FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K141435 |
08/27/2014 |
OPAL CHIRO, 20/20 P-DR |
2020 IMAGING |
DANIEL KAMM, P.E. |
K133769 |
08/25/2014 |
3B RESMART BPAP 25A, BMC RESMART BPAP 25A |
3B MEDICAL, INC |
ALEX LUCIO |
K140392 |
08/13/2014 |
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER |
3M COMPANY |
SUZANNE LEUNG |
K140330 |
08/18/2014 |
3M STERI-DRAPE FABRIC SURGICAL DRAPES |
3M HEALTH CARE |
MARK BURVILLE |
K141823 |
08/07/2014 |
AAP LOQTEC CLAVICLE PLATES 2.7/3.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
K141782 |
08/07/2014 |
HI-TORQUE VERSATURN GUIDE WIRE |
Abbott Vascular |
VIVEK THAKKAR |
K141215 |
08/21/2014 |
SURGISEAL TWIST TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
RICHARD JONES |
K141065 |
08/22/2014 |
CONSTELLATION VISION SYSTEM |
ALCON RESEARCH, LTD. |
ROBERT LUNDBERG |
K140933 |
08/15/2014 |
ALIVECOR HEART MONITOR |
ALIVECOR, INC. |
Albert Boniske |
K140009 |
08/29/2014 |
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM |
ALMA LASERS LTD. |
KATHY MAYNOR |
K133991 |
08/06/2014 |
ISY |
ALTATEC GMBH |
LINDA SCHULZ |
K133685 |
08/13/2014 |
0.9% SODIUM CHLORIDE FLUSH SYRINGE |
AMUSA |
ALEX FERRI |
K141567 |
08/21/2014 |
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM |
APIRA SCIENCE, INC. |
RAYMOND R BLANCHE |
K141288 |
08/22/2014 |
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE |
APPLIED MEDICAL RESOURCES |
JESSICA CHO |
K141573 |
08/28/2014 |
SILVERLON ISLAND WOUND DRESSING |
ARGENTUM MEDICAL |
RICH FOSTER |
K140723 |
08/19/2014 |
NOMAD MD 75K V HANDHELD X-RAY SYSTEM |
ARIBEX, INC. |
CHRISTOPHER DODGE |
K141735 |
08/15/2014 |
ARTHREX ANKLE FUSION PLATING SYSTEM |
ARTHREX, INC. |
LAURA MEDLIN |
K140476 |
08/13/2014 |
ARTHREX FIBERTAK SUTURE ANCHOR |
ARTHREX, INC. |
COURTNEY SMITH |
K140944 |
08/22/2014 |
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP |
ATHEROMED INC |
JEAN CHANG |
K142120 |
08/28/2014 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
ATRICURE, INC. |
JONATHAN MCELWEE |
K133981 |
08/15/2014 |
AVACEN 100 |
AVACEN INC. |
THOMAS G MUEHLABUER |
K142036 |
08/25/2014 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS |
B. BRAUN MEDICAL, INC. |
TRACY MADDOCK |
K131407 |
08/12/2014 |
BAHADIR STERILIZATION TRAYS |
BAHADIR USA CORP. |
ISMAIL KILIC |
K142011 |
08/18/2014 |
SOLUTION SET/EXTENSION SET |
BAXTER HEALTHCARE CORPORATION |
TIFFANY LIN |
K141128 |
08/13/2014 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
K141141 |
08/14/2014 |
KIVA VCF TREATMENT SYSTEM |
BENVENUE MEDICAL, INC. |
CINDY DOMECUS, R.A.C. |
K141581 |
08/06/2014 |
ASTROGLIDE NATURAL |
BIOFILM, INC. |
Sherry Castello |
K142097 |
08/29/2014 |
SELEC-3 I.V.ADMINISTRATION SET |
BIOMEDIX, INC. |
MYRA J BENDER |
K133817 |
08/05/2014 |
VITEK 2 AST - YEAST FLUCONAZOLE |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
K133952 |
08/19/2014 |
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE |
BIOMERIEUX, INC. |
CHARLENE FERRAND |
K141653 |
08/18/2014 |
BIOLOX DELTA CERAMIC OPTION HEADS |
BIOMET, INC. |
BECKY EARL |
K141762 |
08/27/2014 |
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
K140210 |
08/22/2014 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 |
BIONIME CORPORATION |
Feng-Yu Lee |
K134037 |
08/07/2014 |
PREMVIA |
BIOTIME, INC. |
DAVID C FURR |
K132892 |
08/01/2014 |
