| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K153387 |
09/08/2016 |
Luna CPAP and Auto CPAP System |
3B MEDICAL, INC. |
ALEX LUCIO |
| K151285 |
09/23/2016 |
VSP Cranial System |
3D Systems, Inc. |
Kim Torluemke |
| K153705 |
09/02/2016 |
PROcedure Rehearsal Studio |
3DSYSTEMS, SIMBIONIX PRODUCTS |
KIM TORLUEMKE |
| K161922 |
09/01/2016 |
XP202 |
3M DEUTSCHLAND GMBH |
RUEDIGER FRANKE |
| K151455 |
09/06/2016 |
3Shape Abutment Designer Software |
3Shape A/S |
Hanne Nielsen |
| DEN150056 |
09/16/2016 |
Acclarent Aera Eustachian Tube Balloon Dilation System |
ACCLARENT, INC. |
JAMES PATRICK GARVEY |
| K153207 |
09/07/2016 |
Additive Orthopaedics Bone Wedge System |
Additive Orthopaedics, LLC |
GREGORY KOWALCZYK |
| K160903 |
09/26/2016 |
STERRAD 100NX Sterilizer with ALLClearTM Technology |
ADVANCED STERILIZATION PRODUCTS |
JAMIE BYUN |
| K160818 |
09/27/2016 |
STERRAD« NX Sterilizer with ALLClearÖ Technology |
ADVANCED STERILIZATION PRODUCTS |
Jamie Byun |
| K161994 |
09/22/2016 |
Aerin Medical Stylus |
Aerin Medical, Inc. |
Scott Wolf |
| K162228 |
09/09/2016 |
TorqVue Low Profile Delivery Catheter |
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR |
Mary Johnson |
| K161368 |
09/22/2016 |
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) |
Agfa HealthCare N.V. |
Koen Vervoort |
| K160221 |
09/12/2016 |
Implance Dental Implant System, Implance Dental Abutment System |
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. |
Gorkem Serce |
| K160862 |
09/19/2016 |
AirStrip RPM |
AirStrip Technologies, Inc. |
Andy Miller |
| K161984 |
09/27/2016 |
Interlocked Circular Small Field Collimators, Elekta Integrated |
AKTINA MEDICAL CORPORATION |
TONY SPACCAROTELLA |
| K162013 |
09/15/2016 |
Eusol-C |
AL.CHI.MI.A. S.r.l. |
Mauro Beccaro |
| K161625 |
09/19/2016 |
PixelShine |
ALGOMEDICA |
Jagdish Vij |
| K160958 |
09/08/2016 |
Battalion Universal Spacer System |
ALPHATEC SPINE |
MARY FUNK |
| K161439 |
09/21/2016 |
E-CUBE 11 |
ALPINION MEDICAL SYSTEMS CO., LTD. |
DONGHWAN KIM |
| K160784 |
09/14/2016 |
CAM Titanium Blanks |
ALTATEC GMBH |
COLLEEN BOSWELL |
| K161656 |
09/01/2016 |
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor |
AMBU A/S |
CAMILLA WISMAR |
| K151839 |
09/09/2016 |
AMC Health VitalCaregiving System |
AMC Health |
Jonathan Shankman |
| K161658 |
09/14/2016 |
Anexa Wound Flush, Sterile Water & Sterile Normal Saline |
ANEXA BIOMEDICAL, INC. |
LENNY BUDLOO |
| K161765 |
09/06/2016 |
CG+ Arrow JACC |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, |
JULIE LAWSON |
| K161581 |
09/09/2016 |
Arthrex Synergy RF System |
ARTHREX, INC. |
William Heard |
| K162126 |
09/29/2016 |
Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) |
ArthroCare Corporation |
Ashley M. Johnson |
| K160582 |
09/02/2016 |
WiCap |
Athena GTX |
Sean Mahoney |
| K161239 |
09/01/2016 |
MTA2.2 MATERIAL |
AVALON BIOMED INC. |
CAROLYN PRIMUS |
| K161878 |
09/26/2016 |
PORTAGE System |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K153542 |
09/07/2016 |
Pelican Sling Retractor |
Beacon Surgical, Inc. |
Allan Alward |
| K160657 |
09/23/2016 |
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube |
BECTON, DICKINSON AND COMPANY |
Branden Reid |
| K151589 |
09/06/2016 |
BD MAX CT/GC/TV, BD MAX INSTRUMENT |
