| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K100536 |
02/25/2010 |
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE |
3M UNITEK |
NIEDRE M HECKMAN |
| K103601 |
12/08/2010 |
AUDIT MICROCV IMMUNOASSAY LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K103627 |
12/13/2010 |
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS |
ABBOTT LABORATORIES |
JUDITH R WALLACH |
| K103595 |
12/08/2010 |
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
ACCLARENT, INC. |
GURVINDER SINGH NANDA |
| K103790 |
12/27/2010 |
ACE TRIMARK TRICAM DENTAL IMPLANT |
ACE SURGICAL SUPPLY COMPANY INC. |
DENISE WILLIAMS |
| K103772 |
12/27/2010 |
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) |
ADVANCED MEDICAL DEVICES FACTORY |
XINGYUAN WANG |
| K103573 |
12/06/2010 |
ARTS2 SPINAL FIXATION SYSTEM |
ADVANCED MEDICAL TECHNOLOGIES |
J. D WEBB |
| K103533 |
12/01/2010 |
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K103635 |
12/13/2010 |
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S |
AEROGEN LTD |
MARTHA FOLAN |
| K103544 |
12/02/2010 |
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D |
AGAMATRIX INC |
WILLIAM H MCGRAIL |
| K103597 |
12/08/2010 |
DX-D 100 |
AGFA HEALTHCARE N.V. |
PHIL CUSCUNA |
| K103616 |
12/10/2010 |
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER |
AKTINA MEDICAL PHYSICS CORP. |
TONY SPACCAROTELLA |
| K103610 |
12/09/2010 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Anne Jepson |
| K103615 |
12/09/2010 |
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K100303 |
02/03/2010 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K103714 |
12/21/2010 |
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA |
ANSELL HEALTHCARE PRODUCTS, LLC |
MARY L ARMSTRONG |
| K100404 |
02/16/2010 |
ASCENDX VCF REDUCTION SYSTEM |
AOI MEDICAL, INC. |
JANICE M HOGAN |
| K103535 |
12/01/2010 |
VACPLUS SUCTION UNIT |
APEX MEDICAL CORP. |
|
| K103706 |
12/20/2010 |
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR |
APPLIED CARDIAC SYSTEMS, INC. |
R. BEN GHADIMI |
| DEN100026 |
12/14/2010 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K103705 |
12/20/2010 |
LOW PROFILE SCREWS |
ARTHREX, INC. |
COURTNEY SMITH |
| K100457 |
02/17/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K100479 |
02/18/2010 |
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K100353 |
02/12/2010 |
SPINEWAND SURGICAL DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K100448 |
02/17/2010 |
ASCENSION MODULAR TOTAL SHOULDER SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
STANLEY J HARRIS |
| K100502 |
02/22/2010 |
ASCENSION TOTAL PLATE SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K100537 |
02/25/2010 |
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K103634 |
12/13/2010 |
ASCOM CLINICALCONNEX CARDIOMAX |
ASCOM (US), INC. |
THOMAS KROENKE |
| K103643 |
12/13/2010 |
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) |
ASCOT TECHNOLOGIES, INC. |
MARY E RANDALL |
| K103759 |
12/23/2010 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K103828 |
12/28/2010 |
BILI-THERAPY SPOT TYPE |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K100501 |
02/22/2010 |
MULTIFUNCTIONAL LINEAR PEN |
ATRICURE, INC. |
JAMES LUCKY |
| K103679 |
12/17/2010 |
AXIS PACS, HMS PACS |
AXIS HEALTH CARE, LLC |
RONALD W GRAHAM |
| K103546 |
12/02/2010 |
AYCAN WORKSTATION OSIRIX PRO |
AYCAN DIGITALSYSTEME GMBH |
MATTHIAS BROENNER |
| K100334 |
02/05/2010 |
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 |
B. BRAUN AVITUM AG |
ANGELA J CARAVELLA |
| K103792 |
12/27/2010 |
BARCO MAMMO TOMOSYNTHESIS |
BARCO NV |
LIEVEN DE WANDEL |
| K100402 |
02/16/2010 |
SITE-RITE VISION ULTRASOUND SYSTEM |
BARD ACCESS SYSTEMS, INC. |
KIMBERLY GEISLER |
| K103551 |
12/02/2010 |
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K100489 |
02/19/2010 |
DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 |
BECKMAN COULTER CELLULAR |
JEANNE ROSCOE |
| K103842 |
12/30/2010 |
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K103798 |
12/27/2010 |
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS |
BECTON DICKINSON & CO. |
Thalia Charles |
| K103685 |
12/17/2010 |
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA |
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. |
Diana Hong |
| K100437 |
02/17/2010 |
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K103631 |
12/13/2010 |
SLEEPMINDER BREATHING FREQUENCY INDICATOR |
BIANCAMED LIMITED |
PAUL PHILLIPS |
| K100320 |
02/04/2010 |
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 |
BIO-MEDICAL RESEARCH, LTD. |
DEIRDRE BARROW |
| K103684 |
12/17/2010 |
VRESELECT CULTURE MEDIUM |
BIO-RAD |
FRAN WHITE |
| K103834 |
12/30/2010 |
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS |
Bio-Rad Laboratories |
Juang Wang |
| K103691 |
12/17/2010 |
BIOHORIZONS ABUTMENTS FOR ZIMMER |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K103752 |
12/23/2010 |
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K100469 |
02/18/2010 |
ARCOS INTERLOCKING DISTAL STEMS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K103755 |
12/23/2010 |
TAPERLOC COMPLETE, SIZE 5 AND 6 |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K100409 |
02/16/2010 |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY MS, RAC |
| K103553 |
12/03/2010 |
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION |
BIONOSTICS, INC. |
RANDY BYRD |
| K103746 |
12/23/2010 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K103545 |
12/02/2010 |
BT-350 |
BISTOS CO., LTD. |
STEVE KOHN |
| K103668 |
12/16/2010 |
BNX FINE NEEDLE ASPIRATION SYSTEM |
BOSTON ENDOSCOPIC ENGINEERING |
ANNETTE M FAGNANT |
| K103751 |
12/23/2010 |
MUSTANG BALLOON DILATATION CATHETERS |
BOSTON SCIENTIFIC |
ANNE V ROSSI |