TEBCO-W |
BOMED INC |
B. BO SRAMEK, PH.D |
K141597 |
08/22/2014 |
MUSTANG BALLOON DIALATION CATHETER |
Boston Scientific Corporation |
MELANIE RASKA |
K141521 |
08/21/2014 |
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
MELANIE RASKA |
K141236 |
08/07/2014 |
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) |
Boston Scientific Corporation |
ADRIENNE HOTCHKISS |
K140999 |
08/06/2014 |
TANDEMHEART VENO-VENOUS CANNULA |
CARDIACASSIST INC. |
Greg Johnson |
K140850 |
08/27/2014 |
GENESIS REUSABLE RIGID CONTAINER SYSTEM |
CAREFUSION 2200, INC. |
JANE WEBER |
K133532 |
08/21/2014 |
ALARIS SYSTEM WITH GUARDRAILS SUITE MX |
CAREFUSION 303, INC. |
CHRISTINE CATON |
K133925 |
08/22/2014 |
VYNTUS/ SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
K140782 |
08/13/2014 |
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR |
CELLERATION, INC. |
KATHY SIMPSON |
K141209 |
08/07/2014 |
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES |
CELONOVA BIOSCIENCES, INC. |
NICOLE BARBER |
K141859 |
08/01/2014 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
Yon Yu, Pharm.D. |
K132049 |
08/15/2014 |
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS |
CHOICE SPINE |
KIM FINCH |
K141318 |
08/27/2014 |
CIANNA MEDICAL SGS SYSTEM |
CIANNA MEDICAL, INC. |
GARY MONCNIK |
K140703 |
08/19/2014 |
OPA 30 SOLUTION |
CIDEN TECHNOLOGIES LLC |
COURTNEY CLARK |
K141480 |
08/22/2014 |
CVI42 |
CIRCLE CARDIOVASCULAR IMAGING INC |
SHIRANTHA SAMARAPPULI |
K140490 |
08/29/2014 |
CIVA SHEET PD-103 |
CIVATECH ONCOLOGY, INC. |
BLIX WINSTON |
K141364 |
08/29/2014 |
CLIMB MAMMOGRAPHY VIEWER SOFTWARE |
CLIMB MEDICAL SYSTEMS, INC. |
KENNETH WADE |
K140748 |
08/20/2014 |
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD |
CO-INNOVATION BIOTECH CO.,LTD. |
HONG FENG |
K133703 |
08/18/2014 |
PHYSIOGLOVE ET SYSTEM |
COMMWELL R&D LTD. |
JONATHON KAHAN |
K140945 |
08/22/2014 |
COMPACTCATH INTERMITTENT URINARY CATHETER |
COMPACTCATH INC |
GREGORY MATHISON |
K140953 |
08/01/2014 |
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER |
CONVATEC LTD. |
CLARE WILLIAMSON |
K141818 |
08/05/2014 |
TURBO-JECT PICC SETS |
COOK CORPORATED |
SEAN SPENE |
K140306 |
08/15/2014 |
CORMATRIX PROTECT ECM ENVELOPE |
CORMATRIX CARDIOVASCULAR, INC. |
BRYAN BROSSEAU |
K141858 |
08/05/2014 |
CLOSURERFG RADIOFREQUENCY GENERATOR |
COVIDIEN |
Laura Moen-Ftacek |
K141153 |
08/14/2014 |
LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED |
COVIDIEN |
|
K141357 |
08/21/2014 |
BARRX FLEX RFA ENERGY GENERATOR |
COVIDIEN IIC |
Tim Thomas |
K141371 |
08/07/2014 |
SONICISION CORDLESS ULTRASONIC DISSECTOR |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
DAVID HORTON |
K140338 |
08/27/2014 |
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) |
CREGANNA-TACTX MEDICAL |
NIALL FOX |
K140620 |
08/07/2014 |
SPORVIEW PLUS BI TEST PACK |
CROSSTEX INTERNATIONAL |
MICHAEL G NOLAN |
K140585 |
08/18/2014 |
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM |
CUREXO TECHNOLOGY CORPORATION |
GLEN EMELOCK |
K133945 |
08/11/2014 |
CUTERA PICOSECOND LASER SYSTEM |
CUTERA, INC. |
BRADLEY RENTON |
K141264 |
08/21/2014 |
TENSYN BAND, TENSYN FRACTURE PLATES |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
K140175 |
08/05/2014 |
INTRAVASCULAR ADMINISTRATION SET |
DELTA MED SPA |
ROGER GRAY |
K140537 |