BECTON, DICKINSON, AND COMPANY |
KATIE COYLE |
| K161166 |
09/08/2016 |
StageOne Select Cement Spacer Molds for Temporary Hip Replacement |
BIOMET, INC. |
Carmen Albany |
| K161051 |
09/09/2016 |
All-Bond Universal w/BAC (not finalized) |
Bisco, Inc. |
Ryan Hobson |
| K160274 |
09/01/2016 |
Hi bebe plus |
BISTOS CO., LTD. |
Jenny Cho |
| K161568 |
09/16/2016 |
Bone Solutions Mixing and Delivery System |
BONE SOLUTIONS, INC. |
DREW DIAZ |
| K161068 |
09/22/2016 |
Ahead 300 |
BRAINSCOPE COMPANY INC |
Michael Singer |
| K161551 |
09/13/2016 |
TR-100 |
BTL INDUSTRIES, INC. |
Jan Zarsky |
| K161424 |
09/29/2016 |
Phasix Mesh |
C.R. BARD INC. |
JANNA BABSON |
| K162377 |
09/22/2016 |
PowerGlide Pro Midline Catheter |
C.R. BARD, INC. |
JACOB LEE |
| K161151 |
09/21/2016 |
Spinal fixation system |
CANWELL MEDICAL CO., LTD. |
CHEN HUI |
| K160413 |
09/21/2016 |
Sterling 5W Diode Laser |
CAO Group, Inc. |
Robert K Larsen |
| K153654 |
09/16/2016 |
Sentry WEB SmartInterp |
CareFusion Germany 234 GmbH |
Elmar Niedermeyer |
| K162178 |
09/01/2016 |
CareView 1500P X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
XU WEI |
| K160867 |
09/12/2016 |
Pavati Z40.2 Zirconia |
CCRI, INC. |
ROBIN CARDEN |
| K160957 |
09/27/2016 |
CDB Self Ligating Bracket 8F |
CDB CORPORATION |
YANNIRE THOMPSON |
| K161446 |
09/27/2016 |
Biopor Porous Polyethylene Implants |
Ceremed , Inc. |
Chelsea Mitchell |
| K162172 |
09/14/2016 |
EBit Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
QIFEI LIU |
| K161915 |
09/09/2016 |
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant |
CHURCH & DWIGHT CO.,INC. |
Lisa Burns |
| K161406 |
09/08/2016 |
Navident |
ClaroNav Inc. |
Doron Dekel |
| K162224 |
09/22/2016 |
ArtPix Mobile EZ2GO |
CMT MEDICAL TECHNOLOGIES, LTD. |
LILIA SCHLOSBERG |
| K161672 |
09/29/2016 |
SpeediCath Flex Coude |
Coloplast Corp. |
Rebecca S. Roberts |
| DEN150049 |
09/02/2016 |
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm |
CONCENTRIC MEDICAL, INC. |
JIM LEATHLEY |
| K153599 |
09/01/2016 |
Concert Medical Hands-Free Syringe (HFS) |
Concert Medical, LLC |
Timothy S Powers |
| K161344 |
09/20/2016 |
GentleCath Glide Intermittent Catheter |
CONVATEC LIMITED |
ELINOR JONES |
| K160136 |
09/28/2016 |
Flowable Wound Matrix |
COOK BIOTECH INCORPORATED |
PERRY W. GUINN |
| K161002 |
09/28/2016 |
Aprima Smartesis Centesis Pump |
COOK INCORPORATED |
ERUM B. NASIR |
| K153761 |
09/22/2016 |
Emergency Transtracheal Airway Catheter |
COOK INCORPORATED |
KOTEI AOKI |
| K160593 |
09/02/2016 |
Indy OTW Vascular Retriever |
COOK INCORPORATED |
Chad Schulenburg |
| K160423 |
09/02/2016 |
Perineologic Access Needle |
Corbin Clinical Resources, LLC |
Kenneth K. Kleinhenz |
| K162110 |
09/15/2016 |
CORGRIP NG/NI Tube Retention System |
CORPAK MedSystems, Inc. a Division of Haylard Health |
Stephanie Wasielewski |
| K162047 |
09/15/2016 |
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated |
COVIDIEN |
CELSO DURAN |
| K161804 |
09/16/2016 |
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider |
COVIDIEN |
DAWN D. TINDALL |
| K161963 |
09/01/2016 |
Monoject Enteral Syringe with ENFit Connector |
COVIDIEN |
SONA MANICKAM |
| K161347 |
09/07/2016 |
Signia sterilization tray |
COVIDIEN |
KATHERINE Y. CHOI |
| K151090 |
09/21/2016 |
CPL Insulin Pen Needle |
