FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K151933 |
07/14/2015 |
BRX PRO Bruxism Guard |
12TH MAN TECHNOLOGIES, INC. |
ALEX STENZLER |
K152060 |
07/24/2015 |
3M Attest Rapid Readout Biological Indicator 1295 |
3M COMPANY |
MATT MORTENSEN |
K152086 |
07/27/2015 |
3Shape Ortho System |
3Shape A/S |
Hanne Nielsen |
K152078 |
07/27/2015 |
Implant Studio 2015 |
3Shape Medical A/S |
Hanne Nielsen |
K151953 |
07/15/2015 |
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors |
A&D COMPANY, LTD |
JERRY WANG |
K151822 |
07/06/2015 |
ab medica irrigation/suction gravity system |
AB MEDICA S.A.S. |
ALEXANDRE BLANC |
K151783 |
07/01/2015 |
COMPACT INTUITIV Multiple-Use Pack |
Abbott Medical Optics Inc. |
Priya Viswanathan |
K152135 |
07/31/2015 |
Quantitative Electrocardiographic Detector (QED 2000) |
ACME Portable Machines, Inc. |
James Cheng |
K151886 |
07/09/2015 |
Acumed Ankle and Small Fragment Base Set Update |
Acumed, LLC |
Kara Budor |
K152040 |
07/22/2015 |
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) |
ADVANCED BRAIN MONITORING, INC. |
DANIEL J. LEVENDOWSKI |
K151971 |
07/16/2015 |
STERRAD CYCLESURE 24 Biological Indicator |
ADVANCED STERILIZATION PRODUCTS |
SUN CHOI |
K151938 |
07/14/2015 |
S4 Cervical Spinal and Occiput Systems |
AESCULAP IMPLANT SYSTEMS, LLC |
LISA BOYLE |
K151858 |
07/08/2015 |
Caiman Seal and Cut Technology |
Aesculap, Inc. |
Denise Adams |
K151865 |
07/08/2015 |
PremiPatch PTFE Pledget |
AESCULAP, INC. |
KATHY A. RACOSKY |
K151935 |
07/14/2015 |
Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only |
ALERE SAN DIEGO, INCORPORATED |
JOSEPH DE LA ROSA |
K151809 |
07/02/2015 |
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer |
Alere Technologies AS |
Kari Skinnemoen |
K152122 |
07/30/2015 |
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) |
ALFA SCIENTIFIC DESIGNS, INC. |
MICHAEL CHANG-CHIEN |
K151839 |
07/06/2015 |
AMC Health VitalCaregiving System |
AMC Health |
Jonathan Shankman |
K152058 |
07/24/2015 |
Tyvek Sterilization Pouches with Chevron Seal |
Andersen Sterilizers,Inc. |
William K Andersen |
K152003 |
07/20/2015 |
iHealth BP3L Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
Liu Yi |
K151877 |
07/09/2015 |
MicroTract Access System |
ARSTASIS, INC. |
Debra Cogan |
K152046 |
07/23/2015 |
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) |
ART OPTICAL CONTACT LENS, INC. |
MICHAEL JOHNSON |
K151897 |
07/10/2015 |
MultiFIX« P Knotless Fixation Device |
ArthroCare Corporation |
Laura Kasperowicz |
K152047 |
07/23/2015 |
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid |
ASCENSION ORTHOPEDICS |
WILLIAM GARZON |
K152025 |
07/22/2015 |
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
ASSURE TECH. CO., LTD. |
ERIC LIN |
K151998 |
07/20/2015 |
TraceIT Tissue Marker - 3mL |
AUGMENIX, INC. |
NOEL ROLON |
K152032 |
07/22/2015 |
ELUMI 810 + 980 Soft Tissue Laser |
AZENA MEDICAL, LLC |
ALEX DI SESSA |
K152050 |
07/23/2015 |
Pencylcap |
B. BRAUN MELSUNGEN AG |
HANS-ULRICH GAUDIN |
K151918 |
07/13/2015 |
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist |
BAUSCH & LOMB INCORPORATED |
Barbara Klube-Falso |
K152129 |
07/31/2015 |
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution |
BAXTER HEALTHCARE CORPORATION |
TIFFANY LIN |
K152057 |
07/24/2015 |
OsteoCool V-3 RF Ablation System |
BAYLIS MEDICAL COMPANY INC. |
MEGHAL KHAKHAR |
K151866 |
07/09/2015 |
BD BACTEC Peds Plus/F Culture Vials (plastic) |
BECTON DICKINSON AND COMPANY |
ASHANTI C. BROWN |
K151870 |
07/09/2015 |
BD U-500 INSULIN SYRINGE |
BECTON, DICKINSON AND COMPANY |
LUISA F. METRIO |
K151834 |
07/06/2015 |
BEMER Classic Set, BEMER Pro-Set |
BEMER Int. AG |