| K100528 |
02/24/2010 |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S |
BREATHE TECHNOLOGIES, INC. |
SUZON LOMMEL |
| K103640 |
12/13/2010 |
MIDMARK IQECG |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
GREG HOLLAND |
| K100310 |
02/03/2010 |
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS |
BTL INDUSTRIES, INC |
RICHARD VINCINS, CQA, RAC (US,EU) |
| K100362 |
02/12/2010 |
CAMBRIDGE HEART OEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K103591 |
12/07/2010 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K100540 |
02/25/2010 |
ASCENT F-COAT MODEL: 006-00097 |
CAO GROUP, INC. |
ROBERT LARSEN |
| K103651 |
12/14/2010 |
CARDIOMED |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K100508 |
02/22/2010 |
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K100468 |
02/18/2010 |
ZEISS INFRARED 800 WITH FLOW 800 OPTION |
CARL ZEISS SURGICAL GMBH |
JUDITH BRIMACOMBE |
| K103734 |
12/22/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K103562 |
12/06/2010 |
CENTURION PRESSURE INJECTABLE EXTENSION SET |
CENTURION MEDICAL PRODUCTS CORPORATION |
MATTHEW K PRICE |
| K103766 |
12/23/2010 |
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
CEPHEID |
KERRY J FLOM |
| K103820 |
12/30/2010 |
REPROBONE DENTAL GRAFTING MATERIAL |
CERAMISYS LTD |
HILLARD W WELCH |
| K100386 |
02/16/2010 |
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Diana Hong |
| K103675 |
12/16/2010 |
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
CHIENMAX VIETNAM CO. LTD |
JIGAR SHAH |
| K103695 |
12/17/2010 |
PREPEX SYSTEM |
CIRC MEDTECH |
SHOSHANA FRIEDMAN |
| K100553 |
02/26/2010 |
BLOOD PRESSURE METER MODEL CH-101 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K100490 |
02/19/2010 |
LITEPAC, MODEL 682 |
CLEAR STREAM TECHNOLOGIES, LTD. |
FIONA NI MHULLAIN |
| K100400 |
02/16/2010 |
PRESTODR PORTABLE |
CMT MEDICAL TECHNOLOGIES, LTD. |
SHLOMI DINES |
| K100360 |
02/12/2010 |
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
COCHLEAR AMERICAS |
SEAN BUNDY |
| K100351 |
02/12/2010 |
NEUROSCOUT STEERABLE GUIDEWIRE |
Codman & Shurtleff, Inc. |
JOAN BARTLE |
| K103568 |
12/06/2010 |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
COLOPLAST A/S |
JANELL A COLLEY |
| K103791 |
12/27/2010 |
PHYSIOGLOVE ES WITH ECG ANALYSIS |
COMMWELL LTD. |
IRVING LEVY |
| K103665 |
12/16/2010 |
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O |
CONMED CORPORATION |
SHAWN RIEDEL |
| K100542 |
02/25/2010 |
CONSENSUS REVISION KNEE SYSTEM |
Consensus Orthopedics, Inc |
LUKE ROSE |
| K100283 |
02/01/2010 |
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
COOK, INC. |
SUSANNE GALIN |
| K100365 |
02/12/2010 |
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K100511 |
02/22/2010 |
COTEC DENTAL IMPLANT SYSTEM |
COTEC IMPLANT CO., LTD. |
JOYCE BANG |
| K100306 |
02/03/2010 |
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES |
COVIDIEN |
MIA PROLI |
| K100418 |
02/16/2010 |
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE |
COVIDIEN |
WING NG |
| K100548 |
02/26/2010 |
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
ANGELA VAN ARSDALE |
| K103709 |
12/20/2010 |
CERACELL DENTAL |
CURASAN AG |
ROGER GRAY |
| K103626 |
12/10/2010 |
CUTERA GENESISPLUS LASER SYSTEM |
CUTERA, INC. |
Connie Hoy |
| K100378 |
02/16/2010 |
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K100424 |
02/16/2010 |
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS |
DANMEDICAL LIMITED |
IAN DRYSDALE |
| K103667 |
12/15/2010 |
SAPPHIRE ST PORTABLE DIODE LASER |
DEN-MAT HOLDINGS, LLC |
ALAN B MATTHEWS |
| K103549 |
12/03/2010 |
DENOVO TEDDY GEL INFANT HEEL WARMER |
DENOVO PRODUCTS LLC |
DALE WALTERS |
| K103653 |
12/13/2010 |
E3 TORQUE CONTROL MOTOR |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K103831 |
12/30/2010 |
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K103712 |
12/20/2010 |
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K100532 |
02/25/2010 |
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K103756 |
12/23/2010 |
DEPUY ATTUNE TOTAL KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K100391 |
02/16/2010 |
DEPUY UNIVERSAL GRIPTION TF CONES |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR, MA |
| K100446 |
02/17/2010 |
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE |
DEVON MEDICAL INC. |
RUTH WU |
| K100312 |
02/04/2010 |
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM |
DGIMED ORTHO, INC |
SCOTT P YOUNGSTROM |
| K100352 |
02/12/2010 |
DIAGNOSOFT HARP MODEL 2.06 |
DIAGNOSOFT, INC. |
JEFFREY ROBERTS |
| K103529 |
12/01/2010 |
LIAISON XL ANALYZER MODEL 10050 |
DIASORIN, INC. |
Mari Meyer |
| K103557 |
12/02/2010 |
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K103600 |
12/08/2010 |
PORTABLE X-RAY SYSTEM |
DIGIMED CORPORATION |
KIM ANTOL |
| K103736 |
12/22/2010 |
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE |
DMC MEDICAL LTD. |
TRACY BEST |
| K100510 |
02/22/2010 |
CERAMIR CROWN & BRIDGE |
DOXA AB |
MARGARETH JORVID |
| K103625 |
12/10/2010 |
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE |
Draeger Medical Systems, Inc. |
JOYCE KILROY |
| K100376 |
02/12/2010 |
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K100438 |
02/17/2010 |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K100487 |
02/19/2010 |
EQUINOX CO2 LASER SYSTEM |
ECLIPSEMED GLOBAL, INC |
Connie Hoy |
| K100358 |
02/12/2010 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K103724 |
12/21/2010 |
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) |
EIZO GMBH |
GUENTER M VOLZ |
| K100425 |
02/16/2010 |
HASKAL TORQUE DEVICE |
ELCAM MEDICAL A.C.A.L. |
SHAY SHAHAM |
| K103738 |
12/22/2010 |
H-WAVE |
ELECTRONIC WAVEFORM LABORATORY, INC. |
RYAN P HEANEY |
| K103747 |
12/23/2010 |
