| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K101910 |
12/08/2010 |
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS |
3M COMPANY |
SUZANNE LEUNG |
| K093721 |
02/19/2010 |
COSP2 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K100715 |
12/23/2010 |
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K101427 |
12/23/2010 |
AUDIT MICROCV HS-CRP LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K103122 |
12/30/2010 |
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG |
AAT ALBER ANTRIEBSTECHNIK GMBH |
STEFANIE D BANKSTON |
| K093318 |
02/19/2010 |
ACCELERATOR APS |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K102705 |
12/07/2010 |
ARMADA 14 PTA CATHETER |
ABBOTT VASCULAR INC. |
LAARNI RICAFORT |
| K103153 |
12/30/2010 |
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER |
ABBOTT VASCULAR-CARDIAC THERAPIES |
SUZANNE REDMAN |
| K102981 |
12/20/2010 |
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM |
ACE SURGICAL SUPPLY COMPANY INC. |
CAROL A HOUTS |
| K093192 |
02/12/2010 |
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE |
ADVANCED VASCULAR DYNAMICS |
HERBERT SEMLER |
| K101558 |
12/16/2010 |
GNR TRAFFIC LIGHT PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K101815 |
12/20/2010 |
ENDURO KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS |
KATHY A RACOSKY |
| K103284 |
12/02/2010 |
LAMINOPLASY PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K102424 |
12/09/2010 |
PREVISION HIP SYSTEM WITH RECON RING |
AESCULAP IMPLANT SYSTEMS, LLC |
KATHY A RACOSKY |
| K102057 |
12/21/2010 |
TARGON FN SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
KATHY A RACOSKY |
| K091860 |
02/23/2010 |
AESKULISA MPO, MODEL 30-7303US |
AESKU.DIAGNOSTICS |
SASCHA PFEIFFER |
| K091363 |
02/04/2010 |
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER |
AG INDUSTRIES |
IAN GORDON |
| K093476 |
02/05/2010 |
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
AGA MEDICAL CORP. |
AMANDA JOHNSON |
| K092821 |
02/01/2010 |
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 |
AGENCY FOR MEDICAL INNOVATIONS, INC. |
ANDREW BENDHEIM |
| K101806 |
12/07/2010 |
AIDERA DIASEND SYSTEM |
AIDERA AB |
ANDERS SONESSON |
| K102700 |
12/21/2010 |
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS |
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN |
EDWARD BREHM |
| K100138 |
02/17/2010 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K102609 |
12/09/2010 |
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON MEDICAL CO., LTD. |
LIU YI |
| K102796 |
12/15/2010 |
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K093567 |
02/05/2010 |
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM |
ANOVA IMPLANT SOLUTIONS, LLC |
WALTER SPIRES |
| K092733 |
02/26/2010 |
PYTON |
ARM MEDICAL DEVICES, INC. |
ANTHONY CALDERONI |
| K091006 |
02/25/2010 |
ITG VASCULAR ACCESS SYSTEM, MODEL 300 |
ARSTASIS, INC. |
DOMINIQUE FILLOUX |
| K101837 |
12/28/2010 |
ACL TIGHTROPE DOUBLE BUNDLE |
ARTHREX, INC. |
GEENA AUGUSTINE |
| K103466 |
12/22/2010 |
ARTHREX UNIVERS II SHOULDER PROSTHESIS |
ARTHREX, INC. |
SALLY FOUST, RAC |
| K091188 |
02/26/2010 |
ASAHI ZENYTEEX GUIDING CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K102549 |
12/21/2010 |
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY |
ASCENSION ORTHOPEDICS, INC. |
SUSAN WALTON |
| K091880 |
02/24/2010 |
CLAYTON INTRA-AURAL DEVICE (CID) |
ASCENTIA HEALTH INCORPORATED |
ROGER WIXTROM |
| K102279 |
12/29/2010 |
INCU I |
ATOM MEDICAL CORPORATION |
TSUYOSHI SUGINO |
| K102710 |
12/22/2010 |
NEO-SERVO I |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K102624 |
12/16/2010 |
AVITA WRIST TYPE BLOOD PRESSURE MONITOR |
AVITA CORPORATION |
JENNIFER REICH |
| K103412 |
12/30/2010 |
AXIOM FASCIAL CLOSURE SYSTEM |
AXIOM TECHNOLOGY PARTNERS, LLC |
RICHARD RUSH |
| K083460 |
02/18/2010 |
DIALOG WITH ADIMEA OPTION |
B. BRAUN AVITUM AG |
BONNIE KINCAID, RAC |
| K103367 |
12/08/2010 |
SEEKER CROSSING SUPPORT CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
CANDACE WADE |
| K090917 |
02/19/2010 |
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
BAXA CORP. |
JIM MORGAN |
| K093120 |
02/17/2010 |
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
DIANE RENNPFERD |
| K100790 |
12/21/2010 |
COULTER LIN-X LINEARITY CONTROL, MODEL A81196 |
BECKMAN COULTER, INC. |
LOURDES M COBA |
| K100209 |
02/19/2010 |
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
| K082315 |
02/01/2010 |
EC50 MICRO+ SMOKERLYZER |
BEDFONT SCIENTIFIC LTD. |
GLEN HILLSLEY |
| K101577 |
12/02/2010 |
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K100700 |
12/13/2010 |
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES |
BENLAN, INC. |
CHERYL BROWN |
| K100092 |
02/23/2010 |
CORVUS RADIATION THERAPY PLANNING SYSTEM |
BEST NOMOS |
CHI PALKO |
| K091210 |
02/05/2010 |
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT |
BEST SANITIZERS, INC. |
NORMAN MINER |
| K091766 |
02/24/2010 |
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 |
BINAX, INC. |
SUZANNE M VOGEL |
| K093015 |
02/25/2010 |
BINDER INTERVERTEBRAL BODY FUSION DEVICE |
BINDER BIOMEDICAL, INC |
LAWRENCE BINDER |
| K092587 |
12/03/2010 |
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
Patricia Klimley |
| K102755 |
12/16/2010 |
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER |
BIOLITEC, INC. |
NANCY FOLEY |
| K102579 |
12/02/2010 |
HYPERQ AD-100 SYSTEM |
BIOLOGICAL SIGNAL PROCESSING LTD. |
GEORGE J HATTUB |
| K102607 |
12/03/2010 |
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K091951 |
02/19/2010 |
HAMMERLOCK |
BIOMEDICAL ENT., INC. |
JOE W SOWARD |
| K102209 |
12/03/2010 |
ENCODE PATIENT SPECIFIC ABUTMENT |
BIOMET 3I, INC. |
SIMEON SIMONE |
| K100469 |
12/07/2010 |
ARCOS INTERLOCKING DISTAL STEMS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K100761 |
12/03/2010 |
BIOPRO POLAR HEAD |
BIOPRO, INC. |
DAVID MRAK |
| K093470 |
02/17/2010 |
CORE-FLO D/C |
BISCO, INC. |
Michelle Schiltz-Taing |
| K093379 |
