| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K053409 |
12/07/2005 |
3M LIQUID BANDAGE |
3M COMPANY |
BRYAN BECKER |
| K053438 |
12/09/2005 |
GLASS CERAMICS |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
| K053552 |
12/20/2005 |
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
| K053551 |
12/20/2005 |
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL |
INTL., INC. |
MICHAEL D CECCHI |
| K050500 |
02/28/2005 |
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
KIMBERLEY KLINE |
| K053330 |
12/01/2005 |
ARCHITECT B12 CALIBRATORS |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K050501 |
02/28/2005 |
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT VASCULAR DEVICES |
ANN E LEONARD |
| K050279 |
02/07/2005 |
AXS-1 LITE WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K050280 |
02/07/2005 |
RUNABOUT WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K050281 |
02/07/2005 |
TRANSPORT SERIES TRANSPORT CHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K053509 |
12/16/2005 |
ACUBAND ACUPRESSURE WRIST BAND DEVICE |
ACUBAND INC. |
RICHARD GRIFFITH |
| K053400 |
12/06/2005 |
ACUMEN SINGLE-LUMEN DELIVERY SHEATH |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K053358 |
12/02/2005 |
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES |
AD-TECH MEDICAL INSTRUMENT CORP. |
Gary Syring |
| K053363 |
12/02/2005 |
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES |
AD-TECH MEDICAL INSTRUMENT CORP. |
Gary Syring |
| K053495 |
12/15/2005 |
EQUIPMENT SLUSH DRAPE |
ADVANCE MEDICAL DESIGNS, INC. |
WILLIAM SLEVIN |
| K053481 |
12/14/2005 |
KELO-COTE SPRAY |
ADVANCED BIO-TECHNOLOGIES, INC. |
STEVEN CHERNOFF |
| K050468 |
02/23/2005 |
TRIABSORB COMPOSITE SCREW |
ADVANCED BIOMATERIALS |
PATRICK JANIN |
| K053473 |
12/14/2005 |
MAESTRO MDTL LASER SYSTEM |
ADVANCED MEDICAL TECHNOLOGIES, INC. |
M. JOYCE HEINRICH |
| K050241 |
02/02/2005 |
AOS HUMERAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
GARY SOHNGEN |
| K050428 |
02/18/2005 |
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) |
ADVANCED SPINAL TECHNOLOGIES, INC. |
JEFFREY R PERELMAN |
| K053360 |
12/02/2005 |
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C |
AEROVECTRX CORPORATION |
DAVE PIPER |
| K053389 |
12/05/2005 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP, INC. |
MATTHEW M HULL |
| K053390 |
12/05/2005 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K053579 |
12/22/2005 |
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE |
AESCULAP, INC. |
MATTHEW M HULL |
| K053526 |
12/19/2005 |
MICROSPEED UNI MOTOR SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K053440 |
12/09/2005 |
AMPLATZER SIZING BALLOON II |
AGA MEDICAL CORP. |
AMANDA JOHNSON |
| K053458 |
12/13/2005 |
WEB1000 |
AGFA CORP. |
PHIL CUSCUNA |
| K053634 |
12/29/2005 |
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION |
AGFA CORPORATION |
JEFFERY A JEDLICKA |
| K050338 |
02/11/2005 |
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM |
Akers Biosciences, Inc. |
ERIKA AMMIRATI |
| K053479 |
12/14/2005 |
VERIFY DRY HEAT LABEL |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K050390 |
02/16/2005 |
TAMARACK ANTERIOR THORACOLUNBAR |
ALPHATEC/NEXMED |
ELLEN A YARMALL |
| K053550 |
12/20/2005 |
AMBU BLUE SENSOR NEO AND NEO X |
AMBU A/S |
SANJAY PARIKH |
| K053422 |
12/08/2005 |
RAPIDONE-COCAINE-150 TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K053359 |
12/02/2005 |
RAPIDTOX |
AMERICAN BIO MEDICA CORP. |
FRAN WHITE |
| K050445 |
02/22/2005 |
AMS COLLAGEN DERMAL MATRIX |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
| K053371 |
12/05/2005 |
AMS MALE TRANSOBTURATOR SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
FRANK B FREEDMAN |
| K050352 |
02/11/2005 |
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT |
AMERITEK RESEARCH LLC |
KUD CHAIANG YEE |
| K050413 |
02/18/2005 |
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 |
AMPLIFE CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K053407 |
12/07/2005 |
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M |
ANALYTICAL INDUSTRIES, INC. |
PATRICK J PRINDIBLE |
| K050256 |
02/03/2005 |
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
JAMES DELANEY |
| K053590 |
12/23/2005 |
SILVERLON CA (CALCIUM ALGINATE) |
ARGENTUM MEDICAL, LLC. |
WILLIAM A CLEMNTI |
| K053645 |
12/30/2005 |
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K053401 |
12/06/2005 |
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K050358 |
02/14/2005 |
ARTHERX CORKSCREW FT II SUTURE ANCHOR |
ARTHREX, INC. |
ANN WATERHOUSE |
| K053543 |
12/20/2005 |
ARTHREX ARTHOERESIS IMPLANT |
ARTHREX, INC. |
ANN WATERHOUSE |
| K050259 |
02/03/2005 |
ARTHREX BIO-PIN |
ARTHREX, INC. |
ANN WATERHOUSE |
| K053338 |
12/01/2005 |
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS |
ARTHREX, INC. |
ANN WATERHOUSE |
| K053447 |
12/09/2005 |
ARTHROCARE PERC-D SPINEWAND |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K053567 |
12/22/2005 |
ATHROCARE TOPAZ ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K050373 |
02/14/2005 |
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS |
ARTHROSURFACE, INC. |
STEVEN EK |
| K053461 |
12/13/2005 |
EZLOC FEMORAL FIXATION DEVICE |
ARTHROTEK, INC. |
SUSAN ALEXANDER |
| K050320 |
02/09/2005 |
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT |
ASCENDIA MEDTECH AB |
JANE B CAMPBELL |
| K053585 |
12/23/2005 |
VANGUARD REPROCESSED SUTURE PASSER |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
| K050313 |
02/09/2005 |
BIS SRS (SEMI-RESUABLE SENSOR) |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K053384 |
12/05/2005 |
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM |
ASTRA TECH, INC. |
FLOYD G LARSON |
| K050425 |
02/18/2005 |
AURA-PSG |
ASTRO-MED, INC. |
MICHAEL J SULLIVAN |
