FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K101468 |
04/14/2011 |
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE |
3M COMPANY CORP |
LINDA JOHNSON |
K103277 |
04/19/2011 |
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER |
3M COMPANY-3M HEALTH CARE |
SUZANNE LEUNG |
K102699 |
04/01/2011 |
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS |
ABBOTT LABORATORIES |
JUDITH WALLACH |
K110909 |
04/29/2011 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. |
ABBOTT LABORATORIES |
CHERECE L JONES |
K110845 |
04/27/2011 |
IMPELLA CONTROLLER WITH FLOW CONTROL |
ABIOMED, INC. |
ROBERT STEWART |
K103595 |
04/01/2011 |
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
ACCLARENT, INC. |
GURVINDER SINGH NANDA |
K103298 |
04/08/2011 |
ACAM 5 AUDIOMETER SYSTEM |
ACOUSTICON GMBH |
Maureen Garner |
K110705 |
04/14/2011 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING INC. |
ADRIENNE LENZ |
K103362 |
04/18/2011 |
AOI CRANIAL HELMET |
ADVANCED ORTHOPRO INC. |
MOHAMAD MANSOORI |
K103218 |
04/01/2011 |
STERRAD CHEMICAL INDICATOR STRIP |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K103219 |
04/01/2011 |
STERRAD SEALSURE CHEMICAL INDICATOR TAPE |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K101348 |
04/29/2011 |
AGACHAMBER SPACER |
AGAPLASTIC IND. COM. LTDA. |
MARIA F GRIFFIN |
K102225 |
04/06/2011 |
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST |
ALCOPRO, INC. |
PERRY RUCKER |
K102557 |
04/26/2011 |
NOVAKONE SPHERICAL AND TORIC LENSES |
ALDEN OPTICAL LABS., INC. |
CHARLES H CREIGHTON |
K110767 |
04/15/2011 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
JONATHAN S KAHAN |
K102481 |
04/28/2011 |
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP |
APEX BIOTECHNOLOGY CORP. |
LISA LIU |
K110123 |
04/28/2011 |
PCL TIGHTROPE |
ARTHREX, INC. |
COURTNEY SMITH |
K101332 |
04/11/2011 |
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 |
ASEPTICO, INC. |
CHERIE A TREGONING |
K103759 |
04/08/2011 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT |
ASTRA TECH, INC. |
BETSY A BROWN |
K103042 |
04/15/2011 |
ATMOS E 201 THORAX AND ATMOS S 201 THORAX |
ATMOS INC. |
MARCO SCHLEGEL |
K102542 |
04/06/2011 |
RESUSCI FLOW; RESUSCI FLOW 104 |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
K103317 |
04/20/2011 |
RESUSCITATION UNIT 105 |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
K110117 |
04/08/2011 |
ATRICURE BIPOLAR SYSTEM |
ATRICURE, INC. |
JAMES LUCKY, RAC |
K102194 |
04/25/2011 |
SOLCART B |
B. BRAUN AVITUM AG |
ANGELA CARAVELLA |
K110744 |
04/06/2011 |
PRONTOSAN WOUND IRRIGATION SOLUTION |
B. BRAUN MEDICAL, INC. |
NANCY SKOCYPEC |
K102033 |
04/07/2011 |
COMBITRANS MONITORING SETS AND ACCESSORIES |
B. BRAUN MELSUNGEN AG |
LISA GIAQUINTO |
K102948 |
04/01/2011 |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
K103842 |
04/27/2011 |
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
K110105 |
04/28/2011 |
BD PEN NEEDLE |
BECTON DICKINSON AND COMPANY (BD) |
PASQUALE AMATO |
K110434 |
04/19/2011 |
TRIXEL CO2 LASER |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
K100724 |
04/01/2011 |
OSSEOTITE II MODEL XIFOSSXXX |
BIOMET 3I, INC. |
JOSE E CABRERA |
K103343 |
04/29/2011 |
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) |
BIONESS INC. |
ADELE SHOUSTAL |
K110461 |
04/20/2011 |
SELECTRA CS LEAD INTRODUCER SYSTEM |
BIOTRONIK, INC. |
Jon Brumbaugh |
K102034 |
04/19/2011 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
ALBERT ZICKMANN |
K110479 |
04/08/2011 |
ACUITY WHISPER VIEW GUIDE WIRES |