02/09/2010 |
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
| K100044 |
02/04/2010 |
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY |
BLACKSTONE |
WHITNEY TORNING |
| K100785 |
12/03/2010 |
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES |
BONART CO. LTD. |
ERIC L ONG |
| K103668 |
12/30/2010 |
BNX FINE NEEDLE ASPIRATION SYSTEM |
BOSTON ENDOSCOPIC ENGINEERING |
ANNETTE M FAGNANT |
| K103008 |
12/10/2010 |
INZONE DETACHMENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
| K100078 |
02/12/2010 |
MODIFIED STRAIGHT FIRE LASER FIBER |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K093142 |
02/04/2010 |
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
| K102764 |
12/22/2010 |
RESOLUTION II CLIP |
Boston Scientific Corporation |
ELENA NIEVES |
| K102525 |
12/02/2010 |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) |
BREATHE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K093515 |
02/16/2010 |
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON |
BRIVANT, LTD. |
TOMAS FUREY |
| K103459 |
12/13/2010 |
VASCUTRAK PTA DILATATION CATHETER |
C. R. BARD, INC. |
CANDACE WADE |
| K102766 |
12/16/2010 |
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM |
C.R. BARD INC |
KETI SINO |
| K103109 |
12/22/2010 |
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE |
C.R. BARD INC |
DENNIS SALZMANN |
| K093927 |
02/04/2010 |
6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER |
C.R. BARD, INC. |
SARABJYOT MANKOO |
| K102391 |
12/22/2010 |
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM |
C.R. BARD, INC. |
SCOTT PEASE |
| K103359 |
12/27/2010 |
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) |
C.R. BARD, INC. |
CINDY MOSS |
| K101118 |
12/15/2010 |
ACTIVON TULLE |
CALIDAD SOLUTIONS, INC. |
JOHN BILLINGS |
| K103249 |
12/16/2010 |
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K093463 |
02/26/2010 |
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 |
CAREFUSION |
SHARON NICHOLS |
| K102179 |
12/02/2010 |
ENVIEW (TM) |
CAREFUSION 2200 |
PATRICIA A AYERS |
| K094030 |
12/23/2010 |
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K102739 |
12/08/2010 |
HYDROCOLOR 5 |
CASCADES DEVICE CONSULTING ASSOCIATES |
GERALD W SHIPPS |
| K090068 |
02/24/2010 |
STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
TANIA LUPU |
| K102382 |
12/03/2010 |
SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT |
CENDRES & METAUX SA |
TANJA BONGNI |
| K083876 |
02/26/2010 |
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT |
CENDRES & METAUX SA |
PETER W FLEETWOOD |
| K093696 |
02/12/2010 |
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K102989 |
12/09/2010 |
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS |
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC |
BOB LEIKER |
| K093059 |
02/04/2010 |
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT |
CLASSONE ORTHODONTICS, INC. |
JUDY RIBORDY |
| K093565 |
12/03/2010 |
PLEURAFLOW CATHETER SYSTEM |
CLEAR CATHETER SYSTEMS |
MONICA DOUGHERTY |
| K102035 |
12/01/2010 |
SLEEK OTW PTA CATHETERS |
CLEAR STREAM TECHNOLOGIES, LTD. |
FIONA NI MHULLAIN |
| K100218 |
02/17/2010 |
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM |
COLOPLAST A/S |
REBEKA STOLTMAN |
| K103568 |
12/22/2010 |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
COLOPLAST A/S |
JANELL A COLLEY |
| K093112 |
02/01/2010 |
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE |
COLOPLAST MANUFACTURING US, LLC |
JANELL COLLEY |
| K100703 |
12/21/2010 |
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS |
COMED CO., LTD |
BRANDON CHOI |
| K102734 |
12/14/2010 |
COMFORT STANDING WHEELCHAIR, HERO SERIES |
COMFORT ORTHOPEDIC CO. LTD. |
JEN KE-MIN |
| K102410 |
12/21/2010 |
MATRYX INTERFERENCE SCREW (5.0-6.5MM) |
CONMED LINVATEC |
ASHLEA BOWEN |
| K102399 |
12/02/2010 |
CONSENSUS TAPERSET HIP SYSTEM |
Consensus Orthopedics, Inc |
MATTHEW HULL |
| K102536 |
12/01/2010 |
VITALA CONTINENCE CONTROL DEVICE |
CONVATEC INC |
CHARLES RYAN |
| K101450 |
12/30/2010 |
CANTATA MICROCATHETER |
COOK, INC. |
MIRONDA CARPENTER |
| K093209 |
02/26/2010 |
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE |
COOK, INC. |
SEAN WERNER |
| K091077 |
02/04/2010 |
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
KAREN WILK |
| K101126 |
12/02/2010 |
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS |
CORE ESSENCE ORTHOPAEDICS, INC. |
JEFF MILLER |
| K082525 |
02/04/2010 |
CORIN METAFIX FEMORAL STEM |
CORIN USA |
ASHLEA BOWEN |
| K100267 |
02/24/2010 |
FLEXIMARC, MODEL CM-0.9-2-10-GG-L |
CORTEX MANUFACTURING, INC. |
ANDREW JONES |
| K093174 |
02/26/2010 |
SPIROPALM |
COSMED S.R.L. |
ROBERT SCHIFF |
| K102605 |
12/22/2010 |
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER |
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA |
Daniel Campion |
| K100850 |
12/20/2010 |
COWELL IMPLANT SYSTEM |
COWELLMEDI CO., LTD |
JOYCE BANG |
| K102645 |
12/10/2010 |
WILLOW/ELM PTA BALLOON DILATATION CATHETER |
CREAGH MEDICAL LTD |
MAUREEN O'CONNELL |
| K102214 |
12/16/2010 |
ENDO FLIP |
CROSPON, LTD. |
PAUL DRYDEN |
| K103303 |
12/23/2010 |
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE |
CROSSTEX INTERNATIONAL, INC. |
RICHARD M ORMSBEE |
| K091298 |
02/24/2010 |
LUBREASE FEMALE LUBRICANT |
CURVES LIMITED |
NILUFER SMITH |
| K102937 |
12/27/2010 |
OSTEOPHIL BETA-TCP |
CYTOPHIL INC |
VICTOR M BOWERS |
| K093848 |
12/20/2010 |
PT-MULTI-CALIBRATOR, MODEL OPAT07 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K102761 |
12/20/2010 |
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION |
DANA PRODUCTS, INC. |
HARRY BALA |
| K103667 |
12/29/2010 |
SAPPHIRE ST PORTABLE DIODE LASER |
DEN-MAT HOLDINGS, LLC |
ALAN B MATTHEWS |
| K093748 |
02/24/2010 |
DD BIO Z AND DD BIO Z - TRANSPA |
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) |
GERHARD DE BOER |
| K101996 |
12/15/2010 |
DEPUY GLOBAL UNITE SHOULDER SYSTEM |
DEPUY (IRELAND) |
RHONDA MYER |
| K092836 |
02/04/2010 |
