FDA 510(k) Decisions During June, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K171086 06/08/2017 Accuray Precision Treatment Planning System Accuray Incorporated Shweta Kaushik
K170763 06/08/2017 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend ACell, Inc. Salman Elmi
K170001 06/02/2017 Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini, Jr.
K163593 06/20/2017 Additive Orthopaedics Bunion System Additive Orthopaedics, LLC. Gregory Kowalczyk
K161354 06/12/2017 MELODY, Remote Control System for Ultrasound Probe AdEcho Tech Nicolas LEFEBVRE
K171606 06/22/2017 AOS Anterolateral Proximal Humeral Plate Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K170039 06/20/2017 STERRAD VELOCITY Biological Indictator and Reader Advanced Sterilization Products (ASP) Sun Choi
K170661 06/08/2017 Novosyn Quick Absorbable Suture Aesculap, Inc. Kathy A. Racosky
K163228 06/05/2017 APVolution System AESTHETIC-PRESS, LLC Jorg Muller
K171256 06/08/2017 Quingo Flyte Mobility Scooter Agile Distributors LLC Steven Mahaffy
K171533 06/29/2017 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap Ahlstrom Nonwovens LLC Gary Jackson
K170850 06/15/2017 Alma Q Alma Lasers LTD Rekha Anand
K170591 06/06/2017 Altomed Malhotra Platinum Segments Altomed Limited Stuart March
K163580 06/08/2017 ASD Oral Appliances AMERICAN SLEEP DENTISTRY RYAN GREGERSON
K163049 06/21/2017 GOLNIT Non-Absorbable PTFE Surgical Suture Antarma dba Golnit Sutures Armine Badalyan
K161177 06/15/2017 Axiom PX ANTHOGYR SAS THERESE CANDAU
K171586 06/30/2017 Smart External Drain (SED) System Aqueduct Critical Care, Inc Thomas Clement
K162822 06/29/2017 ADAMS A1c HA-8180V, CALIBRATOR 80 Arkray Factory, Inc. Kazuya Yorimitsu
K171231 06/14/2017 Endoform Topical Matrix Aroa Biosurgery Tina OÆBrien
K171146 06/23/2017 Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. Arrow International, Inc. (Subsidiary of Telelflex Inc.) Fallon Young
K162625 06/12/2017 SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters B. BRAUN INTERVENTIONAL SYSTEMS INC. PETER FLOSDORF
K161582 06/16/2017 DORA Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd Sophia Shao
K163420 06/14/2017 UltraScore Focused Force PTA Balloon BARD PERIPHERAL VASCULAR, INC. TIMOTHY WADE
K161808 06/21/2017 Solution Set with 1.2 Micron Air Eliminating Filter Baxter Healthcare Corporation John Lamela
DEN160047 06/29/2017 ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M Beckman Coulter Anthony Dennis
K162897 06/23/2017 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser BECKMAN COULTER Suzana Otano
K171047 06/22/2017 Sterile Polyisoprene Powder Free Surgical Gloves Better Care Plastic Technology Co.,Ltd. Zhu Chunyan
K170890 06/02/2017 TELIX K Interbody System Biedermann Motech GmbH & Co. KG Gerd Federle
K163467 06/14/2017 C-Line Orthodontic Ceramic Bracket BIOCETEC CO., LTD DAVE KIM
K170883 06/22/2017 FilmArray NGDS Warrior Panel BioFire Defense, LLC Cynthia Phillips
K161533 06/16/2017 A1C EZ Glycohemoglobin Analysis System BioHermes Co., Ltd Rao Qiangying
K162689 06/08/2017 Vibrance Pelvic Trainer BIOINFINITY (M) SDN. BHD. NG SHEA KANG
K162737 06/21/2017 VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4?g/mL) bioMerieux, Inc CHERECE L. JONES
K163029 06/19/2017 HydrisÖ Oral Rinse BIOPHARM CONSULT, L.L.C. DAVID S. JOHNSON