BOSTON SCIENTIFIC CORP. |
KIRSTIN JOHNSTON |
K110833 |
04/20/2011 |
CRE BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
JANIS TARANTO |
K110887 |
04/14/2011 |
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER |
Boston Scientific Corporation |
ASHLEY PYLE |
K102990 |
04/04/2011 |
BRAINLAB KNEE |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
K101722 |
04/01/2011 |
ALYTE Y-MESH GRAFT |
C.R. BARD, INC. |
SCOTT ROBIRDS |
K110820 |
04/01/2011 |
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM |
C.R. BARD, INC. |
KETI SINO |
K110395 |
04/22/2011 |
C.T.M. MOBILITY SCOOTER - MODEL HS 118 |
C.T.M. HOMECARE PRODUCT, INC. |
SHEILA RAMERMAN |
K110567 |
04/22/2011 |
C.T.M. MOBILITY SCOOTER HS515(3W) |
C.T.M. HOMECARE PRODUCT, INC. |
SHEILA RAMERMAN |
K110772 |
04/28/2011 |
BIOMARC FIDUCIAL MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ANDREW J ADAMS |
K110499 |
04/06/2011 |
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL LTD. |
CLAY ANSELMO |
K110921 |
04/15/2011 |
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
K103140 |
04/08/2011 |
NICOLET WIRELESS EEG |
CAREFUSION 209, INC. |
ROBERT BURDGE |
K110023 |
04/12/2011 |
INFUSION ADAPTER C100 |
CARMEL PHARMA AB. |
KJELL ANDREASSON |
K100714 |
04/01/2011 |
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 |
CEDARS-SINAI MEDICAL CENTER |
DAVID R DILLS |
K110203 |
04/07/2011 |
XPERT C. DIFFICLE/EPI ASSAY |
CEPHEID |
RUSSEL K ENNS |
K103766 |
04/21/2011 |
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
CEPHEID |
KERRY J FLOM |
K103196 |
04/29/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
CHANGDA PLASTIC PRODUCT CO., LTD |
WANG LIN |
K100767 |
04/05/2011 |
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
K102859 |
04/20/2011 |
RETCAM 3 OPTHALMIC IMAGING SYSTEM |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
K110849 |
04/26/2011 |
PRESTODR 4143 |
CMT MEDICAL TECHNOLOGIES, LTD. |
SHLOMI DINES |
K110270 |
04/07/2011 |
ACCULIF CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
K110483 |
04/04/2011 |
MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
K110542 |
04/01/2011 |
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW HULL |
K102943 |
04/12/2011 |
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
K110139 |
04/21/2011 |
CURVE IMAGE |
CURVE DENTAL, INC. |
CAROLINE TONTINI |
K103626 |
04/05/2011 |
CUTERA GENESISPLUS LASER SYSTEM |
CUTERA, INC. |
Connie Hoy |
K102957 |
04/28/2011 |
CUTTING EDGE SPINE INTERBODY FUSION DEVICE |
CUTTING EDGE SPINE, LLC |
JOHN KAPITAN |
K101484 |
04/01/2011 |
COMPRESSYN BAND |
DALLEN MEDICAL |
AL MEMMOLO |
K110253 |
04/29/2011 |
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS |
DANA PRODUCTS, INC. |
HARRY BALA |
K103549 |
04/08/2011 |
DENOVO TEDDY GEL INFANT HEEL WARMER |
DENOVO PRODUCTS LLC |
DALE WALTERS |
K110216 |
04/01/2011 |
EXPEDIUM SYSTEM, VIPER SYSTEM |
DEPUY SPINE, INC. |
EUGENE BANG |
K110353 |
04/07/2011 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
LUKE BULINO |
K103557 |
04/27/2011 |
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
K103600 |
04/08/2011 |
PORTABLE X-RAY SYSTEM |
DIGIMED CORPORATION |
KIM ANTOL |
K110521 |
04/19/2011 |
EVERON CENTRAL DISPLAY STATION (CDS) |
EARLYSENSE LTD. |
DALIA ARGAMAN |
K110999 |
04/26/2011 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
K093640 |
04/29/2011 |
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA |
ELECTRON JSCO. |
TANMAY SHUKLA |
K110173 |
04/07/2011 |
EMS AIR-FLOW MASTER PIEZON |
EMS ELECTRO MEDICAL SYSTEMS SA |
CYNTHIA J M. NOLTE, PH.D, RAC |