| K053476 |
12/14/2005 |
ALLWOUND |
AT SQUARED, LLC |
JULIA C TIERNEY |
| K053654 |
12/30/2005 |
ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K053373 |
12/05/2005 |
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE |
ATLANTIS COMPONENTS, INC. |
BETSY BROWN |
| K053450 |
12/12/2005 |
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K050459 |
02/23/2005 |
ATRICURE ISOLATOR TRANSPOLAR PEN |
ATRICURE, INC. |
ELSA ABRUZZO |
| K050311 |
02/08/2005 |
ATRIUM MEDICAL CORPORATION C-QUR MESH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K053355 |
12/02/2005 |
BTI INTERNA DENTAL IMPLANT SYSTEM |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
ALFREDO GOMEZ MENGOD |
| K050310 |
02/08/2005 |
BARDPORT TITANIUM PORTS |
BARD ACCESS SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K053589 |
12/23/2005 |
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING |
BARD ACCESS SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K053501 |
12/16/2005 |
POWERPICC |
BARD ACCESS SYSTEMS, INC. |
LYNN M KIRCHOFF |
| K053406 |
12/07/2005 |
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K053512 |
12/16/2005 |
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K050495 |
02/28/2005 |
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) |
BAXTER HEALTHCARE CORP., BIOSCIENCE |
RON LAGERQUIST |
| K053539 |
12/20/2005 |
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 |
BAXTER HEALTHCARE CORPORATION |
DAVID E CURTIN |
| K050374 |
02/14/2005 |
ADVIA IMS LITHIUM ASSAY |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K053612 |
12/27/2005 |
DRI-STAT ACID PHOSPHATASE REAGENT |
BECKMAN COULTER, INC. |
ERI HIRUMI |
| K050400 |
02/16/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K053611 |
12/27/2005 |
SMOOTHSHAPES |
BICELLULASE, INC. |
ROBERT NAGEL |
| K050408 |
02/17/2005 |
BICON ORTHODONTIC IMPLANT SYSTEM |
BICON, INC. |
VINCENT J MORGAN |
| K053452 |
12/12/2005 |
PURE-AID PREGNANCY TEST |
BIO FOCUS CO., LT. |
LAUREN HONG |
| K050328 |
02/09/2005 |
PREGNANCY-SKREEN |
BIOCHEMICAL DIAGNOSTIC, INC. |
ALLEN PANETZ |
| K053492 |
12/15/2005 |
BIODUCT |
BIODUCT, LLC |
HERB SCHWARTZ |
| K050318 |
02/09/2005 |
BARI-KAD PACKING DEVICE |
BIOENVELOP AGRO, INC. |
ROBERT SCHIFF |
| K050493 |
02/28/2005 |
QUANTIA IGE |
BIOKIT S.A. |
JOAN GUIXER |
| K050487 |
02/25/2005 |
QUANTIA LA(A) |
BIOKIT S.A. |
JOAN GUIXER |
| K053595 |
12/23/2005 |
CURAY CUSTOM SEED ARRAY |
BIOLUCENT, INC. |
SHERYL HIGGINS |
| K053383 |
12/05/2005 |
FIDIS CELIAC |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K053653 |
12/30/2005 |
FIDIS CONNECTIVE 10, MODEL MX006 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
CHRISTELLE COURIVAUD |
| K050286 |
02/07/2005 |
FIDIS CONNECTIVE 8 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K053505 |
12/16/2005 |
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS |
BIOMET MANUFACTURING, INC. |
TRACY B JOHNSON |
| K050251 |
02/03/2005 |
BALANCE HIP SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K050327 |
02/09/2005 |
E-POLY (VITAMIN E) ACETABULAR LINERS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K050441 |
02/22/2005 |
TAPER 2 POROUS FEMORAL STEM |
BIOMET, INC. |
KACY ARNOLD |
| K053635 |
12/29/2005 |
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K053327 |
12/01/2005 |
OXICOM CONTROL |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K050305 |
02/08/2005 |
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 |
BIOSCREEN MEDICAL INC. |
JIMMY LIANG |
| K053329 |
12/01/2005 |
KORLEX-GR GINGIVAL RETRACTION PASTE |
BIOTECH ONE, INC. |
KAREN UYESUGI |
| K050361 |
02/14/2005 |
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K050232 |
02/01/2005 |
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K050403 |
02/17/2005 |
SPYGLASS DIRECT VISULATION PROBE |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K050389 |
02/15/2005 |
ULTRA-SOFT SV BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
ANGIE BYLAND |
| K053500 |
12/16/2005 |
FRAMELESS RADIOSURGERY COMPONENTS |
BRAINLAB AG |
RAINER BIRKENBACH |
| K053584 |
12/23/2005 |
IPLAN RT DOSE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K053607 |
12/27/2005 |
BREAS VIVO 40 SYSTEM |
BREAS MEDICAL AB |
KARL-JOHAN HOLM |
| K053424 |
12/08/2005 |
POPMESH |
CALDERA MEDICAL, INC. |
MARLA KENGEN |
| K050357 |
02/14/2005 |
CAMCERAM TCP |
CAM IMPLANTS B.V. |
KIM GROENEWEGAN VAN DER WEIJDEN |
| K050225 |
02/01/2005 |
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K053395 |
12/06/2005 |
BP PRO BLOOD PRESSURE MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K053524 |
12/19/2005 |
C-PORT DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
DAVID CASAL |
| K050230 |
02/01/2005 |
TURBO TEMP TRIO |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K050366 |
02/14/2005 |
IMAGENPRO |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MELANIE HASEK |
| K050345 |
02/11/2005 |
CIE FOLDAWAY WHEELCHAIR |
CARLSBAD INTERNATIONAL EXPORT, INC. |
LAURA MEYER |
| K050324 |
02/09/2005 |
INFPUMP INFILTRATION PUMP |
CAROLINA MEDICAL, INC. |
LEON WILSON |
| K050440 |
02/22/2005 |
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K053324 |
12/01/2005 |
CHROMOLITE SYSTEM |
CHROMOGENEX PLC |
CHRIS WILLIAMS |
| K050265 |
02/04/2005 |
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 |
CHRONO-LOG CORP. |
NICHOLAS J VERIABO |
| K053376 |
12/05/2005 |
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 |
CHUNG CHENG ELECTRIC HEATING CO., LTD. |
JENNIFER REICH |
| K050250 |
02/03/2005 |
AQUIFY MULTIPURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K053379 |
12/05/2005 |
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE |
CLASSONE ORTHODONTICS, INC. |
JUDY RIBORDY |
| K053350 |
12/02/2005 |
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS |
Codman & Shurtleff, Inc. |