08/20/2014 |
TENURE4G |
DEN-MAT HOLDINGS, LLC |
HELEN RAGUS |
K133255 |
08/12/2014 |
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS |
DENTALPOINT AG |
ROSHANA AHMED |
K140347 |
08/20/2014 |
ANKYLOS C/X IMPLANT SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K140896 |
08/05/2014 |
VAPR ARCTIC SUCTION ELECTRODE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
K140880 |
08/04/2014 |
DEVILBISS SMARTLINK II SYSTEM |
DEVILBISS HEALTHCARE LLC |
BETTY MILLER |
DEN140016 |
08/19/2014 |
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE |
DEXCOM, INC. |
ANDREW BALO |
K133751 |
08/08/2014 |
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
K133803 |
08/06/2014 |
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
K140458 |
08/26/2014 |
DIOTECH LASER FIBER |
DIOTECH CO |
PETER CHUNG |
K121886 |
08/08/2014 |
SAVINA 300 SAVINA 300, COUNTRY VARIANTS |
DRAEGER MEDICAL GMBH |
BETH ZIS |
K140168 |
08/28/2014 |
EASYSTIM TN28_OTC |
EASYMED INSTRUMENTS CO., LTD. |
JEFFERY WU |
K142080 |
08/28/2014 |
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED |
ECOLAB, INC. |
JENNIFER WILLNER |
K140381 |
08/08/2014 |
SENSILIGHT/ SENSILIGHT PLUS |
EL GLOBAL TRADE LTD. |
SHLOMIT SEGMAN |
K141916 |
08/07/2014 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
K140689 |
08/22/2014 |
IKNEE DISTAL FEMORAL CUTTING GUIDE |
EVERGREEN ORTHOPEDIC RESEARCH LAB |
JEFF STEPANIAN |
K141821 |
08/28/2014 |
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET |
EXACTECH, INC. |
THOMAS MCNAMARA |
K141129 |
08/15/2014 |
EXACTECH CERVICAL SPACER SYSTEM |
EXACTECH, INC. |
MEREDITH MAY MS, RAC |
K133638 |
08/21/2014 |
GEKO |
FIRSTKIND LIMITED |
SHEILA HEMEON-HEYER |
K141281 |
08/14/2014 |
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
K140149 |
08/22/2014 |
EPX-4440HD DIGITAL VIDEO PROCESSOR |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
MARY K MOORE |
K142017 |
08/22/2014 |
X-PORTE ULTRASOUND SYSTEM |
FUJIFILM SonoSite, Inc. |
Patricia Liau |
K140028 |
08/21/2014 |
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER |
GALT MEDICAL CORP. |
DAVID DERRICK |
K141768 |
08/04/2014 |
LOGIQ V5/LOGIQ V3 |
GE HEALTHCARE |
BRYAN BEHN |
K133695 |
08/07/2014 |
TITAN 11 |
GEMSS MEDICAL SYSTEMS CO., LTD |
DAVE KIM |
K140086 |
08/22/2014 |
PERSONAL KINETIGRAPH (PKG) SYSTEM |
GKC MANUFACTURING PTY LTD. |
MARIE SCHROEDER |
K133678 |
08/26/2014 |
CONFIRM BIOACTIVE |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
K142044 |
08/25/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K133222 |
08/06/2014 |
SAAD PATIENT MONITOR (SPM) |
HANIN MEDICAL SERVICES CO. LTD |
RAYMOND J KELLY |
K141614 |
08/07/2014 |
MAGELLAN ROBOTIC SYSTEM |
Hansen Medical |
KATE W LEE |
K141822 |
08/05/2014 |
SENSEI X ROBOTIC CATHETER SYSTEM |
HANSON MEDICAL, INC. |
TODD MILHOLLAND |
K140270 |
08/20/2014 |
NEXUS MIDLINE CT CATHETER |
HEALTH LINE INTERNATIONAL CORPORATION |
JOHN E LINCOLN |
K132855 |
08/29/2014 |
HEARTWAY POWER MOBILITY SCOOTER |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
K140988 |
08/12/2014 |
POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
CHARLES SHEN |
K141021 |
08/26/2014 |
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR |
HL RUBBER INDUSTRIES SDN BHD |
NOORZALIZA AHMAD |
K140366 |
08/15/2014 |
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER |
HOGUE SURGICAL LLC |
ROGER S HOGUE, MD |
K141642 |
08/22/2014 |
VAPRO INTERMITTENT CATHETER |
HOLLISTER, INCORPORATED |
JEANNE LEE |
K133108 |
08/05/2014 |
FIT BELT |
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED |
XU JIAN HUA |
K142135 |
08/28/2014 |
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION |
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
JAN TRIANI |
K141451 |
08/26/2014 |
VixWin Platinum |
IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC) |
SANJAY AHUJA |
K131348 |
08/05/2014 |
ORTOMED |
INFOMED SERVICIOS INFORMATICOS S.L. |
SANTIAGO SOLA |
K141443 |
08/28/2014 |
INFRONT LUMBAR INTERBODY FUSION SYSTEM |
INFRONT MEDICAL, LLC |
JOHN KUCZYNSKI |
K140886 |
08/08/2014 |
WALKAIDE SYSTEM |
INNOVATIVE NEUROTRONICS INC. |
GLEN NEALLY |
K133582 |
08/15/2014 |
HEMOSIL D-DIMER HS 500 CONTROL |
INSTRUMENTATION LABORATORY |
CAROL MARBLE |
K141841 |
08/01/2014 |
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP |
INTEGRA LIFESCIENCE CORPORTATION |
NICOLE C HARLAN |
K133942 |
08/01/2014 |
ENDOSCOPE STERILIZATION TRAY |
INTUITIVE SURGICAL |
BRANDON HANSEN |
K141077 |
08/12/2014 |
DA VINCI FIREFLY IMAGING SYSTEM |
INTUITIVE SURGICAL, INC. |
MELISSA S GONZALEZ |
K141848 |
08/29/2014 |
IOGYN SYSTEM |
IOGYN, INC. |
RICH CHRISTENSEN |
K131290 |
08/06/2014 |
IQ TECHNOLOGIES |
IQ TECHNOLOGIES INC. |
ELI JOSEF |
K131285 |
08/19/2014 |
SONOSENTRY |
ISONEA LTD |
KORINA AKHONDZADEH |
K141505 |
08/26/2014 |
BASAL DIGITAL THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JM LIN |
K140308 |
08/15/2014 |
MASTERSURG / EXPERTSURG |
KALTENBACH & VOIGT GMBH |
STEFAN TRAMPLER |
K141059 |
08/01/2014 |
NATURAL RUBBER LATEX MALE CONDOMS |
KAREX INDUSTRIES SDN BHD |
MARY GOH |
K131384 |
08/07/2014 |
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE |
KERICURE INC. |
JONATHAN WARD |
K140305 |
08/26/2014 |
CAYA CONTOURED DIAPHRAGM |
KESSEL MEDINTIM GMBH |
KESSEL MARKETING |
K141294 |
08/25/2014 |
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS |
KIMBERLY-CLARK CORP. |
CHARNELLE THOMAS |
K141612 |
08/07/2014 |
KIMGUARD ONE-STEP STERILIZATION WRAP |
KIMBERLY-CLARK HEALTH CARE |
MARCIA JOHNSON |
K140516 |
08/05/2014 |
Terumo Pen Injector Needle 34 |
KOFU FACTORY OF TERUMO CORP. |
PHILLIP LESTER |
K141891 |
08/04/2014 |
MEDICAL LCD MONITOR |
KOSTEC CO., LTD |
Priscilla Chung |
DEN140001 |
08/20/2014 |
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
TANIS JIMENEZ |
K141136 |
08/19/2014 |
LEICA FL800 |
LEICA BIOSYSTEMS RICHMOND |
BARBARA-ANN CONWAY-MYERS |
K141769 |
08/18/2014 |
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER |
LIGHTLAB IMAGING, INC. |
JEFFREY ROBERTS |
K141327 |
08/06/2014 |
MINIMA S SYSTEM |
LIMACORPORATE S.P.A. |
STEPHEN PEOPLES |
K140965 |
08/20/2014 |
MULTIPIEZO PRO, MULTIPIEZO |
MECTRON SPA |
ROGER GRAY |
K141988 |
08/19/2014 |
M.U.S.T PEDICLE SCREW SYSTEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K141044 |
08/18/2014 |
M.U.S.T. EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K141553 |
08/25/2014 |
MEDELA THOPAZ+ |
MEDELA AG |
ORLANDO ANTUNES |
K140812 |
08/07/2014 |
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
ROBERT HESS |
K133724 |
08/27/2014 |
MINNCARE HD |
MEDIVATORS, INC. |
KINNARI SHAH |
K141127 |
08/21/2014 |
MEDLINE ANTI-EMBOLISM STOCKING |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K141509 |