K162674 06/16/2017 BioPro Foot Plating Systems BIOPRO, INC. AL LIPPINCOTT
DEN160040 06/21/2017 Embosphere Microspheres Biosphere Medical S.A. Alix Fonlladosa
K162569 06/09/2017 YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer BIOTECH LUBRICANTS LTD Sarah Brooks
K171514 06/29/2017 BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set BIOTRONIK, Inc. Jon Brumbaugh
K170629 06/22/2017 VITRUVIAN INFILTRATION PUMP Black & Black Surgical, Inc. CYNTHIA REES
K171485 06/21/2017 BSD4343R Digital Flat Panel X-ray Detector Bontech Inc. Kwang S. Choi
K171612 06/30/2017 ACUITY Pro Lead Delivery System Boston Scientific Corporation Lori Berends
K170759 06/23/2017 CRE Pulmonary Balloon Dilatation Catheter Boston Scientific Corporation Jia Huang
K163399 06/22/2017 Tria Firm Ureteral Stent Boston Scientific Corporation Christine Shoemaker
K153138 06/23/2017 Cerdak Basic BU POLYSCIENCES EQUIPMENT & TRADING, LLC N. T. UMAMAHESWARAN
K163437 06/23/2017 hypodermic PinpointÖ GT Needle C. R. Bard, Inc. Jamie Howell
K170158 06/01/2017 PowerGlide ST Midline Catheter C. R. Bard, Inc. JACOB LEE
K163216 06/27/2017 Pinpoint GT Needles C.R. Bard, Inc. Silvia De La Barra
K162723 06/22/2017 TransFix/EDTA Vacuum Blood Collection Tubes Caltag Medsystems Ltd. Daniel Harrison
K162986 06/12/2017 SPIRA Open Matrix ALIF CAMBER SPINE TECHNOLOGIES Michael Black
K170762 06/09/2017 Cardinal Health Non-Reinforced Surgical Gown Cardinal Health 200, LLC Caroline Miceli
K170198 06/15/2017 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) Cardinal Health, Inc. Megan Middaugh
K170568 06/26/2017 CardioLogs ECG Analysis Platform Cardiologs Technologies Quentin de Snoeck
K170792 06/09/2017 Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. Kara Cutshall
K163316 06/22/2017 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System CAREFUSION 303, INC. Erika Fernandez
K170755 06/21/2017 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria Wheeler
K170638 06/21/2017 Retina Workplace Carl Zeiss Meditec AG Christian Muenster
K163195 06/21/2017 PRIMUS Carl Zeiss Suzhou Co., Ltd. Huang XiaoDong
K170940 06/29/2017 Rickettsia Real-time PCR Assay Centers for Disease Control and Prevention (CDC) Yon Yu
K170374 06/06/2017 SonoBook Series Diagnostic Ultrasound System CHISON Medical Imaging Co., Ltd. Qifei Liu
K170821 06/08/2017 ChoiceSpineÖ Proliant« Posterior Pedicle Screw and Hook Fixation System Choice Spine, LP Kim Finch
K163313 06/09/2017 ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor CIVCO MEDICAL INSTRUMENTS CO., INC. Kevin Mader
DEN160043 06/01/2017 Sentinel Cerebral Protection System Claret Medical, Inc. Zachary Woodson
K171088 06/07/2017 Cochlear Baha SoundArc Cochlear Americas Beth Murray
K170656 06/01/2017 Reinforced Flexible Collagen Nerve Cuff Collagen Matrix, Inc. Peggy Hansen
K162719 06/14/2017 iTotal« Hip Replacement System ConforMIS, Inc. Amita Shah
K170016 06/21/2017 Biodesign Fistula Plug Cook Biotech Incorporated Perry W Guinn
K162109 06/07/2017 Kwart Retro-Inject Ureteral Stent COOK INCORPORATED KARA KANORR
K163104 06/21/2017 TerraceÖ Anterior Cervical Plate System CoreLink, LLC Stephan Jones
K162942 06/20/2017 Corin MetaFix Hip Stem CORIN USA LIMITED RACHEL KING