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
| K101433 |
12/10/2010 |
DEPUY ATTUNE KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
KATHY BOGGS |
| K093474 |
02/02/2010 |
DEPUY FRACTURE AND FUSION PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K103408 |
12/16/2010 |
POSTERIOR LATERAL PLATES |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K101923 |
12/01/2010 |
CONCORDE CURVE SYSTEM |
DEPUY SPINE |
EUGENE BANG |
| K102249 |
12/16/2010 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
DAPHNEY GERMAIN |
| K100070 |
02/04/2010 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER ROGERS |
| K101993 |
12/07/2010 |
VIPER SYSTEM, EXPEDIUM SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K101723 |
12/23/2010 |
COMPACT WHEELCHAIR PLATFORM |
DESIGN SPECIFIC FLETCHER |
RICHARD FLETCHER |
| K102765 |
12/07/2010 |
PRONEX |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K093208 |
02/12/2010 |
SIMPLISEAL |
DISCUS DENTAL, LLC |
CLARK D VONAHSEN |
| K102639 |
12/01/2010 |
SL3 |
DISCUS DENTAL, LLC |
CLARK D VONAHSEN |
| K093338 |
02/12/2010 |
SELF ADHESIVE COMPOSITE LUTING CEMENT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K102252 |
12/03/2010 |
DMP PIT & FISSURE SEALANT |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K102618 |
12/10/2010 |
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K102408 |
12/27/2010 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM |
DRGEM CORPORATION |
CHARLIE MACK |
| K092574 |
02/04/2010 |
ESL SPINAL SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K102830 |
12/02/2010 |
ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
YUE QIUHONG (TRACY) |
| K102854 |
12/03/2010 |
PC ECG |
EDAN INSTRUMENTS, INC. |
YUE QIUHONG (TRACY) |
| K102835 |
12/27/2010 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K100709 |
12/07/2010 |
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M |
EDWARDS LIFESCIENCES, LLC. |
PATRICIA MILBANK, JD |
| K100739 |
12/07/2010 |
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 |
EDWARDS LIFESCIENCES, LLC. |
PATRICIA MILBANK |
| K092844 |
12/21/2010 |
GEOSOURCE |
ELECTRICAL GEODESICS, INC. |
PAUL HOLMAN |
| K103093 |
12/21/2010 |
LEKSELL GAMMAPLAN |
ELEKTA INSTRUMENT AB |
BO NILSSON |
| K103608 |
12/27/2010 |
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND |
ELLEX, INC. |
JONATHAN STRAWN |
| K103223 |
12/21/2010 |
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS |
ENCORE MEDICAL, L.P. |
ALBERT E ALONSO |
| K092144 |
02/22/2010 |
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR |
ENDOCHOICE, INC. |
SHOSHANA FRIEDMAN |
| K093007 |
02/05/2010 |
ENTELLUS MEDICAL BALLOON DEVICE |
Entellus Medical, Inc. |
Sew-Wah Tay |
| K092894 |
02/24/2010 |
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K103235 |
12/23/2010 |
ERBEFLO 2 DISPOSABLE TUBING SYSTEM |
ERBE USA, INC. |
JOHN TARTAL |
| K100883 |
12/21/2010 |
CARRIGEN |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K093447 |
02/18/2010 |
CARRIGEN |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K102812 |
12/03/2010 |
GAMMA-BSM; BETA-BSM; EQUIVABONE |
ETEX CORPORATION |
CHRISTOPHER KLACZYK |
| K101520 |
12/10/2010 |
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH |
ETHICON ENDO-SURGERY, INC. |
RUTH WOOD |
| K092590 |
02/17/2010 |
PDS PLATES |
ETHICON, INC. |
LESLIE YOUNG |
| K093908 |
12/01/2010 |
CCPOINT |
EURO-DIAGNOSTICA AB |
ROBERT SCHIFF |
| K101413 |
12/16/2010 |
EUROMI EVA SP6 |
EUROMI SA |
CURTIS RAYMOND |
| K103322 |
12/06/2010 |
EVERCROSS 0.035 OTW PTA DILATION CATHETER |
EV3 INC |
DAVID WORRELL, MS, RAC |
| K100063 |
02/02/2010 |
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL |
EV3 INC |
Laura Heaton |
| K102600 |
12/22/2010 |
SIMPLYGO BREAST PUMP |
EVENFLO COMPANY, INC. |
AMY NEFF |
| K103419 |
12/13/2010 |
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM |
EXACTECH, INC. |
PATRICK HUGHES |
| K100126 |
12/03/2010 |
STELLATE GRIDVIEW |
EXCEL-TECH LTD. (XLTEK) |
GOLDY SINGH |
| K092192 |
02/12/2010 |
WAYPOINT STEREOTACTIC SYSTEM |
FHC, INC. |
LEE D MARGOLIN |
| K100837 |
12/03/2010 |
PACENTRIC CONNECT, TRAVELER AND WEB |
FIMREITE SOFTWARE AS |
SVEIN FIMREITE |
| K092175 |
02/17/2010 |
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 |
FLOWCARDIA, INC. |
Dustin Michaels |
| K100205 |
12/13/2010 |
FRONTIER DEVICES NEURO SYSTEM |
FOLSOM METAL PRODUCTS, INC. |
DON PETERSON |
| K093026 |
02/24/2010 |
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER |
FOOTPRINT MEDICAL |
CLYDE BAKER |
| K101715 |
12/21/2010 |
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
RANDOLPH QUINN |
| K091806 |
02/22/2010 |
POGO SCREW INSTRUMENTATION TRAY |
FXDEVICES |
RICH LIPSCHUTZ |
| K100451 |
12/21/2010 |
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K102808 |
12/22/2010 |
MI VARNISH |
GC AMERICA INC. |
MARK HEISS |
| K093749 |
12/06/2010 |
GC AADVA IMPLANT SYSTEM |
GC AMERICA, INC. |
CARL JENKINS |
| K092369 |
02/24/2010 |
12SL ECG ANALYSIS PROGRAM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOE LUCAS |
| K103432 |
12/17/2010 |
UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
ROBERT CASARSA |
| K102952 |
12/03/2010 |
PRODESSE PROADENO |
GEN-PROBE PRODESSE, INC |
EMILY ZIELGER |
| K092970 |
02/02/2010 |
GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H |
GENERAL MEDITECH, INC. |
LEE FU |
| K103034 |
12/10/2010 |
GENESYS SPINE INTERBODY FUSION SYSTEM |
GENESYS SPINE |
JOSH KAUFMANN |
| K100090 |
02/02/2010 |
IMPLANTABLE CLIP |
GENICON |
GARY HABERLAND |
| K102242 |
12/21/2010 |
OSOM C. DIFFICILE TOXIN A/B TEST |
GENZYME CORPORATION |
CAROL C RYERSON |
| K092421 |
02/12/2010 |
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC |
GIMMI GMBH |
KEN BLAKE |
| K102543 |
12/01/2010 |
BRAVO PH MONITORING SYSTEM AND ACCESSORIES |
GIVEN IMAGING LTD. |
Tim Thomas |
| K102392 |
12/22/2010 |
MICROFUSE PUTTY AND MICROFUSE ST MIS |
GLOBUS MEDICAL INC. |
KELLY J BAKER PH.D. |
| K093294 |
02/17/2010 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER, PH.D |
| K102313 |
