| 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 System, Uni*Fuse Infusion System |
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 |
| K170891 |
05/24/2017 |
Mako Partial Knee Application |
MAKO Surgical Corp. |
Shikha Khandelwal |
| K170584 |
05/11/2017 |
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 |