K162515 06/20/2017 COSMED K5 Wearable Metabolic Technology COSMED S.r.l. Andrea Duca
K171066 06/08/2017 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, llc Sharon McDermott
K162682 06/01/2017 MATISSE Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation Tosan Onosode
K171111 06/13/2017 Sculpsure Cynosure, Inc Amy Tannenbaum
K170849 06/15/2017 SIMPLANT Guide Dentsply Sirona Helen Lewis
K170806 06/15/2017 ATTUNE Cemented Tibial Base, Fixed Bearing DePuy (Ireland) Carol S. Ming
K170803 06/15/2017 HydroMARK Breast Biopsy Site Markers Devicor Medical Products, Inc. Shawna Rose
K170708 06/27/2017 OWL RF INSULATED CANNULAE Diros Technology Inc. Ron Baker
K170918 06/20/2017 Compex Sport Elite DJO, LLC Natalia Shirina
K170903 06/19/2017 Compex Wireless USA DJO, LLC Natalia Shirina
K170122 06/28/2017 Delta III Lithotripter Dornier MedTech America John Hoffer
K162821 06/23/2017 Babyleo TN500 Draegerwerk AG & Co. KGaA Bettina Moebius
K163668 06/23/2017 SUITESTENSA EBIT srl Marco Fruscione
K170995 06/02/2017 Electrocardiograph Edan Instruments, Inc. Alice Yang
K170499 06/15/2017 sensiLift EL GLOBAL TRADE LTD Yael Liebes-Peer
K162886 06/19/2017 DEKA MOTUS AX EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K171307 06/22/2017 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories EndoGastric Solutions, Inc. Steve Hoffman
K162797 06/26/2017 SpringTMS eNeura Inc. Larry W. Getlin
K170726 06/02/2017 Biopsy Forceps Fehling Instruments GmbH & Co. KG Ulrike Lindner
K163524 06/29/2017 Vessel Dilator Fetzer Medical GmbH & Co. KG Harald Jung
K171163 06/27/2017 Contact Lens Case Round Glasses FiftyTwoWays Ltd Jos Reinders
K162582 06/23/2017 HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit FISHER & PAYKEL HEALTHCARE Tina O'Brien
K170652 06/01/2017 ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls Fisher Diagnostics Connie Yang
K170687 06/06/2017 Flower Bone Screw Set Flower Orthopedics Corporation Jessica Huang
K163624 06/30/2017 Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) FUJIFILM Medical Systems U.S.A., Inc. Dharaben Desai
K162749 06/15/2017 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR FUJIFILM Medical Systems U.S.A., Inc. Shraddha S. More
K171437 06/12/2017 SonoSite X-Porte Ultrasound System FujiFilm SonoSite, Inc. Jordan Lydia Grimmer
K171013 06/05/2017 Revolution ACT GE Hangwei Medical Systems, Co., Ltd. Wang Xing
K170155 06/06/2017 EK12 Algorithm GE Medical Systems Information Technologies, Inc. Amy Yang
K170714 06/21/2017 Venue GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K170878 06/14/2017 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K170847 06/14/2017 EchoPAC Software Only, EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics Renee Webb
K170823 06/12/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K163652 06/09/2017 ePlex Instrument GenMark Diagnostics, Incorporated Alan Maderazo
K163636 06/09/2017 ePlex Respiratory Pathogen Panel GENMARK DIAGNOSTICS, INCORPORATED ALAN MADERAZO
K170741 06/01/2017 GTK Disposable Needle Guides GEOTEK Medikal Ltd Sti Latif Iba
K163412 06/22/2017 Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) Girgis Scope LLC Madgy S. Girgis
K171494 06/15/2017 TroClose1200, TroClose1200 Cannula Gordian Surgical Ltd. Amir Schvartzer
