| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K152769 |
05/06/2016 |
FREMAP ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORPORATION |
LISA THEAMA |
| K153111 |
05/06/2016 |
TOUAREG CloseFitÖ UNP 2.75mmD |
Adin Dental Implants Systems Ltd. |
Ilana Lutvak |
| K152776 |
05/27/2016 |
Glocyte Automated Cell Counter System |
Advanced Instruments, Inc. |
Robert Mello |
| K153629 |
05/25/2016 |
ArcadiusXP C Spinal System |
Aesculap Implant Systems, Inc. |
Lisa M Boyle |
| K153396 |
05/16/2016 |
Aesculap OrthoPilot Next Generation |
AESCULAP IMPLANT SYSTEMS, LLC |
Paul Amudala |
| K160393 |
05/26/2016 |
AdTec |
AESCULAP, INC. |
Jessica Stigliano |
| K160609 |
05/02/2016 |
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric |
Alcon Laboratories, Inc. |
Alicia M. Plesnarski |
| K160952 |
05/05/2016 |
Alma Diode Tabletop Laser |
ALMA LTD |
Ariela Albalak |
| K160710 |
05/13/2016 |
Oasis Lacrimal Intubation Set |
ANODYNE |
VALERIE ANDERSON |
| K160319 |
05/10/2016 |
FiberTak DR |
ARTHREX, INC. |
IVETTE GALMEZ |
| K150553 |
05/19/2016 |
Filbloc |
ASSUT EUROPE |
GLORIA AGGIO |
| K160154 |
05/13/2016 |
ALTA Anterior Cervical Interbody Spacer |
Astura Medical |
Troy Taylor |
| K152319 |
05/26/2016 |
Auris Robotic Endoscopy System (ARES) |
AURIS SURGICAL ROBOTICS, INC. |
MICHAEL A. DANIEL |
| K160356 |
05/17/2016 |
Third Eye Panoramic Auxiliary Endoscopy System - Resposable |
AVANTIS MEDICAL SYSTEMS, INC. |
Louis Fries |
| K151391 |
05/02/2016 |
BTI Dental Implant System UnicCa |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
FERNANDA OLABARRIA ROS |
| K161229 |
05/18/2016 |
Mammo Tomosynthesis (MDMG-5221) |
BARCO N.V. |
Lieven De Wandel |
| K161208 |
05/24/2016 |
CROSSER CTO Recanalization Catheter |
Bard Peripheral Vacular, Inc. |
Melanie Hadlock |
| K152510 |
05/13/2016 |
UltraCor Twirl Breast Tissue Marker |
BARD PERIPHERAL VASCULAR, INC. |
KRISTEN DEJEU |
| K161170 |
05/27/2016 |
BD Eclipse Hypodermic Needle |
Becton, Dickinson and Company |
Priyanka Apte |
| K152571 |
05/26/2016 |
Stivax |
BIEGLER GMBH |
FRIEDRICH NETAUSCHEK |
| K152679 |
05/10/2016 |
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak |
BIO-RAD LABORATORIES |
ELIZABETH PLATT |
| K152754 |
05/16/2016 |
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K161190 |
05/26/2016 |
G7 Dual Mobility System, Active Articulation System |
Biomet, Inc |
Emily Manuel |
| K153657 |
05/10/2016 |
Vanguard XP Knee System |
BIOMET, INC. |
JULIE GANTENBERG |
| K160537 |
05/19/2016 |
Navio |
Blue Belt Technologies, Inc. |
Richard G. Confer |
| K152020 |
05/13/2016 |
Bindex BI-100 |
BONE INDEX FINLAND, LTD. |
JANNE KARJALAINEN |
| K160845 |
05/03/2016 |
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device |
BOSTON SCIENTIFIC CORPORATION |
Yingying Gao |
| K161125 |
05/19/2016 |
OptiCross X, 40 MHz Coronary Imaging Catheter |
Boston Scientific Corporation |
Eric Elliott |
| K152842 |
05/19/2016 |
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL |
BOSTON SCIENTIFIC CORPORATION |
CARAH KUCHARSKI |
| K160900 |
05/31/2016 |
CapSure Fixation System - Straight 5mm x 37 cm û 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm û 15 Permanent fasteners |