08/22/2014 |
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS |
MEDOS SARL |
KIRSTEN LEHMULLER |
K133023 |
08/27/2014 |
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 |
MEDRAD, INC. |
ARMA RACIC |
K141951 |
08/15/2014 |
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE |
MEDTRONIC INC. |
KEVIN T LAM |
K141090 |
08/15/2014 |
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER |
MEDTRONIC INC. |
JOHN KILMARTIN |
DEN120017 |
08/22/2014 |
Medtronic DUET External Drainage and Monitoring System |
MEDTRONIC NEUROSURGERY |
DONOVAN MAY |
K141494 |
08/06/2014 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
ERIKKA EDWARDSEN |
K141870 |
08/07/2014 |
BREAST VOLUME NAVIGATOR |
METRITRACK LLC |
MIRELA WOHLFORD |
K141083 |
08/22/2014 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K140735 |
08/29/2014 |
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS |
MICROPORT ORTHOPEDICS INC. |
CAROLINE FRYAR |
K140342 |
08/29/2014 |
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT |
MINDWAYS SOFTWARE, INC. |
KEENAN BROWN |
K130631 |
08/13/2014 |
BUZZY |
MMJ LABS, LLC |
VALERIE STAFFEY |
K141230 |
08/27/2014 |
DOSELAB PRO |
MOBIUS MEDICAL SYSTEMS, LP |
STAN ESHELMAN |
K140862 |
08/27/2014 |
MONICA NOVII WIRELESS PATCH SYSTEM |
MONICA HEALTHCARE LTD. |
CARL BARRATT |
K141983 |
08/11/2014 |
NEUROBLATE SYSTEM |
MONTERIS MEDICAL CORP |
CRAIG COOMBS |
K141684 |
08/01/2014 |
JUSHA-C33C LCD MONITOR |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
LI LE |
K141679 |
08/01/2014 |
JUSHA-C61 LCD MONITOR |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
LI LE |
K141690 |
08/01/2014 |
JUSHA-M33C LCD MONITOR |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
LI LE |
K141446 |
08/22/2014 |
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, |
NATUS MEDICAL INCORPORATED |
JUDY BUCKHAM |
K133592 |
08/22/2014 |
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM |
NEODENT USA, INC. |
CHRISTOPHER KLACZYK |
K141061 |
08/01/2014 |
REMOTEYE VIEWER |
NEOLOGICA S.R.L. |
MARCO SAMBIN |
K141291 |
08/26/2014 |
VERTIFORM POSTERIOR FIXATION SYSTEM |
NEXT ORTHOSURGICAL |
HUAN TRAN |
K133358 |
08/12/2014 |
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT |
NIDEK CO., LTD |
ENRICO BISSON |
K140100 |
08/01/2014 |
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
NIPRO DIAGNOSTICS, INC. |
BETH FOSTER |
K133506 |
08/06/2014 |
NORAS OR HEAD HOLDER FLEXIBILITY |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
K140956 |
08/07/2014 |
LCD MONITOR |
NORDICNEUROLAB |
CHANDANA G BHANDARI |
K140946 |
08/22/2014 |
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE |
NovaBone Products, LLC |
Lisa Simpson |
K141308 |
08/20/2014 |
NUTRA LIGHT RED |
NUTRA LUXE MD, LLC |
JILL CREASY |
K140563 |
08/07/2014 |
LATERAL VBR SYSTEM |
NUVASIVE, INCORPORATED |
JEREMY MARKOVICH |
K141352 |
08/18/2014 |
ENDOCYN ROOT CANAL IRRIGATION SOLUTION |
OCULUS INNOVATIVE SCIENCES |
BRIAN W MARTIN |
K141012 |
08/08/2014 |
HYDROCLEANSE WOUND CARE SOLUTION |
OCULUS INNOVATIVE SCIENCES |
BRIAN W MARTIN |
K141440 |
08/29/2014 |
DICOMPACS DX-R WITH FLAT PANEL |
OEHM UND REHBEIN GMBH |
DANIEL KAMM, P.E. |
K133562 |
08/12/2014 |
CATARHEX 3 |
OERTLI INSTRUMENTE AG |
KARIN ROHR |
K132633 |
08/14/2014 |
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM |
OK BIOTECH CO., LTD. |
JEN KE-MIN |
K133538 |
08/07/2014 |
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE |
OLYMPUS CORPORATION OF THE AMERICAS |
SHERI L MUSGNUNG |
K141225 |
08/12/2014 |
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD |
OLYMPUS WINTER & IBE GMBH |
GRAHAM A L BAILLIE |
K141787 |
08/07/2014 |
SAGITTILT |
ORFIT INDUSTRIES NV |
Lee Leichter |
K123690 |
08/05/2014 |
CAPNOSTREAM20P WITH HIFI C02 MONITORING |
ORIDION MEDICAL 1987 LTD. |
DALIA GIVONY |
K141004 |
08/21/2014 |
INTRAOSSEOUS FIXATION SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
K142148 |
08/21/2014 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
K140550 |
08/25/2014 |
ORTHOHUB EXTERNAL FIXATOR SOFTWARE |
ORTHOHUB, INC. |
PEGGY MCLAUGHLIN |
K141930 |
08/21/2014 |
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML |
OSSEON LLC |
KEITH BURGER |
K140507 |
08/20/2014 |
HIOSSEN PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO., LTD. |
PATRICK LIM |
K140600 |
08/21/2014 |
SB ANCHOR |
OSSTEM IMPLANT CO., LTD. |
PATRICK LIM |
K141497 |
08/26/2014 |
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
K140551 |
08/01/2014 |
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR |
PERKINELMER, INC. |
DAWN SPOONER |
K132631 |
08/29/2014 |
EIA SMDP IMMUNOASSAY |
PHADIA US INC. |
MARTIN ROBERT MANN |
K141979 |
08/19/2014 |
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES |
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. |
JEANETTE BECKER |
K131230 |
08/04/2014 |
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION |
PHILOSYS, INC. |
LINDA CHAN |
K141423 |
08/07/2014 |
NASOPORE-FD |
Polyganics BV |
BETTY IJMKER |
K133921 |
08/22/2014 |
PRECEPTIS TYMPANOSTOMY TUBE INSERTER |
PRECEPTIS MEDICAL |
KEITH LELAND |
K141788 |
08/20/2014 |
OBSIDIAN MILLING BLOCKS |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K132380 |
08/27/2014 |
PREVANTICS DEVICE SWAB |
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. |
ELIZABETH ERNST |
K141956 |
08/13/2014 |
FIBERGRAFT BG MORSELS |
PROSIDYAN, INC |
JANICE M HOGAN |
K133546 |
08/06/2014 |
STARLITE-OM, LIGHT EFFECTS, THIBIANT |
PS ADVANCED ENGINEERING |
CD FEAK |
K141834 |
08/05/2014 |
SAPPHIRE ADMINISTRATION SET |
Q CORE MEDICAL LTD |
Rhona Shanker |
K142002 |
08/22/2014 |
BREAST SPEEDER CX, GRID HOLDER CX |
QUALITY ELECTRODYNAMICS, LLC. |
Kathleen Aras |
K141101 |
08/08/2014 |
LITHO |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
K141403 |
08/07/2014 |
LITHO DK30 |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
K141496 |
08/04/2014 |
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER |
REFLECTANCE MEDICAL, INC. |
Nandini Murthy |
K133973 |
08/14/2014 |
TEMPUS PRO WITH ENHANCED FEATURES |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD |
LEIGH CORNOCK |
K134014 |
08/12/2014 |
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
LEIGH CORNOCK |
K141813 |
08/05/2014 |
RHYTHMSTAR SYSTEM |
RHYTHMEDIX, LLC |
M.W.(ANDY) ANDERSON |
K141162 |
08/27/2014 |
ALL-CERAMIC ZIRCONIA BLOCK |
RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
HELEN NAN |
K133741 |
08/29/2014 |
ACCU-CHEK Performa Blood Glucose Monitoring System |
Roche Diagnostics |
NATHAN CARRINGTON |
K142021 |
08/12/2014 |
Elecsys Estradiol III CalSet |
Roche Diagnostics |
KELLI TURNER |
K133325 |
08/08/2014 |