Sven Bieler |
K151903 |
07/10/2015 |
Slendertone connect Abs |
BIO-MEDICAL RESEARCH LTD. |
ANNE-MARIE KEENAN |
K151876 |
07/09/2015 |
Bio2 Fusion Implant System |
Bio2 Technologies, Inc |
Janet Krevolin |
K151955 |
07/15/2015 |
YuGo System |
BIOGAMING LTD. |
RONIT HARPAZ |
K151817 |
07/06/2015 |
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL |
BIOMERIEUX INC |
KAREN RUSSELL |
K151873 |
07/09/2015 |
Etest Ceftaroline (0.002 - 32ug/ml) |
BIOMERIEUX SA |
CLAIRE DUMAS |
K152075 |
07/27/2015 |
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) |
bioMerieux, Inc |
Cherece L Jones |
K151923 |
07/13/2015 |
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) |
BIOMERIEUX, INC. |
Cherece L Jones |
K151974 |
07/16/2015 |
Polaris Spinal System |
BIOMET SPINE |
ALEXANDRA BECK |
K151910 |
07/13/2015 |
Ultrasound Scanner System BK2300 |
BK MEDICAL APS |
Randi Hauerberg |
K152052 |
07/23/2015 |
Ultrasound Scanner System bk2300 |
BK MEDICAL APS |
Michael J. Doyle |
K151801 |
07/02/2015 |
Arc Endocuff Vision |
BODDINGTONS PLASTICS LTD |
PAUL BLACKMORE |
K151990 |
07/20/2015 |
Tissue Removal System |
BOEHRINGER LABORATORIES LLC |
CHRIS RADL |
K152125 |
07/31/2015 |
Oral Surgery System and Accessories |
BONART CO., LTD. |
BANKSON TSAI |
K152020 |
07/21/2015 |
Bindex BI-100 |
BONE INDEX FINLAND, LTD. |
JANNE KARJALAINEN |
K151895 |
07/10/2015 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
BOSTON SCIENTIFIC CORPORATION |
YINGYING GAO |
K151840 |
07/06/2015 |
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire |
Boston Scientific Corporation |
Nikki M Wahlberg |
K151802 |
07/02/2015 |
Resolution Clip |
BOSTON SCIENTIFIC CORPORATION |
ELENA NIEVES |
K151957 |
07/16/2015 |
BOX DICOM Viewer |
BOX INC. |
CRISPEN MAUNG |
K152113 |
07/29/2015 |
BioHPP - breCAM.BioHPP |
Bredent GmbH & Co.KG |
Stefanie Bochtler |
K151985 |
07/17/2015 |
PowerPICC« EtOH Catheter and PowerPICC SOLO«2 EtOH Catheter |
C.R. Bard, Inc |
Bryan Stone |
K152136 |
07/31/2015 |
Recovery Cone Removal System |
C.R. Bard, Inc. |
Joni Creal |
K151778 |
07/01/2015 |
Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating |
CARDINAL HEALTH 200, INC. |
CAROLINE MICELI |
K151788 |
07/01/2015 |
Cardinal Health Sterilization Wrap |
Cardinal Health 200, LLC |
MEGAN MIDDAUGH |
K151959 |
07/16/2015 |
AirLife Infant Single Limb Heated Wire Circuit |
CAREFUSION INC |
ERIKA FERNANDEZ |
K151774 |
07/01/2015 |
CARESTREAM Vue Motion |
CARESTREAM HEALTH, INC. |
CAROLYN L WAGNER |
K151875 |
07/09/2015 |
Pavati Zirconia |
CCRI, INC. |
ROBIN CARDEN |
K151784 |
07/01/2015 |
ActTrust |
CONDOR INSTRUMENTS LTDA. - EPP |
RODRIGO TREVISAN OKAMOTO |
K152033 |
07/22/2015 |
Cook ECM Powder |
Cook Biotech Incorporated |
Perry W Guinn |
K152044 |
07/23/2015 |
Flexor Radial Hydrophilic Introducer Access Set |
COOK INCORPORATED |
SARAH REEVES |
K151845 |
07/07/2015 |
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) |
COOPERSURGICAL, INC. |
ROAIDA JOHNSON |
K152084 |
07/27/2015 |
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug |
CORENTEC CO., LTD |
J S Daniel |
K152127 |
07/31/2015 |
CorMatrix Tyke |
CORMATRIX CARDIOVASCULAR, INC. |
ANDREW M. GREEN |
K152095 |
07/28/2015 |
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) |
COSMEDICO LIGHT, INC. |
STEVEN SCHLITT |
K152072 |
07/27/2015 |
CrossRoads Screw System |
CrossRoads Extremity Systems, LLC |
Vernon Hartgegen |
K151896 |
07/10/2015 |
Houdini Catheter |
Cruzar Medsystems, Inc. |
Tom Kramer |
K151854 |
07/07/2015 |
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display |
D-VIEW DISPLAY TECHNOLOGY CO., LTD. |
JIANFEI SUN |
K151795 |
07/02/2015 |