K110802 |
04/08/2011 |
A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 |
ESAOTE S.P.A. |
Allison Scott |
K110373 |
04/06/2011 |
TEMPOROMANIBULAR COIL 15 |
ESAOTE S.P.A. |
DONATELLA RAGGHIANTI |
K103672 |
04/08/2011 |
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
K110319 |
04/14/2011 |
EVERCROSS 0.035 OTW PTA DILATATION CATHETER |
EV3 INC |
PAULA CORDERO |
K110547 |
04/14/2011 |
OPTERTRAK LOGIC PSC TIBIAL INSERT |
EXACTECH SARASOTA |
PATRICK HUGHES |
K110708 |
04/01/2011 |
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... |
EXACTECH, INC. |
LINDY KNISELY |
K090277 |
04/19/2011 |
NATUS SLEEPWORKS, MODEL 104017 |
EXCEL-TECH LTD. (XLTEK) |
GOLDY SINGH |
K110288 |
04/28/2011 |
FEMVUE SALINE-AIR DEVICE |
FEMASYS INC. |
LISA PEACOCK |
K103336 |
04/13/2011 |
MPS450 MULTIPARAMETER SIMULATOR |
FLUKE BIOMEDICAL |
JOHN NELSON |
K110186 |
04/07/2011 |
SYNAPSE 3D LIVER ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KIMERLY A SHARP |
K110436 |
04/20/2011 |
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA |
FUJIREBIO DIAGNOSTICS, INC |
KENT PRUETT |
K110920 |
04/08/2011 |
UF-760AG |
FUKUDA DENSHI CO., LTD. |
LORAN VAN NOY |
K110834 |
04/26/2011 |
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION |
GE HEALTHCARE |
HELEN PENG |
K110266 |
04/29/2011 |
MAC 5500 HD, MAC 3500 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
PATRICIA TAIGE |
K110610 |
04/01/2011 |
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL |
GE MEDICAL SYSTEMS, LLC |
MICHELLE SCHEIDT |
K093581 |
04/19/2011 |
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS |
GE MEDICAL SYSTEMS, LLC |
TRACEY ORTIZ |
DEN110012 |
04/19/2011 |
APTIMA TRICHOMONAS VAGINALIS ASSAY |
GEN-PROBE INCORPORATED |
MARIA CARMELITA S BALUYOT |
K110286 |
04/28/2011 |
GN OTOMETRICS TYPE 1053 FREEFIT |
GN OTOMETRICS A/S |
TOM RINIKER |
K102152 |
04/28/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI TENGDA PLASTIC CO., LTD |
CHU XIAOAN |
K102151 |
04/27/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
HEBEI TENGDA PLASTIC CO., LTD |
CHU XIAOAN |
K110037 |
04/29/2011 |
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
K101888 |
04/08/2011 |
SCENARIA WHOLE-BODY X-RAY CT SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K110862 |
04/26/2011 |
VAPRO PLUS INTERMITTENT CATHETER |
HOLLISTER, INCORPORATED |
CHRIS STUKEL |
K100496 |
04/25/2011 |
INVADER MTHFR 1298 |
HOLOGIC, INC. |
RANDALL J COVILL |
K101072 |
04/11/2011 |
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K110764 |
04/27/2011 |
FILMARRAY RP PANEL |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
K103318 |
04/07/2011 |
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR |
IMPACT INSTRUMENTATION, INC. |
SUSAN MCNEVIN |
DEN100020 |
04/08/2011 |
DENV DETECT IGM CAPTURE ELISA |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
K102552 |
04/05/2011 |
HEMOSIL LA POSITIVE CONTROL |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K103248 |
04/05/2011 |
INTEGRITY SPINAL CARE SYSTEM |
INTEGRA LIFE SCIENCES |
JAMES J GIBSON |
K103527 |
04/15/2011 |
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
K103524 |
04/15/2011 |
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
K103194 |
04/21/2011 |
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM |
INTRA-LOCK INTERNATIONAL, INC. |
ANGELA BLACKWELL |
K101581 |
04/08/2011 |
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
BRANDON HANSEN |
K103556 |
04/13/2011 |
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
K103817 |
04/22/2011 |
POSEY BED |
J. T. POSEY CO. |