K162299 06/22/2017 Spiral Shape Dental Implant System GP Implants Pivovarov German
K163679 06/07/2017 Digital Automatic Blood Pressure Monitor MD3600 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K163603 06/06/2017 Digital Thermometer Guangzhou Jinxinbao Electronic Co., Ltd Mowu Zhu
K170794 06/30/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K163079 06/13/2017 HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System HealthLight, LLC Warren Graber
K162673 06/15/2017 Aptima Herpes Simplex Viruses 1 & 2 Assay HOLOGIC, INC. Ron Domingo
K163449 06/23/2017 HyPHo Laser System Hyper Photonics SRL Isabella Carrer
K170325 06/13/2017 SECRET RF Ilooda Co., Ltd. Yun Jung Ha
K162788 06/19/2017 ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K161216 06/14/2017 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators IMMUNALYSIS CORPORATION Joseph Ginete
K171484 06/14/2017 hema-screen SPECIFIC Gold Immunostics, Inc. Elizabeth Galella
K170551 06/21/2017 ImPACT Quick Test ImPACT Applications, Inc. Michael Zagorski
K170730 06/09/2017 JAZZ System, including JAZZ Band Implanet, S.A. Fabienne Larquey Cadiere
K163345 06/21/2017 TVC Imaging System, TVC Catheter Infraredx, Inc. Stephen Sum
K170311 06/02/2017 Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC. Amy Stoklas-Oakes
K170474 06/16/2017 Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter Innovative Health, LLC. Amy Stoklas-Oakes
K170922 06/22/2017 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) Innovative Health, LLC. Amy Stoklas-Oakes
K170354 06/07/2017 Straumann Variobase Abutments Institut Straumann AG Christopher Klaczyk
K170356 06/07/2017 Straumann Variobase Abutments Institut Straumann AG Christopher Klaczyk
K160673 06/07/2017 Insulin Algorithms System INSULIN ALGORITHMS Josh Davidson
K171357 06/07/2017 SurgiMend PRS Meshed, Revize-X Integra LifeSciences Corporation (Owner of TEI Biosciences) Kavita Amin
K170101 06/08/2017 Valiant Curing Light Inter-Med / Vista Dental Products Alex Johnson
K170713 06/13/2017 da Vinci Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K171426 06/13/2017 da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree Intuitive Surgical, Inc. Brittany Cunningham
K163512 06/02/2017 Zio AT ECG Monitoring System IRHYTHM TECHNOLOGIES, INC. RICH LAGUNA
K170681 06/08/2017 Continuous Single Culture -NX (CSCM-NX) Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K170602 06/07/2017 Continuous Single Culture-NX Complete (CSCM-NXC) Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K163632 06/15/2017 Katalyst Cyclophotocoagulation Probe Katalyst Surgical, LLC Meryl Koch
K162759 06/02/2017 KeraStat(R) Gel KeraNetics, LLC. Luke Burnett
K170203 06/01/2017 System, Applicator, Radionuclide, Remote Controlled Kobold, LLC Deanna Hughes
K170366 06/08/2017 Laser Peripherals, LLC Family of Bare Laser Fibers Laser Peripherals, LLC Jeff Stein
K171429 06/06/2017 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K163334 06/05/2017 LiDCOunity v2 Hemodynamic Monitor LiDCO Ltd JI HEE KO
K162685 06/09/2017 2-Piece Hammertoe Correction System Life Spine, Inc. Randy Lewis
K170299 06/22/2017 Ion PGM Dx System LIFE TECHNOLOGIES CORPORATION EMILY FINNEGAN
K163153 06/28/2017 Livia LIFECARE LTD. AMNON NAHUM SHARON