ML24000 UVA-1 Phototherapy Cabinet |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
K151987 |
07/17/2015 |
DCI Edge Dental Chair with Operative Unit |
DCI |
ROBERT BELLINGHAM |
K151945 |
07/14/2015 |
Triumph Resin Dam |
DENALI CORPORATION |
JAN G. STANNARD |
K151926 |
07/14/2015 |
QuickRay HD Intraoral Sensor |
DENTERPRISE INTERNATIONAL, INC. |
CLAUDE BERTHOIN |
K151885 |
07/09/2015 |
SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System |
DEPUY SYNTHES, Inc. |
Karen K Sylvia |
K151867 |
07/09/2015 |
STA R MAX |
DIAGNOSTICA STAGO S.A.S. |
ARNAUD COLLIN |
K151860 |
07/08/2015 |
Infinity CentralStation Wide |
Draeger Medical Systems, Inc. |
Thomas Ostrowski |
K151942 |
07/14/2015 |
EVS 3643 |
DRTECH Corporation |
Choul-Woo Shin |
K152110 |
07/29/2015 |
e-1 etchants |
E DENTAL PRODUCTS |
JEFF BANYAS |
K151912 |
07/13/2015 |
AIR-FLOW handy 3.0 PLUS |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
Suzanne Fassio-Hardy |
K152034 |
07/22/2015 |
FS-PACS |
EC-WEB CO., LTD. |
KE-MIN JEN |
K151978 |
07/17/2015 |
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control |
EDAN INSTRUMENTS, INC. |
TRACY YUE |
K151787 |
07/01/2015 |
Holter System |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
K151878 |
07/09/2015 |
Video Colposcope |
EDAN INSTRUMENTS, INC. |
Queena Chen |
K151883 |
07/09/2015 |
5MP Monochrome LCD Monitor, RadiForce GX540 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
K152096 |
07/28/2015 |
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive |
Ethicon, Inc. |
Donna Marshall |
K152070 |
07/27/2015 |
BioZorb LP Marker |
FOCAL THERAPEUTICS |
George Hermann |
K151893 |
07/10/2015 |
P.R.O. CG Manual Wheelchair |
FREEDOM DESIGNS, INC. |
Nancy F Schmidt |
K151944 |
07/14/2015 |
Luggie Super |
Freerider Corporation |
Arthur Wang |
K151888 |
07/10/2015 |
Frontier Medical Devices In-line Orthopedic Cable Cerclage System |
FRONTIER MEDICAL DEVICES, INC. |
BETHANY BYMAN |
K152138 |
07/31/2015 |
FDR D-EVO GL Flat Panel Detector System |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
Katherine Y Choi |
K151859 |
07/08/2015 |
Synapse Cardiovascular |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
JYH-SHYAN LIN |
K152133 |
07/31/2015 |
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System |
GALIL MEDICAL LTD |
LYNNE DAVIES |
K152099 |
07/28/2015 |
Genesys Spine Apache« Anchored Cervical Interbody Fusion System |
GENESYS SPINE |
BEN KELLER |
K152039 |
07/22/2015 |
Genesys Spine TiLock2 Spinal System |
Genesys Spine |
William W Sowers |
K151846 |
07/07/2015 |
Rainbow LS Pressing |
GENOSS |
BYUNGSUN KIM |
K151844 |
07/07/2015 |
Rainbow Shade |
GENOSS |
BYUNGSUN KIM |
K151842 |
07/07/2015 |
Rainbow Shine |
GENOSS |
BYUNGSUN KIM |
K151939 |
07/14/2015 |
COALITION Spacers |
GLOBUS MEDICAL INC. |
KELLY J. BAKER |
K152022 |
07/21/2015 |
SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers |
GLOBUS MEDICAL INC. |
KELLY J. BAKER |
K152029 |
07/22/2015 |
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 |
HAMILTON MEDICAL AG |
STEFFEN BODEN |
K152077 |
07/27/2015 |
MaxiGen |
HANS BIOMED CORP. |
LUCY CHOI |
K151997 |
07/20/2015 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) |
HARTALEGA NGC SDN BHD |
Kuan Mun Leong |
K151836 |
07/06/2015 |
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK |
HARTALEGA NGC SDN BHD |
KUAN MUN LEONG |
K152107 |
07/29/2015 |
HealthChek Network Health Station |
HEALTHCHEK NETWORK, LLC |
JAMES EVANS |
K151968 |
07/16/2015 |
Cryocare CS-3 Surgical System version 5 |
HEALTHTRONICS |
SCOTT EDEN |
K151905 |
07/13/2015 |
3400E series; E5400 series; E6400 series; Sundazzler series |
HEARTLAND TANNING, INC. |
Jon Marcum |
K152126 |
07/31/2015 |
UST-5550-R; UST-5536-R; L43K |