ROBERT KELLEHER |
K102847 |
04/14/2011 |
DISPOSABLE ENDOMETRIAL SUCTION CURETTE |
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. |
Diana Hong |
K102480 |
04/19/2011 |
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA |
JIEYING LABORATORY INC. |
GRACE HOLLAND |
K103617 |
04/04/2011 |
DIGITAL FOREHEAD THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
K101201 |
04/13/2011 |
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, |
KAT IMPLANTS, LLC |
VITALI BONDAR |
K103582 |
04/14/2011 |
KELYNIAM CUSTOM SKULL IMPLANT (CSI) |
KELYNIAM GLOBAL, INC |
JAMES KETNER |
K110092 |
04/08/2011 |
TAKE 1 ADVANCED RIGID TRAY |
KERR CORPORATION |
Wendy Garman |
K110455 |
04/29/2011 |
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS |
KIMBERLY-CLARK CORP. |
ANN WATERHOUSE |
K103091 |
04/15/2011 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
K110487 |
04/19/2011 |
FLEXIBLE CARDIAC COIL |
LBDS HOLDING COMPANY |
RICHARD BRYANT |
K103368 |
04/06/2011 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CASPER E ULDRIKS ESQ. |
K110116 |
04/08/2011 |
XEROS DRY MOUTH PUMP |
LORIN TECHNOLOGIES CORPORATION |
AL TOMAN |
K103455 |
04/28/2011 |
SPECTRA LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
K102726 |
04/04/2011 |
CARDIOHELP SYSTEM |
MAQUET CARDIOPULMONARY AG |
ROLAND JEHLE |
K110911 |
04/28/2011 |
RENAISSANCE SYSTEM |
MAZOR ROBOTICS LTD |
AHAVA STEIN |
K111021 |
04/27/2011 |
CUBESCAN / BIOCON-700 |
MCUBE TECHNOLOGY CO., LTD. |
SEUNGTAI KIM |
K110377 |
04/25/2011 |
PROTECTIVE RESTRAINT |
MEDI-TECH INTL. CORP. |
MARILYN GEIGER |
K101088 |
04/04/2011 |
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT |
MEDICA CORP. |
Photios Makris |
K110675 |
04/21/2011 |
EASYRA UREA NITROGEN AND CREATININE REAGENTS |
MEDICA CORP. |
Photios Makris |
K102222 |
04/08/2011 |
ULTIMATE VIT ENHAMCER (UVE) |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
LINDA UPTON |
K103602 |
04/21/2011 |
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K110259 |
04/13/2011 |
ARCHITEX SPACE MAINTENANCE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KELLY DAVIDSON |
K110522 |
04/01/2011 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
NICHOLAS TABRIZI |
K103565 |
04/12/2011 |
MEDVOXEL HEARTPRO SOFTWARE APPLICATION |
MEDVOXEL SYSTEMS INC |
BONNIE SEWLOCHAN |
K110282 |
04/27/2011 |
LIGHTY DD INFUSION SET |
MEDX-SET LTD |
RAYMOND KELLY |
K110067 |
04/08/2011 |
LP CAGE |
MEDYSSEY CO., LTD. |
RICH JANSEN |
K102895 |
04/28/2011 |
ONE DAY FLAT PACK |
MENICON CO. LTD. |
MARTIN DALSING |
K103599 |
04/27/2011 |
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 |
MERIDIAN MEDICAL SYSTEMS, LLC |
ARIEL MARCIANO |
K101745 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K101744 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K101742 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K101753 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K101752 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS |
MICROGENICS CORP. |
LISA CHARTER |
K101754 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K101746 |
04/08/2011 |
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
K103680 |
04/06/2011 |
MICROLIFE DIGITAL UNDERARM THERMOMETER |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K110148 |
04/19/2011 |
WEXLER VASCULAR CLAMP SERIES |
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
LISA S JONES |
K103758 |
04/28/2011 |
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
MICROVENTION, INC. |
LARAINE PANGELINA |
K101805 |
04/08/2011 |
HYDROFIX VASO SHIELD |
