wheelchair Kunshan Aoshida Electric Technology Co., Ltd Shen Wenhua
K170486 05/25/2017 CATHTONG II PICC Catheter L&Z US, Inc. Jenella Coutts
K163482 05/31/2017 Orthodontic Acrylic 2 Lang Dental Manufacturing Co., Inc. Dave Lang
K162133 05/16/2017 VerteFIT Corpectomy Cage System LDR SPINE USA, INC. JAMIE WILSON
K170576 05/05/2017 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K170899 05/30/2017 27HJ713S LG Electronics Jinhwan Jun
K162266 05/01/2017 The Cranial Fusion System LIFE SPINE INC. RANDY LEWIS
K170804 05/18/2017 The Solstice OCT System Life Spine Inc. Randy Lewis
K170892 05/25/2017 Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K171135 05/18/2017 Lipogems System Lipogems International SpA Carlo Russo
K170121 05/22/2017 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Lumenis Ltd. Yehudit Kraizer
K163626 05/02/2017 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation Kate Linak
K170446 05/21/2017 LT-300 SD Digital Video Colposcope Lutech Industries, Inc. Leanna Vachula
K163196 05/24/2017 ACTION II Laser System LUTRONIC CORPORATION Jhung Won Vojir
K170584 05/11/2017 Mako Partial Knee Application MAKO Surgical Corp. Shikha Khandelwal
K170891 05/24/2017 Mako Partial Knee Application MAKO Surgical Corp. Shikha Khandelwal
K170581 05/11/2017 Mako Total Knee Application MAKO Surgical Corp. Shikha Khandelwal
K162603 05/26/2017 Masimo O3 Regional Oximeter System MASIMO CORPORATION MARGUERITE THOMLINSON
K170419 05/11/2017 SurgiCase Viewer Materialise NV Oliver Clemens
K171170 05/25/2017 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws Medacta International SA Stefano Baj
K163119 05/01/2017 NaviSuite SSI Edition MEDCOM GMBH JOHANNES MESSOW
K170172 05/24/2017 UNiD Spine Analyzer MEDICREA INTERNATIONAL David Ryan
K170078 05/17/2017 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
K170639 05/18/2017 HEALIX ADVANCE Anchor with PERMATAPE Suture Medos International SARL Julie Vafides
K170543 05/04/2017 VIPER PRIMEÖ Screws with Fenestrations Medos International, SARL Karen Sylvia
K162330 05/04/2017 Flex Robotic System and Flex Colorectal Drive Medrobotics Corporation John D. Bonasera
K171253 05/25/2017 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead Medtronic Debra Taitague
K170011 05/01/2017 StealthStation S8 Spine Software v1.0.0 MEDTRONIC NAVIGATION JOHN CONNOR
K170018 05/19/2017 StealthStationTM S8 ENT Software Medtronic Navigation, Inc. K. Elizabeth Waite
K170312 05/15/2017 IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools MEDTRONIC POWERED SURGICAL SOLUTIONS DEEP PAL
K170679 05/11/2017 CD HORIZON« Spinal System, Medtronic Reusable Instruments for Use with the IPC« POWEREASE« System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION« and IPC« POWEREASE« Systems Medtronic Sofamor Danek Kanesha Hines
K162212 05/19/2017 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K163181 05/16/2017 TRANSLACEÖ Spinal Tethering System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K170658 05/31/2017 Lympha Press Optimal Plus Mego Afek AC Ltd. Reuven Yunger
K160677 05/19/2017 MICRORUPTOR 6 MERIDIAN AG FRANZISKA GOTSCHI
K170108 05/02/2017 Xultan 5.5 Pedicle Screw System Met One Technologies Dan Gerbec
K171268 05/31/2017 Reverse 021 Micro Catheter, Reverse 027 Micro Catheter MicroTherapeutics, Inc. d/b/a ev3 Neurovascular Eric Elliott
K163349 05/26/2017 MIS V3 Conical Connection Dental Implant System¡ MIS Implants Technologies Ltd. Arbel Shezaf
K163131 05/11/2017 A-dec NLZ Electric Motor System NAKANISHI, INC. KIMIHIKO SATOH
K162378 05/17/2017 FREND PSA PLUS (reagent cartridge) NANOENTEK USA INC SUNMI HAN
K163672 05/05/2017 Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor NANOVA BIOMATERIALS, INC. ANDREW RITTS