HITACHI ALOKA MEDICAL AMERICA, INC. |
ANGELA VAN ARSDALE |
K152087 |
07/27/2015 |
HeatLux Pro II |
HOME SKINOVATIONS LTD. |
Ahava Stein |
K151969 |
07/16/2015 |
Hospira Extension Sets |
Hospira, Inc. |
Charles Neitzel |
K151977 |
07/17/2015 |
icotec Pedicle System |
ICOTEC AG |
JORG SCHNEIDER |
K152006 |
07/21/2015 |
Cogent Hemodynamic Monitoring System |
ICU MEDICAL INC. |
Natalie Hepworth |
K151941 |
07/14/2015 |
DEXIS Webview |
Imaging Sciences International /Gendex/Dexis |
Sanjay Ahuja |
K152097 |
07/28/2015 |
Retraction Aspirator |
INARI MEDICAL |
EBEN GORDON |
K151793 |
07/01/2015 |
InMode RF System |
INMODE MD LTD. |
AHAVA STEIN |
K151785 |
07/01/2015 |
Px HA PEEK IBF System |
INNOVASIS, INC. |
MARSHALL MCCARTY |
K152013 |
07/21/2015 |
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
K151819 |
07/06/2015 |
Integrity Spine Lumbar Interbody Fusion System |
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM |
LISA PETERSON |
K152112 |
07/29/2015 |
VisualEyes |
INTERACOUSTICS A/S |
ERIK NIELSEN |
K151794 |
07/01/2015 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
K151894 |
07/10/2015 |
IPS Ivocolor |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
K152103 |
07/29/2015 |
IPS Style Ceram, IPS Style Ceram One, IPS Style Press |
Ivoclar Vivadent AG |
Sandra Cakebread |
K151781 |
07/01/2015 |
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor |
IVY BIOMEDICAL SYSTEMS INC. |
DICK LISTRO |
K152091 |
07/27/2015 |
Fingertip Pulse Oximeter |
Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd |
Li Xu |
K152089 |
07/27/2015 |
Wrist Pulse Oximeter |
Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd |
Li Xu |
K151949 |
07/15/2015 |
Disposable Insulin Syringe |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
K151991 |
07/20/2015 |
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
K152015 |
07/21/2015 |
Pyrenees Cervical Plate System |
K2M, INC. |
NANCY GIEZEN |
K152080 |
07/27/2015 |
Metacross OTW PTA Balloon Dilatation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
K151962 |
07/16/2015 |
KBL Sunlamp Products (= Device Bundling name) |
KBL AG |
NORBERT BECKER |
K152098 |
07/28/2015 |
ODALYS Pedicle Screw System |
Kisco International |
Hiroko Ito |
K151970 |
07/16/2015 |
KJ Mini Implant System |
KJ MEDITECH CO., LTD. |
GOONG-SAN NAM |
K151983 |
07/17/2015 |
KLS Martin LSS Plating System |
KLS MARTIN L.P. |
JENNIFER DAMATO |
K151824 |
07/06/2015 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested |
KOSSAN INTERNATIONAL SDN. BHD. |
CHO SOW FONG |
DEN150030 |
07/02/2015 |
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay |
KRONUS, INC. |
BRIAN DEIS |
K152137 |
07/31/2015 |
FacetBRIDGE System |
LDR SPINE USA |
James Wilson |
K151934 |
07/14/2015 |
ROI-C Titanium-Coated Implant System |
LDR SPINE USA |
JAMES WILSON |
K151835 |
07/06/2015 |
Vital Signs Patch System |
LIFEWATCH TECHNOLOGIES LTD. |
ASHER KASSEL |
K152120 |
07/30/2015 |
OPTIS Mobile System |
LIGHTLAB IMAGING, INC. |
PADMINI SURAVARAM |
K152008 |
07/21/2015 |
Physica PS Knee System |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
K151857 |
07/08/2015 |
Love Alchemy's Love Lotion |
LOVE ALCHEMY LLC |
Eric Weiss |
K151947 |
07/15/2015 |
LightSheer Desire Light Laser System |
LUMENIS LTD |
ELISSA BURG |
K151906 |
07/13/2015 |
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) |
LUMINEX CORPORATION |
RONALD DUNN |
K151917 |
07/13/2015 |
ARIES System |
LUMINEX CORPORATION |
RONALD DUNN |
K151814 |
07/06/2015 |
SERVO-U Ventilator System, SERVO-n Ventilator System |
MAQUET CRITICAL CARE AB |
MARIA VON BAHR |
K151965 |
07/16/2015 |
Dentti System |
Martz, Inc |
Andrew Martz |
K152028 |