BLUE NITRILE POWDER FREE EXAM GLOVES |
SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD. |
RAY ZHOU |
K140681 |
08/21/2014 |
BELTER INFRA-RED EAR THERMOMETER |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
PANG MING |
K140582 |
08/28/2014 |
FINGERTIP PULSE OXIMETER |
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
FIELD FU |
K132662 |
08/01/2014 |
PASSPORT SERIES PATIENT MONITORS |
SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD |
YANHONG BAI |
K141307 |
08/27/2014 |
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG AOK PLASTIC CO., LTD. |
CHU XIAOAN |
K141305 |
08/27/2014 |
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. |
CHU XIAOAN |
K141772 |
08/19/2014 |
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Asha Gartland |
K141846 |
08/07/2014 |
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
K142006 |
08/21/2014 |
SYMBIA 6.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CYNTHIA BUSCH |
K140232 |
08/14/2014 |
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
K140892 |
08/28/2014 |
DISTAL ELBOW PLATING SYSTEM |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
K132211 |
08/04/2014 |
SKAFFOLD NMX BONE VOID FILLER |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
K141058 |
08/01/2014 |
ENSIZOR ENDOSCOPIC SCISSORS |
SLATER ENDOSCOPY, LLC |
CRAIG PAGAN |
K141473 |
08/01/2014 |
SMC ACUPUNCTURE NEEDLE |
SMC INTL., INC. |
JONG-MAN LEE |
K141585 |
08/21/2014 |
SMITH & NEPHEW DISPOSABLE FIN PUNCH |
SMITH & NEPHEW, INC. |
JENNY WALDRIP |
K142221 |
08/29/2014 |
MEMO 3D ReChord |
SORIN GROUP ITALIA S.R.L |
MAURO ERCOLANI |
K142116 |
08/12/2014 |
LLD EZ |
SPECTRANETICS, INC. |
PHAROAH GARMA |
K141372 |
08/22/2014 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
JASON BLAIN |
K141508 |
08/21/2014 |
ROMEO 2 PAD POSTERIOR AXIAL DEVICE |
SPINEART |
FRANCK PENNESI |
K133549 |
08/27/2014 |
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
STERITEC PRODUCTS MFG., CO., INC. |
JONATHAN RUTIGLIANO |
K133322 |
08/25/2014 |
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
STERITEC PRODUCTS MFG., CO., INC. |
JONATHAN RUTIGLIANO |
K141871 |
08/07/2014 |
Straumann Bone Level NC Angled Screw Retained Abutments |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
K140878 |
08/20/2014 |
STRAUMANN BONE LEVEL TAPERED IMPLANT |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
K140737 |
08/14/2014 |
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
K133461 |
08/01/2014 |
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM |
Stryker |
JULIE SCHOELL |
K141095 |
08/26/2014 |
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS |
STRYKER CORPORATION |
JULIA HELGESON |
K141056 |
08/05/2014 |
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS |
STRYKER ORTHOPAEDICS |
KAREN ARIEMMA |
K141992 |
08/07/2014 |
VARIAX 2 SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
K133979 |
08/26/2014 |
TENS |
SUNMAS (H.K.) TRADING LIMITED |
Diana Hong |
K132943 |
08/29/2014 |
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE |
SYNAPTIC MEDICAL LIMITED |
Diana Hong |
K141394 |
08/06/2014 |
X-REPAIR |
SYNTHASOME |
ANTHONY RATCLIFFE |
K141796 |
08/29/2014 |
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
KARA ELKIN |
K141241 |
08/07/2014 |
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
SUSAN LEWANDOWSKI |
K130720 |