BRIAN KANERVIKO |
| K050426 |
02/18/2005 |
TEMPOSIL, MODEL 6720 |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K050470 |
02/23/2005 |
CONCENTRIC EMBOLIC PEARLS |
CONCENTRIC MEDICAL, INC. |
JEAN M CAILLOUETTE |
| K053488 |
12/15/2005 |
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
PATRICK HESS |
| K050304 |
02/08/2005 |
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE |
CONMED CORP. |
THOMAS HIRTE |
| K053464 |
12/13/2005 |
SERVICE MANAGER SM40SE |
CONMED INTEGRATED SYSTEMS, CANADA, ULC |
MICHAEL T TAGGART |
| K053561 |
12/21/2005 |
BIO-MINI REVO SUTURE ANCHOR |
CONMED LINVATEC |
ELIZABETH PAUL |
| K050246 |
02/02/2005 |
SIS DERMAL AUGMENTATION STRAND |
COOK BIOTECH, INC. |
MARK BLEYER |
| K050337 |
02/10/2005 |
SIS FISTULA PLUG |
COOK BIOTECH, INC. |
MARK BLEYER |
| K050294 |
02/07/2005 |
COOK IRELAND SONNET POLYPECTOMY SNARE |
COOK IRELAND LTD |
EMMETT DEVEREUX |
| K053415 |
12/07/2005 |
LESIONPOINT RF CANNULA |
COSMAN MEDICAL, INC. |
MICHAEL ARNOLD |
| K053436 |
12/09/2005 |
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
| K050272 |
02/04/2005 |
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS |
CRYOMEDICAL INSTRUMENTS, LTD. |
GARETH COPPING |
| K050379 |
02/15/2005 |
CS MEDICAL ADULT TTCF CATHETER |
CS MEDICAL INC. |
LEWIS WARD |
| K050381 |
02/15/2005 |
CS MEDICAL TTCF GAS DELIVERY SYSTEM |
CS MEDICAL INC. |
LEWIS WARD |
| K053538 |
12/20/2005 |
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER |
CURAPHARM, INC. |
THOMAS M HNAT |
| K050507 |
02/28/2005 |
SMARTECH, MODEL HOLI I |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
CHANG WAN-LAN |
| K050382 |
02/15/2005 |
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM |
CYNOSURE, INC. |
GEORGE CHO |
| K053608 |
12/27/2005 |
CYNOSURE PHOTOGENICA V-STAR LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K053421 |
12/08/2005 |
YAG MIR FAMILY LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K053337 |
12/01/2005 |
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 |
DADE BEHRING, INC. |
YUK-TING LEWIS |
| K053577 |
12/22/2005 |
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K053531 |
12/19/2005 |
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K053576 |
12/22/2005 |
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K053504 |
12/16/2005 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K053580 |
12/22/2005 |
DOCTOR'S NIGHTGUARD |
DENTAL CONCEPTS LLC. |
HOWARD M HOLSTEIN |
| K053368 |
12/05/2005 |
INTERPROXIMAL REDUCTION SYSTEM |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K050386 |
02/15/2005 |
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K053569 |
12/22/2005 |
AGILITY LP TOTAL ANKLE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K050315 |
02/09/2005 |
DELTA HUMERAL CUPS |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI D ROGERS |
| K053445 |
12/12/2005 |
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K053593 |
12/23/2005 |
PRODIGY |
DIAGNOSTIC DEVICES INC. |
DANIEL KAMM |
| K053533 |
12/19/2005 |
IMMULITE/IMMULITE 1000 TURBO INTACT PTH |
DIAGNOSTIC PRODUCTS CORPORATION |
DEBORAH L MORRIS |
| K053566 |
12/22/2005 |
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A |
DIAZYME LABORATORIES |
HUAN TRAN |
| K050447 |
02/22/2005 |
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
DIDECO S.R.L. |
BARRY SALL |
| K053640 |
12/30/2005 |
INTEGRA |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K053399 |
12/06/2005 |
VERSALET 7700 CARE CENTER |
DRAEGER MEDICAL INFANT CARE, INC. |
MONICA FERRANTE |
| K053484 |
12/15/2005 |
INFINITY GAMMA / GAMMAXL, INFINITY VISTA |
Draeger Medical Systems, Inc. |
KAREN A LORIO |
| K050234 |
02/01/2005 |
REMOTE CARE |
E.CARE SOLUTIONS, INC. |
CONSTANCE G BUNDY |
| K053333 |
12/01/2005 |
EAGLEVISION GELLANSERTS, MODEL REF 0040 |
EAGLE VISION, INC. |
JEFF COBB |
| K053347 |
12/02/2005 |
KODAK CARESTREAM PACS |
EASTMAN KODAK COMPANY |
CAROLYN L WAGNER |
| K053606 |
12/27/2005 |
BE PLUS / AURA-LTM64 AMPLIFIER |
EB NEURO, S.P.A. |
CARRI GRAHAM |
| K050446 |
02/22/2005 |
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K053404 |
12/07/2005 |
LIFESTENT FLEXSTART BILIARY STENT SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K053609 |
12/27/2005 |
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
DIANE PETERSON |
| K053432 |
12/09/2005 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K053437 |
12/09/2005 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K050472 |
02/24/2005 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K053405 |
12/07/2005 |
BACSTOP |
ELCAM MEDICAL A.C.A.L. |
TALI HAZAN |
| K050248 |
02/03/2005 |
ELECTRODE |
ELECTRAMOLD |
E.W. JOHNSON |
| K053563 |
12/21/2005 |
HUMAPEN MEMOIR |
ELI LILLY AND COMPANY |
LEEANN CHAMBERS |
| K053507 |
12/16/2005 |
ELITE ELECTROMED L.I.T.E. 4/1 |
ELITE ELECTROMEDICAL |
GARY HUDDLESTON |
| K050239 |
02/02/2005 |
EMD THERMOGRAPHY SYSTEM |
EM DIAGNOSTICS, INC. |
RICHARD KEEN |
| K053455 |
12/09/2005 |
ENCOMPASS.NET |
EMPIRIC SYSTEMS, LLC |
CARL ALLETTO |
| K050347 |
02/11/2005 |
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
EBEN GORDON |
| K053326 |
12/01/2005 |
ESTECH COBRA ELECTROSURGICAL UNIT & CABLE |
ENDOSCOPIC TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K053429 |
12/09/2005 |
ADVANCED UROLOGICAL CATHETER |
ENTRACARE, LLC |
AL BOEDEKER |
| K050326 |
02/09/2005 |
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K053557 |
12/21/2005 |
ESKA-LIBUR HIP STEM |
ESKA IMPLANTS GMBH & CO. |
J. D WEBB |
| K050344 |
02/11/2005 |
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER |
ETHICON ENDO SURGERY, INC. |
KIMBERLY SHOEMAKER |
| K053631 |
12/29/2005 |
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET |
ETHICON ENDO-SURGERY, INC. |
WENDY TURNER |
| K053493 |
12/15/2005 |
BERRY FRUITY TEETHER |
EVENFLO COMPANY, INC. |