07/22/2015 |
Volpara Imaging Software |
MATAKINA TECHNOLOGIES LIMITED |
RALPH HIGHNAM |
K152041 |
07/22/2015 |
Renaissance X System |
Mazor Robotics Ltd. |
Ayelet Matia |
K151850 |
07/07/2015 |
McKesson Cardiology |
MCKESSON ISRAEL LTD. |
GILBERT WONG |
K152121 |
07/30/2015 |
NuVent EM Sinus Dilation System |
MEDTRONIC XOMED, INC. |
Gabriela Anchondo |
K152054 |
07/23/2015 |
Confida Adaptive Sheath |
Medtronic, Inc. |
Matthew Lobeck |
K152116 |
07/30/2015 |
5.5 F Worley Advanced LVI Lateral Vein Introducer |
MERIT MEDICAL SYSTEMS, INC. |
ALINA STUBBS |
K151967 |
07/16/2015 |
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter |
Merit Medical Systems, Inc. |
Susan Christensen |
K151925 |
07/13/2015 |
Elation Wireguided Balloon Dilation Catheter |
MERIT MEDICAL SYSTEMS, INC. |
DAVID THOMAS |
K151776 |
07/01/2015 |
Central Venous Pressure System |
Mespere LifeSciences Inc. |
Helen Tan |
K152001 |
07/20/2015 |
Sterile Repositionable Hemostasis Clipping Device |
Micro-Tech (Nanjing) CO.,Ltd. |
Becky Li |
K151869 |
07/09/2015 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
GERHARD FRICK |
K151913 |
07/13/2015 |
MIM-Thin Client (mobile) |
MIM Software Inc. |
Lynn Hanigan |
K151825 |
07/06/2015 |
Viradius Neurowire |
MIVI NEUROSCIENCE, INC. |
RANDY LABOUNTY |
K152059 |
07/24/2015 |
Disposable General Electrode |
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED |
THOMAS CHAN TSZ FUNG |
K151872 |
07/09/2015 |
Avance Y-Connector S |
MOLNLYCKE HEALTH CARE, US LLC |
ANGELA BUNN |
K152051 |
07/23/2015 |
ClearMet |
Mycone Dental Supply Co., t/a Keystone Industries |
Tracey Schwear |
K151861 |
07/08/2015 |
JUSHA-C23C LCD Monitor |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
MA JING |
K151972 |
07/16/2015 |
JUSHA-C43 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Ma Jing |
K152004 |
07/20/2015 |
Nanova Universal Composite |
NANOVA BIOMATERIALS INC |
ANDREW RITTS |
K151943 |
07/14/2015 |
Vas-Q-Clip |
NANOVA BIOMATERIALS INC |
ANDREW RITTS |
K152069 |
07/27/2015 |
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter |
NAVILYST MEDICAL, INC. |
MICHAEL P. HANLEY |
K152031 |
07/22/2015 |
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with |
NEW DEANTRONICS TAIWAN, LTD. |
JANE LIU |
K151995 |
07/20/2015 |
Painmaster MCT Patch |
NEWMARK, INC. |
Francis Powell |
K151797 |
07/02/2015 |
Nuocande Plastic Manual Wheelchair Model NKD L07 |
NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. |
CHARLES SHEN |
K152093 |
07/28/2015 |
NobelZygoma 45? |
NOBEL BIOCARE AB |
JI EUN HWANG |
K151909 |
07/13/2015 |
Noris Medical Zygomatic Dental Implant System |
NORIS MEDICAL LTD. |
SIMHA SIBONY |
K151982 |
07/17/2015 |
Stat Profile Prime ABG Analyzer System |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
K152071 |
07/27/2015 |
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) |
NOVABONE PRODUCTS, LLC |
RICHARD A. DAVIS |
K152088 |
07/27/2015 |
IV-eye |
Novarix Limited |
JOHN SCOTT |
K151832 |
07/06/2015 |
NOVATECH TALCAIR |
NOVATECH S.A. |
JENNIFER NEFF |
K152055 |
07/24/2015 |
Ceramax Skin Barrier Cream |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
K152092 |
07/28/2015 |
Resection Electrodes |
Olympus Winter & Ibe GmbH |
Katharina Schnackenburg |
K151976 |
07/16/2015 |
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode |
OMNITECH SYSTEMS, INC. |
JON D. BARRETT |
K151946 |
07/14/2015 |
Thermofit |
ORFIT INDUSTRIES |
EDDY MAROVOET |
K152005 |
07/20/2015 |
MONTAGE Settable, Resorbable Hemostatic Bone Putty |
ORTHOCON, INC. |
HOWARD SCHRAYER |
K151979 |
07/17/2015 |
STARband, STARlight |
ORTHOMERICA PRODUCTS, INC. |
DAVID C. KERR |
K151951 |
07/15/2015 |
Destino Reach |