K163357 06/07/2017 OneTouch Via On-Demand Insulin Delivery System LifeScan Europe, a division of Cilag GmbH Kirsten Franco
K163397 06/29/2017 SMR Hybrid Glenoid System Limacorporate S.p.A. Michela Zanotto
K170416 06/26/2017 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators Lin-Zhi International, Inc. Bernice Lin
K170772 06/07/2017 Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 ?g/mL Liofilchem s.r.l. Fabio Brocco
K171188 06/23/2017 Ossler Exam Scope LR Med Inc Prashant Deshpande
K170270 06/23/2017 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline LS Scientific Inc. D.B.A. KSE Scientific Jordan Reynolds
K163639 06/02/2017 LS-5 ePTFE Suture LSI SOLUTIONS Kevin Bentley
K171009 06/23/2017 LASEMD Laser System Lutronic Corporation Jhung Won Vojir
K170864 06/21/2017 VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company LLC James Champlin
K170893 06/19/2017 Materialise Glenoid Positioning System Materialise NV Oliver Clemens
K171591 06/22/2017 CUBEScanÖ BioCon-900 (Bladder Volume Measurement System) Mcube Technology Co., Ltd. Changhyun Kim
K162389 06/01/2017 Medcomp Vessel Dilator MEDCOMP ( MEDICAL COMPONENTS) COURTNEY NIX
K171538 06/16/2017 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K170395 06/02/2017 Talos« Lumbar (HA) PEEK IBF Devices Meditech Spine, LLC Bruce Dunaway
K162993 06/23/2017 Gemini Sterilization Wrap Medline Industries, Inc. Jennifer Mason
K171468 06/13/2017 FUSE Spinal System Medtronic Sofamor Danek Ankit K. Shah
K171427 06/13/2017 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Medtronic Vascular, Inc. Burt Goodson
K170191 06/16/2017 SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System MEDTRONIC VASCULAR, INC. AARON HAGE
K171308 06/02/2017 Tubing Pack Medtronic, Inc. Renee Cveykus
K171509 06/12/2017 Iliad« Pedicle Screw System and Zenius« Pedicle Screw System Medyssey USA, Inc. Shawn Kim
K163084 06/15/2017 Merit Coronary Control Syringe Merit Medical Systems, Inc. Cory Marsh
K170933 06/22/2017 Merit Hydrophilic Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K170444 06/26/2017 PROCOTYL« PRIME Acetabular Cup System MicroPort Orthopedics Inc Kaitlin Grove
K170288 06/15/2017 BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell MicroPort Orthopedics, Inc. Grace Johnson-Bann
K162459 06/15/2017 AccuPoint Electrode MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON Martin Bak
K161883 06/09/2017 CompuFlo Epidural Computer Controlled Anesthesia System MILESTONE SCIENTIFIC, INC. STEPHEN SOLOMON
K171353 06/07/2017 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris MinXray, Inc. Keith Kretchmer
K170441 06/05/2017 ElectroTek MobileMedTek Bryan Ehret
K162588 06/19/2017 M÷ller Medical Biopsy Needles and Systems Moller Medical GmbH Christoph Traxler
K162395 06/02/2017 MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup MP BIOMEDICALS, LLC STAR HAN
K170655 06/02/2017 Zepto Mynosys Cellular Devices, Inc. Dan Marinsik
K170848 06/14/2017 Alzair Allergy Blocker Nasaleze International Ltd Matt Duxbury
K162874 06/27/2017 Cannulated Screws Neoortho Neoortho Produtos Ortopedicos S/A Mariana de Oliveira Quinzani
K162681 06/02/2017 Enobio Wireless EEG Neuroelectrics Barcelona S.L.U. Anna Maiques
K170238 06/14/2017 BodyTom Elite NeuroLogica Corporation, a Subsidiary of Samsung Electronics Ninad Gujar