CPL CO., LTD. |
CHOI KYOUNG SOO |
| K160436 |
09/29/2016 |
CreoDent Solidex Custom Abutment |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K160410 |
09/29/2016 |
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head |
Dental Savings Club |
Chadi Saade |
| K160828 |
09/15/2016 |
Dentium Implantium & SuperLine Prosthetics |
DENTIUM CO., LTD. |
Sangpil Yoon |
| K160207 |
09/21/2016 |
ATLANTIS ISUS Implant Suprastructures |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K160825 |
09/27/2016 |
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology |
DENTSPLY SIRONA |
Helen Lewis |
| K162107 |
09/27/2016 |
TPH Spectra+ Universal Composite Restorative |
DENTSPLY SIRONA |
HELEN LEWIS |
| K161721 |
09/20/2016 |
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set |
Diazyme Laboratories |
Abhijit Datta |
| K160443 |
09/30/2016 |
TempoCem Clear |
DMG USA, INC. |
Gordon Craig |
| K161187 |
09/09/2016 |
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs |
ECO MEDI GLOVE SDN BHD |
Suresh Kumar |
| K161320 |
09/01/2016 |
EMG Pink Nitrile Examination Glove Powder Free |
ECO MEDI GLOVE SDN. BHD. |
Suresh Kumar |
| K162184 |
09/02/2016 |
Edwards eSheath Introducer Set |
Edward Lifesciences |
Yi Gao |
| K162497 |
09/19/2016 |
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR |
EIZO CORPORATION |
Hiroaki Hashimoto |
| K153644 |
09/07/2016 |
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II |
ELITechGroup |
Valerie Gourdon |
| K161162 |
09/16/2016 |
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra |
ELLIPSE A/S |
OLE KOFOD |
| K161945 |
09/23/2016 |
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K160945 |
09/26/2016 |
Endophys Blood Pressure Monitor |
ENDOPHYS HOLDINGS, LLC |
Rebecca K. Pine |
| K161067 |
09/15/2016 |
Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö |
ENGINEERED TISSUE SOLUTIONS, LLC |
Mark Borden |
| K161168 |
09/02/2016 |
MyLabSix Ultrasound System |
Esaote Europe B.V. |
Bert Vorstenbosch |
| K160554 |
09/09/2016 |
Enseal X1 Large Jaw Tissue Sealer |
ETHICON ENDO-SURGERY, LLC |
DAVID LOCKE |
| K161004 |
09/09/2016 |
Self-retaining Retractor |
FETZER MEDICAL GMBH & CO.KG |
Harald Jung |
| K161940 |
09/18/2016 |
Guidewire 0.6 Single Use |
FIAGON GMBH |
Dirk Mucha |
| K160531 |
09/01/2016 |
Noiselezz |
FIRMA INGEMARSSON |
Natashia Ingemarsson-Matzen |
| K153505 |
09/20/2016 |
F&P Eson 2 Nasal Mask |
FISHER & PAYKEL HEALTHCARE LIMITED |
SUE CHO |
| K160735 |
09/16/2016 |
CATSmart |
FRESENIUS KABI AG |
Barry G. Hicks |
| K162288 |
09/08/2016 |
SonoSite iViz Ultrasound System |
FUJIFILM SONOSITE, INC. |
Patricia Liau |
| K153130 |
09/13/2016 |
Initial LiSi Block |
GC AMERICA INC. |
MARK HEISS |
| K162012 |
09/15/2016 |
CARESCAPE Central Station V2 |
GE HEALTHCARE |
ROBERT CASARSA |
| K161567 |
09/01/2016 |
SIGNA Voyager |
GE HEALTHCARE |
Glen Sabin |
| K162059 |
09/29/2016 |
EZEE RETRIEVAL |
GENICON, INC |
KATLYN KACHMAN |
| K153676 |
09/14/2016 |
OSTEON III |
GENOSS CO., LTD. |
EUNSANG LEE |
| K161717 |
09/20/2016 |
Personal Kinetigraph (PKG) System |
GKC MANUFACTURING PTY LTD. |
BRENDAN FAFIANI |
| K142846 |
09/08/2016 |
BBX1, BBX2, BBX1MO, BBX1MC |
GLOBALDENTAL, INC. |
EBLESS V BAEZ ALERS |
| K161591 |
09/21/2016 |
QUARTEXÖ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K161379 |