12/03/2010 |
PATRIOT TRANSCONTINENTAL M SPACERS |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K093751 |
02/24/2010 |
CL-DC20, CL-DC21 |
GOOD DOCTORS CO., LTD. |
KEVIN WALLS, RAC |
| K101224 |
12/03/2010 |
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS |
GRIFFITHS AND NIELSEN LTD |
EDWIN LINDSAY |
| K100516 |
12/03/2010 |
ANYPLUS PEEK CAGES |
GS MEDICAL CO., LTD. |
DONALD W GUTHNER |
| K093759 |
02/19/2010 |
MULTIPLE NAME MODEL MULTIPLE |
GX CORPORATION SDN BHD (PLANT 1) |
CHO SOW FONG |
| K093181 |
02/24/2010 |
GYRUS ACMI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K101907 |
12/03/2010 |
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM |
HAEMONETICS CORP. |
GREG CALDER |
| K103538 |
12/17/2010 |
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 |
HARDY DIAGNOSTICS |
WENDY HADLEY |
| K100731 |
12/03/2010 |
BOSWORTH AIR POLISHER |
HARRY J. BOSWORTH CO. |
GARY CHUVEN |
| K103340 |
12/06/2010 |
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
JOHN D BONASERA |
| K102305 |
12/03/2010 |
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P |
HASS CORP. |
Priscilla Chung |
| K093824 |
02/16/2010 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K102817 |
12/23/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. |
RICHARD LU |
| K102819 |
12/23/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. |
RICHARD LU |
| K100103 |
12/15/2010 |
SPECIALTY ASSAYED CONTROL-2 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K102459 |
12/03/2010 |
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE |
HEMOSTASIS, LLC |
BERNARD HORWATH |
| K102770 |
12/21/2010 |
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
| K102977 |
12/20/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HEZE JUXINYUAN FOOD CO., LTD |
CHU XIAOAN |
| K102976 |
12/13/2010 |
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) |
HEZE JUXINYUAN FOOD CO., LTD |
CHU XIAOAN |
| K090250 |
02/11/2010 |
ELECTRO-LIGHT THERAPY |
HILL LABORATORIES CO. |
BRADY ALLER |
| K102783 |
12/22/2010 |
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS |
HINSON AND HALE MEDICAL TECHNOLOGIES, INC |
JEFFREY O STULL |
| K102889 |
12/20/2010 |
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGH THISTLETHWAITE |
| K102768 |
12/02/2010 |
SECRMARK BIOPSY SITE MARKING SYSTEM |
HOLOGIC, INC. |
ALYSSA M LOBO |
| K103344 |
12/10/2010 |
INFUSION SETS |
HOSPIRA, INC. |
REBECCA ANDERSEN |
| K102282 |
12/07/2010 |
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
STEPHANIE FITTS |
| K102992 |
12/22/2010 |
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K093475 |
02/24/2010 |
BASESENS BLOOD GLUCOSE MONITORING SYSTEM |
HYGEIA, INC. |
ROBERT J BARD |
| K100937 |
12/21/2010 |
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE |
i-SENS, Inc. |
HYUN OH |
| K100576 |
12/17/2010 |
HIGH PRESSURE SETS-400 PSI |
ICU MEDICAL, INC. |
TRACY BEST |
| K091522 |
02/04/2010 |
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K101319 |
12/09/2010 |
IMMULISA DSDNA ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K102281 |
12/22/2010 |
THERMAL MASSAGE BED, MODEL 2D-GX |
INAREX CORPORATION |
EILEEN YANG |
| K092805 |
02/16/2010 |
COLLAGEN SPONGE |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K102867 |
12/03/2010 |
IROOT FS |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K090755 |
02/01/2010 |
QUANTA LITE APS/PT IGG AND IGM ELISA |
INOVA DIAGNOSTICS, INC. |
D. WALTER L BINDER |
| K103392 |
12/17/2010 |
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER |
INOVO, INC. |
MICHAEL T DILDINE |
| K101465 |
12/13/2010 |
STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR |
INSTITUT STRAUMANN AG |
JANET KAY |
| K090264 |
02/05/2010 |
HEMOSIL D-DIMER HS 500, CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K092227 |
02/17/2010 |
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS |
INTEGRA LIFESCIENCES CORP. |
JENNIFER BOSLEY |
| K102875 |
12/20/2010 |
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C |
INTEGRA LIFESCIENCES CORPORATION |
DONNA MILLISKY |
| K102364 |
12/23/2010 |
NYDIAG 200 |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K102969 |
12/20/2010 |
IMC PISTON SYRINGES |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K102718 |
12/13/2010 |
DIGITAL THERMOMETER; DIGITAL THERMOMETER |
INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) |
JACOB CHANG |
| K093284 |
02/01/2010 |
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K093861 |
02/05/2010 |
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE |
IRIS INTERNATIONAL, INC. |
ELLEN JOHNSTON |
| K101563 |
12/17/2010 |
SMARTO |
JEIL MEDICAL CORPORATION |
KIM SEONG NAM |
| K093637 |
02/09/2010 |
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 |
JMS NORTH AMERICA CORP. |
E J SMITH |
| K100061 |
02/12/2010 |
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX |
K2M, INC. |
RICHARD W WOODS |
| K102956 |
12/15/2010 |
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
Shannon Scott |
| K093298 |
12/10/2010 |
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 |
KEELER INSTRUMENTS, INC. |
EUGENE VAN ARSDALE |
| K092681 |
02/23/2010 |
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE |
KHAI HOAN JOINT STOCK COMPANY |
PHAM N THANH |
| K103311 |
12/10/2010 |
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS |
KIMBERLY CLARK CORPORATION |
CHERYL SANZARE |
| K103406 |
12/23/2010 |
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K101609 |
12/09/2010 |
SELF RETAINING SOFT TISSUE RETRACTOR |
KOROS USA, INC. |
TIBOR KOROS |
| K092870 |
02/16/2010 |
NON-STERILE DISPOSABLE VAGINAL SPECULUM |
KUNSHAN DEYI PLASTIC CO., LTD. |
CHARLIE MACK |
| K102166 |
12/10/2010 |
ELECTRO INTERSTITIAL SCAN |
L.D. TECHNOLOGY, LLC |
RICHARD CLEMENT |
| K092965 |
02/26/2010 |
TRAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K092800 |
02/04/2010 |
ANTI-WRINKLE (AGING) LIGHT, MODEL AAL |
LED INTELLECTUAL PROPERTIES, LLC |
ROBERT T WAGNER |
| K103356 |
12/08/2010 |
PRUITT CAROTID KIT |