C.R. BARD INC. |
Andrew Harrell |
| K153359 |
05/20/2016 |
BardPort«, SlimPort«, and X-Port« Implanted Ports |
C.R. BARD, INC. |
JAMES R. DAVIS |
| K153236 |
05/13/2016 |
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay |
C.R. BARD, INC. |
SHWETA CONNER |
| K160994 |
05/19/2016 |
C2 CryoBalloon Focal Pear Catheter |
C2 THERAPEUTICS, INC. |
Theresa Brandner-Allen |
| K153720 |
05/03/2016 |
ENZA Zero-Profile Anterior Interbody Fusion |
Camber Spine Technologies |
Michael Black |
| K153316 |
05/12/2016 |
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) |
Cardinal Health, Inc. |
Megan Middaugh |
| K152825 |
05/11/2016 |
Catalyst CSR Shoulder System |
CATALYST ORTHOSCIENCE LLC |
STEPHEN HERRINGTON |
| K152826 |
05/27/2016 |
NoCord |
CENTRIX, INC. |
GREG MOREAU |
| DEN140032 |
05/13/2016 |
Cereve Sleep System |
CEREVE, INC. |
Eric Nofzinger |
| K153107 |
05/19/2016 |
Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine VEOÖ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System |
CHOICE SPINE, LP |
KIM FINCH |
| K161123 |
05/20/2016 |
Baha 5 Power Sound Processor |
Cochlear Americas |
Laura Blair |
| K151784 |
05/25/2016 |
ActTrust |
CONDOR INSTRUMENTS LTDA. - EPP |
RODRIGO TREVISAN OKAMOTO |
| K161017 |
05/09/2016 |
True HD 3MOS Camera System |
CONMED CORPORATION |
Diair Cantisani |
| K153506 |
05/06/2016 |
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit |
CONSURE MEDICAL PVT LTD. |
Nishith Chasmawala |
| K161000 |
05/11/2016 |
Biodesign Otologic Repair Graft |
COOK BIOTECH INCORPORATED |
PERRY W. GUINN |
| K161221 |
05/26/2016 |
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug |
Cook Biotech Incorporated |
Perry W. Guinn |
| K153778 |
05/19/2016 |
Nester Embolization Coils, Tornado Embolization Coils |
COOK INCORPORATED |
David Lehr |
| K160419 |
05/12/2016 |
Monoject Enteral Feeding Syringe with ENFit Connector |
COVIDIEN |
Sona Manickam |
| K160654 |
05/04/2016 |
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) |
Covidien LLC |
Rebecca Magnanimo |
| K160290 |
05/19/2016 |
Valleylab REM Polyhesive Infant Patient Return Electrode |
Covidien LLC |
Nancy Sauer |
| K160725 |
05/01/2016 |
EndoFLIP |
CROSPON LTD. |
JOHN O'DEA |
| K160118 |
05/03/2016 |
STROPP (Single Tunnel Repair of Plantar Plate) |
CROSSROADS EXTREMITY SYSTEMS, LLC |
Vernon Hartdegen |
| K160480 |
05/17/2016 |
PicoSure Workstation |
Cynosure, Inc |
Amy Tannenbaum |
| K150980 |
05/12/2016 |
Venous Assist System |
DAESUNG MAREF CO., LTD. |
JAE-WHA LEE |
| K160922 |
05/03/2016 |
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) |
Dako North America, Inc. |
Joel Weisenberger |
| K153490 |
05/13/2016 |
DD medical polymers |
DENTAL DIREKT GMBH |
UWE GREITENS |
| K161021 |
05/05/2016 |
HydroMARK Breast Biopsy Site Marker |
DEVICOR MEDICAL PRODUCTS, INC. |
SHAWNA ROSE |
| K161209 |
05/31/2016 |
Cirona 6400 |
DEVON MEDICAL PRODUCTS |
ROCCO BRAVOCO |
| K152556 |
05/26/2016 |
Oragene Dx |
DNA Genotek Inc |
Dan Fullerton |
| K152464 |
05/26/2016 |
ORAcollect.Dx |
DNA GENOTEK INC. |
Dan Fullerton |
| K152507 |
05/20/2016 |
Dr. Wolff Vagisan Moisturising Cream |
DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL |
THOMAS FLOETOTTO |
| K152911 |
05/06/2016 |
EarlySense Insight Sytem |
EarlySense Ltd. |
Dalia Argaman |
| K153045 |
05/13/2016 |
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator |
EASYMED INSTRUMENT CO., LTD. |
Jeffery Wu (Tingjie Wu) |
| K161300 |
05/31/2016 |
Acclarix AX8 Diagnostic Ultrasound System |
EDAN INSTRUMENTS INC. |
ERICO LI |
| K160084 |
05/03/2016 |
Swan Ganz Catheters |
Edwards Lifesciences, LLC |
Mugdha Dongre |
| K151540 |
05/26/2016 |
MC BIO Supertack Tack 3mm, 4mm and 5mm |
ELI-KA TECHNOLOGIES |
LUIGI GIROTTO |
| K160342 |
05/19/2016 |
EMPOWR PS Knee System |
Encore Medical, L.P. |
Teffany Hutto |
| K161167 |
05/26/2016 |
Seal Single-Use Biopsy Valve |
ENDOCHOICE, INC. |
Daniel Hoefer |
| K160403 |
05/19/2016 |
SmartStart Air/Water and Suction Valves |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K160960 |
05/01/2016 |
EsophyX« Z Device with SerosaFuse Fasteners and Accessories |
ENDOGASTRIC SOLUTIONS, INC. |
STEVEN J HOFFMAN |
| K150364 |
05/05/2016 |
ERBE ESU Model VIO dV with Accessories |
ERBE ELEKTROMEDIZIN GMBH |
Axel Retzlaff |
| K153277 |
05/04/2016 |
6200 Ultrasound System and 6250 Ultrasound System |
Esaote S.p.A. |
Donatella Ragghianti |
| K160324 |
05/05/2016 |
Cervical Interbody Fusion System |
EVOLUTION SPINE, LLC |
ASHTON KOUZBARI |
| K161246 |
05/31/2016 |
Ez3D-i / E3 |
EWOO SOFT CO., LTD. |
Young Seok Kim |
| K161117 |
05/13/2016 |
EzDent-i / E2 / Prora View |
EWOO SOFT CO., LTD. |
YOUNG SEOK KIM |
| K153585 |
05/05/2016 |
Flip Button Suture Anchor |
FIRST RAY LLC |
Robert Hoy |
| K161119 |
05/13/2016 |
SonoSite iViz Ultrasound System |
FUJIFILM SONOSITE,INC. |
Patricia Liau |
| K160090 |
05/16/2016 |
Lumipulse G ROMA |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K153127 |
05/20/2016 |
everX Posterior |
GC AMERICA INC. |
MARK HEISS |
| K161047 |
05/05/2016 |
LOGIQ P9 and LOGIQ P7 |
GE Healthcare |
Bryan Behn |
| K160065 |
05/20/2016 |
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System |
GEMSS MEDICAL SYSTEMS CO., LTD |
Sang Woo Lee |
| K152612 |
05/26/2016 |
eSensor Warfarin Sensitivity Saliva Test |
GENMARK DIAGNOSTICS, INCORPORATED |
ALAN MADERAZO |
| K153670 |
05/12/2016 |
Genteel Lancing Device |
Genteel, LLC |
Christopher Jacobs |
| K153716 |
05/17/2016 |
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. |
GPC MEDICAL LTD |
VIKAS NARANG |
| K160197 |
05/24/2016 |
Haemonetics Cell Saver Elite Autotransfusion System |
Haemonetics Corporation |
Mark Anzalone |
| K152029 |
05/03/2016 |
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 |
HAMILTON MEDICAL AG |
STEFFEN BODEN |
| K153597 |
05/23/2016 |
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
Jianqiu Fang |
| K152205 |
05/06/2016 |
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor |
Heidelberg Engineering GmbH |
Gerhard Zinser |
| K153582 |
05/25/2016 |
Prometheus ChitoGauze XR PRO |
HEMCON MEDICAL TECHNOLOGIES, INC. |
Maire Ni Beilliu |
| K160152 |
05/20/2016 |
Trillium Oval V 5.1 MRI System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Douglas Thistlethwaite |
| K153615 |
05/06/2016 |
NeoFuse HA Enhanced PLIF/TLIF |