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
ELITECHGROUP SEPPIM S.A.S. |
DEBRA K HUTSON |
| K103608 |
12/09/2010 |
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND |
ELLEX, INC. |
JONATHAN STRAWN |
| K100390 |
02/16/2010 |
SURGIMAX/ SURGIMAX PLUS |
ELLIQUENCE LLC |
JOSEPH AZARY |
| K100377 |
02/12/2010 |
DIAMONDBACK SPINAL SYSTEM |
EMINENT SPINE |
KAREN WARDEN |
| K103801 |
12/28/2010 |
HYPOTHERMX INTRAVENOUS FLUID WARMER |
EMIT CORPORATION |
DARLA J ELKIN |
| K103554 |
12/03/2010 |
METRON-CP/MD |
EPONATECH LLC |
K. BRIAN MATLOCK |
| K100336 |
02/05/2010 |
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 |
ERAGEN BIOSCIENCES |
RANDAL VADER |
| K103696 |
12/17/2010 |
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES |
ERBE USA, INC. |
JOHN TARTAL |
| K100509 |
02/22/2010 |
THL1 LASER |
ERCHONIA CORPORATION |
Kevin Walls |
| K103637 |
12/13/2010 |
ERKA. PERFECT-ANEROID |
ERKA KALLMEYER MEDIZINTECHNIK GMBH |
JAN WEISS |
| K103672 |
12/16/2010 |
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
| K100423 |
02/16/2010 |
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 |
ETHICON, INC. |
NEELU MEDHEKAR |
| K100280 |
02/01/2010 |
GYNCARE MORCELLEX TISSUE MORCELLATOR |
ETHICON, INC. |
BRYAN LISA |
| K100485 |
02/19/2010 |
GYNECARE TVT EXACT CONTINENCE SYSTEM |
ETHICON, INC. |
SUSAN LIN |
| K103618 |
12/10/2010 |
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K100435 |
02/16/2010 |
AMEDA PLATINUM BREAST PUMP |
EVENFLO COMPANY, INC. |
STEVE NOWAK |
| K103719 |
12/21/2010 |
LIFECARE CONDUCTIVE GARMENTS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K103699 |
12/20/2010 |
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC |
EXACTECH, INC. |
SHING JEN TAI, PHD |
| K103655 |
12/15/2010 |
OCTANE-C INTERBODY FUSION DEVICE SYSTEM |
EXACTECH, INC. |
PATRICK HUGHES |
| K103783 |
12/27/2010 |
EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC |
FIAB S.P.A. |
ALBERTO CALABRO |
| K100333 |
02/05/2010 |
FIAB SPA, MODELS F7244, F7233, F7234, F7277 |
FIAB SPA |
FRANCESCO BATISTINI |
| K103767 |
12/23/2010 |
DUAL HEATED INFANT VREATHING CIROUITS |
FISHER & PAYKEL HEALTHCARE LTD. |
ROBERT PETRY |
| K100554 |
02/26/2010 |
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 |
FISHER & PAYKEL HEALTHCARE, LTD. |
IVY CHENG |
| K103786 |
12/27/2010 |
ZEST PETITE NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K103840 |
12/10/2010 |
CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE |
FLEXBAR MACHINE CORP. |
STEPHEN T MLCOCH |
| K103550 |
12/03/2010 |
YOBOSHI DENTAL UNIT |
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD |
SABRINA WEI |
| K103687 |
12/17/2010 |
SYNAPSE 3D CEREBRAL ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K103720 |
12/21/2010 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KIMERLY A SHARP |
| K103596 |
12/08/2010 |
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KATHERINE Y CHOI |
| K103676 |
12/16/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA LYN DICKSON |
| K100364 |
02/12/2010 |
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K100451 |
02/17/2010 |
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 |
| K103832 |
12/30/2010 |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K103649 |
12/15/2010 |
VOLUSON S6, VOLUSON S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K103802 |
12/28/2010 |
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
GE HEALTHCARE FINLAND OY |
TATJA PASANEN |
| K103633 |
12/13/2010 |
ACHILLES |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
CHRIS PAULIK |
| K103678 |
12/16/2010 |
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
ALBRECHT MALKMUS |
| K103765 |
12/23/2010 |
MAC 600 RESTING ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
JOE LUCAS |
| K103730 |
12/21/2010 |
GE LUNAR VISCERAL FAT SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
CHRIS PAULIK |
| K103671 |
12/16/2010 |
GENESYS SPINE TILOCK SYSTEM |
GENESYS SPINE |
BRIAN J BERGERON |
| K103745 |
12/23/2010 |
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
WENDY A MCMANUS |
| K103757 |
12/23/2010 |
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT |
GRIFOLS |
Gary Lehnus |
| K100411 |
02/16/2010 |
VARIOUS DENTAL IMPLANTS |
GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC |
WILLIAM SIMMONS |
| K100516 |
02/23/2010 |
ANYPLUS PEEK CAGES |
GS MEDICAL CO., LTD. |
DONALD W GUTHNER |
| K100551 |
02/26/2010 |
ORLOCATE SYSTEM MODEL ORL 100 |
HALDOR ADVANCED TECHNOLOGIES LTD |
SARIT GELBART GAL-ROM |
| K103803 |
12/28/2010 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
FREDERIKE BRUEHSCHWEIN |
| K100389 |
02/16/2010 |
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT |
HANDPIECE HEADQUARTERS |
TINA STEFFAINE-OAK |
| K103538 |
12/02/2010 |
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 |
HARDY DIAGNOSTICS |
WENDY HADLEY |
| K103585 |
12/07/2010 |
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP |
HARRY J. BOSWORTH CO. |
GARY CHUVEN |
| K100531 |
02/24/2010 |
VISCOPE, MODEL 100P,100S |
HD MEDICAL SERVICES (INDIA) PVT.LTD |
BILL MURPHY |
| K100327 |
02/04/2010 |
HEARTWAY POWER CHAIR, P23 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
| K103641 |
12/13/2010 |
GUARDACARE |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K103537 |
12/02/2010 |
ET III SA ULTRA WIDE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K100369 |
02/12/2010 |
POWDER-FREE NITRILE GLOVES, BLACK |
HL RUBBER INDUSTRIES SDN BHD |
LAU SIONG HUT |
| K100496 |
02/22/2010 |
INVADER MTHFR 1298 |
HOLOGIC, INC. |
RANDALL J COVILL |
| K103788 |
12/27/2010 |
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
HORIBA ABX SAS |
CAROLINE FERRER |
| K100350 |
02/12/2010 |
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT |
HOVEROUND CORP. |
TONY GIOVANNI |
| K100527 |
02/24/2010 |
HOVEROUND TEKNIQUE, MODEL HD-6 |
HOVEROUND CORP. |
TONY DIGIOVANNI |
| K103835 |
12/30/2010 |
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K100475 |
02/18/2010 |
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K100401 |
02/16/2010 |
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM |
HU-FRIEDY MFG. CO., INC |
MARIA VRABIE |
| K103613 |
12/09/2010 |
INPECTRA STO2 SPOT CHECK |
HUTCHINSON TECHNOLOGY, INC. |
COLIN M MCGRAW |
| K100523 |
02/24/2010 |
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA |
HYGIA HEALTH SERVICES, INC. |
LAKE TRECHSEL |
| K100315 |
02/04/2010 |
12 LEAD GLOVE |
I NEEDMD, INC |
IRVING L WIESEN, ESQ |
| K100305 |
02/03/2010 |
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER |
ICOTEC |
BARBARA ATZENHOEFER STEGMEIER |
| K100434 |
02/16/2010 |
CLAVE NEUTRON |
ICU MEDICAL, INC. |
TRACY BEST |
| K100534 |
02/25/2010 |
DENV DETECT IGM CAPTURE ELISA |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
| K103737 |
12/22/2010 |
OMNI II PATIENT MONITOR |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K103648 |
12/14/2010 |
COLLAGEN POWDER |
INNOCOLL PHARMACEUTICALS LTD |
AARON WYSE |
| K103670 |
12/16/2010 |
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) |
INNOVATIVE GLOVES CO; LTD |
RAJEEV SOOD |
| K100517 |
02/23/2010 |
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K100518 |
02/23/2010 |
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K103742 |
12/23/2010 |
ACCELL EVO3 (FORMERLY ACCELL A2I) |
INTEGRA LIFESCIENCES |
JENNY FAM |
| K103726 |
12/22/2010 |
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS |
INTEGRA LIFESCIENCES CORPORATION |
STEPHANIE SHEESLEY |
| K100417 |
02/16/2010 |
XKNIFE 5 |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K103760 |
12/23/2010 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K103741 |
12/23/2010 |
SURGISURE TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL, INC. |
JOHN J VOZELLA |
| K103523 |
12/01/2010 |
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103525 |
12/01/2010 |
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103527 |
12/01/2010 |
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K103524 |
12/01/2010 |
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K100441 |
02/17/2010 |
XINIWAVE, MODEL XW-18 |
INTERNATIONAL TRADE GROUP, INC. |
BRENT C REIDER |
| K103700 |
12/20/2010 |
ESSENTIAL MRI PATIENT MONITOR |
INVIVO CORPORATION |
RUSTY KELLY |
| K103586 |
12/07/2010 |
IOS FASTSCAN SPRAY |
IOS TECHNNOLOGIES, INC. |
DUANE DURBIN |
| K103799 |
12/28/2010 |
INQU PASTE MIX PLUS |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER, JD, RAC |
| K103556 |
12/02/2010 |
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 |
| K103697 |
12/20/2010 |
TORQTECH |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K103817 |
12/29/2010 |
POSEY BED |
J. T. POSEY CO. |
ROBERT KELLEHER |
| K103778 |
12/27/2010 |
LEFORTE NEURO SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
PAUL SUMNER |
| K103830 |
12/30/2010 |
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) |
JIANGSU SHENLI MEDICAL PRODUCTION FACTORY |
DARREN REEVES |
| K103743 |
12/23/2010 |
CONCORDE CURVE SYSTEM |
JOHNSON & JOHNSON |
EUGENE BANG |
| K100349 |
02/12/2010 |
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER |
JOHNSON & JOHNSON VISION CARE, INC. |
CATHERINE DILLON |
| K103617 |
12/10/2010 |
DIGITAL FOREHEAD THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K103797 |
12/27/2010 |
K2M COCR WIRE |
K2M, INC. |
NANCY GIEZEN |
| K103800 |
12/28/2010 |
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS |
KAZ USA, INC (A SUBSIDIARY OF KAZ INC) |
RAJ KASBEKAR |
| K103839 |
12/30/2010 |
BEHIND EAR GENTLE TOUCH THERMOMETER |
KAZ, INC. |
RAJ S KASBEKAR |
| K100500 |
02/22/2010 |
PSL CLASSIC SLIT LAMP |
KEELER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K103582 |
12/08/2010 |
KELYNIAM CUSTOM SKULL IMPLANT (CSI) |
KELYNIAM GLOBAL, INC |
JAMES KETNER |
| K103787 |
12/27/2010 |
MEDEOR MATRIX |
KENSEY NASH CORP. |
Lori Burns |
| K100526 |
02/24/2010 |
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE |
KENTEC MEDICAL, INC. |
KEITH ROOKS |
| K100347 |
02/12/2010 |
OPTIBOND SE |
KERR CORPORATION |
Wendy Garman |
| K103810 |
12/29/2010 |
KJ SUBMERGED SYSTEM |
KJ MEDITECH CO., LTD |
Priscilla Chung |
| K103703 |
12/20/2010 |
REGUIS SIGMA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K100328 |
02/04/2010 |
CLEARFIL MAJETY POSTERIOR |
KURARAY MEDICAL INC. |
KIYOYUKI ARIKAWA |
| K100373 |
02/12/2010 |
TYCHE PEDICLE SCREW SYSTEM |
KYUNGWON MEDICAL CO., LTD. |
JOYCE BANG |
| K100429 |
02/16/2010 |
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K100430 |
02/16/2010 |
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K103660 |
12/15/2010 |
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
LANX, INC. |
WILLIAM SANDUL |
| K103666 |
12/15/2010 |
LANX LATERAL |
LANX, INC. |
ALAN BRUKHOLDER |
| K103686 |
12/17/2010 |
STAR 50 N |
LARSEN & TOUBRO LIMITED |
E. J SMITH |
| K103763 |
12/23/2010 |
STELLAR 300 |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K103574 |
12/06/2010 |
PREGNANCY ONE STEP RAPID TEST |
Lehnus & Associates Consulting |
Gary Lehnus |
| K103771 |
12/27/2010 |
LOTUS BLAKE ESTEEM SCOOTER |
LETRIX POWER HANGZHOU PTY LTD |
ROBERT DUNN |
| K100407 |
02/16/2010 |
LIFE SPINE INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
CHARLES P GILL |
| K103547 |
12/02/2010 |
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
LIGHTMED CORP. |
JOCELYN LIU |
| K100415 |
02/16/2010 |
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM |
LUMENIS |
AHAVA STEIN |
| K100384 |
02/16/2010 |
FIBERLASE C02 LASER WAVEGUIDE |
LUMENIS, LTD. |