LEMAITRE VASCULAR, INC. |
VIC ZHANG |
| K102007 |
12/22/2010 |
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, |
LIFE-TECH, INC. |
JEFF KASOFF |
| K103357 |
12/27/2010 |
LIFEBRIDGE |
LIFEBRIDGE MEDIZINTECHNIK AG |
KATHLEEN JOHNSON |
| K103214 |
12/01/2010 |
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 |
LIFELINE SYSTEMS, INC. |
CARLOS O ACOSTA |
| K100858 |
12/10/2010 |
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, |
LIMA-LTO S.P.A. |
CHERYL HASTINGS |
| K102210 |
12/28/2010 |
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K091769 |
02/05/2010 |
TRUST DAM |
LINE ONE LABORATORIES, INC. |
ELI J CARTER |
| K092712 |
02/23/2010 |
SKIN BARRIER FILM |
LODESTAR PRODUCTS, INC. |
ERIC LUO |
| K100228 |
02/24/2010 |
VERSAPULSE MODEL P20 LASER SYSTEM |
LUMENIS, INC. |
DOUG STANTE |
| K093715 |
12/22/2010 |
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE |
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL |
DON CAMPBELL |
| K093425 |
02/24/2010 |
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K102659 |
12/08/2010 |
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER |
MANUKA MEDICAL LIMITED |
James Smith |
| K101153 |
12/08/2010 |
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K093533 |
02/17/2010 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 |
MATERIALISE N.V. |
KARL VOM BERGE |
| K102837 |
12/23/2010 |
HIROLLER ELEVATING WHEELCHAIR |
MAX MOBILITY, LLC |
WILLIAM M RICHTER |
| K103189 |
12/20/2010 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K102537 |
12/10/2010 |
APTUS 1.5 TRILOCK |
MEDARTIS AG |
KEVIN A THOMAS |
| K102966 |
12/21/2010 |
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC |
MEDCOMP |
JEAN CALLOW |
| K092491 |
02/03/2010 |
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K102595 |
12/27/2010 |
MEDISTIM VERIQC SYSTEM |
MEDI-STIM ASA |
CONSTANCE G BUNDY |
| K100372 |
12/14/2010 |
SAFECT MODEL VER 1.0 |
MEDIC VISION BRAIN TECHNOLOGIES LTD |
DAN LAOR |
| K093409 |
02/24/2010 |
POWERPUMP ARTHROSCOPY SYSTEM |
MEDICAL VISION AB |
CONSTANCE G BUNDY |
| K100916 |
12/06/2010 |
MEDICON MOGEN CLAMP |
MEDICON, E.G. |
JOACHIM SCHMID |
| K093444 |
02/04/2010 |
EXAPACS |
MEDINCOM TECHNOLOGY CORP |
ANDREW LEE |
| K093726 |
02/22/2010 |
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K092897 |
02/01/2010 |
LAP LOOP |
MEDSYS, S.A. |
WILLIAM F GREENROSE |
| K102965 |
12/08/2010 |
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K100646 |
12/16/2010 |
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K093650 |
02/17/2010 |
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM |
MEDTRONIC INC. |
JEFFREY KOLL |
| K093203 |
02/26/2010 |
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 |
MEDTRONIC INC. |
MARY E DONLIN |
| K103314 |
12/03/2010 |
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K103313 |
12/01/2010 |
HEPARIN ASSAY CONTROLS |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K103464 |
12/22/2010 |
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER |
MEDTRONIC INC. |
HEATHER MOROSE |
| K103049 |
12/23/2010 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LILA JOE |
| K100779 |
12/13/2010 |
SUSTAIN SPACE MAINTENANCE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHELLE OBENAUER |
| K103147 |
12/16/2010 |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K103272 |
12/29/2010 |
ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K102723 |
12/09/2010 |
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS |
MEMTEC CORP. |
DENNIS GARBOSKI |
| K102688 |
12/03/2010 |
MERETE LOCKING BONE PLATE SYSTEM II |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K102777 |
12/20/2010 |
TWISTCUT ENDOSORB SCREWS |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K093004 |
02/12/2010 |
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K093081 |
02/05/2010 |
POCKET BVM |
MICROBVM SYSTEMS LTD |
ELI ORBACH |
| K093647 |
02/24/2010 |
TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
Naomi Gong |
| K102818 |
12/03/2010 |
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K100596 |
12/06/2010 |
CRYOPETTE |
MID-ATLANTIC DIAGNOSTICS, INC. |
ELISA D HARVEY |
| K093544 |
02/16/2010 |
TROPAZONE CR |
MIDLOTHIAN LABORATORIES |
BRYCE HARVEY |
| K091496 |
02/23/2010 |
MEP-90 HAIR GROWTH STIMULATION SYSTEM |
MIDWEST R.F. LLC. |
HELMUT KEIDL |
| K093188 |
02/17/2010 |
AFM ULTRA AG DRESSINGS |
MILLIKEN & CO. |
MARY MCNAMARA-CULLINANE |
| K093449 |
02/12/2010 |
MINI LAP RETRACTORS |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K102452 |
12/23/2010 |
DEFOGGING AND CLEANING SOLUTION- FLO-X |
MINIMALLY INVASIVE DEVICES LLC |
MARK L FRIEDMAN, PH.D |
| K093339 |
02/19/2010 |
ELI PC ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K101363 |
12/16/2010 |
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE |
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS |
Glenn Stiegman |
| K093329 |
02/16/2010 |
SCOPE INTRODUCER MODEL 7400 |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K092746 |
02/03/2010 |
MICRONJET 600 |
NANOPASS TECHNOLOGIES LTD. |
JONATHAN KAHAN |
| K102663 |
12/30/2010 |
AED RESECTOSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE BUTLER |
| K090019 |
02/22/2010 |
NATUS NEUROWORKS, MODEL 104196 |
NATUS MEDICAL, INC. |
GOLDY SINGH |
| K103342 |
12/23/2010 |
3.0T METAFLEXCOIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K102641 |
12/20/2010 |
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
LINDA K SCHULZ |
| K100668 |
12/08/2010 |
NEMA-ST, MODEL V1.0.2 |
NERVOMATRIX LTD |
DAN LAOR |
| K102862 |
12/21/2010 |
NEUROVISION SE (NERVEANA) |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K092527 |
02/04/2010 |
NEXUS INJECTION SITE, MODEL NIS-8 |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K101278 |
12/20/2010 |
INERTIA PEDICLE SCREW SYSTEM |
NEXXT SPINE LLC |
KAREN WARDEN |
| K102106 |
12/17/2010 |
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K102376 |
12/07/2010 |
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K102436 |