HT MEDICAL, LLC |
ROBERT COMPTON |
| K151362 |
05/05/2016 |
HC Spinal System |
HUNG CHUN BIO-S CO., LTD. |
HSIN TAI HU |
| K152006 |
05/05/2016 |
Cogent Hemodynamic Monitoring System |
ICU MEDICAL INC. |
Natalie Hepworth |
| K152818 |
05/26/2016 |
Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves |
Ideal Plastic Co., Ltd. |
Lily Li |
| K161082 |
05/17/2016 |
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK HENDERSON |
| K160226 |
05/18/2016 |
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector |
Implanet, S.A. |
Regis Le Couedic |
| K153650 |
05/20/2016 |
Microdent Ektos Implant System |
IMPLANTS MICRODENT SYSTEM S.L |
JORDI CLAPES DONADEU |
| K153350 |
05/09/2016 |
IBS Implant System |
INNOBIOSURG CO., LTD |
Bo-reum Yoo |
| K160242 |
05/10/2016 |
Reprocessed Livewire Steerable Diagnostic EP Catheter |
INNOVATIVE HEALTH, LLC |
RAFAL CHUDZIK |
| K160303 |
05/10/2016 |
Reprocessed Polaris X Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Rafal Chudzik |
| K160773 |
05/04/2016 |
Yarlap II |
INTERNATIONAL TRADE GROUP, INC. |
BRENT C. REIDER |
| K160006 |
05/04/2016 |
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit |
Irvine Scientific |
Jayme Yamaguchi-Owens |
| K152103 |
05/20/2016 |
IPS Style Ceram, IPS Style Ceram One, IPS Style Press |
Ivoclar Vivadent AG |
Sandra Cakebread |
| K151781 |
05/27/2016 |
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor |
IVY BIOMEDICAL SYSTEMS INC. |
DICK LISTRO |
| K152336 |
05/02/2016 |
HEX tanning booth |
J & B PRODUCTS LTD DBA HEX TANNING |
LINDA BOMMARITO |
| K153520 |
05/05/2016 |
Electronic Pulse Stimulator |
JKH HEALTH CO.,LTD. |
Pu Jiang |
| K152583 |
05/31/2016 |
KARL STORZ Endoscopic ICG Imaging System |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
Mike Samuels |
| K160357 |
05/02/2016 |
TRINITY |
KOELIS |
LAETITIA GERVAIS |
| K153762 |
05/25/2016 |
Smartdop XT6 |
KOVEN TECHNOLOGY, INC. |
Heather Bell |
| K160380 |
05/13/2016 |
LT-300 HD |
Lutech Industries, Inc. |
Ronald Vachula |
| K160623 |
05/31/2016 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
Umesh Sharma |
| K160416 |
05/20/2016 |
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
VERONIQUE DENTAN |
| K151390 |
05/02/2016 |
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
MAXTER GLOVE MANUFACTURING SDN BHD |
YAP PEAK GEEH |
| K153743 |
05/25/2016 |
PIEZOSURGERY PLUS |
MECTRON SPA |
ZUNINO FRANCO |
| K160289 |
05/20/2016 |
MasterLoc Stem |
MEDACTA INTERNATIONAL |
MICHAEL G. LOITERMAN |
| K153663 |
05/18/2016 |
Vario 8/18/ci |
MEDELA AG |
MARKUS BUTLER |
| K153264 |
05/19/2016 |
EasyPass Guidewire |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K153331 |
05/17/2016 |
SafeCT-29 |
MEDIC VISION IMAGING SOLUTIONS |
EYAL AHARON |
| K160503 |
05/04/2016 |
Vented Vial Adapter Transfer Device - 13mm |
MEDIMOP MEDICAL PROJECTS LTD. |
Ilanit Goldgraber |
| K153026 |
05/25/2016 |
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement |
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
AMANDA STAHLE |
| K152452 |
05/19/2016 |
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 |
MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING |
GARY RICHARDSON |