RUBEN D COLMENARES |
| K053427 |
12/08/2005 |
FRESH, DENTAL IMPRESSION MATERIAL |
EXACTA DENTAL PRODUCTS, INC. |
RICHARD KEEN |
| K050398 |
02/16/2005 |
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS |
EXACTECH, INC. |
Lisa Simpson |
| K053386 |
12/05/2005 |
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
| K050243 |
02/02/2005 |
IMMEDIA PROTHROMBIN TIME SYSTEM |
FARALLON MEDIAL INC |
JAMES MCKINLEY |
| K053494 |
12/15/2005 |
OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE |
FERTI PRO N.V. |
GRACE HOLLAND |
| K050424 |
02/18/2005 |
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 |
FIM MEDICAL |
DANIEL KAMM |
| K050293 |
02/07/2005 |
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS |
FOTONA D.D. |
STOJAN TROST |
| K053460 |
12/13/2005 |
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, |
FOX HOLLOW TECHNOLOGIES |
MELISSA MURPHY |
| K050273 |
02/07/2005 |
FRESENIUS ART HEMOADSORPTION SYSTEM |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K050363 |
02/14/2005 |
FUKUDA DENSHI MODEL UF-850XTD |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K053356 |
12/02/2005 |
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RONALD N BLASKI |
| K050489 |
02/25/2005 |
INNOVA 2100 |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K053446 |
12/12/2005 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 |
GEN-PROBE, INC. |
BRIAN J SHEA |
| K050255 |
02/03/2005 |
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 |
GENDEX DENTAL SYSTEMS |
JOHN R MILLER |
| K053435 |
12/09/2005 |
GE VOLUSON I |
GENERAL ELECTRIC CO. |
ALLEN SMITH |
| K053559 |
12/21/2005 |
PF4 ENHANCED SOLID PHASE ELISA |
GENETIC TESTING INSTITUTE |
LEIGH ANN TIDEY |
| K053463 |
12/13/2005 |
AIM ACCURACY IN MARKING SYSTEM |
GEORGENE AUSTRIA |
GEORGENE AUSTRIA |
| K053639 |
12/30/2005 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K050473 |
02/24/2005 |
RBK PATELLA FEMORAL KNEE |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
CARL KNOBLOCH |
| K050391 |
02/16/2005 |
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K053573 |
12/22/2005 |
GSS PEDICLE SCREW SYSTEM |
GS MEDICAL CO., LTD. |
SUN-EUN JUNG |
| K053497 |
12/15/2005 |
GUAVA EZCD4 SYSTEM |
GUAVA TECHNOLOGIES, INC. |
LAWRENCE F BRUDER |
| K053459 |
12/13/2005 |
OMNILINK .035 BILIARY STENT SYSTEM |
GUIDANT CORPORATION |
SYLVIA HERNANDEZ |
| K053454 |
12/09/2005 |
RX HERCULINK ELITE BILIARY STENT SYSTEM |
GUIDANT CORPORATION |
KEITH KROHN |
| K053555 |
12/20/2005 |
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
| K050460 |
02/23/2005 |
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES |
GYRUS MEDICAL, INC. |
MARK A JENSON |
| K050277 |
02/07/2005 |
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K050508 |
02/28/2005 |
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES |
HAYWOOD VOCATIONAL OPPORTUNITIES |
TIM KELLEY |
| K050491 |
02/25/2005 |
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050249 |
02/03/2005 |
HL168JP |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050228 |
02/01/2005 |
AGFA HEARTLAB CARDIOVASCULAR |
HEARTLAB, INC. |
RICHARD PETROCELLI |
| K050295 |
02/07/2005 |
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
| K050307 |
02/08/2005 |
AIRIS ELITE RAPID BODY COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K053486 |
12/15/2005 |
TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET |
HOFFRICHTER GMBH |
STEPHEN H GORSKI |
| K050483 |
02/24/2005 |
EVADRI BLADDER CONTROL SYSTEMS |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K053453 |
12/12/2005 |
HOMMED CENTRAL STATION, VERSION 3.5 |
HONEYWELL HOMMED LLC |
TOMMIE J MORGAN |
| K050448 |
02/22/2005 |
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 |
HORIBA ABX |
TIM LAWTON |
| K053472 |
12/14/2005 |
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K053349 |
12/02/2005 |
HOFFMANN II ROD TO WIRE COUPLING |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K053348 |
12/02/2005 |
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K050274 |
02/07/2005 |
DIODENT II DENTAL LASER SYSTEM |
HOYA PHOTONICS, INC. |
JIM GREEN |
| K053466 |
12/13/2005 |
HSINER RESUSCITATOR |
HSINER CO., LTD. |
TOM SHANKS |
| K053369 |
12/05/2005 |
MEDILOG DARWIN HOLTER ANALYSIS |
HUNTLEIGH HEALTHCARE |
JAMES PARDEY |
| K053618 |
12/28/2005 |
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 |
HUTCHINSON TECHNOLOGY, INC. |
JOSEPH P ORTNER |
| K050410 |
02/17/2005 |
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) |
HWANG SUN ENTERPRISE CO., LTD. |
SING-HONG YEUNG |
| K053575 |
12/22/2005 |
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS |
HYGIA HEALTH SERVICES, INC. |
KYLE FERGUSON |
| K050367 |
02/14/2005 |
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 |
HYPHEN BIOMED |
OLA ANDERSON |
| K050365 |
02/14/2005 |
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 |
HYPHEN BIOMED |
OLA ANDERSON |
| K053597 |
12/23/2005 |
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) |
I-STAT CORPORATION |
SUE KENT |
| K050395 |
02/16/2005 |
IMPEDIMED - BODY COMPOSITION ANALYSIS |
IMPEDIMED PTY LTD. |
NEVELLI BERTWISTLE |
| K050415 |
02/18/2005 |
IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS |
IMPEDIMED PTY LTD. |
NEVILLE BERTWISTLE |
| K050505 |
02/28/2005 |
DEPOTONE |
IMPRINT PHARMACEUTICALS LIMITED |
MERVYN LITTLE |
| K050275 |
02/07/2005 |
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN |
INION LTD. |
HANNA MARTTILA |
| K053367 |
12/05/2005 |
MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
GOH MIAH KIAT |
| K050278 |
02/07/2005 |
HEMOSIL D-DIMER |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K053499 |
12/16/2005 |
HEMOSIL PROS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K050492 |
02/28/2005 |
INTEGRA BONE FIXATION SYSTEM |
INTEGRA LIFESCIENCES CORP. |