MIMEDX GROUP, INC |
SALLY THORSEN |
K110750 |
04/28/2011 |
PERIOPATCH |
MIS IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
K110411 |
04/08/2011 |
ATAMA SYSTEM |
MONTERIS MEDICAL, INC. |
JEFF WILSON |
K103784 |
04/13/2011 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
K103795 |
04/13/2011 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
K103833 |
04/20/2011 |
NEOPIP PATIENT CIRCUIT WITH PEEP |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
K110138 |
04/08/2011 |
PAIRED HYDROGEL ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
K110210 |
04/20/2011 |
SATURN 8000-GS |
NEW MEDICAL CO., LTD. |
JUN-HSIUNG LIN |
K093914 |
04/14/2011 |
NEWDEAL COMPRESSION PLATES |
NEWDEAL SAS |
STEPHEN BEIER |
K110262 |
04/05/2011 |
SHARPS CONTAINER |
NOBLE MARKETING |
Allison Scott |
K110368 |
04/14/2011 |
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
K110903 |
04/29/2011 |
PTS-X SIZING BALLOON CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
K103829 |
04/04/2011 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
K110787 |
04/21/2011 |
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) |
ORTHOGEM LIMITED |
WE-JEN LO |
K103015 |
04/13/2011 |
ODRC-DYNAMIC HIP SCREW SYSTEM |
ORTHOPAEDIC DEVICE RESEARCH CENTER |
CHENG-KUNG CHENG |
K110626 |
04/20/2011 |
JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
K103604 |
04/06/2011 |
ISA CO2, ISA AX+, ISA OR+ |
PHASEIN AB |
DAVID WEISSBURG |
K111024 |
04/21/2011 |
JETPACK 2.0 |
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
LORI R PETERSON |
K100862 |
04/21/2011 |
BODYFLOW P2CH |
PHYSIOMED ELEKTROMEDIZIN AG |
BIRGIT SCHMID |
K103729 |
04/18/2011 |
INFILL INTERVERTEBRAL BODY FUSION DEVICE |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
K110561 |
04/29/2011 |
FORTROSS BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE |
K110727 |
04/01/2011 |
HYLATOPICPLUS CREAM |
PRECISION DERMATOLOGY INCORPORATED |
RONALD M GURGE |
K103324 |
04/21/2011 |
PRECISION LIQUID OXYGEN SYSTEM |
PRECISION MEDICAL, INC. |
JAMES PARKER |
K110260 |
04/06/2011 |
NEWTOM 5G / NEWTOM 5G VERSION FP |
QR S.R.L. |
LORENZO BORTOLOTTI |
K101578 |
04/28/2011 |
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
NANCY RING |
K092269 |
04/08/2011 |
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K102985 |
04/05/2011 |
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS |
Respironics Inc. |
TAMATHA LEY |
K103428 |
04/04/2011 |
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS |
RESTORATION ROBOTICS, INC |
KIT CARIQUITAN |
K103370 |
04/05/2011 |
RT200 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
K103366 |
04/04/2011 |
RT600 |
RESTORATIVE THERAPIES INC. |
SCOTT SIMCOX |
K110055 |
04/05/2011 |
REVERSE MEDICAL REFLEX GUIDE CATHETER |
REVERSE MEDICAL CORPORATION |
AMY ESKINA |
K102418 |
04/15/2011 |
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM |
REVERSE MEDICAL CORPORATION |
AMY ESKINA |
K103200 |
04/12/2011 |
PROPEP DELIVERY DEVICE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
K110112 |
04/20/2011 |
CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE |
RONGSHAN LI |
RONGSHAN LI |
K110177 |
04/21/2011 |
HELENA SYSTEM |
ROYAL OAK MEDICAL DEVICES |
MATTHEW KROLL |
K102902 |
04/22/2011 |
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR |
RUBBERCARE PROTECTION PRODUCTS SDN BHD |
LIM KWEE SHYAN |
K101057 |
04/05/2011 |
AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 |
SALIENT SURGICAL TECHNOLOGIES |
KERRI MORTON |
K110304 |
04/08/2011 |
APEX ER. YAG / IPL SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES LLC |