08/14/2014 |
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
THOMAS SHEA |
K141353 |
08/01/2014 |
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR |
TELEFLEX MEDICAL , INC. |
JAMES A COCHIE |
K140686 |
08/06/2014 |
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS |
THE BINDING SITE GROUP LTD |
SUZANNE HORNE |
K133847 |
08/01/2014 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
K133667 |
08/26/2014 |
SLIT LAMP SL-D701 |
TOPCON CORP. |
MAUREEN O'CONNELL |
K140478 |
08/06/2014 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
Tornier SAS |
MAGALIE HENNEQUIN |
K140919 |
08/15/2014 |
RESPICONNECT ADAPTER |
TRUDELL MEDICAL INT'L |
DARRYL FISCHER |
K132772 |
08/22/2014 |
LUBRIGYN CREAM |
UNIDERM FARMACEUTICI SRL |
GUIDO BONAPACE |
K141592 |
08/04/2014 |
UNIMICRO SUCTION IRRIATION TUBING SET |
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
LONG YANG |
K133712 |
08/08/2014 |
EMBRYOVIEWER SOFTWARE |
UNISENSE FERTILITECH A/S |
Henrik Wahlgren |
K141283 |
08/07/2014 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
K141336 |
08/06/2014 |
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
K132983 |
08/07/2014 |
TON-95LH, PAX-I3D ORTHO |
VATECH CO., LTD. |
DAVE KIM |
K140966 |
08/15/2014 |
VONFLEX S BITE |
VERICOM CO., LTD. |
Myung-Hwan Oh |
K133334 |
08/26/2014 |
VERITRACT ENTERAL FEEDING TUBE SYSTEM |
VERITRACT, INC. |
TIM NIEMAN |
K132326 |
08/21/2014 |
IONSIL GEL |
VIRCHOW BIOTECH PVT. LTD. |
BRUCE GIBBINS, PHD. |
K141302 |
08/01/2014 |
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) |
VITAL IMAGES, INC. |
PARTHIV SHAH |
K141610 |
08/01/2014 |
FUTURABOND M+ |
VOCO GMBH |
T. GERKENSMEIER |
K142086 |
08/28/2014 |
NIO -INTRAOSSEOUS DEVICE |
WAISMED LTD. |
JONATHAN S KAHAN |
K132518 |
08/17/2014 |
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE |
WELLQUEST INTL., INC. |
ROBERT SEIPLE, RAC |
K141438 |
08/14/2014 |
WHITNEY MEDICAL SOLUTIONS ESHIELD |
WHITNEY MEDICAL SOLUTIONS |
SAAGAR PATEL |
K141365 |
08/07/2014 |
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
KATIE-LOU BUSCHER |
K141746 |
08/04/2014 |
AS20 COMPOSITE GRAFT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
K142121 |
08/21/2014 |
VALOR HINDFOOT FUSION NAIL SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
K133168 |
08/07/2014 |
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
K140204 |
08/28/2014 |
JWX-2 |
YAMAHA MOTOR CO., LTD. |
MASANORI YONEMITSU |
K141005 |
08/07/2014 |
Z-LINK CERVICAL |
ZAVATION, LLC |
JOHN WALKER |
K141239 |
08/27/2014 |
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES |
ZIBO LITONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K142166 |
08/28/2014 |
TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES |
ZIMMER, INC. |
ANGELA ESTRADA |
K141734 |
08/13/2014 |
ZIMMER PERIARTICULAR LOCKING SYSTEM |
ZIMMER, INC. |
STEPHEN H MCKELVEY, MA,RAC |
K141517 |
08/13/2014 |
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES |
ZIMMER, INC. |
STEPHEN H MCKELVEY,MA, RAC |
K140508 |
08/14/2014 |
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS |
ZIMMER, INC. |
STEPHEN H MCKELVEY, MA, RAC |
K133706 |
08/21/2014 |
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM |
ZL MICRODENT-ATTACHMENT GMBH & CO. KG |
SYNNOVE LINDEMAN |
K133484 |
08/01/2014 |
ZOLL X SERIES |
ZOLL MEDICAL CORP. |
TANMAY SHUKLA |