DONNA WALLACE |
| K050319 |
02/09/2005 |
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 |
INTEGRA LIFESCIENCES CORP. |
CHARLES E DINKLER II |
| K053655 |
12/30/2005 |
TENDON WRAP TENDON PROTECTOR |
INTEGRA LIFESCIENCES CORPORATION |
DIANA M BORDON |
| K050496 |
02/28/2005 |
REM440 |
INTERACOUSTICS A/S, ASSENS |
DANIEL EGGAN |
| K053571 |
12/22/2005 |
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM |
INTERLAB S.R.L. |
Gary Lehnus |
| K053540 |
12/20/2005 |
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE |
INTERMEDIC ARFRAN, S.A. |
KLAUS SIVEC |
| K050404 |
02/17/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K050369 |
02/14/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K050276 |
02/07/2005 |
DIVER C.E. CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
PATRICE STROMBERG |
| K053462 |
12/13/2005 |
3160 MRI PATIENT MONITORING SYSTEM |
INVIVO CORPORATION |
NEIL BATTISTE |
| K050399 |
02/16/2005 |
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 |
INVIVO RESEARCH, INC. |
NEIL BATTISTE |
| K053641 |
12/30/2005 |
IBA PROTON THERAPY SYSTEM-PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
| K053622 |
12/28/2005 |
SURGISIS OCULAR GRAFT |
IOP, INC. |
JASON MALECKA |
| K050301 |
02/08/2005 |
MRIDIUM 3850 MRI PUMP SYSTEM |
IRADIMED CORPORATION |
FRANCIS X CASEY |
| K050235 |
02/01/2005 |
IQ 200 URINE ANALYZER BODY FLUIDS MODULE |
IRIS INTERNATIONAL, INC. |
HARVEY L KASDAN |
| K053582 |
12/23/2005 |
INQUIRY AFOCUS II DIAGNOSTIC CATHETER |
IRVINE BIOMEDICAL, INC. |
ELVIA ZAVALA |
| K050453 |
02/22/2005 |
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
IVOCLAR VIVADENT, INC. |
DONNA HARNETT |
| K053556 |
12/20/2005 |
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 |
JAWON MEDICAL CO., LTD. |
HEUNG BONG LIM |
| K053403 |
12/06/2005 |
LUCAS |
JOLIFE AB |
HOWARD HOLSTEIN |
| K050384 |
02/15/2005 |
KAPP BARI-RING, MODEL KS-BR-2005 |
KAPP SURGICAL INSTRUMENT, INC. |
ALBERT SANTILLI |
| K053627 |
12/29/2005 |
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
KCI USA, INC. |
CHRISTY H OVIATT |
| K053410 |
12/07/2005 |
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR |
KENDALL |
JIM WELSH |
| K050443 |
02/22/2005 |
ACCU-LEAD |
KENTEC MEDICAL, INC. |
DAVID SHERATON |
| K050261 |
02/04/2005 |
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
KINETIC CONCEPTS, INC. |
CHRISTY OVIATT |
| K053629 |
12/29/2005 |
ANCHOR PLUS/NEO ANCHOR PLUS |
KJ MEDITECH |
CHARLIE MACK |
| K053419 |
12/08/2005 |
KONICA MINOLTA PULSOX-300, 300I |
KONICA MINOLTA SENSING, INC. |
NANCI DEXTER |
| K050271 |
02/04/2005 |
KOWA GENESIS-D HAND-HELD RETINAL CAMERA |
KOWA CO. LTD. |
SATOHIKO TAKANISHI |
| K053444 |
12/09/2005 |
KOWA KT-800 |
KOWA CO. LTD. |
SHINICHI YAMANAKA |
| K050339 |
02/11/2005 |
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K050290 |
02/07/2005 |
LERADO, COSCO |
LERADO OVERSEA LTD. TWN BRANCH (BVI) |
JEN KE-MIN |
| K053630 |
12/29/2005 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
FARZAD PARSALE |
| K050435 |
02/22/2005 |
E-STIM II |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K050499 |
02/28/2005 |
PROBLOC, HN SERIES AND PROLONG, PL SERIES |
LIFE-TECH, INC. |
JEFF KASOFF |
| K050506 |
02/28/2005 |
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS |
LIFECORE BIOMEDICAL, INC. |
RACHEL KENNEDY |
| K053643 |
12/30/2005 |
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 |
LIFECORE BIOMEDICAL, INC. |
BRIAN SMEKAL |
| K053529 |
12/19/2005 |
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
LISA MCGRATH |
| K053510 |
12/16/2005 |
IR WIRELESS FOOT SWITCH |
LINEMASTER SWITCH CORP. |
MIKE SZOSTEK |
| K050497 |
02/28/2005 |
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET |
LINVATEC CORP. |
ELIZABETH PAUL |
| K050227 |
02/01/2005 |
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER |
LINVATEC CORP. |
ELIZABETH M PAUL |
| K053372 |
12/05/2005 |
LBI CATHETER SYSTEM |
LUMEN BIOMEDICAL, INC. |
AMY PETERSON |
| K053628 |
12/29/2005 |
LIGHTSHEER DUET LASER SYSTEM |
LUMENIS, INC. |
Connie Hoy |
| K053568 |
12/22/2005 |
BILISOFT PHOTOTHERAPY SYSTEM |
LUMITEX, INC. |
JEFF WILLIAMS |
| K050263 |
02/04/2005 |
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU |
M.O.C.O.M. SRL |
DANIELE TOSI |
| K050504 |
02/28/2005 |
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS |
MAINE STANDARDS CO. |
CHIRSTINE BEACH |
| K053637 |
12/29/2005 |
MANI NEEDLE & SUTURE PACK (NYLON) |
MANI, INC. |
DAVID J BLOCH |
| K053636 |
12/29/2005 |
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) |
MANI, INC. |
DAVID J BLOCH |
| K053638 |
12/29/2005 |
MANI NEEDLE & SUTURE PACK (SILK) |
MANI, INC. |
DAVID J BLOCH |
| K050252 |
02/03/2005 |
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K053477 |
12/14/2005 |
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K050332 |
02/10/2005 |
SURGI-WRAP MAST BIORESORBABLE SHEET |
MAST BIOSURGERY USA INC. |
KENNETH K KLEINHENZ |
| K053592 |
12/23/2005 |
SIMPLANT DR. JAMES |
MATERIALISE N.V. |
CARL VAN LIERDE |
| K050372 |
02/14/2005 |
VISITRAK, VERSION 1, RELEASE 1 |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K050254 |
02/03/2005 |
SPECTRA-SP CO2 LASER SYSTEM |
MAX ENGINEERING LTD. |
MAUREEN O'CONNEL |
| K053397 |
12/06/2005 |
K-Y BRAND SENSUAL MIST |
MCNEIL-PPC, INC. |
NADER FOTOUHI |
| K053485 |
12/15/2005 |
THERATRON EQUINOX, MODELS 80 CM AND 100 CM |
MDS NORDION INC. |
ROSS KACHANIWSKY |
| K053345 |
12/02/2005 |
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D |
MEDCOMP |
JEAN CALLOW |
| K053518 |
12/19/2005 |
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
| K050376 |
02/14/2005 |
PROWIN |
MEDICAL TECHNOLOGIES INTERNATIONAL, INC. |
MARC BOZENAN |
| K050478 |
02/24/2005 |
MEDICON IMF-ORION SCREWS |
MEDICON, E.G. |
JOACHIM SCHMID |
| K053624 |
12/28/2005 |