MARK ROHRER |
K110502 |
04/27/2011 |
TRIPLEX ER. YAG / ND: YAG SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
K110768 |
04/20/2011 |
COMPUTED DENTAL RADIOGRAPHY |
SCHICK TECHNOLOGIES, INC. |
SCOTT DOYLE |
K110025 |
04/28/2011 |
SECTRA MICRODOSE MAMMOGRAPHY |
SECTRA IMTEC AB |
ALEXANDER ASKLOV |
K110841 |
04/15/2011 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
FLOWER CAI |
K102085 |
04/14/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG GLORY PLASTIC CO., LTD. |
CHU XIAOAN |
K110838 |
04/21/2011 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
JANICE M HOGAN |
K110366 |
04/12/2011 |
SYNGO.CT CARDIAC FUNCTION |
SIEMENS AG |
RALF HOFFMANN |
K110169 |
04/07/2011 |
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN ANN DRAY-LYONS |
K100321 |
04/12/2011 |
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE MARINELLI |
K100344 |
04/18/2011 |
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE MARINELLI |
K103683 |
04/28/2011 |
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) |
SIEMENS HEALTHCARE DIAGNOSTICS |
Garo Mimaryan |
K100375 |
04/06/2011 |
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 |
Siemens Healthcare Diagnostics Inc. |
PAMELA JURGA |
K103606 |
04/15/2011 |
ARTISTE SOLUTION WITH SYS_VB50 UPDATE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
K110844 |
04/20/2011 |
SYMBIA.NET |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
K110494 |
04/06/2011 |
SYNGO MBF |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
K110127 |
04/08/2011 |
PRELUDE III TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
K110837 |
04/22/2011 |
REVISION PROTHESIS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
K110240 |
04/14/2011 |
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
K110101 |
04/11/2011 |
TAPER OXINIUM FEMORAL HEAD |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
K101377 |
04/08/2011 |
SMITH & NEWPHEW ULTRABRAID II SUTURE |
SMITH & NEWPHEW, INC |
CHRISTINA FLORES |
K110816 |
04/19/2011 |
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
K110815 |
04/19/2011 |
PARIETEX OPTIMIZED COMPOSTIE MESH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
K103204 |
04/27/2011 |
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
SOLARC SYSTEMS INC. |
BRUCE ELLIOTT |
K110782 |
04/07/2011 |
XVAC |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
K110255 |
04/04/2011 |
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
STEPHEN C SMITH |
K110779 |
04/19/2011 |
SPACELABS SMART DISCLOSURE SYSTEM |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
K103369 |
04/04/2011 |
VAULT ALIF SYSTEM |
SPINAL USA |
LINDA POLK |
K110378 |
04/05/2011 |
IMPRESSION COMPOUND |
SPOFADENTAL |
Wendy Garman |
K110152 |
04/15/2011 |
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS |
SPSMEDICAL SUPPLY CORP. |
GARY J SOCOLA |
K103083 |
04/08/2011 |
AGILIS ES STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
K103654 |
04/06/2011 |
VELA XL |
STARMEDTEC GMBH |
GREGOR WEIDEMANN |
K110147 |
04/08/2011 |
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE |
STI MEDICAL SYSTEMS, LLC |
ROLF WOLTERS |
K102606 |
04/22/2011 |
AVS ANCHOR-C CERVICAL CAGE SYSTEM |
STRYKER SPINE |
KIMBERLY LANE |
K110814 |
04/08/2011 |
AMBIT TUNNELER |
SUMMIT MEDICAL PRODUCTS, INC |
MARKO V AMEN |
K103770 |
04/21/2011 |
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL |
SYNTEX HEALTHCARE PRODUCTS CO., LTD |
KATHY LIU |
K110125 |
04/21/2011 |
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM |
SYNTHES USA |