| K160713 |
05/26/2016 |
Stealth-Midas System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
DEEP PAL |
| K153139 |
05/06/2016 |
Achieve ST Mapping Catheter, Catheter Connecting Cable |
MEDTRONIC, INC. |
Heath Taylor |
| K160809 |
05/26/2016 |
Reveal LINQ |
MEDTRONIC, INC. |
Dianna L Johannson |
| K160091 |
05/20/2016 |
Temperature Probe, Affinity Temperature Probe |
Medtronic, Inc. |
Choua Thao |
| K161176 |
05/23/2016 |
ARTOURA Breast Tissue Expanders with Smooth Surface |
MENTOR WORLDWIDE LLC |
LAURA C. VELLUCCI |
| K150979 |
05/31/2016 |
CT/MR Compatible M.A.C. Interstitial GYN Template |
Mick Radio-Nuclear Instruments, Inc. |
Chuck Smith |
| K152745 |
05/12/2016 |
ReNew Sterilization Trays(Catalog #3708 and #3709) |
MICROLINE SURGICAL, INC. |
ANU GAUR |
| K152749 |
05/12/2016 |
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager |
Moor Instruments Ltd |
Stewart Lillington |
| K160305 |
05/27/2016 |
neoBLUE« LED Phototherapy System |
Natus Medical Incorporated |
Judy Buckham |
| K161228 |
05/26/2016 |
Radiance Ultra Series ZeroWire Embedded |
NDS SURGICAL IMAGING, LLC. |
Jim Leng |
| K161057 |
05/13/2016 |
Diagnostic Imaging Color LCD Monitor |
NEC DISPLAY SOLUTIONS LTD. |
SATORU KOTANI |
| K160936 |
05/04/2016 |
Certus 140 2.45GHz Ablation System |
NEUWAVE MEDICAL, INC |
DAN KOSEDNAR |
| K152603 |
05/02/2016 |
Green Laser Photocoagulator GYC-500 |
NIDEK CO., LTD. |
YONEJI MIZUNO |
| K152340 |
05/31/2016 |
NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six |
North American Rescue, LLC |
William Slevin |
| K150956 |
05/23/2016 |
PINPOINT Endoscopic Fluorescence Imaging System |
NOVADAQ TECHNOLOGIES, INC. |
TIM VERSPAGEN |
| K153162 |
05/24/2016 |
Hypocore |
NOVOCOR MEDICAL SYSTEMS, INC |
TAMMY CARREA |
| K160501 |
05/26/2016 |
Noxilizer Surgical Ruler |
Noxilizer,Inc. |
Mary Dadone |
| K160889 |
05/20/2016 |
BIB Stent Placement Catheter |
NUMED, INC. |
NICHELLE LAFLESH |
| K160639 |
05/04/2016 |
Electrosurgical Generator ESG-200 |
OLYMPUS WINTER & IBE GMBH |
Katharina Campbell |
| K160053 |
05/06/2016 |
Monopolar single-use HF cable |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K153620 |
05/05/2016 |
Enovare Ultrasound System |
OREON TECHNOLOGIES INC. |
Howard Fidel |
| K161080 |
05/17/2016 |
Escalade Legend Acetabular Shell |
ORTHO DEVELOPMENT CORPORATION |
Drew Weaver |
| K161140 |
05/20/2016 |
VITROS Chemistry Products Calibrator Kit 3 |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
MARLENE HANNA |
| K161041 |
05/19/2016 |
OsteoMed ExtremiLOCK Wrist Plating System |
OSTEOMED |
KATHRYN JAYNE |
| K150044 |
05/27/2016 |
O-PEP |
PARI RESPIRATORY EQUIPMENT, INC. |
Michael Judge |
| K160533 |
05/24/2016 |
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) |
PENUMBRA, INC. |
RICHARD KIMURA |
| K160449 |
05/25/2016 |
Penumbra System, Penumbra Pump MAX |
PENUMBRA, INC. |
RICHARD KIMURA |
| K152930 |
05/05/2016 |
PeriFlux6000 |
PERIMED AB |
MARIA PRANS LILJEVRET |
| K160240 |
05/13/2016 |
Perimeter OtisÖ 1.0 Optical Coherence Tomography System |
PERIMETER MEDICAL IMAGING, INC. |
ELIZABETH MUNRO |
| K160951 |
05/05/2016 |