09/29/2016 |
ELSA Spacers |
GLOBUS MEDICAL, INC. |
KELLY J. BAKER |
| K161707 |
09/01/2016 |
Madsen Zodiac |
GN OTOMETRICS |
Asif Muhammad |
| K153580 |
09/07/2016 |
Central Monitoring System |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Jin Liang |
| K161825 |
09/26/2016 |
PK AIM |
GYRUS ACMI INC. |
GRAHAM A.L. BAILLIE |
| K160709 |
09/06/2016 |
HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves |
Halyard Health |
Gwendolyn George |
| K161232 |
09/30/2016 |
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit |
HALYARD HEALTH |
GWENDOLYN GEORGE |
| K153046 |
09/06/2016 |
HAMILTON-MR1 |
HAMILTON MEDICAL AG |
KATRIN VOGT |
| K160919 |
09/20/2016 |
Hansen Medical Magellan Robotic Catheter 9Fr |
HANSEN MEDICAL, INC. |
MARYSA LOUSTALOT |
| K160255 |
09/15/2016 |
HBOTC Muscle and Nerve Stimulator |
HB MEDICAL, INC. |
RYAN HEANEY |
| K160140 |
09/30/2016 |
DENTRIa series |
HDX WILL CORP. |
Hyung-suk Oh |
| K162338 |
09/21/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K162079 |
09/16/2016 |
TRILLIUM Oval Head Coil 32 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K152405 |
09/01/2016 |
IBL 5000 Tanning Booth |
IBL ACQUISITIONS LLC |
MICHAEL GILLEY |
| K160023 |
09/30/2016 |
Electronic Stethoscope DS301 |
IMEDIPLUS INC. |
SHIRLEY LAI |
| K153609 |
09/08/2016 |
RTS Flexible 1 MPJ Implant w/Grommets |
In2BonesUSA, LLC |
Joe Clift |
| K160365 |
09/28/2016 |
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System |
Infopia Co., Ltd. |
NA YUN KIM |
| K161262 |
09/19/2016 |
Super Distal Access (SDA) |
INNEUROCO, INC |
Marc Litzenberg |
| K162143 |
09/23/2016 |
FixxSure« X-Link |
INNOVASIS, INC. |
MARSHALL MCCARTY |
| K161464 |
09/30/2016 |
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters |
Innovative Health, LLC |
Rafal Chudzik |
| K160262 |
09/16/2016 |
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, |
Institut Straumann AG |
Christopher Klaczyk |
| K161818 |
09/14/2016 |
GEM Premier 3000 |
Instrumentation Laboratory Co. |
Nikita Malladi |
| K161992 |
09/22/2016 |
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems |
INTEGRA LIFESCIENCES CORPORATION |
JENNIFER SIEGEL |
| K162411 |
09/21/2016 |
da Vinci Xi 12 û 8 mm Reducer |
Intuitive Surgical, Inc. |
Vishal Kanani |
| K160630 |
09/27/2016 |
Invacare Platinum Mobile Oxygen Concentrator |
INVACARE CORPORATION |
ELIJAH N. WREH |
| K162177 |
09/14/2016 |
dS FootAnkle I6CH 1.5T Coil |
Invivo Corporation |
Ken Revennaugh |
| K162053 |
09/15/2016 |
PhotonBlade |
Invuity Inc. |
John Kang |
| K162416 |
09/29/2016 |
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate |
IRIDEX CORPORATION |
KATHY MAYNOR |
| K161746 |
09/21/2016 |
ARIX Hand System |
Jeil Medical Corporation |
Seungyong Lee |
| K160964 |
09/16/2016 |
Neodent Implant System - Titanium Base for CEREC |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
JACSON Cambruzzi |
| K161895 |
09/08/2016 |
2MP Color LCD Monitor CCL214 (CL21214) |
JVC KENWOOD Corporation |
Tsukasa Tashiro |
| K162264 |
09/21/2016 |
Cascadia Interbody System |
K2M, Inc. |
NANCY GIEZEN |
| K161112 |
09/17/2016 |
KARL STORZ Flexible Video-Neuro-Endoscope System |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE S. CHEN |
| K151962 |
09/15/2016 |
KBL Sunlamp Products (= Device Bundling name) |