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM |
MEDICON, E.G. |
ANGELIKA SCHERP |
| K050490 |
02/25/2005 |
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER |
MEDICREA |
J.D. WEBB |
| K053530 |
12/19/2005 |
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K053325 |
12/01/2005 |
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 |
MEDIWATCH LTD |
ANDREW HOPKINS |
| K053574 |
12/22/2005 |
MEDLINE PEDIATRIC WHEELCHAIRS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K050456 |
02/23/2005 |
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM |
MEDRAD, INC. |
GEOFF M FATZINGER |
| K050371 |
02/14/2005 |
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER |
MEDRAD, INC. |
GEOFF M FATZINGER |
| K050394 |
02/16/2005 |
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K053431 |
12/09/2005 |
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM |
MEDTRONIC IRELAND |
MICHELLE NIVALA |
| K053474 |
12/13/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050282 |
02/07/2005 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K053483 |
12/15/2005 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050484 |
02/25/2005 |
BASIS SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARME |
| K050439 |
02/22/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K050438 |
02/22/2005 |
STEALTHSTATION SYSTEM UPDATE |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
TINA DREILING |
| K053430 |
12/09/2005 |
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER |
MEDTRONIC XOMED, INC. |
PENNY LAYMAN |
| K053354 |
12/02/2005 |
INTERMEZZO PLUS FIXTURE |
MEGAGEN CO., LTD. |
DAE CHANG |
| K053353 |
12/02/2005 |
RESCUE IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
DAE CHANG |
| K050421 |
02/18/2005 |
MS 4/5 HEMATOLOGY ANALYZER |
MELET SCHLOESING LABORATORIES USA |
JACKIE COLEMAN |
| K050436 |
02/22/2005 |
MS 9/5 HEMATOLOGY ANALYZER |
MELET SCHLOESING LABORATORIES USA |
JACKIE COLEMAN |
| K053414 |
12/07/2005 |
MENTOR NOVASILK MESH |
MENTOR CORP. |
DONNA A CRAWFORD |
| K050457 |
02/23/2005 |
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM |
MERETE MEDICAL GMBH |
JENIK RADON |
| K053335 |
12/01/2005 |
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K050430 |
02/18/2005 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR |
MERITS HEALTH PRODUCTS CO., LTD. |
Lee Leichter |
| K053490 |
12/15/2005 |
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K050303 |
02/08/2005 |
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
| K053546 |
12/20/2005 |
SONICATOR 740, MODEL ME 740 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K053411 |
12/07/2005 |
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS |
MICROGENICS CORP. |
TONY C LAM |
| K050340 |
02/11/2005 |
MICROMEDICS SPHENOID SINUS STENT |
MICROMEDICS, INC. |
THOMAS A LOPAC |
| K050322 |
02/09/2005 |
MICROTEK EQUIPMENT DRAPES |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
| K053554 |
12/20/2005 |
COMPUFLO |
MILESTONE SCIENTIFIC, INC. |
HOWARD HOLSTEIN |
| K053451 |
12/12/2005 |
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); |
MOELLER MEDICAL GMBH & CO. KG |
BILL KELLEY |
| K050257 |
02/03/2005 |
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) |
MONDEAL MEDICAL SYSTEMS GMBH |
ANGELIKA SCHERP |
| K053361 |
12/02/2005 |
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K050299 |
02/07/2005 |
HRK-123 KNEE ARRAY COIL |
MRI DEVICES CORPORATION |
TOM SCHUBERT |
| K053339 |
12/01/2005 |
ALLOFIX ANCHOR |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY L BENNEWITZ |
| K053623 |
12/28/2005 |
NFIX FUSION SYSTEM |
N-SPINE, INC. |
ELAINE DUNCAN |
| K050469 |
02/23/2005 |
EZ-STIK ELECTRODES |
NAIMCO, INC. |
ROBERT L MCCLURE |
| K053468 |
12/13/2005 |
NESS L300 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
JONATHAN S KAHN |
| K053626 |
12/28/2005 |
INTERX500 FLEXIBLE ARRAY ELECTRODE |
NEURO RESOURCE GROUP, INC. |
KRISTA OAKES |
| K050377 |
02/15/2005 |
NBD HEAD SCREW |
NEW BUSINESS DEVELOPMENT, LLC |
TIM B LUSBY |
| K050346 |
02/11/2005 |
STABILIZATION SCREW |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K053502 |
12/16/2005 |
NEWPORT E360 VENTILATOR |
NEWPORT MEDICAL INSTRUMENTS, INC. |
RICHARD WATERS |
| K053408 |
12/07/2005 |
NEXA BONE PLATE AND SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K053394 |
12/06/2005 |
NEXA BONE SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K050336 |
02/10/2005 |
OPD-STATION SOFTWARE |
NIDEK, INC. |
CAROL PATTERSON |
| K050312 |
02/08/2005 |
AMIGO INSULIN PUMP |
NIPRO DIABETES SYSTEMS, INC. |
CLARENCE ODOM |
| K050356 |
02/14/2005 |
COMPRESSION ANASTOMOSIS RING (CAR) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
| K050258 |
02/03/2005 |
GROOVY IMPLANTS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K050406 |
02/17/2005 |
NOBELSPEEDY IMPLANTS |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K053602 |
12/23/2005 |
PROCERA SOFTWARE, MODEL 33145 |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K050393 |
02/16/2005 |
THE GUIDED SURGERY CONCEPT |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K050444 |
02/22/2005 |
NOBELREPLACE ADAPTER, MODEL 32412 |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K053478 |
12/14/2005 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
NORTHERN IMPLANTS, LLC |
GRETA M HOLS |
| K050350 |
02/11/2005 |
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) |
NOTAL VISION, INC. |
RICHARD E LIPPMAN |
| K053387 |
12/05/2005 |
PERIOGLAS BONE GRAFT PARTICULATE |
NovaBone Products, LLC |
DAVID M GAISSER |
| K053470 |
12/14/2005 |
NOVOFINE 32G TIP |
NOVO NORDISK INC. |
JOHN SIGNORIN |
| K050244 |
02/02/2005 |
MALE NATURAL RUBBER LATEX CONDOM |
NRS GLOBAL PARTNERS |
ELI J CARTER |
| K053581 |
12/23/2005 |
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K050237 |
02/02/2005 |