12/09/2010 |
NOBEL ACTIVE 3.0 |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K102350 |
12/22/2010 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI M MITCHELL |
| K102715 |
12/17/2010 |
REGIONAL OXIMETER |
NONIN MEDICAL, INC. |
LORI M MITCHELL |
| K090111 |
02/01/2010 |
FLEXPEN NEEDLE |
NOVO NORDISK INC. |
RICK SPRING |
| K102473 |
12/09/2010 |
MULLINS-X PTV CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K093804 |
02/19/2010 |
NUVASIVE HELIX REVOLUTION ACP SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K102514 |
12/01/2010 |
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM |
NUVASIVE, INC. |
ELISA KETCHUM |
| K090609 |
02/04/2010 |
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM |
OK BIOTECH CO., LTD. |
Ke-Min Jen |
| K093106 |
02/12/2010 |
ENDOSCOPE REPROCESSOR OER-PRO |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K093572 |
02/03/2010 |
R650 QDASM COLLIMATOR |
OMEGA MEDICAL IMAGING, INC. |
James Princehorn |
| K093496 |
02/03/2010 |
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT |
OON CORP. RESOURCES |
JANNA P TUCKER |
| K091493 |
02/05/2010 |
ORTHO SELECT BONE PLATES AND SCREW SYSTEM |
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT |
ANGELIKA SCHERP |
| K093086 |
02/23/2010 |
ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 |
ORTHODYNAMIX, LLC |
BRIAN S ZIMOVAN |
| K102201 |
12/15/2010 |
CONTOURS LAPIDUS PLATING SYSTEM |
ORTHOFIX INC. |
MARY BIGGERS |
| K093900 |
02/17/2010 |
EDGELOCK |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K093805 |
02/19/2010 |
OSCAR 3 |
ORTHOSONICS, LTD. |
MICHAEL J.R. YOUNG, PH.D. |
| K091678 |
02/18/2010 |
HG II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K101428 |
12/01/2010 |
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET |
OVESCO ENDOSCOPY AG |
ARNE BRIEST |
| K102910 |
12/23/2010 |
MODEL LUNA MANUAL WHEELCHAIR |
P.D.G., INC. |
EDWARD A KROLL |
| K100380 |
02/22/2010 |
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 |
PARI RESPIRATORY EQUIPMENT, INC. |
JAMES L MCINTIRE |
| K092918 |
02/04/2010 |
PARI VIOS |
PARI RESPIRATORY EQUIPMENT, INC. |
MICHAEL JUDGE |
| K102061 |
12/13/2010 |
TREVAIR CHAIR ADULT |
PATMONT MOTOR WERKS, INC. |
STEVEN J PATMONT |
| K102709 |
12/17/2010 |
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
AN NGUYEN |
| K102029 |
12/16/2010 |
PEAK PULSAR II GENERATOR MODEL PS100-102 |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K093796 |
02/26/2010 |
ASEPT PERITONEAL DRAINAGE SYSTEM |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K100999 |
12/15/2010 |
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
PHADIA AB |
MARTIN MANN |
| K093426 |
02/22/2010 |
BACT-TRAP HEPA MIDI |
PHARMA SYSTEMS AB |
PAUL DRYDEN |
| K092028 |
02/17/2010 |
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MICHAEL ASMALSKY |
| K093563 |
02/01/2010 |
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS |
PHILIPS ULTRASOUND, INC. |
NANCY BURKE |
| K102972 |
12/22/2010 |
LIFEPAK 12 |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K092295 |
02/19/2010 |
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
EMILY M DOWNS |
| K101835 |
12/03/2010 |
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 |
POREX SURGICAL, INC. |
STEPHANIE FULLARD |
| K100854 |
12/09/2010 |
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 |
PREMIUM PLUS INTERNATIONAL LIMITED |
DENNIS NG |
| K100932 |
12/27/2010 |
INCLUSIVE MINI IMPLANT |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K100993 |
12/28/2010 |
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K102749 |
12/10/2010 |
QUANTA CYBER TM 150W |
Quanta System SpA |
ISABELLA CARRER |
| K102027 |
12/22/2010 |
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM |
QUANTEL MEDICAL S.A. |
MICHAEL JOHNSON |
| K090105 |
12/30/2010 |
LUPOTEK KCT |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K100169 |
02/18/2010 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K103097 |
12/29/2010 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
JAMES HUANG |
| K102187 |
12/10/2010 |
RII INFRARED EAR THERMOMETER, |
RADIANT INNOVATION, INC. |
JAMES HUANG |
| K100777 |
12/10/2010 |
ABL837 FLEX ANALYZER |
RADIOMETER MEDICAL APS |
ROWENA JANSSON |
| K093154 |
02/05/2010 |
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM |
RADIOMETER MEDICAL APS |
JANA HELLMAN |
| K102348 |
12/22/2010 |
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
| K101189 |
12/22/2010 |
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC |
REAVILLMED |
MICHELE H VOVOLKA |
| K102842 |
12/02/2010 |
ADHESIVE ELECTRODES |
RENO MEDICAL LIMITED |
Diana Hong |
| K101682 |
12/07/2010 |
S 100 PEDICLE SCREW SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
J.D. WEBB |
| K093684 |
02/26/2010 |
EASYCARE ONLINE |
RESMED LTD. |
DAVID D'CRUZ |
| K102746 |
12/28/2010 |
MIRAGE FX |
RESMED LTD. |
DAVID D'CRUZ |
| K102224 |
12/10/2010 |
PIXI PEDIATRIC MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K102054 |
12/22/2010 |
V200 VENTILATOR |
RESPIRONICS CALIFORNIA, INC. |
TAMATHA LEY |
| K092835 |
02/12/2010 |
COMFORTGEL NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K102502 |
12/22/2010 |
GOLIFE NASAL MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K091029 |
02/18/2010 |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K103221 |
12/23/2010 |
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 |
Roche Diagnostics |
KELLY C O'MAINE ADAMS |
| K103099 |
12/06/2010 |
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH |
Roche Diagnostics |
Susan Hollandbeck |
| K083764 |
02/03/2010 |
AMPHETAMINES II |
ROCHE DIAGNOSTICS CORP. |
MICHELLE NEFF |
| K092649 |
02/04/2010 |
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 |
ROCHE DIAGNOSTICS CORP. |
JANE E PHILLIPS |
| K100227 |
02/23/2010 |
SAS FLUALERT A&B, SAS INFLUENZA A TEST |
SA SCIENTIFIC, INC. |
ROBBI PERRY |
| K100192 |
02/04/2010 |
STRONG DENTAL HANDPIECES |
SAESHIN PRECISION CO., LTD. |
Y.S. LEE |
| K102572 |
12/27/2010 |