K171085 05/11/2017 GMR40 NeuroLogica Corporation, a Subsidiary of Ninad Gujar
K171022 05/09/2017 Ablation Confirmation NeuWave Medical, Inc. Dan Kosednar
K163564 05/19/2017 SLIT LAMP SL-2000 NIDEK CO., LTD. Yoneji Mizuno
K163644 05/19/2017 Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation Tom Bento
K170135 05/11/2017 TREFOIL System Nobel Biocare AB Charlemagne Chua
K171059 05/26/2017 Nova StatSensor Creatinine Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K171130 05/04/2017 Nucleus Image Management System NucleusHealth, LLC Linda Moore
K163707 05/01/2017 NuVasive CoRoent Ti-C System NuVasive, Incorporated Cynthia Adams
K162647 05/01/2017 NuVasive NuvaLine Mobile App NUVASIVE, INCORPORATED Olga Lewis
K170469 05/09/2017 NxStage System One Plus NxStage Medical, Inc Randall Covill
K170752 05/19/2017 OEC Elite OEC Medical Systems, Inc. Helen Peng
K170269 05/03/2017 Hee HR Mini Oriental Inspiration Limited Andy Wu
K171168 05/16/2017 VITROS Immunodiagnostic Products Insulin Calibrators Ortho Clinical Diagnostics Bradley P. Boyer
K170093 05/26/2017 AcceleDent Optima OrthoAccel Technology Inc. Jouana Harris-Livings
K170647 05/11/2017 Connector System Orthofix Inc. Jacki Koch
K171082 05/05/2017 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System Orthofix Inc. Jacki Koch
K170650 05/10/2017 Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl Gianluca Ricadona
K163621 05/02/2017 Vitoss Bioactive (BA) Injectable Orthovita, Inc. John Rossman
K171217 05/26/2017 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System Osprey Medical, Inc. Melanie Hess
K161689 05/22/2017 OSSTEM Implant System - Abutment OSSTEM IMPLANT Co., Ltd. Hee Kwon
K163557 05/15/2017 SS SA Fixture OSSTEM IMPLANT Co., Ltd. Mr. HeeKwon
K162542 05/19/2017 OsteoMed PINNACLE Driver OSTEOMED KATHRYN A. JAYNE
K163382 05/09/2017 Oxitone 1000 Oxitone Medical Ltd. Leon Eisen
K162433 05/24/2017 GCE Zen-O Portable Oxygen Concentrator OXUS, INC RYAN LENARCIC
K163618 05/24/2017 INDIGO Aspiration System PENUMBRA, INC. RICHARD KIMURA
K163370 05/05/2017 ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE PHADIA AB Carina Magnusson
K162756 05/03/2017 PHAKOS Disposable Retinal Cryo Probe PHAKOS OLIVER AUMAITRE
K171314 05/30/2017 QLAB Advanced Quantification Software Philips Healthcare Penny Greco
K163250 05/11/2017 Longitudinal Brain Imaging (LoBI) application Philips Medical Systems Nederland B.V. Yoram Levy
K170133 05/26/2017 FFR V2.5 Philips Volcano Elaine Alan
K151562 05/08/2017 Resultz Lice & Egg Removal Kit Piedmont Pharmaceuticals, LLC Kathleen G. Palma
K163327 05/08/2017 Precifit Medical Kirschner Wires PRECIFIT MEDICAL LTD ZHEN YU(ERIC) WU
K161950 05/11/2017 Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle Promisemed Hangzhou Meditech Co., Ltd. Keshin Hu
K170306 05/24/2017 FIBERGRAFT BG Putty Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K170698 05/31/2017 ALLY(TM) Bone Screws Providence Medical Technology, Inc. Margaret Wong
K161807 05/19/2017 BEAMSCAN PTW-Freiburg Physikalisch Technische-Werksraetten Sandor-Csaba Ats
K170111 05/08/2017 Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 Pulsaderm LLC Gloria Avendano
K170195 05/17/2017 QuantX Quantitative Insights, Inc. Robert Tomek
K171229 05/26/2017 DELL UP3017 with QUBYX PerfectLum bundle Qubyx Software Technologies Inc. Marc Leppla
K170491 05/11/2017 Solana C. difficile Assay Quidel Corporation Ronald H. Lollar
K170349 05/24/2017 RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems, Inc. Dean Irwin
K162620 05/01/2017 Remel Spectra ESBL REMEL, INC. CYNTHIA KNAPP
K170744 05/08/2017 Adhesive Electrodes Reno Medical Ltd. LiMing Ren