STARSHIELD V3 RF TRNT |
ODIN MEDICAL TECHNOLOGIES LTD. |
ADI ICKOWICZ |
| K053382 |
12/05/2005 |
LAPARO-THORACO VIDEOSCOPE XLTF-VAW |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
TRACY GULSEN |
| K050503 |
02/28/2005 |
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LARUA STORMS-TYLER |
| K050502 |
02/28/2005 |
SINGLE USE BALLOON DILATOR MAXPASSTM |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
| K050454 |
02/22/2005 |
OMNITECH FULGURATING ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
| K050233 |
02/01/2005 |
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI |
OMRON HEALTHCARE, INC. |
JIM LI, PH.D. |
| K053583 |
12/23/2005 |
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL |
OPTIVIA MEDICAL LLC |
ROBERT M KELLEY |
| K050260 |
02/03/2005 |
BIORESORB MACRO PORE |
ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH |
CHAD BARTEE |
| K053587 |
12/23/2005 |
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K053374 |
12/05/2005 |
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) |
OSSACUR AG |
KRISTI KISTNER |
| K050416 |
02/18/2005 |
OSSAPLAST ORTHO |
OSSACUR AG |
KRISTI KISTNER |
| K050370 |
02/14/2005 |
PALOMAR LUXIR HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K053516 |
12/16/2005 |
MUCOHARD |
PARKELL, INC. |
NELSON J GENDUSA |
| K053564 |
12/22/2005 |
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 |
PENLON LIMITED |
BARRY PEARCE |
| K053491 |
12/15/2005 |
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K053522 |
12/19/2005 |
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HERBERT VAN DYK |
| K053570 |
12/22/2005 |
TREP-SURE TREPONEMAL ANTIBODY EIA |
PHOENIX BIOTECH CORP. |
Gary Lehnus |
| K053553 |
12/20/2005 |
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL |
POLYMEDCO, INC. |
HELEN LANDRICHO |
| K053417 |
12/08/2005 |
M-COR HIP REPLACEMENT SYSTEM |
PORTLAND ORTHOPAEDICS PTY. LTD. |
ELAINE DUNCAN |
| K053542 |
12/20/2005 |
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM |
PRAXIM SA |
RANDY VEALE |
| DEN050003 |
02/28/2005 |
PAXGENE BLOOD RNA SYSTEM |
PREANALYTIX GMBH |
JING ZHANG |
| K053425 |
12/08/2005 |
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS |
PRECISION OPTICS CORP. |
ERWIN HEIDER |
| K050488 |
02/25/2005 |
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES |
PROSURG, INC. |
ASHVIN DESAI |
| K053548 |
12/20/2005 |
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
PROTEIN POLYMER TECHNOLOGIES, INC. |
R. STEPHEN REITZLER |
| K053366 |
12/05/2005 |
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE |
PT. MAHAKARYA INTI BUANA |
SASITHARAN NAIR |
| K053657 |
12/05/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE |
PT. MAHAKARYA INTI BUANA |
P. SASITHARAN NAIR |
| K053388 |
12/05/2005 |
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION |
PURITAN BENNETT CORP. |
JAMES BONDS |
| K050449 |
02/22/2005 |
QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
JASON BLAIN |
| K050298 |
02/07/2005 |
IPACS PRISM-5.0 |
REALTIMEIMAGE INC. |
CARL ALLETTO |
| K053475 |
12/14/2005 |
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 |
REFRACTEC, INC. |
GARY MOCNIK |
| K053443 |
12/09/2005 |
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K053441 |
12/09/2005 |
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K053442 |
12/09/2005 |
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K050359 |
02/14/2005 |
ULTRA MIRAGE II MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K053352 |
12/02/2005 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
ZITA A YURKO |
| K050414 |
02/18/2005 |
PLIX |
RESPIRONICS, INC. |
ZITA YURKO |
| K053342 |
12/01/2005 |
GENGIGEL MOUTHRINSE |
RICERFARMA SRL |
PAUL KETTERIDGE |
| K050423 |
02/18/2005 |
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) |
Roche Diagnostics |
DIMITRIS DEMIRTZOGLOU |
| K053603 |
12/23/2005 |
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K050387 |
02/15/2005 |
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K053426 |
12/08/2005 |
ROCHE ELECSYS ANTI-TG |
ROCHE DIAGNOSTICS CORP. |
RANDY JOHNSON |
| K053646 |
12/30/2005 |
INVITRO MATURATION MEDIA |
SAGE IN-VITRO FERTILIZATION INC. |
GRACE HOLLAND |
| K053328 |
12/01/2005 |
BIOSPLINT SPLINTING RIBBON |
SATELEC |
STEVEN SALESKY |
| K053558 |
12/21/2005 |
CEPH, MODEL 4900 |
SCHICK TECHNOLOGIES, INC. |
DANIEL MICHAELI |
| K053412 |
12/07/2005 |
FLEXISCOPE, MODELS 50MH AND 50 MHC |
SCHOELLY IMAGING, INC. |
PAMELA PAPINEAU |
| K050407 |
02/17/2005 |
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 |
SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
| K050348 |
02/11/2005 |
CO VERTEBRAL BODY REPLACEMENT |
SCIENT'X |
J.D. WEBB |
| K053578 |
12/22/2005 |
SCORPION ULTRASONIC SCALING INSERTS |
SCORPION |
DANIEL KAMM |
| K053398 |
12/06/2005 |
COMPASS COMPRESSION ASSIST HANDLE |
SEMLER TECHNOLOGIES, INC. DBA |
HERBERT J SEMLER |
| K053332 |
12/01/2005 |
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 |
SENTECH KOREA CORP. |
MATTHEW SON |
| K050419 |
02/18/2005 |
QMS VANCOMYCIN |
SERADYN INC. |
JACK ROGERS |
| K050360 |
02/14/2005 |
TULIP CONDOM |
SHANGHAI LATEX FACTORY |
LOU JI |
| K050467 |
02/23/2005 |
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
| K053346 |
12/02/2005 |
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLSTEIN-FALK |
| K053523 |
12/19/2005 |
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
MICKY LIN |
| K053521 |
12/19/2005 |
PRE-POWDERED STERILE VINYL GLOVE, CLEAR |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
WILLIAM WANG |
| K050434 |
02/22/2005 |
SHL DISPOSABLE AUTOINJECTOR |
SHL MEDICAL, USA |
LUCIO GIAMBATTISTA |
| K050401 |
02/17/2005 |
CERAMAGE |
SHOFU DENTAL CORP. |
DAVID MORAIS |
| K053511 |
12/16/2005 |
DA VINCI FEMTOSECOND SURGICAL LASER |
SIE LTD SURGICAL INSTRUMENT ENGINEERING |