KBL AG |
NORBERT BECKER |
| K153469 |
09/01/2016 |
Cathtong I PICC Catheter |
L&Z US, INC. |
JENELLA COUTTS |
| K152981 |
09/02/2016 |
JET SET 4 DENTURE REPAIR RESIN |
LANG DENTAL MANUFACTURING COMPANY, INC |
DAVID LANG |
| K161173 |
09/28/2016 |
Avenue« T TLIF Cage |
LDR SPINE USA, INC. |
JOHN ROSSMAN |
| K160066 |
09/02/2016 |
Pro-Link« Stand-Alone Cervical Spacer System |
Life Spine, Inc. |
Randy Lewis |
| K160529 |
09/15/2016 |
Pledgeted COR-SUTURE QUICK LOAD |
LSI SOULTIONS |
KEVIN BENTLEY |
| K161573 |
09/02/2016 |
FilmArray RP EZ Control Panel M265 |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
JOAN GORDON |
| K161585 |
09/06/2016 |
Mano and Mano Personal Lubricant |
Mano and Mano Proprietary Limited |
Katrina Allen |
| K160117 |
09/09/2016 |
AbClose - Port Site Closure Device |
Medeon Biodesign, Inc |
GRETA CHANG |
| K160698 |
09/02/2016 |
LigaPASS |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K160640 |
09/23/2016 |
PASS XS Spinal System |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| K161602 |
09/02/2016 |
Arctic Sun Temperature Management System |
Medivance, Inc. |
Stacci Cronk |
| K161294 |
09/15/2016 |
Compound W Wart Removal System Dual Power |
MEDTECH PRODUCTS INC. |
JEAN BOYKO |
| K160860 |
09/22/2016 |
MiniMed Quick-serter |
MEDTRONIC MINIMED |
Noreen Bajwa |
| K153660 |
09/14/2016 |
StealthStation System with Cranial Software |
MEDTRONIC NAVIGATION, INC. |
Augusta Henao |
| K162384 |
09/22/2016 |
TrailBlazer Angled Support Catheter |
Medtronic Vascular, Inc.(formerly ev3 Inc.) |
David Robertson |
| K162016 |
09/21/2016 |
Affinity NT Oxygenator with Cortiva BioActive Surface |
MEDTRONIC, INC. |
RENEE CVEYKUS |
| K161392 |
09/01/2016 |
Elation Pulmonary Balloon Dilation |
MERIT MEDICAL SYSTEMS, INC. |
DAVID THOMAS |
| K161879 |
09/21/2016 |
Solitaire Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K161803 |
09/30/2016 |
Traxcess .007 Mini Guidewire |
MICROVENTION, INC. |
SAPNA SINGH |
| K160429 |
09/01/2016 |
BC-5390 Auto Hematology Analyzer |
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Min Zheng |
| K161465 |
09/03/2016 |
CardioConfirm |
MORTARA INSTRUMENT, INC. |
Margaret Mucha |
| K160015 |
09/22/2016 |
Pure Vu |
Motus GI Medical Technologies Ltd. |
Hagit Ephrath |
| K161485 |
09/06/2016 |
Nanovis Intervertebral Body Fusion System and Forticore(R) |
NANOVIS LLC |
MATTHEW HEDRICK |
| K161866 |
09/08/2016 |
BioFlo Midline Catheter |
NAVILYST MEDICAL, INC. |
ROBIN FULLER |
| K162345 |
09/21/2016 |
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge |
NEOTRACT, INC. |
LOUIS-PIERRE MARCOUX |
| K161519 |
09/11/2016 |
NeuroStar TMS Therapy System |
NEURONETICS, INC. |
JUDY P. WAYS |
| K162332 |
09/29/2016 |
Nexcore GI Insufflator |
NEXCORE TECHNOLOGY, LLC |
Julie Broderick |
| K160816 |
09/21/2016 |
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) |
NEXMED TECHNOLOGY CO., LTD |
Ellen Xu |
| K161608 |
09/30/2016 |
InterForm Cervical Interbody Cage System |
NEXT ORTHOSURGICAL |
ELLEN YARNALL |
| K161165 |
09/07/2016 |
Next Science Irrigation Solution |
NEXT SCIENCE, LLC |
MATTHEW MYNTTI |
| K153707 |
09/02/2016 |
Nihon Kohden Vital Sign Telemeter |
NIHON KOHDEN CORPORATION |
TOM BENTO |
| K153665 |
09/15/2016 |
PROW FUSION-L |
NLT SPINE LTD |