K162131 05/09/2017 ExSpiron 1Xi Respiratory Motion Inc. Edwin Rule
K170692 05/26/2017 Respire Pink Series with DentiTrac Respire Medical Holding Jonathan Sandler
K170334 05/01/2017 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack RevMedx, Inc. Amy K. Pointer
K171081 05/09/2017 Guider Catheter Introducer Rhythm Xience, Inc. (RXI) James Hassett
K162526 05/26/2017 Creatine Kinase-MB ROCHE DIAGNOSTICS NOEL B. MENCIAS
K171080 05/10/2017 ALP IFCC Gen.2 Roche Diagnostics Operations (RDO) Patrick Stimart
K163673 05/23/2017 FortilinkÖ-C with TETRAfuseÖ 3D Technology RTI Surgical, Inc. Diana Taylor
K171119 05/12/2017 GM85 Samsung Electronics Co.,Ltd. Chulsin Kim
K171230 05/26/2017 My Dose Coach Sanofi Robert Ezzell
K163610 05/19/2017 PIEZOTOME M+, PIEZOTOME M+ Handpiece SATALEC-ACTEON GROUP PHILIPPE GIRARD
K171165 05/18/2017 SmartByte Device Scientific Intake Marc Gibeley
K160950 05/05/2017 MINISCAV Sedation Systems LLC S. Michael Bender
K160781 05/02/2017 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves SEMPERIT INVESTMENTS ASIA PTE. LTD. CLEMENS EICHLER
K170290 05/24/2017 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr Shen Wei USA Inc. Cheryl Reep
K163606 05/09/2017 Digital Blood Pressure Monitor-Automatic Upper Arm Style Shenzhen Combei Technology CO., LTD Huaguang Meng
K170205 05/11/2017 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K162601 05/31/2017 Infusion Set for Single Use SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD. Xiaolei Tian
K170475 05/05/2017 SICAGEÖ System Sicage LLc Kristi Vondra
K163658 05/23/2017 ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Siemens Healthcare Diagnostics Inc. Darius Daruwala
K171072 05/12/2017 N Latex Cystatin C; N Protein Standard UY Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K171005 05/03/2017 Silhouette Featherlift Silhouette Lift Inc. Anthony DiBernardo
K163257 05/24/2017 VitreOx Anti-fog Solution SiO2 Nanotech, LLC CLARIZZA WATSON
K170489 05/23/2017 Skylit Phototherapy System Skylit Medical Martyn Gross
K162303 05/01/2017 REDAPT Sleeved Monolithic Revision Stems SMITH & NEPHEW INC. KIM PHAN
K170282 05/22/2017 Smith & Nephew VISIONAIRE Adaptive Guides Smith & Nephew, Inc Brad Sheals
K170648 05/11/2017 ANTHEM CR Total Knee System Smith & Nephew, Inc. Thomas Fearnley
K170977 05/03/2017 SURESHOT Distal Targeting System V4.0 Trauma Interface Smith & Nephew, Inc. Allison Chan
K163172 05/24/2017 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit SMITHS MEDICAL ASD, INC. Bruce Backlund
K170021 05/22/2017 SMV Scientific Cannulated Screws SMV Scientific Nephi Zufelt
K163073 05/19/2017 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder Sol-Millennium Medical, Inc. Jim Barley
K171098 05/02/2017 AXIS Image Management System Sonomed, Inc. Mark Wallace
K170303 05/19/2017 E5 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K170291 05/01/2017 IontoDC SOTERIX MEDICAL,INC. ABHISHEK DATTA
K163670 05/08/2017 Rampart One Lumbar Interbody Fusion Device SPINEOLOGY INC. Jacqueline A. Hauge
K170990 05/11/2017 Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator Spiration, Inc. Cheryl Frederick
K170141 05/02/2017 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated Elizabeth Greene
K170338 05/16/2017 A-View Stroke2Prevent B.V. Maarten Nibbelke
K171152 05/19/2017 Stryker Universal Neuro III System AXS Screw Stryker Jonathan Schell
K170242 05/25/2017 MultiGenÖ 2 RF Generator System STRYKER CORPORATION BECKY DITTY
K170496 05/16/2017 Xia« 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory Stryker Corporation Meriam Gabera
K170771 05/08/2017 VariAx 2 Foot System Stryker GmbH Paul Nelson