Philips Efficia CMS200 Central Monitoring System |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K153736 |
05/27/2016 |
3mensio Workstation |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K160506 |
05/20/2016 |
Planmeca ProMax 3D Max, Planmeca Maximity |
PLANMECA OY |
LARS MORING |
| K160568 |
05/04/2016 |
Precision Spine Interspinous Plate System |
Precision Spine, Inc. |
Michael C. Dawson |
| K153099 |
05/23/2016 |
INCLUSIVE TAPERED IMPLANT SYSTEM |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K152466 |
05/19/2016 |
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) |
PROSURG, INC |
Ashvin Desai |
| K152353 |
05/13/2016 |
SeraQuest HSV Type 2 Specific IgG |
Quest International, Inc. |
David J Kiefer |
| K151492 |
05/20/2016 |
Kudu |
R82 A/S |
Kent Rasmussen |
| K160463 |
05/20/2016 |
Reliance Lumbar IBF System |
Reliance Medical Systems, LLC |
Bret M Berry |
| K153673 |
05/02/2016 |
AirFit N20 |
ResMed Ltd |
Kim Kuan Lee |
| K153563 |
05/13/2016 |
AirFit F20 |
RESMED LTD. |
Johanna Wright |
| K152068 |
05/13/2016 |
Astral 100/150 |
RESMED LTD. |
Peter Jennings |
| K160877 |
05/20/2016 |
United Urologics Closed System Catheter |
ROBLING MEDICAL, INC. |
Diane Peper |
| K160570 |
05/25/2016 |
Creatine Kinase |
Roche Diagnostics Operations (RDO) |
Noel B. Mencias |
| K153683 |
05/16/2016 |
Trak Male Fertility Testing System |
SANDSTONE DIAGNOSTICS, INC. |
Greg Sommer |
| K152043 |
05/06/2016 |
Diagnostic Station DS20 |
SCHILLER AG |
ZHENRONG YU |
| K160902 |
05/26/2016 |
Mariner Pedicle Screw System |
SEASPINE ORTHOPEDICS CORPORATION |
GINA FLORES |
| K153149 |
05/27/2016 |
Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
Ren Yunhua |
| K152429 |
05/11/2016 |
Slit Lamp Microscope |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. |
WEIDA ZHAN |
| K152544 |
05/23/2016 |
Agem Ag Mesh Dressing with Silver |
SHENZHEN YUANXING NANO-PHARMA CO., LTD |
LIU LONGQING |
| K160647 |
05/31/2016 |
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K153553 |
05/17/2016 |
SiO2 Coated syringe 3 ml |
SiO2 Medical Products |
Sandra L True |
| K152657 |
05/17/2016 |
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens |
SMART PERFORMER CORP. LTD. |
Jeffersion Shen |
| K153239 |
05/12/2016 |
LSFG-NAVI |
Softcare Co., Ltd |
Noriyoshi Takahashi |
| K160980 |
05/26/2016 |
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System |
SPINEOLOGY INC |
JACQUELINE A HAUGE |
| K153783 |
05/04/2016 |
SpaceVision« PLIF, SpaceVision« OLIF, SpaceVision« TLIF |
SpineVision S.A. |
Helene PLAS |
| K161102 |
05/19/2016 |
Nanostim Introducer Kit |
ST JUDE MEDICAL, INC. |
Hassan Labay |
| K153358 |
05/02/2016 |
Standard Clamp |
STANDARD BARIATRICS |
ALISON SATHE |
| K152630 |
05/12/2016 |
VERIFY STEAM Integrating Indicator |
STERIS CORPORATION |
BILL BRODBECK |
| K160050 |
05/03/2016 |
SERFAS 90-S Electrosurgical Probe |
STRYKER CORPORATION |
SOMI EKWEALOR |
| K160332 |
05/18/2016 |
Stryker SDC3 HD Information Management System with Wireless Device Control Capability |
Stryker Endoscopy |
Angela Wong |
| K153379 |
05/26/2016 |
AxSOS 3Ti |
Stryker GmbH |
Saad Attiyah |
| K153658 |
05/19/2016 |
Target Detachable Coils |
Stryker Neurovascular |
Kate Taylor |