K171112 06/08/2017 Trifore(tm) Cervical Plating System NeuroStructures, Inc. Kathleen Wong
K170843 06/16/2017 Alians Fragment Specific Newclip Technics Gaelle Lussori
K162610 06/08/2017 NEXA Negative Pressure Wound Therapy System Nexa Medical Ltd. Keith Heaton
K170297 06/27/2017 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K170302 06/23/2017 YELLOW LASER PHOTOCOAGULATOR YLC-500 NIDEK CO., LTD. Yoneji Mizuno
K170169 06/09/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. Cora Sim
K170961 06/08/2017 NuVasive CoRoent Small Interlock II System NuVasive, Incorporated Cynthia Adams
K170962 06/26/2017 NuVasive« CoRoent« Thoracolumbar System NuVasive, Incorporated Marysa E. Loustalot
K163475 06/09/2017 iVue Optovue, Inc. Edward J. Sinclair
K170620 06/23/2017 ReBOSSIS85 ORTHOREBIRTH Co., Ltd. Yasutoshi Nishikawa
K170736 06/07/2017 HySil Impression Materials Osstem Implant Co., Ltd.. Heekwon Son
K163609 06/01/2017 Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) PALL INTERNATIONAL SARL Karen Peterson-Doyle
K170966 06/14/2017 TONOPORT VI PAR Medizintechnik GmbH & Co. KG Buelent Tek
K170693 06/19/2017 Phantom Small Bone Intramedullary Nail System Paragon 28, Inc. Frank S. Bono
K170877 06/02/2017 Parcus SLiK Fix Screw Parcus Medical Paul Vagts
K163432 06/27/2017 Stellar LEAP PDG Product Design Group, Inc Torr Brown
K163011 06/29/2017 PHA S1 Spinal System Phamedica, Inc. Henry Fam
K170144 06/07/2017 StentBoost Live Philips Medical Stystems Nederland BV Elaine Alan
K170130 06/02/2017 Dynamic Coronary Roadmap Philips Medical Systems Nederland BV Elaine Alan
K170830 06/28/2017 Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Sarah Pleaugh
K171157 06/02/2017 PolyDev Soft Contact Lenses Polydev Ltd. John Mulvihill
K170213 06/28/2017 SupraSDRM Biodegradable Matrix Wound Dressing PolyMedics Innovations GmbH Kenneth K. Kleinhenz
K163447 06/20/2017 Premium Plus Disposable Barrier Sleeve PREMIUM PLUS INTERNATIONAL LIMITED JESSICA MAO
K170515 06/09/2017 Sterile Nitrile Surgical Gloves, Powder-free Primus Gloves PVT Limited Jose Paul M
K170044 06/06/2017 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System PRISMATIK DENTALCRAFT, INC. MARIA E. WAGNER
K171284 06/30/2017 FIBERGRAFT BG Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K162372 06/06/2017 QT Ultrasound Breast Scanner-1 QT ULTRASOUND LLC ELAINE IUANOW
K162954 06/01/2017 OARtrac System with Patient Specific Reusable Universal PSD Sensors RADIADYNE, LLC JOHN K. ISHAM
K171418 06/12/2017 1417WCC_127um and1417WCC_140um Rayence Co., Ltd Kevin Kim
K171417 06/12/2017 1417WGC_127um and 1417WGC_140um Rayence Co., Ltd Kevin Kim
K171420 06/09/2017 1717SCC_127um and 1717SCC_140um Rayence Co., Ltd Kevin Kim
K171419 06/09/2017 1717SGC_127um and 1717SGC_140um Rayence Co., Ltd Kevin Kim
K171536 06/27/2017 RayStation RaySearch Laboratories AB (publ) David Hedfors
K170996 06/09/2017 Wingman 14C Crossing Catheter ReFlow Medical, Inc. Rebecca K. Pine
K162640 06/30/2017 iVitri EZ REPROBITECH CORP. Huai L. Feng
K163585 06/02/2017 Responsive Orthopedics Total Hip Arthroplasty System Responsive Orthopedics, LLC Kathy Remsen
K171060 06/02/2017 OrthoButton AL Riverpoint Medical Nathan Cook
K162678 06/23/2017 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl ROCHE DIAGNOSTICS Kelli Turner