CHRISTOPHER HACK, ESQ. |
K110763 |
04/11/2011 |
LATARJET CORTICAL SCREW SET |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
GEORGE J HATTUB |
K110185 |
04/04/2011 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
TANGSHAN BAOJIE GLOVE CO., LTD |
CHU XIAOAN |
K100183 |
04/15/2011 |
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER |
TANITA CORP. |
TOSHISHIKO ISHIKAWA |
K101827 |
04/20/2011 |
OSTEOSCAF |
TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL |
JERRY CHANG |
K110563 |
04/08/2011 |
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP |
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.) |
JULIE POWELL |
K102804 |
04/20/2011 |
SPI TITANIUM BASE FOR CAD/CAM |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
K102517 |
04/27/2011 |
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS |
THUNDER TIGER CORP. |
JO LEE |
K110178 |
04/05/2011 |
ESTELITE COLOR |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
K110595 |
04/07/2011 |
4D SONO-SCAN 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
K110667 |
04/08/2011 |
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
K110865 |
04/27/2011 |
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
K103262 |
04/05/2011 |
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
HOWARD L SCHRAYER |
K110331 |
04/27/2011 |
SENSITITRE AIM (TM) |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
K110136 |
04/18/2011 |
RESPICHAMBER VALVED HOLDING CHAMBER |
TRUDELL MEDICAL INTL. |
DARRYL FISHER |
K110515 |
04/20/2011 |
UCP DRUG SCREENING TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
K110582 |
04/28/2011 |
VALO CORDLESS |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K110452 |
04/20/2011 |
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, |
UNILENS CORP., USA |
ALAN J FRAZER |
K103326 |
04/06/2011 |
MULTIPLE BIOPSY SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
K100669 |
04/06/2011 |
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES |
US MEDICAL INNOVATIONS LLC |
KRISTA OAKES |
K102467 |
04/07/2011 |
UTA AND UHA |
UTA |
ANGELA BLACKWELL |
K101412 |
04/13/2011 |
EVA TPN BAG |
VALMED S.R.L. |
WALTER SVANOSIO |
K102212 |
04/08/2011 |
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
K110355 |
04/22/2011 |
VENX REVOLUTION |
VENX LLC |
IRA DUESLER |
K101867 |
04/14/2011 |
VICOR PD2I ANALYZER |
VICOR TECHNOLOGIES, INC. |
GLEN PARK |
K110334 |
04/12/2011 |
WALDO PATIENT MONITOR |
WALDO HEALTH |
ALAN R WEISS |
K103484 |
04/22/2011 |
GSP NEONATAL THYROXINE (T4) |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
SUSAN K HAMANN |
K110219 |
04/19/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
WEALTH ON (JIANGSU) CO., LTD |
CHENGYU SHEN |
K103587 |
04/06/2011 |
DISPOSABLE BLLOD COLLECTION NEEDLE |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
Diana Hong |
K110421 |
04/26/2011 |
DISPOSABLE INSULIN SYRINGE |
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD |
Diana Hong |
K110671 |
04/22/2011 |
WINCO STRETCHAIR |
WINCO MFG., LLC |
JIM ANKOVIAK |
K110029 |
04/19/2011 |
CONSERVE BIO FOAM SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
K103363 |
04/26/2011 |
ZEUS ELISA HSV GC-I IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
K110338 |
04/19/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUECHUAN PLASTIC PRODUCTS CO., LTD. |
FRANK LIU |
K103662 |
04/15/2011 |
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI |
ZIMMER, INC. |
REBECCA BROOKS |
K110742 |
04/13/2011 |
ONESTEP ADULT MULTI-FUNCTION ELECTRODE |
ZOLL MEDICAL CORPORATION |
ROBERT MORSE |