| 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 |
| K170356 |
06/07/2017 |
Straumann Variobase Abutments |
Institut Straumann AG |
Christopher Klaczyk |
| K170354 |
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 |
| K171438 |
06/02/2017 |
PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline A. Hauge |
| K170372 |
06/30/2017 |
SpiralTech Dental Implant System |
SpiralTech Superior Dental Implants, Inc. |
Daniel Rosenthal |
| K170902 |
06/26/2017 |
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit |
SPR Therapeutics, LLC |
Kathryn Stager |
| K170727 |
06/22/2017 |
VariAx 2 Compression Plating System |
Stryker GmbH |
Tina Mornak |
| K170418 |
06/20/2017 |
Stryker SonicPin System |
Stryker Trauma Gmbh |
Heike Gustke |
| K163494 |
06/20/2017 |
Summit Spine Channel Cervical Interbody Fusion System |
Summit Spine |
Eric Buescher |
| K171324 |
06/23/2017 |
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics |
Surgical Instrument Service and Savings Inc |
Brandi J. Panteleon |
| K161327 |
06/08/2017 |
SYNTEC HUMERAL NAIL SYSTEM |
SYNTEC SCIENTIFIC CORPORATION |
KAVIN CHU |
| K160553 |
06/30/2017 |
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws û MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) û MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System ûMR Conditional, DePuy Synthes Small Fragment Dynamic Compressi |
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
ELIZABETH JACOBS |
| K170728 |
06/07/2017 |
E. HISTOLYTICA QUIK CHEK |
TECHLAB, Inc. |
Donna T. Link |
| K170200 |
06/01/2017 |
Carbon Dioxide Reagent Set |
Teco Diagnostics, Inc. |
Hyun Bin Song |
| K163531 |
06/07/2017 |
Advanced Perfusion System 1 |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
BRYAN HANN |
| K161420 |
06/06/2017 |
MOVES SLC |
THORNHILL RESEARCH INC. |
KIPTON LADE |
| K162564 |
06/07/2017 |
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 |
Tianjin Empecs Medical Device Co.,Ltd. |
Chae Chung Lyuel |
| K171481 |
06/16/2017 |
MagVita TMS Therapy System |
Tonica Elektronik A/S |
Lise Terkelsen |
| K160899 |
06/22/2017 |
CoVa Monitoring System 2 |
TOSENSE, INC. |
SUSAN PEDE |
| K170909 |
06/16/2017 |
Infinix INFX-8000V, V6.40 |
Toshiba Medical Systems Coroporation |
Paul Biggins |
| K170177 |
06/30/2017 |
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K170490 |
06/01/2017 |
Celesteion, PCA-9000A/3 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K170412 |
06/07/2017 |
Vantage Titan 1.5T, MRT-1510, M-Power GX |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171222 |
06/08/2017 |
Vitrea Software Toshiba Package; VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171239 |
06/28/2017 |
TULA Tube Delivery System |
Tusker Medical |
Pavan Sethi |
| K170571 |
06/20/2017 |
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw |
Tyber Medical, LLC |
Mark F. Schenk |
| K163193 |
06/08/2017 |
UTF Stem, reduced, #0, #00 |
UNITED ORTHOPEDIC CORPORATION |
GIMPEL CHIEN |
| K170817 |
06/27/2017 |
Halcyon |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K171335 |
06/07/2017 |
Venture 038 catheter |
Vascular Solutions, Inc. |
Beka Vite |
| K162794 |
06/30/2017 |
Gelweave Vascular Grafts |
VASCUTEK LTD. |
NEIL MCLACHLAN |
| K170066 |
06/16/2017 |
Green16/Green18 (Model: PHT-65LHS) |
VATECH CO., LTD. |
Daniel Kim |
| K163506 |
06/19/2017 |
CoalesceÖ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System |
Vertera, Inc. |
Wei Allen Chang |
| K162572 |
06/30/2017 |
NextDent Denture, E-Denture |
VERTEX-DENTAL BV |
O. F. Beckeringh van Loenen |
| K170684 |
06/29/2017 |
Firebow Wire Torque Assist Device |
Vesatek, LLC |
David Look |
| K170094 |
06/23/2017 |
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED |
Viet Glove Corporation |
Pham Ngoc Thanh |
| K170751 |
06/07/2017 |
MRIdian Linac System with 138-leaf Collimator |
ViewRay Incorporated |
Sean Delaney |
| K170026 |
06/02/2017 |
Radiopaque Tissue Marker |
Viscus Biologics, LLC |
Leslie Rebecca Clark |
| K170973 |
06/02/2017 |
VitalWatch Software User Interface |
VitalConnect, Inc. |
Kevin Potgieter |
| K161970 |
06/14/2017 |
Follicle Aspiration Set |
VITROLIFE SWEDEN AB |
ANJA BENGTZELIUS |
| K170896 |
06/29/2017 |
Admira Fusion x-base |
VOCO GmbH |
M. Th. Plaumann |
| K170669 |
06/19/2017 |
Insulia Diabetes Management Companion |
Voluntis S.A. |
Raffi Krikorian |
| K171621 |
06/30/2017 |
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor |
Welch Allyn, Inc. |
Mark Alsberge |
| K160753 |
06/13/2017 |
COOK Vacuum Pump |
WILLIAM A. COOK AUSTRALIA PTY LTD |
Gordana Pozvek |
| K171223 |
06/16/2017 |
Quantum TTC Biliary Balloon Dilator |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K160890 |
06/14/2017 |
Howell Biliary Introducer Needle |
WILSON-COOK MEDICAL, INC. |
ASHLEY HOWARD |
| K162755 |
06/12/2017 |
Picocare |
WON TECH CO., LTD. |
James Hoon Lim |
| K170249 |
06/30/2017 |
GRAVITYÖ Syndesmosis LP |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MICHAEL MULLINS |
| 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 |
| DEN160012 |
06/30/2017 |
D2 Dressing |
Z-MEDICA, LLC |
SHEILA K. WALLIN |
| K170735 |
06/27/2017 |
Powder-Free Clear Vinyl Patient Examination Gloves |
Zibo Yue Fan Medical Products Co, Ltd. |
Wu Xiaoli |
| K170711 |
06/01/2017 |
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System |
Zimmer GmbH |
Roberto Tommasini |