K171355 05/17/2017 Surefire Precision Infusion System Surefire Medical, Inc. Lynne Aronson
K161272 05/18/2017 Supreme and Response Electrophysiology Catheters Surgical Instrument Service and Savings Inc Brandi J. Panteleon
K162751 05/01/2017 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider Surgical Instrument Services and Savings, Inc Brandi J Panteleon
K162125 05/10/2017 MALUCÖ Total Hip Arthroplasty System SurgTech, Inc., Xuegong Yu
K170597 05/25/2017 PicoWay Laser System Syneron Candela Corporation Ruthie Amir
K170370 05/15/2017 ULTRASHAPE POWER SYSTEM Syneron Medical Ltd. Ruthie Amir
K162594 05/08/2017 Craniomaxillofacial Distraction System (CMFD) SYNTHES USA PRODUCTS, LLC NICHOLAS FOUNTOULAKIS
K170216 05/26/2017 Flexitouch System Tactile Systems Technology, Inc (dba Tactile Medical) Thomas A. Dold
K161770 05/05/2017 Rusch Silicone Foley Catheter Teleflex Medical, Inc. Lori Pfohl
K170975 05/01/2017 Televere Digital Imaging System Televere Systems Randell Quaal
K170779 05/24/2017 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein Terang Nusa Sdn Bhd Robert Hill
K170680 05/16/2017 TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant Nadav Reuben
K160109 05/19/2017 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber THAYER MEDICAL CORPORATION MEGHAN MCGOVERN
K162263 05/03/2017 Optilite Rheumatoid Factor Kit THE BINDING SITE GROUP LTD. JON LAUDER
K171234 05/26/2017 Mistral-Air Warming Unit The Surgical Company International BV (as The 37Company) Kees van Hassel
K170082 05/17/2017 Test of Variables of Attention (T.O.V.A.) Version 9.0 THE TOVA COMPANY CHRIS HOLDER
K171094 05/08/2017 Thermi Reusable Non-invasive RF Electrode ThermGen, L.L.C Suzanne Cheang
K170114 05/01/2017 MagVita TMS Therapy - w/MagPro R20 TONICA ELEKTRONIK A/S LISE TERKELSEN
K163702 05/30/2017 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K163640 05/03/2017 QZA and RS Dental Implant Systems TRINON Titanium GmbH Katja Lvova
K170259 05/25/2017 TruAbutment DS TRUABUTMENT BRANDON KIM
K171327 05/16/2017 Tyber Medical Wedge System Tyber Medical LLC Mark F. Schenk
K161961 05/11/2017 UniTex Non-Sterile, Powder-Free, Latex Examination Glove UG GLOBAL RESOURCES SDN BHD Wong See Keong
K171138 05/17/2017 Nexus DR Digital X-ray Imaging System Varex Imaging Corporation Catherine Mulcahy
K170023 05/15/2017 SPiN Thoracic Navigation System Veran Medical Technologies, Inc. Scott Wrightstone
K163576 05/11/2017 GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc. Michael J. Titus
K170740 05/08/2017 GORE VIABIL Short Wire Biliary Endoprosthesis W.L. Gore & Associates, Inc. Barbara L. Smith
K170784 05/15/2017 PNEUMOCLEAR W.O.M World Of Medicine GmbH Soeren Markworth
K170068 05/05/2017 Softcure 96 WELLRAY MEDICAL LASER, INC. Richard O DeRoberts
K161813 05/19/2017 Frova Intubating Introducer WILLIAM COOK EUROPE APS Henriette Stordal Christiansen
K162328 05/11/2017 Winner Transfer Wheelchair Winner SG Pte Ltd Michael Pang
K170611 05/25/2017 SETx Pedicle Screw System Xenco Medical, LLC Gustavo Prado
K161938 05/08/2017 Fingertip Pulse Oximeter XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD YANLI LI
K163476 05/10/2017 Lubricity You First Services, Incorporated Jeffrey Eberhard
K163665 05/05/2017 MATRx plus Zephyr Sleep Technologies Sabina Bruehlmann
K171076 05/05/2017 Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd. Wang ChangShen
K170393 05/09/2017 Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) Zibo Chengxun Automatic Device Co., Ltd Ding Wei
K160398 05/17/2017 MRI Compatibility for Existing Zimmer Dental Implant Systems Zimmer Dental, Inc. Alex Eastes


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