AHAVA STEIN |
| K103776 |
12/27/2010 |
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| K100385 |
02/16/2010 |
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP |
LUV N' CARE, LTD. |
JEAN ASQUITH |
| K100278 |
02/01/2010 |
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K100403 |
02/16/2010 |
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100428 |
02/16/2010 |
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100366 |
02/12/2010 |
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY |
MAXTER CATHETERS |
M. BERNARD DAURELLE |
| K103721 |
12/21/2010 |
MPACT ACETABULAR SYSTEM |
MEDACTA INTERNATIONAL |
NATALIE J KENNEL |
| K100314 |
02/04/2010 |
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US |
MEDACTA INTERNATIONAL, SA |
HEATHER NEELY |
| K100372 |
02/12/2010 |
SAFECT MODEL VER 1.0 |
MEDIC VISION BRAIN TECHNOLOGIES LTD |
DAN LAOR |
| K100388 |
02/16/2010 |
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
WAYNE GEROW |
| K103530 |
12/01/2010 |
SPIRODOC |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
ED KOHERE |
| K103805 |
12/28/2010 |
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K100484 |
02/18/2010 |
IMPIX MANTA CERVICAL INTERBODY DEVICE |
MEDICREA |
J.D. WEBB |
| K100544 |
02/25/2010 |
IMPIX LUMBAR INTERBODY DEVICE |
MEDICREA TECHNOLOGIES |
JD WEBB |
| K100297 |
02/02/2010 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K100543 |
02/25/2010 |
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 |
MEDISISS |
BRANDI JAMES |
| K103722 |
12/21/2010 |
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
PARK KYEONG-MI |
| K103735 |
12/22/2010 |
MEDILED MINI |
MEDIX I.C.S.A. |
JAMES H KNAUSS |
| K103718 |
12/21/2010 |
DYNACOR LUBRICATION GEL |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K103602 |
12/08/2010 |
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K100302 |
02/03/2010 |
MEDLINE PVC URETHRAL CATHETER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K100284 |
02/01/2010 |
LIQUIBAND ULTIMA, LUT 003 |
MEDLOGIC GLOBAL LIMITED |
MICHAEL BROWNE |
| K100470 |
02/18/2010 |
GTX 12 GIDEWIRE |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K103764 |
12/23/2010 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
YUKIKO CORSON |
| K100432 |
02/16/2010 |
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS |
MEDTRONIC MINIMED |
MARK FAILLACE |
| K103731 |
12/22/2010 |
CAPSTONE R SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
THAO PHAN |
| K103565 |
12/06/2010 |
MEDVOXEL HEARTPRO SOFTWARE APPLICATION |
MEDVOXEL SYSTEMS INC |
BONNIE SEWLOCHAN |
| K100521 |
02/23/2010 |
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS |
MEGO AFEK AC LTD |
AVAHA STEIN |
| K103561 |
12/06/2010 |
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K100414 |
02/16/2010 |
PROTOE ENDOSORB SMALL HAMMER TOE PIN |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K103599 |
12/08/2010 |
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 |
MERIDIAN MEDICAL SYSTEMS, LLC |
ARIEL MARCIANO |
| K100319 |
02/04/2010 |
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L |
MERIT MEDICAL SYSTEMS, INC. |
JEFF CARLSTROM |
| K103656 |
12/15/2010 |
THERMO SCIENTIFIC MAS R DOA TOTAL |
Microgenics Corporation |
LISA CHARTER |
| K103680 |
12/17/2010 |
MICROLIFE DIGITAL UNDERARM THERMOMETER |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K100454 |
02/17/2010 |
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K103758 |
12/23/2010 |
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K103780 |
12/27/2010 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K103576 |
12/06/2010 |
MIM 5.2 (BRACHY) |
MIM SOFTWARE INC. |
LYNN HANIGAN |
| K103785 |
12/27/2010 |
MOBILE MIM |
MIM SOFTWARE INC. |
LYNN HANIGAN |
| K100313 |
02/04/2010 |
HYDROFIX SURGICAL SHEET |
MIMEDX GROUP, INC |
SALLY THORSEN |
| K100449 |
02/17/2010 |
MINXRAY MODEL CMDR-2S |
MINXRAY, INC. |
DANIEL KAMM, P.E. |
| K103715 |
12/21/2010 |
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE |
MIRADOR BIOMEDICAL, INC. |
JUSTIN HULVERSHORN |
| K103784 |
12/27/2010 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K103795 |
12/27/2010 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K100447 |
02/17/2010 |
MYOSCIENCE CRYO-TOUCH |
MYOSCIENCE INC |
TRACEY HENRY |
| K100497 |
02/22/2010 |
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) |
N.M.B. MEDICAL APPLICATIONS, LTD. |
HILA WACHSLER-AVRAHAMI |
| K103589 |
12/07/2010 |
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
NATUS MEDICAL INCORPORATED |
JULIE FREED |
| K103833 |
12/30/2010 |
NEOPIP PATIENT CIRCUIT WITH PEEP |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
| K100288 |
02/01/2010 |
NEOMED ENTERAL ONLY EXTENSION SET |
NEOMED, INC. |
PENNY NORTHCUTT |
| K103623 |
12/10/2010 |
NEWDEAL INTERPHALANGEAL IMPLANT |
NEWDEAL SAS |
MARILYSE LATOUR |
| K100520 |
02/23/2010 |
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K100512 |
02/22/2010 |
NOBELPROCERA IPS E.MAX CROWN |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K100371 |
02/12/2010 |
SPY INTRA-OPERATIVE IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
DANA NOHYNEK |
| K103750 |
12/23/2010 |
NUVASIVE TRAVERSE PLATE SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K100335 |
02/05/2010 |
ORS VISUAL |
OBJECT RESEARCH SYSTEMS, INC. |
ERIC FOURNIER |
| K100345 |
02/05/2010 |
SYSTEMS INTEGRATION MODEL: ENDOALPHA |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY KLUESNER |
| K100275 |
02/01/2010 |
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS |
OLYMPUS WINTER & IBE GMBH |
STACY KLUESNER |
| K103650 |
12/14/2010 |
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM |
OON CORP. RESOURCES |
JANNA P TUCKER |
| K103657 |
12/15/2010 |