| K153345 |
05/25/2016 |
Stryker Orthopaedics Hip Systems Labeling Update |
STRYKER ORTHOPAEDICS |
MARGARET KLIPPEL |
| K160057 |
05/13/2016 |
ArcCHECK-MR |
Sun Nuclear Corporation |
James Luker |
| K152423 |
05/20/2016 |
Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy |
Sunfire Industries Inc. |
Doug Tyler |
| K160740 |
05/06/2016 |
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K153745 |
05/02/2016 |
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN |
BRANDI J. PANTELEON |
| K152415 |
05/06/2016 |
Digital Blood Pressure Monitor |
SUZHOU SUNSPIRIT CO., LTD. |
Jing Zhang |
| K152956 |
05/06/2016 |
Pulp Canal Sealer, Pulp Canal Sealer EWT |
SYBRON DENTAL SPECIALTIES |
COURTNEY CLARK |
| K152680 |
05/06/2016 |
TD-1035 Thermometer |
TAIDOC TECHNOLOGY CORPORATION |
C.W CHEN |
| K152535 |
05/26/2016 |
Z5 Slit lamp microscope, Z2 Slit lamp microscope |
TAKAGI SEIKO CO., LTD. |
Nagaike Yoshio |
| K153703 |
05/12/2016 |
Guiding Catheter |
Texas Medical Technologies, Inc. |
Aaron Chiu |
| K161046 |
05/12/2016 |
Laser Helmet LH40-EVO |
Theradome, Inc |
Tamim Hamid |
| K160052 |
05/20/2016 |
CUR Model 1 |
Thimble Bioelectronics, Inc. |
Shaun Rahimi |
| K160280 |
05/16/2016 |
MagPro R20 |
TONICA ELEKTRONIK A/S |
Lise Terkelsen |
| K152559 |
05/20/2016 |
TruAbutment DS |
TRUABUTMENT |
BRANDON KIM |
| K152908 |
05/03/2016 |
UCP COMPACT DRUG TESTS |
UCP BIOSCIENCES, INC |
NANCY CHEN |
| K152789 |
05/25/2016 |
FLEX SCORING CATHETER |
VENTUREMED GROUP |
TIFFINI DIAGE |
| K160344 |
05/26/2016 |
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 |
Visco Vision Inc |
Evan Huang |
| K153477 |
05/25/2016 |
EMMa Electronic Monitoring Management |
VITASYSTEMS GMBH |
Michael Rothhaar |
| K160810 |
05/20/2016 |
ViZion DR + Wireless |
Viztek LLC |
Bruce Ashby |
| K160254 |
05/12/2016 |
GORE DrySeal Flex Introducer Sheath |
W.L. GORE & ASSOCIATES, INC. |
Mary Townsend |
| K152431 |
05/09/2016 |
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating |
WALDEMAR LINK GMBH & CO. KG |
HELMUT D. LINK |
| K152443 |
05/11/2016 |
Vericore Gradient Temporary Disc |
WHIP MIX CORPORATION |
JOHN WATERS |
| K160354 |
05/02/2016 |
MX50T(MX50TQS) |
WIDE CORPORATION |
YeoJin Yun |
| K152717 |
05/06/2016 |
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
Gordana Pozvek |
| K152682 |
05/05/2016 |
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit |
WILLIAN A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K161203 |
05/04/2016 |
Soehendra Stent Retriever |
WILSON-COOK MEDICAL, INC. |
DORIS A. HAWKS |
| K152167 |
05/27/2016 |
BIJOU Orthodontic Ceramic Bracket |
WORLD BIO TECH CO., LTD |
JIN-KYU PARK |
| K152062 |
05/17/2016 |
BIOFOAM Bone Wedge |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K153008 |
05/06/2016 |
INVISION Total Ankle Revision System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K160428 |
05/05/2016 |
Certex Spinal Fixation System |
X-spine Systems, Inc. |
David Kirschman |
| K160986 |
05/04/2016 |
Xenco Medical Pedicle Screw System |
XENCO MEDICAL, LLC |
GUSTAVO PRADO |
| K153334 |
05/20/2016 |
Oral-B 5% Sodium Fluoride Varnish |
YOUNG DENTAL MANUFACTURING CO 1, LLC. |
Sarah Moore |