Oscor Inc. |
Jan Flegeau |
K152067 |
07/24/2015 |
Ponto bone anchored hearing system |
OTICON MEDICAL AB |
Carolina Anker Wessling |
K151852 |
07/07/2015 |
PacEndo Sodium Hyprochlorite |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
K151929 |
07/14/2015 |
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE |
PERSYST DEVELOPMENT CORPORATION |
DARI DARABBEIGI |
K151799 |
07/02/2015 |
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 |
PHADIA AB |
CARINA MAGNUSSON |
K151812 |
07/02/2015 |
PATIENT MONITORS VARIOUS MODELS |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
K151780 |
07/01/2015 |
CAAS Workstation |
PIE MEDICAL IMAGING B.V. |
FLORIE DANIELS |
K152014 |
07/21/2015 |
MTS300 Multiple Tray Sterilization System |
PMBS, LLC |
MICHELE E. MAUZERALL |
K151790 |
07/01/2015 |
PMT Platinum Depthalon Depth Electrode |
PMT CORPORATION |
KIM SCHMELZER |
K151940 |
07/14/2015 |
Thora-3Di, Model T-01 |
PneumaCare LIMITED |
MARK HARWOOD |
K151830 |
07/06/2015 |
Hummingbird Tympanostomy Tube |
PRECEPTIS MEDICAL |
Keith Leland |
K151863 |
07/08/2015 |
Precision Spine Interspinous Plate System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
K151798 |
07/02/2015 |
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K152021 |
07/21/2015 |
Pure Tilt |
Proactive Comfort, LLC |
Tracy Augustine |
K151821 |
07/06/2015 |
ER-REBOA Catheter |
Pryor Medical Devices, Inc |
Christopher Banas |
K152030 |
07/22/2015 |
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) |
Qingdao Hisense Medical Equipment Co., Ltd. |
Liu Zhitang |
K151829 |
07/06/2015 |
Atlas SPEEDER Header/Neck |
Quality Electrodynamics, LLC |
KATHLEEN ARAS |
K152012 |
07/21/2015 |
EVO platform |
Quanta System SpA |
Francesco Dell'Antonio |
K152117 |
07/30/2015 |
Dropper hsCRP High Sensitivity CRP Control |
Quantimetrix Corporation |
Kaylna Snylyk |
K151924 |
07/13/2015 |
Q-Rad Radiographic System with Auto-Tracker Option |
QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM |
MARK CAMIRAND |
K152085 |
07/27/2015 |
Liquid CO2-2 (LCO2-2) |
RANDOX LABORATORIES LTD |
PAULINE ARMSTRONG |
K151884 |
07/09/2015 |
K-Y Marilyn Pleasure Gel |
Reckitt Benckiser LLC |
ELIZABETH TORRE |
K151880 |
07/09/2015 |
Wingman Crossing Catheter |
REFLOW MEDICAL |
REBECCA K PINE |
K152131 |
07/31/2015 |
Reliance Spinal Screw System |
Reliance Medical Systems, LLC |
BRET M BERRY |
K152124 |
07/31/2015 |
Tempus IC2 |
REMOTE DIAGNOSTICS TECHNOLOGIES LTD |
CHRIS HANNAN |
K151901 |
07/10/2015 |
AirView |
RESMED LTD. |
Jasjit Baveja |
K152068 |
07/24/2015 |
Astral 100/150 |
RESMED LTD. |
Peter Jennings |
K151786 |
07/01/2015 |
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet |
Roche Diagnostics |
Kelli Turner |
K152105 |
07/29/2015 |
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set |
ROCKET MEDICAL PLC |
TRACY CHARLTON |
K151921 |
07/13/2015 |
STERISPINE PS |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
K151874 |
07/09/2015 |
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal |
Salter Labs |
Mara Caler |
K152094 |
07/28/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
K151808 |
07/02/2015 |
3D/5D Viewer |
SAMSUNG MEDISON CO., LTD |
KIM JIYOUNG |
K152043 |
07/23/2015 |
Diagnostic Station DS20 |
SCHILLER AG |
ZHENRONG YU |
DEN150033 |
07/31/2015 |
Sensor Monitored Alimentary Restriction Therapy (SMART) Device |
SCIENTIFIC INTAKE |
William Longley |
K151856 |
07/08/2015 |
ABL80 FLEX CO-OX with AQURE connectivity |
SENDX MEDICAL INC. |
Vibeke Agerlin |
K151849 |
07/07/2015 |
Seneka I Polyscrew Pedicle Fixation System |
Senecka Spine |
Khalid Sethi |
K151960 |
07/16/2015 |
Sterile High-pressure Angiographic Syringes for Single-use |
SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD |
MINGAN MU |
K151954 |
07/15/2015 |
A7 Anesthesia System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
TANG HAO |
K151810 |
07/02/2015 |
Bpump Blood Pressure Cuff |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
XIE QIONGYU |
K151996 |
07/20/2015 |
TAURUS C1 |
SHINHUNG COMPANY LTD |
SKY SHIN |
K151964 |
07/16/2015 |
Xprecia Stride Coagulation System, Xprecia System PT Controls |
SIEMENS HEALTHCARE DIAGNOSTICS |
NOOR MALKI |
K151986 |
07/17/2015 |
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
MATTHEW GEE |
K152061 |
07/24/2015 |
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
SUSAN BROCCHI |
K151792 |
07/01/2015 |
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System |
Siemens Healthcare Diagnostics,Inc. |
Philip Liu |
K152036 |
07/22/2015 |
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
K151887 |
07/10/2015 |
syngo VSim |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
K151847 |
07/07/2015 |
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens |
SMART PERFORMER CORP. LTD. |
JEFFERSION SHEN |
K151902 |
07/10/2015 |
REDAPT? Revision Femoral System |
SMITH & NEPHEW, INC. |
Natalie P. Williams |
K152000 |
07/20/2015 |
SMV Scientific Bone Plate and Screw System |
SMV Scientific |
Nephi Zufelt |
K152011 |
07/21/2015 |
Lucent Intervertebral Body Fusion Device |
Spinal Elements Inc. |
Julie Lamothe |
K151813 |
07/02/2015 |
Sniper Spine System |
SPINE WAVE, INC. |
Ronald K Smith |
K151911 |
07/13/2015 |
WorkMate Claris System, WorkMate Claris System Display Plus |
ST. JUDE MEDICAL |
MELISSA FRANK |
K152115 |
07/29/2015 |
Renew NCP-5 External Counterpulsation System |
Stage 2 Innovations |
Richard Kotz |
K152009 |
07/21/2015 |
DENSEEMAMMO v1.0 |
STATLIFE |
STEPHANE RAGUSA |
K152090 |
07/27/2015 |
Reprocessed Steerable Introducer |
STERILMED, INC. |
Patricia Kaufman |
K152134 |
07/31/2015 |
Reprocessed Vessel Sealer |
STERILMED, INC. |
PATRICIA KAUFMAN |
K151928 |
07/14/2015 |
PUR Dental Implant System |
STERNGOLD DENTAL, LLC |
MARIA RAO |
K151922 |
07/13/2015 |
StimSox(TM) System |
StimMed, LLC |
Robert E Kaplan |
K152076 |
07/27/2015 |
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority |
Stryker |
Jonathan Schell |
K151932 |
07/14/2015 |
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing |
STRYKER CORPORATION |
SOMI EKWEALOR |
K151879 |
07/09/2015 |
VariAx 2 One-Third Tubular Plating System |
STRYKER GMBH |
HEIKE GUSTKE |
K151855 |
07/08/2015 |
SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber |
SURGICAL LASER INCORPORATED |
GORDON WILLOX |
K152111 |
07/29/2015 |
Symmetry Surgical Quad-Lock Container System |
SYMMETRY SURGICAL INC. |
LORA TJOMSTOL |
K151936 |
07/14/2015 |
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle |
SYNAPTIC MEDICAL LIMITED |
Yang Tiecheng |
K152100 |
07/28/2015 |
Evogue Dental Unit |
TAKARA BELMONT CORPORATION |
Toshinori Kiyomatsu |
K152066 |
07/24/2015 |
Luminesse Anterior Zirconia AT |
TALLADIUM, INC. |
Edward Harms |
K152023 |
07/21/2015 |
Luminesse Shaded Zirconia SZ |
TALLADIUM, INC. |
Edward Harms |
K152081 |
07/27/2015 |
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier |
Teleflex Medical, Inc. |
Ashlea Ricci |
K151791 |
07/01/2015 |
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
JAIME LEE |
K151816 |
07/06/2015 |
TLC-2000 Therapeutic Medical Laser System |
Theralase Inc. |
Roger Dumoulin-White |
K151984 |
07/17/2015 |
Thommen Milling Abutment for CAD/CAM |
THOMMEN MEDICAL AG |
DANIEL SNETIVY |
K152128 |
07/31/2015 |
2-in-1 Abdominal Muscle Training & Back Pain Relief System |
Tohkai Precision Electrical Manufactory (Shenzhen) Limited |