SAPPHIRE |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
| K103808 |
12/29/2010 |
SAPPHIRE NC |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
| K100499 |
02/22/2010 |
ORGENTEC RHEUMATOID FACTOR EIA |
ORGENTEC DIAGNOSTIKA GMBH |
Gary Lehnus |
| K100367 |
02/12/2010 |
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 |
ORIGIO A/S |
RONALD G LEONARDI |
| K103829 |
12/30/2010 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
| K103837 |
12/30/2010 |
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K100354 |
02/12/2010 |
PRIMAL OK INTERSPINOUS FUSION SYSTEM |
OSTEOMED L.P. |
KAREN E WARDEN |
| K103594 |
12/08/2010 |
PONTO PRO POWER |
OTICON MEDICAL AB |
ULRIKA NIELSEN |
| K103664 |
12/16/2010 |
PRIMUS AESTHETIC PLATFORM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K100380 |
02/16/2010 |
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 |
PARI RESPIRATORY EQUIPMENT, INC. |
JAMES L MCINTIRE |
| K100546 |
02/25/2010 |
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE |
PARKERMEDICALINC |
LEWIS WARD |
| K100462 |
02/18/2010 |
JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K103775 |
12/27/2010 |
PEAK SUCTION COAGULATOR |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K103604 |
12/09/2010 |
ISA CO2, ISA AX+, ISA OR+ |
PHASEIN AB |
DAVID WEISSBURG |
| K100495 |
02/19/2010 |
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 |
PHILIPS ELECTRONICS UK LIMITED |
MIRIAM SHARIF-MURRAY |
| K103652 |
12/14/2010 |
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 |
PHILIPS MEDICAL SYSTESMS |
LAWRENCE MILANA |
| K100420 |
02/16/2010 |
PHILIPS OBTRACEVUE MODEL SW REV. G.00 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MICHAEL ASMALSKY |
| K103815 |
12/29/2010 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
NANCY P BURKE |
| K103646 |
12/14/2010 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILLIPS MEDICAL SYSTEMS |
CLAIRE ARAKAKI |
| K103748 |
12/23/2010 |
LAGUNA PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K103567 |
12/06/2010 |
LIFEPAK 15 MONITOR/DEFIBRILLATOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K100292 |
02/02/2010 |
CAAS QVA 3D, CAAS QCA 3D |
PIE MEDICAL IMAGING B.V. |
SASKIA LLOYD |
| K103729 |
12/22/2010 |
INFILL INTERVERTEBRAL BODY FUSION DEVICE |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K100361 |
02/12/2010 |
NANOSS BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE, MD |
| K103689 |
12/17/2010 |
PLANMECA PROMAX 3D MID |
PLANMECA OY |
LARS MORING |
| K103575 |
12/06/2010 |
SPIRO PD |
PMD HEALTHCARE |
E.J. Smith |
| K100524 |
02/24/2010 |
POLYTEL(R) APT MODEL: PWA-08-01 |
POLYMAP WIRELESS, LLC |
PIERRE LANDAU |
| K100550 |
02/26/2010 |
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K100356 |
02/12/2010 |
TDS PRECISION DENTAL BAR |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TASO |
| K100545 |
02/26/2010 |
SLEEPRIGHT |
POWER PRODUCTS, INC.-SPLINTEK |
MELAINE HASEK |
| K103563 |
12/06/2010 |
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K103838 |
12/30/2010 |
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN, PHD. |
| K103819 |
12/30/2010 |
PSL ANTERIOR CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN |
| K100539 |
02/25/2010 |
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE |
PREVENTIVE TECHNOLOGIES, INC. |
KENNETH S PETERSON |
| K100341 |
02/05/2010 |
SPERMCHECK FERTILITY |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K103540 |
12/02/2010 |
PSORIA-LIGHT |
PSORIA-SHIELD INC. |
WAYNE GLOVER |
| K100503 |
02/22/2010 |
PULPDENT COPAL VARNISH WITH FLUORIDE |
PULPDENT CORPORATION |
KENNETH J BERK |
| K100343 |
02/05/2010 |
PAP-CAP |
PUR-SLEEP, INC. |
PAUL DRYDEN |
| K103539 |
12/02/2010 |
QUANTA SYSTEM DUOLITE |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K103744 |
12/23/2010 |
DROPPER A1C DIABETES CONTROL |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
| K100474 |
02/18/2010 |
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W |
QUICKLASE LIMITED |
CALVIN OSTLER |
| K100552 |
02/26/2010 |
RAYSTATION VERSION 1.0 |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K103564 |
12/06/2010 |
VENOFER PUMP |
RENAL SOLUTIONS, INC. |
DAVID VANELLA |
| K100285 |
02/01/2010 |
LITETOUCH MASK |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K103578 |
12/06/2010 |
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST |
RESPIRONICS NOVAMETRIX, LLC |
KEVIN MADER |
| K100461 |
02/18/2010 |
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K103716 |
12/21/2010 |
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET |
Roche Diagnostics |
KATHIE J GOODWIN |
| K100538 |
02/25/2010 |
TINA-QUANT FERRITIN GEN. 4 |
Roche Diagnostics |
KATHIE J GOODWIN |
| K103661 |
12/16/2010 |
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE |
RUBBERCARE PROTECTION PRODUCTS SDN BHD |
LIM KWEE SHYAN |
| K100450 |
02/17/2010 |
I-ROOT |
S-DENTI CO., LTD. |
TAE KYE NAM |
| K100382 |
02/16/2010 |
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 |
SALUMEDICA, L.L.C. |
BOB BRADEN |
| K100410 |
02/16/2010 |
PIEZOELECTRIC SYSTEM |
SATELEC |
RICK ROSATI |
| K103841 |
12/22/2010 |
BELIMED STEAM STERILIZER MST-V |
SAUTER AG |
HANS STADLER |
| K103812 |
12/29/2010 |
MITRA-LIFT |
SCIENCITY CO., LTD |
JOYCE BANG |
| K100307 |
02/03/2010 |
GELSCAN, MODEL 1206 |
SEBIA |
KAREN ANDERSON |
| K103522 |
12/01/2010 |
SEDECAL |
SEDECAL S.A. |
DANIEL KAMM, P.E. |
| K100525 |
02/24/2010 |
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
SEPPIM S.A.S. |
Debra Hutson |
| K100547 |
02/25/2010 |
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K103619 |
12/10/2010 |
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) |
SHANDONG BLUE SAIL INNOVATION CO., LTD. |
YONGCHEN ZHANG |
| K100439 |
02/17/2010 |