Eti Zinger |
| K161792 |
09/20/2016 |
PINPOINT Endoscopic Fluorescence Imaging System |
Novadaq Technologies Inc. |
Jen Pendlebury |
| K161451 |
09/22/2016 |
BIB Stent Placement Catheter |
NUMED, INC. |
Nichelle LaFlesh |
| K160728 |
09/16/2016 |
NutraStim Hair Laser Helmet |
NUTRA LUXE MD LLC |
GLORIA AVENDANO |
| K161442 |
09/28/2016 |
NuVasive« CoRoent« Small InterlockÖ System |
NUVASIVE INCORPORATED |
Cynthia Adams |
| K161751 |
09/02/2016 |
MAGEC« Spinal Bracing and Distraction System |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
REBECCA SHELBURNE WALKER |
| K161014 |
09/28/2016 |
NuVasive« Reline« System |
NUVASIVE, INCORPORATED |
Thao Huynh |
| K162426 |
09/29/2016 |
nva, nvp, and nvt |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
Diana L. Langham |
| K161524 |
09/02/2016 |
Tangis Anterior Cervical Plate |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
DIANA L. LANGHAM |
| K161600 |
09/06/2016 |
Resection Electrodes |
OLYMPUS WINTER & IBE GMBH |
Katharina Campbell |
| K161263 |
09/13/2016 |
OptoMonitor II |
Opsens Inc |
Vanessa Mootoosamy |
| K161455 |
09/20/2016 |
Catalys Precision Laser System |
Optimedica Corporation |
Ankur Kaushal |
| K161129 |
09/08/2016 |
PILLAR SA PTC |
ORTHOFIX INC. |
Natalia Volosen |
| K162307 |
09/27/2016 |
OrthoPediatrics Locking Proximal Femur System Cortical Screws |
ORTHOPEDIATRICS, CORP. |
ADAM CARGILL |
| K161671 |
09/29/2016 |
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower |
OTICON MEDICAL AB |
Satu Hjartstam |
| K161832 |
09/23/2016 |
O2VENT T |
OVENTUS MANUFACTURING PTY LTD |
HEMANGI MALDE |
| K153302 |
09/08/2016 |
coflex-IF |
PARADIGM SPINE, LLC |
Marc Viscogliosi |
| K161506 |
09/26/2016 |
Penumbra Aspiration System |
Penumbra, Inc. |
Richard Kimura |
| K161966 |
09/08/2016 |
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector |
PerkinElmer, Inc. |
Dawn Spooner |
| K161942 |
09/01/2016 |
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector |
PERKINELMER, INC. |
Dawn Spooner |
| K162329 |
09/14/2016 |
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System |
Philips Healthcare |
Maxs Newberry |
| K162112 |
09/21/2016 |
CAAS MRV |
Pie Medical Imaging BV |
Annemiek Bouts |
| K161876 |
09/09/2016 |
Tritium« Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
Sarah Pleaugh |
| K153546 |
09/28/2016 |
PINK CAD/CAM disc |
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
JANJA LIPUSCEK |
| K161814 |
09/27/2016 |
Solana Influenza A+B Assay |
Quidel Corporation |
Ronald H. Lollar |
| K160606 |
09/01/2016 |
BC-5D Hematology Control |
R & D SYSTEMS, INC. |
RAVI KOMMINENI |
| K160822 |
09/09/2016 |
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV |
RESMED LTD |
JASJIT BAVEJA |
| K161487 |
09/09/2016 |
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx |
ResMed Ltd |
Jasjit Baveja |
| K161201 |
09/09/2016 |
ClearRead CT |
RIVERAIN TECHNOLOGIES, LLC |
Jennifer Butsch |
| K161212 |
09/30/2016 |
Atteris Antimicrobial Skin Protectant |
ROCHAL INDUSTRIES LLC |
William J. Coulston |
| K160493 |
09/08/2016 |
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm |
Salvin Dental Specialties |
Jennifer Singer |
| K160269 |
09/06/2016 |
Surgical Face Masks (Ear loops and Tie-on) |
SAN-M PACKAGE CO., LTD. |
Shogo Nagao |
| DEN150033 |