Yuk Wing Li |
K151952 |
07/15/2015 |
Synergy ODM |
TOPCON MEDICAL SYSTEMS, INC. |
Michael Gusel |
K151833 |
07/06/2015 |
Aquilion Lightning (TSX-035A/2, V7.0) |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
K151916 |
07/13/2015 |
TRI Dental Implant System |
TRI DENTAL IMPLANTS INT. AG |
SANDRO VENANZONI |
K151837 |
07/06/2015 |
CS 3D Imaging |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
K152019 |
07/21/2015 |
HairMD |
TROPHY SKIN, INC. |
IMRAN KARIM |
K152064 |
07/24/2015 |
Astringedent Clear |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
K152035 |
07/22/2015 |
iSnare system-Lariat |
United States Endoscopy Group, Inc |
Carroll Martin |
K151889 |
07/10/2015 |
Infinity ERCP Sampling Device |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
K152018 |
07/21/2015 |
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
K151882 |
07/09/2015 |
Varian Treatment (VTx) |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
K151981 |
07/17/2015 |
Turnpike catheter |
VASCULAR SOLUTION, INC. |
BEKA VITE |
K152106 |
07/29/2015 |
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart |
VATECH CO., LTD |
DANIEL KIM |
K152082 |
07/27/2015 |
Vesocclude Polymer Ligating Clip |
Vesocclude Medical, LLC |
Freddy Cannady |
K151881 |
07/09/2015 |
X-Fix Line Additions |
VILEX IN TENNESSEE, INC |
SYLVIA SOUTHARD |
K151988 |
07/17/2015 |
Visible Patient Suite |
VISIBLE PATIENT, SAS |
AUDE PETITJEAN |
K151919 |
07/13/2015 |
Vitrea CT Lung Density Analysis Software |
VITAL IMAGES, INC. |
KATIE RYAN |
K151956 |
07/15/2015 |
Admira Fusion x-tra |
VOCO GMBH |
M TH PLAUMANN |
K151904 |
07/13/2015 |
SyncVision System |
VOLCANO CORPORATION |
ELAINE ALAN |
K151961 |
07/16/2015 |
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens |
Volk Optical Inc. |
Meghan M Leonard |
K152109 |
07/29/2015 |
HD-Camera HDC1000 |
W.O.M. WORLD OF MEDICINE GmbH |
Soeren Markworth |
K151900 |
07/10/2015 |
VariLift-L Interbody Fusion Device |
WENZEL SPINE, INC. |
BECKINAM NOWATZKE |
K151777 |
07/01/2015 |
Intradermal Adapter |
WEST PHARMACEUTICAL SERVICES INC. |
JEFFREY RAVEL |
K152118 |
07/30/2015 |
Zenostar MT, Zenostar Color Liquids |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
K152056 |
07/24/2015 |
Winco Model S550 Stretchair |
WINCO MANUFACTURING LLC |
JAMES ANKOVIAK |
K151841 |
07/06/2015 |
Ultraviolet Sunlamps |
Wolff System Technology Corp. |
Michael Stepp |
K152038 |
07/22/2015 |
MammoGRIP |
Women's Imaging Solutions Enterprises LLC |
Nancy DeRobertis |
K152062 |
07/24/2015 |
BIOFOAM Bone Wedge |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
K151838 |
07/06/2015 |
PRO-TOE Hammertoe Fixation System |
Wright Medical Technology, Inc. |
Michael Mullins |
K152045 |
07/23/2015 |
SALVATION« External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
K151890 |
07/10/2015 |
Medical Diode Laser Systems |
Wuhan Gigaa Optronics Technology Co., Ltd |
Nie Xinxing |
K152132 |
07/31/2015 |
X-spine Pedicle Screw System |
X-spine Systems, Inc. |
David Kirschman |
K151963 |
07/16/2015 |
SmartSite Vented Vial Access Device |
YUKON MEDICAL, LLC |
CARL DUPPER |
K151789 |
07/01/2015 |
LOCATOR F-Tx Attachment System |
ZEST ANCHORS, LLC |
ANNIE WRIGHT |
K151848 |
07/07/2015 |
Cable-Ready« Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System |
ZIMMER, INC. |
PATRICK MCCULLAGH |
K151907 |
07/13/2015 |
Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables |
ZIMMER, INC. |
PATRICK MCCULLAGH |
K151992 |
07/20/2015 |
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control |
ZIMMER, INC. |
PATRICK MCCULLAGH |
K151818 |
07/06/2015 |
SImmetry Sacroiliac Joint Fusion System |
Zyga Technology, Inc. |
Diane Brinza |