MEDIWORKS SLIT LAMP |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
LISA ZHANG |
| K100394 |
02/16/2010 |
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A |
SHANGHAI 3F ELECTRONICS CO LTD |
CHARLES MACK |
| K103560 |
12/03/2010 |
SHASER IPL HAIR REMOVAL SYSTEM |
SHASER, INC. |
GLEN EMELOCK |
| K103542 |
12/02/2010 |
GENSTRIP TEST STRIP MODEL 100-201 |
SHASTA TECHNOLOGIES, LLC |
CAROLINE TONTINI |
| K100488 |
02/19/2010 |
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K103584 |
12/07/2010 |
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
STEPHEN H GORSKI |
| K103583 |
12/07/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103677 |
12/16/2010 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103723 |
12/21/2010 |
SICAT IMPLANT V1.2 |
SICAT GMBH & CO. KG |
MARK W SHEEHAN |
| K100289 |
02/02/2010 |
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 |
SIEMENS HEALTHCARE DIAGNOSTICS |
Sandra D White |
| K100321 |
02/04/2010 |
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 |
02/05/2010 |
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE MARINELLI |
| K100433 |
02/16/2010 |
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROBERT C EUSEBIO |
| K103683 |
12/17/2010 |
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) |
SIEMENS HEALTHCARE DIAGNOSTICS |
Garo Mimaryan |
| K103612 |
12/09/2010 |
DIMENSION VISA ENZ 2 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
ANNA MARIE K ENNIS |
| K103836 |
12/30/2010 |
ENZYME II CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
ANNA MARIE KATH ENNIS |
| K103548 |
12/03/2010 |
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 |
Siemens Healthcare Diagnostics Inc. |
Sandra D White |
| K100375 |
02/12/2010 |
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 |
| K103701 |
12/20/2010 |
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K100293 |
02/02/2010 |
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
Ernest Joseph |
| K103606 |
12/09/2010 |
ARTISTE SOLUTION WITH SYS_VB50 UPDATE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K100370 |
02/12/2010 |
SYMMETRIC TOTAL KNEE AGUMENTS |
SIGNAL MEDICAL CORP. |
BRIAN KATERBERG |
| K103711 |
12/20/2010 |
ORTHOPHOS XG 3D / CEPH |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K103753 |
12/23/2010 |
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K103579 |
12/06/2010 |
INTRA SKAN DC |
SKANRAY TECHNOLOGIES |
PARASURAMAPPA BELUR |
| K103793 |
12/27/2010 |
DURAFIBER AG |
Smith & Nephew, Inc |
TERRY MCMAHON |
| K100412 |
02/16/2010 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K100325 |
02/04/2010 |
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES |
SMITH & NEPHEW, INC. |
LAURA MEDLIN |
| K100481 |
02/18/2010 |
SMITH & NEPHEW MDF MODULAR SLEEVE |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K103682 |
12/17/2010 |
PARIETEX PROGRIP |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K103813 |
12/29/2010 |
SOPRO 281 |
SOPRO |
RICK ROSATI |
| K103762 |
12/23/2010 |
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON, RN, MED, RAC |
| K100507 |
02/22/2010 |
XRES BLOOD COLLECTION RESERVOIR |
SORIN GROUP ITALIA S.R.L |
BARRY SALL |
| K103732 |
12/22/2010 |
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR |
SPACELABS HEALTHCARE LTD. |
THOMAS KROENKE |
| K103740 |
12/22/2010 |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
DAVID L ROSEN, B.S. PHARM., J.D. |
| K100290 |
02/02/2010 |
ESTEMP NE |
SPIDENT CO., LTD. |
I.S. HWANG |
| K100413 |
02/16/2010 |
TEMP IT |
SPIDENT CO., LTD. |
I.S. WHANG |
| K103781 |
12/27/2010 |
MED-LOK SAFETY NEEDLE |
STA-MED, LLC |
RANDALL MAY |
| K100398 |
02/16/2010 |
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM |
STANDARD DIAGNOSTICS, INC. |
SUSAN GOLDSTEIN-FALK |
| K103654 |
12/15/2010 |
VELA XL |
STARMEDTEC GMBH |
GREGOR WEIDEMANN |
| K100395 |
02/16/2010 |
HARMONY VLED SURGICAL LIGHTNING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K103536 |
12/01/2010 |
IBED WIRELESS WITH IBED AWARENESS |
STRYKER CORPORATION |
Diane Horwitz |
| K103807 |
12/29/2010 |
IVAS 2-10MM (10 GUAGE) BALLON CATHETER |
STRYKER CORPORATION |
MELISSA KANN |
| K103693 |
12/17/2010 |
VANTAGE ABI |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K100442 |
02/17/2010 |
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM |
SURGICAL INNOVATIONS GROUP PLC |
MIKE WHITE |
| K103692 |
12/17/2010 |
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
DANIEL DONOVAN |
| K103713 |
12/21/2010 |
ELTA WOUND CLEANSER |
SWISS AMERICAN PRODUCTS, INC. |
ERIC LUO |
| K103770 |
12/27/2010 |
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL |
SYNTEX HEALTHCARE PRODUCTS CO., LTD |
KATHY LIU |
| K103558 |
12/02/2010 |
SYNTHES SCOUT VESSEL GUARD |
SYNTHES SPINE |
HEATHER GUERIN |
| K103822 |
12/30/2010 |
SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
SYNTHES USA PRODUCTS, LLC |
JEFFREY L DOW |
| K100405 |
02/16/2010 |
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100427 |
02/16/2010 |
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY |
TaiDoc Technology Corporation |
TELING HSU |
| K100406 |
02/16/2010 |
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100322 |
02/04/2010 |
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K100339 |
02/05/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN CHANGRONG GLOVE CO., LTD. |
CHU XIAOAN |
| K100324 |
02/04/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HENGTONG PLASTIC PRODUCTS CO. |
CHU XIAOAN |
| K100326 |
02/04/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD |
CHU XIAOAN |
| K100392 |
02/16/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN JIAXING PLASTIC PRODUCTS CO., LT |
CHU XIAOAN |
| K100337 |
02/02/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN QIXIN GLOVE CO., LTD. |