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT |
SAINATH INTELLECTUAL PROPERTIES, LLC |
CHRISTOPHER PARADIES, PH.D. |
| K102587 |
12/01/2010 |
LLX240AB01 |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K093793 |
02/18/2010 |
LS-40 CO2 LASER SYSTEM MODEL LS-40 |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K092947 |
02/26/2010 |
TELESENTRY, MODEL TS01 |
SCOTTCARE CORPORATION |
TIMOTHY J LEYVA |
| K102984 |
12/08/2010 |
AURA |
SDI LIMITED |
RUTH EZEKIEL |
| K091283 |
02/22/2010 |
CAPILLARYS NEONAT HB (PN 2006) |
SEBIA |
KAREN ANDERSON |
| K101267 |
12/03/2010 |
PREMIO 10 MOXA |
SEDATELEC |
Kevin Walls |
| K101690 |
12/03/2010 |
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE |
SENTEC AG |
STEPHEN H GORSKI |
| K100525 |
12/15/2010 |
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
SEPPIM S.A.S. |
Debra Hutson |
| K093711 |
02/17/2010 |
RACEGEL |
SEPTODONT |
WAYNE MATELSKI, ESQ |
| K093138 |
02/12/2010 |
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K103583 |
12/27/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103360 |
12/17/2010 |
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL |
SIEMENS CORP. |
ROSE T MARINELLI |
| K093631 |
02/12/2010 |
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE KATHLEEN ENNIS |
| K093621 |
02/23/2010 |
SYNGO.PET&CT ONCOLOGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K103179 |
12/20/2010 |
PRELUDE II TOUNGE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K102103 |
12/07/2010 |
SKELETAL DYNAMICS STERILIZATION TRAYS |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K091234 |
02/16/2010 |
SKELTEX ISV |
SKELTEX TECHNOLOGIES, INC. |
GEORGE PAPAGIANNIS |
| K102180 |
12/20/2010 |
RHEAD RADIAL HEAD EXTENDED STEMS |
SMALL BONE INNOVATIONS, INC. |
JAMES O'CONNOR |
| K102616 |
12/30/2010 |
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K102660 |
12/13/2010 |
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHLEEN SOLOMON |
| K100197 |
02/19/2010 |
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
GINO BROOKS |
| K100107 |
02/23/2010 |
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 |
SMITH & NEPHEW, INC. |
REGINA HOLMES |
| K100204 |
02/19/2010 |
SONALIS |
SMITH ASSOCIATES |
E J SMITH |
| K093064 |
02/17/2010 |
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
SUSANNE RAAB |
| K101046 |
12/09/2010 |
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K102422 |
12/07/2010 |
SPACELABS MEDICAL PATIENT MONITORS |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
| K100290 |
02/17/2010 |
ESTEMP NE |
SPIDENT CO., LTD. |
I.S. HWANG |
| K092774 |
02/02/2010 |
ATLAS INTERVERTEBRAL BODY CAGE |
SPINAL EDGE, LLC |
CHRISTINA VACCA |
| K092531 |
02/04/2010 |
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM |
SPINE 360 |
JOSHUA KAUFMANN |
| K100122 |
02/12/2010 |
MODIFICATION TO CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K102488 |
12/10/2010 |
APEX SPINE SYSTEM W/ COCR RODS |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K092142 |
02/05/2010 |
SPORT-ELEC BODY CONTROL SYSTEM BS |
SPORT-ELEC |
KIMBERLY JONES |
| K101982 |
12/21/2010 |
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 |
ST JUDE MEDICAL, CRMD |
Gina Correa |
| K093942 |
02/25/2010 |
ENSITE VELOCITY SYSTEM V1.3 |
ST. JUDE MEDICAL |
DONNA LUNAK |
| K101782 |
12/22/2010 |
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE |
STAAR JAPAN |
JACK COGGAN |
| K103193 |
12/27/2010 |
DOSEVIEW 3D |
STANDARD IMAGING, INC. |
RAYMOND T RIDDLE |
| K102244 |
12/03/2010 |
RELIANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
ROBERT F SULLIVAN |
| K090324 |
12/20/2010 |
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY |
STI MEDICAL SYSTEMS |
ROLF WOLTERS |
| K093027 |
02/12/2010 |
STRAUMANN RC TEMPORARY ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K101956 |
12/16/2010 |
STRAUMANN MEMBRAGEL |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
JANET C KAY |
| K103536 |
12/16/2010 |
IBED WIRELESS WITH IBED AWARENESS |
STRYKER CORPORATION |
Diane Horwitz |
| K101870 |
12/20/2010 |
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE |
SUNMAX VIETNAM CO. LTD |
JIGAR SHAH |
| K093798 |
02/23/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
SUPERMAX PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K093797 |
02/23/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) |
SUPERMAX PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K100242 |
02/17/2010 |
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
NISHITH DESAI |
| K093491 |
12/09/2010 |
HIP SEXTANT INSTRUMENT SYSTEM |
SURGICAL PLANNING ASSOCIATES |
JOSEPH AZARY |
| K102143 |
12/08/2010 |
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
JOSEPH AZARY |
| K102095 |
12/07/2010 |
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
CURTIS RAYMOND |
| K093789 |
02/19/2010 |
INTOUCH DIABETES |
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC |
RAE ANN DELAY |
| K093310 |
02/01/2010 |
GEM FLOW COUPLER DEVICE AND SYSTEM |
SYNOVIS MICRO COMPANIES ALLIANCE, INC. |
MELISSA J FORTH |
| K102694 |
12/09/2010 |
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES |
SYNTHES (USA) |
CHRISTOPHER HACK, ESQ |
| K102656 |
12/20/2010 |
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM |
SYNTHES (USA) |
ALAN T HALEY |
| K093299 |
12/16/2010 |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
SYNTHES (USA) |
ALAN T HALEY |
| K093762 |
12/20/2010 |
SYNTHES ZERO-P |
SYNTHES SPINE |
AMNON TALMOR |
| K093592 |
02/25/2010 |
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K093712 |
02/19/2010 |
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K093005 |
02/05/2010 |
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 |
TaiDoc Technology Corporation |
TELING HSU |
| K093635 |
02/18/2010 |
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K101012 |
12/15/2010 |
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 |
TaiDoc Technology Corporation |
TELING HSU |
| K093641 |
12/08/2010 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