09/26/2016 |
Sensor Monitored Alimentary Restriction Therapy (SMART) Device |
SCIENTIFIC INTAKE |
William Longley |
| K161081 |
09/14/2016 |
SeaSpine Shoreline ACS - Anterior Cervical Standalone System |
SEASPINE ORTHOPEDICS CORPORATION |
Michelle Willis |
| K161535 |
09/08/2016 |
SeaSpine« NewPortÖ Spinal System |
SEASPINE ORTHOPEDICS CORPORATION |
Michelle Willis |
| K152946 |
09/15/2016 |
TEMPEDY |
SEIRATHERM GMBH |
MATTHIAS ROTH |
| K161356 |
09/09/2016 |
Matrix LS-40 CO2 Laser System |
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. |
Amy Lee |
| K162527 |
09/30/2016 |
8MP Color LCD Monitor (C81W+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K162267 |
09/06/2016 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
Zhai Pei |
| K152879 |
09/09/2016 |
Sure-Fine Insulin Syringes |
SHINA MED CORPORATION |
SUNG-SOON PARK |
| K161384 |
09/14/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
NORA HADDING |
| K151964 |
09/30/2016 |
Xprecia Stride Coagulation System, Xprecia System PT Controls |
SIEMENS HEALTHCARE DIAGNOSTICS |
NOOR MALKI |
| K161312 |
09/01/2016 |
Sysmex Automated Blood Coagulation Analyzer CS-2100i |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
NILS NEUMANN |
| K161317 |
09/02/2016 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
Siemens Healthcare Diagnostics Products GmbH |
Nils Neumann |
| K160724 |
09/07/2016 |
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K162221 |
09/06/2016 |
ACUSON SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions Inc. Ultrasound Group |
Kevon Kong |
| K162339 |
09/21/2016 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
VERONICA PADHARIA |
| K162417 |
09/28/2016 |
Acuson Freestyle Ultrasound System |
Siemens Medical Solutions, Inc. |
Lawrence Engle |
| K162243 |
09/06/2016 |
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System |
Siemens Medical Solutions, Inc. |
Shelly Pearce |
| K162337 |
09/08/2016 |
Symbia 6.5 |
SIEMENS MEDICAL SOLUTIONS, USA, INC |
Cynthia Busch |
| K160159 |
09/06/2016 |
Active-X Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K153723 |
09/14/2016 |
ACTICOAT Surgical Dressing |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K152163 |
09/29/2016 |
RENASYS GO |
SMITH & NEPHEW, INC. |
Laura Reynolds |
| K153636 |
09/09/2016 |
Liberator Powered Wheelchair with Solar Companion |
SOLAR MOBILITYLLC |
KURT SCHNEIDER |
| K162306 |
09/20/2016 |
SomnoDent ALPHA |
SomnoMed Inc. |
Kien Nguyen |
| K153701 |
09/09/2016 |
ULYSS Multi View Sinuscope |
SOPRO-COMEG GMBH |
HAROLD LETTAU |
| K161562 |
09/28/2016 |
Sound Options Tinnitus Treatment |
Sound Options Tinnitus Treatments Inc. |
Michael Chrostowski |
| K161774 |
09/30/2016 |
i-Sil |
SPIDENT Co., Ltd. |
J. M. Ahn |
| K161888 |
09/12/2016 |
JULIET« LL Lateral Lumbar Cage |
SPINEART |
FRANCK PENNESI |
| K162222 |
09/07/2016 |
GENflex2 Total Knee System |
StelKast, Inc. |
Dave Stumpo |
| K161086 |
09/20/2016 |
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) |
Sterilmed, Inc. |
Patricia Kaufman |
| K161565 |
09/01/2016 |
DUO |
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD |
Juan Ye |
| K161946 |
09/16/2016 |
DoseCHECK |
Sun Nuclear Corporation |
Rene' Hardee |
| K162359 |
09/21/2016 |
Surefire Guiding Catheter |
Surefire Medical, Inc. |
Lynne Aronson |