K162826 06/15/2017 Encore Neutral RyMed Technologies, LLC Anna McCutchen
K170569 06/15/2017 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SeaSpine Orthopedics Corporation Gina Flores
K162659 06/16/2017 Diode Laser Hair Removal System SHANDONG HUAMEI TECHNOLOGY CO.,LTD. Xu QingHua
K163470 06/02/2017 Galvanic Spa, Model: SKB-1405 ShenZhen Siken 3D Technology Development Co., Ltd. Kimi Xue
K171053 06/01/2017 syngo Dynamics Version VA30 Siemens Healthcare GmbH Lauren Bentley
K170992 06/15/2017 AcuNav V 10F Ultrasound Catheter Siemens Medical Solutions USA, Inc Shelly Pearce
K170263 06/15/2017 AcuNav Diagnostic Ultrasound Catheter 8F,10F Siemens Medical Solutions USA, Inc. Shelly Pearce
K170904 06/01/2017 Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc. Alaine Medio
K170396 06/14/2017 MAGNETOM Vida Siemens Medical Solutions USA, Inc. Cordell L. Fields, Esq.
K170747 06/09/2017 syngo Application Software Siemens Medical Solutions, USA, Inc. Patricia D. Jones
K163676 06/16/2017 Silhouette InstaLift SILHOUETTE LIFT, INC. DOUG ABEL
K170967 06/08/2017 Intraskan DC Plus Skanray Technologies Private Limited Mahadevan J.
K171590 06/27/2017 Distal Elbow Plating System Skeletal Dynamics, LLC Ana M. Escagedo
K170250 06/07/2017 SmartTarget SmartTarget, Ltd. Dean Barratt
K170457 06/14/2017 EVOS Small Fragment Lower Extremity Plates Smith & Nephew, Inc. Samantha Staubach
K162996 06/08/2017 INVISIKNOT Ankle Syndesmosis Repair Kit SMITH & NEPHEW, INC. GREGORY NEAL
K171794 06/27/2017 Smith & Nephew 25 Fluid Management System Smith & Nephew, Inc. Kathleen Solomon
K162641 06/19/2017 Smith & Nephew, Inc. R3Ö Constrained Liner Smith & Nephew, Inc. Natalie P. Williams
K163212 06/29/2017 Parietene DS Composite Mesh Sofradim Production Benjamin Rochette
K170460 06/08/2017 Sorin Connect Sorin Group Deutschland GmbH Luigi Vecchi
K162215 06/16/2017 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae SORIN GROUP ITALIA S.R.L Luigi Vecchi
K163060 06/13/2017 Deep Conical (DC) Implants and Accessories SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K161710 06/29/2017 SAGICO IBF SYSTEM û ARIA LUMBAR, SAGICO IBF SYSTEM û ARION CERVICAL SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC JAMES J GIBSON
K170045 06/26/2017 SwedgeÖ Pedicle Screw Fixation System Spinal Resources, Inc. Bernard Bedor
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K170751 06/07/2017 MRIdian Linac System with 138-leaf Collimator ViewRay Incorporated Sean Delaney
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K170669 06/19/2017 Insulia Diabetes Management Companion Voluntis S.A. Raffi Krikorian
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K160753 06/13/2017 COOK Vacuum Pump WILLIAM A. COOK AUSTRALIA PTY LTD Gordana Pozvek
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K171344 06/01/2017 Xenocor Xenoscope Laparoscopic System Xenocor, Inc Spencer Walker
K171347 06/06/2017 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection Xeridiem Medical Devices Steve Murray
K171680 06/30/2017 Infinity-Lock 3, Infinity-Lock 5 Xiros Ltd Stephen Seed
K170709 06/06/2017 CURVE Laser System YOLO Medical, Inc. Robert Krznaric
K171101 06/02/2017 Closed Male Luer Yukon Medical Todd Korogi
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