LORI HOLDER |
| K100074 |
02/26/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100075 |
02/26/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K101401 |
12/07/2010 |
NEUMOVENT GRAPHNET MODEL 3179L1V |
TECME S.A. |
RAYMOND KELLY |
| K100261 |
12/10/2010 |
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K100282 |
02/26/2010 |
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER |
TERUMO CORP. |
CHRISTINA FLANAGAN |
| K102658 |
12/10/2010 |
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS |
THAYER MEDICAL CORP. |
JAMES M STRICKLAND |
| K102323 |
12/16/2010 |
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K103247 |
12/10/2010 |
VASCUCOMP |
THERMOTEK, INC. |
NIRAN BALACHANDRAN |
| K092580 |
02/23/2010 |
TIDI FACEMASK |
TIDI PRODUCTS,LLC |
DION J BRANDT |
| K102599 |
12/01/2010 |
TOMOPHASE OCTIS |
TOMOPHASE CORPORATION |
DEREK BEAUPRE |
| K100207 |
02/12/2010 |
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F |
TOPCON CORP. |
TAKAO SUGAWARA |
| K100445 |
12/03/2010 |
KLASSIC HD HIP SYSTEM |
TOTAL JOINT ORTHOPEDICS, INC. |
KIT CARIQUITAN |
| K093865 |
02/17/2010 |
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CINDY KNAPP |
| K093741 |
02/25/2010 |
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, LTD. |
Cynthia Knapp |
| K094019 |
02/12/2010 |
GLIDER PTA BALLOON CATHETER |
TRIREME MEDICAL INC |
DENNIS SALZMANN |
| K101861 |
12/22/2010 |
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM |
TRUEVISION SYSTEMS, INCORPORATED |
BURTON TRIPATHI |
| K102367 |
12/08/2010 |
OPTIGEN TOTAL KNEE SYSTEM |
U&I CORP. |
GYEONG-JE KWON |
| K091612 |
02/24/2010 |
UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K101522 |
12/23/2010 |
ULTRA SEAL STERILE LUBRICATING JELLY |
ULTRA SEAL CORPORATION |
JAMES DAVIS |
| K102997 |
12/21/2010 |
SONIXTABLET ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K100780 |
12/14/2010 |
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA |
UNILENE S.A.C. |
KEVIN WALLS, RAC |
| K102134 |
12/23/2010 |
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
DAVID O CHANG |
| K103239 |
12/30/2010 |
IRRIGATION SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103437 |
12/23/2010 |
US ENDOSCOPY CYTOLOGY BRUSH |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K093653 |
02/23/2010 |
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
URESIL, LLC |
LEV MELINYSHYN |
| K100251 |
02/17/2010 |
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 |
USGI MEDICAL |
MARY L MOONEY |
| K102931 |
12/30/2010 |
G-CINCH SUTURE GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
| K100504 |
12/01/2010 |
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 |
VALERITAS, LLC |
SCOTT HUIE |
| K101294 |
12/27/2010 |
PT2 VARIAN PROTON THERAPY SYSTEM |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K103405 |
12/22/2010 |
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K101659 |
12/16/2010 |
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K103283 |
12/03/2010 |
PHYSIOFLOW ENDURO |
VASOCOM, INC. |
JAMES GUNNERSON |
| K102404 |
12/02/2010 |
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) |
VENTUS MEDICAL, INC. |
MICHAEL NEVARES |
| K103502 |
12/21/2010 |
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 |
VERIDEX, LLC |
SARAH MCMANUS |
| K102654 |
12/03/2010 |
VERTEX RAPID SIMPLIFIED |
VERTEX-DENTAL B.V. |
WILLIAM GREENROSE |
| K102341 |
12/16/2010 |
VIPI BLOCK |
VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE |
Kevin Walls |
| K093688 |
02/04/2010 |
CANON, MODEL URS-50RF |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K100125 |
02/25/2010 |
VISION SCIENCES FLEXIBLE ENT SCOPE |
VISION-SCIENCES, INC. |
LILLIAN QUINTERO |
| K100060 |
12/15/2010 |
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K101003 |
12/10/2010 |
RAPIDVIT BLAST, RAPIDWARM BLAST |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K102419 |
12/16/2010 |
GSP NEONATAL IRT KIT (3306-001U) |
WALLAC OY, SUBSIDIARY OF PERKINELMER |
SUSAN K HAMANN |
| K091757 |
02/05/2010 |
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K102111 |
12/07/2010 |
MEDICAL MAGNETIC TAPE RECORDER |
WPR MEDICAL AS |
CONSTANCE G BUNDY |
| K102565 |
12/22/2010 |
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K100146 |
02/02/2010 |
EVOLVE EPS ORTHOLOC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K102352 |
12/02/2010 |
EVOLVE EPS ORTHOLOC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K103374 |
12/14/2010 |
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K093062 |
02/04/2010 |
VERTOS MEDICAL MILD DEVICE KIT |
X-STEN CORP. |
CRAIG COOMBS |
| K102084 |
12/16/2010 |
STIMPOD NMS450 NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY), LTD. |
B ROTHMAN |
| K082230 |
02/03/2010 |
VECTRA PLUS LASER SYSTEM AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |
| K103198 |
12/20/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
YOUNGSHENGPLASTIC CO., LTD |
WU WEI |
| K100040 |
12/03/2010 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
CODE CUBITT |
| K093727 |
02/01/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR |
ZIBO BOLIN GLOVES CO., LTD |
CHU XIAOAN |
| K102593 |
12/20/2010 |
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K102724 |
12/20/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUQUN NEW MATERIAL SCIENCE AND TECHNOLOGY CO |
FRANK LIU |
| K102896 |
12/13/2010 |
TRABECULAR METAL TIBIAL CONE AUGMENTS |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
| K101730 |
12/03/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS |
ZIMMER, INC. |
BRADLEY STRASSER |
| K093846 |
02/04/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS |
ZIMMER, INC. |
BENJAMIN CURSON |
| K101229 |
12/03/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER |
ZIMMER, INC. |
REBECCA BROOKS |
| K093718 |
02/22/2010 |
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 |
ZUTRON MEDICAL LLC |
JORDAN HARTONG |
| K102907 |
12/14/2010 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