| K161744 |
09/07/2016 |
Symmetry Sharp Kerrison Rongeur |
Symmetry Surgical Inc. |
Lora Tjomstol |
| K161043 |
09/12/2016 |
Profound System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K160167 |
09/26/2016 |
DePuy Synthes TFNA Augmentation System |
Synthes (USA) Products, LLC |
Christopher J. Medberry |
| K161489 |
09/16/2016 |
Syntorr K-wire and Pin System |
SYNTORR INC |
DANIEL MARTIN |
| K153311 |
09/14/2016 |
Flexitouch System |
TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL) |
Thomas A Dold |
| K152023 |
09/15/2016 |
Luminesse Shaded Zirconia SZ |
TALLADIUM, INC. |
Edward Harms |
| K161758 |
09/07/2016 |
Weck Auto Endo10 Automatic Endoscopic Clip Applier |
TELEFLEX MEDICAL |
HOLLY HALLOCK |
| K153771 |
09/13/2016 |
TXM Guiding Sheath |
Texas Medical Technologies, Inc. |
Aaron Chiu |
| K162195 |
09/14/2016 |
TSolution One Cup1 Surgical System |
THINK SURGICAL INC. |
IN K. MUN |
| K161843 |
09/21/2016 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162187 |
09/30/2016 |
Xario 100 Diagnostic Ultrasound System, V5.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K152865 |
09/27/2016 |
TRACOE smart Cuff Manager |
TRACOE MEDICAL GMBH |
STEPHAN KOHLER |
| K161875 |
09/30/2016 |
LaserCap300, LaserCap224, LaserCap120, LaserCap80 |
TRANSDERMAL CAP, INC. |
MICHAEL RABIN |
| K162475 |
09/16/2016 |
mi-eye 2, mi-eye 2 monitor |
Trice Medical |
Tiffini Diage |
| K161459 |
09/06/2016 |
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) |
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED |
Catherine Mulcahy |
| K161063 |
09/01/2016 |
EzRay Air (Model VEX-P300) |
Vatech Co., Ltd |
Daniel Kim |
| K160754 |
09/09/2016 |
Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) |
VENCLOSE, INC. |
MAI LY WILCOX |
| K161185 |
09/26/2016 |
LUCERNA Dental Laser |
VIAX DENTAL LAB |
EDWIN M. FIRST |
| K153565 |
09/22/2016 |
DONASORB SILVER WOUND DRESSING |
VIRCHOW BIOTECH PVT. LTD. |
BRUCE GIBBINS |
| K153156 |
09/30/2016 |
eCareManager 4.0.1 |
VISICU, INC. |
Daniel R. Plonski |
| K162008 |
09/16/2016 |
JiveX |
VISUS TECHNOLOGY TRANSFER GMBH |
AXEL SCHREIBER |
| K161630 |
09/15/2016 |
Provicol QM Plus |
VOCO GMBH |
TH. PLAUMANN |
| K161756 |
09/05/2016 |
SyncVision System |
Volcano Corporation |
Elaine Alan |
| K161887 |
09/20/2016 |
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip |
Volcano Corporation |
Brian Park |
| K160783 |
09/07/2016 |
Procellera |
VOMARIS INNOVATIONS, INC. |
Timothy Joiner |
| K153733 |
09/16/2016 |
VORTRAN Manometer |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K162188 |
09/22/2016 |
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) |
VR MEDICAL TECHNOLOGY |
LEE PAN |
| K160880 |
09/23/2016 |
Photonica Professional |
Ward Photonics LLC |
Terry Ward |
| K161478 |
09/06/2016 |
Xenco Medical Posterior Cervical System |
Xenco Medical, LLC |
Gustavo Prado |
| K161838 |
09/26/2016 |
Xenocor Xenoscope Laparoscopic System |
Xenocor, Inc |
Spencer Walker |
| K162141 |
09/02/2016 |
Restore PACS |
XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. |
Echo Chou |
| K160341 |
09/14/2016 |
Colposcope System |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD |
JING WANG |
| K160575 |
09/07/2016 |
CareSens Pen Needle, Softip Pen Needle |
YIDOBIO INC. |
KYUNG HEE YOON |