CHU XIAOAN |
| K100419 |
02/16/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN YONGKANG GLOVE CO., LTD |
CHU XIAOAN |
| K100421 |
02/16/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN YONKSHUN GLOVE, CO., LTD |
CHU XIAOAN |
| K103673 |
12/16/2010 |
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
DONNA T LINK |
| K103816 |
12/29/2010 |
COHESION BONE CEMENT |
TEKNIMED, S.A.S. |
J. D WEBB |
| K100506 |
02/22/2010 |
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK |
TELEFLEX MEDICAL |
VALERIE FOLLOWELL |
| K103658 |
12/15/2010 |
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER |
TELEFLEX, INC. |
PAUL AMUDALA |
| K103796 |
12/27/2010 |
TELEMEDCARE HEALTH MONITOR |
TELEMEDCARE PTY LTD |
STEVEN M MOODY |
| K103698 |
12/20/2010 |
TENSCARE ITOUCH SURE MODEL ITS |
TENSCARE LTD. |
ANDREW BROWN |
| K100282 |
02/01/2010 |
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER |
TERUMO CORP. |
CHRISTINA FLANAGAN |
| K103647 |
12/13/2010 |
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES |
THD SPA |
GUIDO BONAPACE |
| K103824 |
12/30/2010 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS |
THE BINDING SITE |
SUZANNE HORNE |
| K100455 |
02/17/2010 |
SPAPLUS ANALYZER |
THE BINDING SITE |
JAY GELLER |
| K103708 |
12/20/2010 |
ML24000 UVA-1 PHOTOTHERAPY UNIT |
THE DAAVLIN DISTRIBUTING COMPANY |
MICHAEL THIEL |
| K103761 |
12/23/2010 |
VISUALIZE: VASCULAR |
THE MEDIPATTERN CORPORATION |
ERIN WALSH |
| K103531 |
12/01/2010 |
PRESTIGE 24I; BIOLIS 24I; MGC 240 |
TOKYO BOEKI MEDISYS INC. |
James M Clinton |
| K103782 |
12/27/2010 |
4D MV-ASSESSMENT 2.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K103629 |
12/13/2010 |
PET-512MC TRANSESOPHAGEAL TRANSDUCER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K103645 |
12/13/2010 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K100304 |
02/03/2010 |
ST AIA PACK HBA1C |
Tosoh BioScience, Inc. |
Judith Ogden |
| K100445 |
02/17/2010 |
KLASSIC HD HIP SYSTEM |
TOTAL JOINT ORTHOPEDICS, INC. |
KIT CARIQUITAN |
| K103532 |
12/01/2010 |
AUTOREADER 2 |
TREK DIAGNOSTIC SYSTEMS |
Cynthia Knapp |
| K103577 |
12/06/2010 |
TRINON Q & Q3 IMPLANT SYSTEM |
TRINON TITANIUM GMBH |
MARKUS DENK |
| K103534 |
12/01/2010 |
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K103659 |
12/15/2010 |
CS 9300, CS 9300C |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K103814 |
12/29/2010 |
PEZO INTERBODY CAGES SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K100301 |
02/03/2010 |
OPAL BOND FLOW |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K100363 |
02/12/2010 |
ULTRA DCI MODEL 5000 |
ULTRASOUND MEDICAL DEVICES, INC. |
PAUL KORTESOJA |
| K103710 |
12/20/2010 |
WBR XPRESS PET |
ULTRASPECT LTD. |
DAN LAOR |
| K100456 |
02/17/2010 |
CVUE ADVANCED DEFINITIVE |
UNILENS CORP., USA |
MARTIN DALSING |
| K103733 |
12/22/2010 |
UNITED U2 XPE TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K103694 |
12/17/2010 |
TISSUE SAMPLING NEEDLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103611 |
12/09/2010 |
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103688 |
12/17/2010 |
G-PROX EZ ENDOSCOPIC GRASPER |
USGI MEDICAL |
Mary Lou Mooney |
| K103825 |
12/30/2010 |
V-GO INSULIN DELIVERY SYSTEM |
VALERITAS, INC. |
SCOTT HUIE |
| K100504 |
02/22/2010 |
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 |
VALERITAS, LLC |
SCOTT HUIE |
| K100317 |
02/04/2010 |
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO |
VATECH CO., LTD. |
DAVE KIM |
| K103707 |
12/20/2010 |
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE |
VECTEC |
DIANE MANDELL HORWITZ |
| K110215 |
12/29/2010 |
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
ROXANE BONNER |
| K103818 |
12/29/2010 |
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYTEMS, INC |
GEORGE DE LA ROSA |
| K103555 |
12/03/2010 |
MULTIPLATE 5.0 AGGREGOMETER |
VERUM DIAGNOSTICA GMBH |
MAXIMILIAN ZUCKER |
| K100533 |
02/25/2010 |
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, |
VIBRYNT, INC |
JULIA S ANASTAS |
| K100346 |
02/12/2010 |
ENDOCLEAR SYSTEM |
VIRTUAL PORTS LTD |
YORAM LEVY |
| K100480 |
02/18/2010 |
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH |
VITALTEC CORPORATION |
JEN KE-MIN |
| K100383 |
02/16/2010 |
VITAPHONE. MODEL 100 BT |
VITASYSTEMS GMBH |
TILO BORCHARDT |
| K103580 |
12/06/2010 |
GRANDIO SO FLOW |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K103639 |
12/13/2010 |
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K100464 |
02/18/2010 |
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION |
WAKO CHEMICALS USA, INC. |
MARTHA MURARI |
| K103587 |
12/07/2010 |
DISPOSABLE BLLOD COLLECTION NEEDLE |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
Diana Hong |
| K100399 |
02/16/2010 |
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSEIH |
| K103773 |
12/27/2010 |
ZENOFLEX DIMENSION |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K100359 |
02/12/2010 |
DARCO HEADED CANNULATED SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K103598 |
12/08/2010 |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K100443 |
02/17/2010 |
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL |
X-CEL CONTACTS, INC. |
MARTIN DALSING |
| K100436 |
02/16/2010 |
CLICKFINE PEN NEEDLE |
YPSOMED AG |
MANFRED MADER |
| K103704 |
12/20/2010 |
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP |
ZEPHYR SLEEP TECHNOLOGIES INC |
SABINA BRUCHLMANN |
| K103603 |
12/08/2010 |
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K100486 |
02/19/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K100294 |
02/02/2010 |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K103662 |
12/15/2010 |
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI |
ZIMMER, INC. |
REBECCA BROOKS |