Kevin Walls |
| K050476 |
02/24/2005 |
CORDLESS COIL |
SIEMENS MEDICAL SOLUTION, INC. USA |
ANA LADINO |
| K050297 |
02/07/2005 |
SOMATOM EMOTION 16 |
SIEMENS MEDICAL SOLUTION, INC. USA |
DEBRA PEACOCK |
| K050240 |
02/02/2005 |
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA INC. |
PATRICK LYNCH |
| K050422 |
02/18/2005 |
550 TXT TREATMENT TABLE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KEN NEHMER |
| K050354 |
02/14/2005 |
PERIOSCAN ULTRASONIC SCALER |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K050462 |
02/23/2005 |
SBI HAND FIXATION SYSTEM (TM) |
SMALL BONE INNOVATIONS LLC |
DONALD GUTHNER |
| K050226 |
02/01/2005 |
ASIAN INTRAMEDULLARY HIP SCREW NAILS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K053344 |
12/02/2005 |
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K050314 |
02/09/2005 |
AQUINOX |
SMITHS MEDICAL ASD, INC. |
DAVID GRAY |
| K050471 |
02/23/2005 |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K050331 |
02/10/2005 |
ADHESIVE 1 |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K053599 |
12/23/2005 |
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES |
SPACELABS MEDICAL INC. |
AL VAN HOUDT |
| K053527 |
12/19/2005 |
SPECTRA HAIR REMOVAL LASER |
SPECTRAGENICS, INC. |
JONATHAN S KAHAN |
| K053336 |
12/01/2005 |
STAXX FX SYSTEM |
SPINE WAVE, INC. |
RONALD K SMITH |
| K050283 |
02/07/2005 |
CREATININE LIQUICOLOR |
STANBIO LABORATORY |
KIRK JOHNSON |
| K050266 |
02/04/2005 |
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR |
STANBIO LABORATORY |
KIRK JOHNSON |
| K050308 |
02/08/2005 |
THERMAL CAUTERY PROBE |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K050264 |
02/04/2005 |
STEALTH PRODUCTS SEATING SYSTEM |
STEALTH PRODUCTS |
EDWARD A KROLL |
| K050343 |
02/11/2005 |
REPROCESSED HARMONIC SCALPELS |
STERILMED, INC. |
BRUCE LESTER |
| K053362 |
12/02/2005 |
CELL-CHEX AUTO |
Streck |
KERRIE OETTER |
| K053528 |
12/19/2005 |
SHORT CITATION FEMORAL STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K053514 |
12/16/2005 |
TRIATHLON TOTAL KNEE SYSTEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
| K050461 |
02/23/2005 |
XIA 4.5 SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K050486 |
02/25/2005 |
PROTECT TOOTH DESENSITIZER |
SUNSTAR BUTLER |
RICHARD O WOOD |
| K050247 |
02/02/2005 |
CONTOUR NECKLIFT THREADS |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K053380 |
12/05/2005 |
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K050292 |
02/07/2005 |
SHARPOINT LUKENS BONE WAX |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K053482 |
12/14/2005 |
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW |
SUTURA, INC. |
GERARD J PRUD'HOMME |
| K053565 |
12/22/2005 |
TEMPBOND CLEAR WITH TRICLOSAN |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K050452 |
02/22/2005 |
AURORA SR AND SRA APPLICATOR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K053616 |
12/28/2005 |
POLARIS WR, ST APPLICATOR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K050397 |
02/16/2005 |
VELASMOOTH, SHAPER |
SYNERON MEDICAL LTD. |
DONALD E SEGAL |
| K050378 |
02/15/2005 |
SYNTHES MANDIBLE EXTERNAL FIXATOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K053508 |
12/16/2005 |
SYNFIX-LR |
SYNTHES SPINE CO.LP |
ANGELA MIKROULIS |
| K053418 |
12/08/2005 |
SYNTHES OC FUSION SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K050451 |
02/22/2005 |
SYNTHES VECTRA SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K050341 |
02/11/2005 |
IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 |
TACTILE TECHNOLOGIES, LTD. |
ZVIKA SLOVIN |
| K050463 |
02/23/2005 |
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K053572 |
12/22/2005 |
C. DIFF QUIK CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K050325 |
02/09/2005 |
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE |
TECHNOMED EUROPE |
RENE RONCKEN |
| K053420 |
12/08/2005 |
TENACORE SP02 SENSORS |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K053413 |
12/07/2005 |
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K050418 |
02/18/2005 |
TISSUE FIXATION SYSTEM |
TFS MANUFACTURING PTY LTD |
ALASTAIR DOWLING |
| K053547 |
12/20/2005 |
SMARTPILL GI MONITORING SYSTEM |
THE SMARTPILL CORPORATION |
KATHLEEN SELOVER |
| K053613 |
12/27/2005 |
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE |
THEO MANUFACTURING BV |
BARBARA DEBIASE |
| K050342 |
02/11/2005 |
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM |
THERALASE INC. |
ROGER WHITE |
| K053365 |
12/02/2005 |
MODIFICATION TO THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K053434 |
12/09/2005 |
MYOTRAC INFINITI ELECTRICAL STIMULATOR |
THOUGHT TECHNOLOGY LTD. |
SURESH R SUGIRTHARAJA |
| K050355 |
02/14/2005 |
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 |
TISSUE SCIENCE LABORATORIES, PLC |
VICTORIA TAYLOR |
| K053562 |
12/21/2005 |
ZIMMER COLLAGEN REPAIR PATCH |
TISSUE SCIENCE LABORATORIES, PLC |
ANGELA BUNN |
| K053378 |
12/05/2005 |
LOOP RECORDER VITAPHONE, 3100 SERIES |
TMS TELEMEDIZINISCHE SYSTEME GMBH |
TILO BORCHARDT |
| K050316 |
02/09/2005 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
Mireille Lemery |
| K050458 |
02/23/2005 |
TSX-201A AQUILION LB CT SCANNER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K050380 |
02/15/2005 |
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K050485 |
02/25/2005 |
20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K053610 |
12/27/2005 |
ABARIS |
TRAXTAL TECHNOLOGIES INC. |
NEIL GLOSSOP |
| K050412 |
02/18/2005 |
VAPORMAX |
TRIMEDYNE, INC. |
GLENN YEIK |
| K053457 |
12/13/2005 |
VAPORMAX II |
TRIMEDYNE, INC. |
GLENN D YEIK |
| K053520 |
12/19/2005 |
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 |
TRIPATH IMAGING, INC. |
BRYAN J TUCKER |
| K053605 |
12/27/2005 |
AEROECLIPSE II BREATH ACTUATED NEBULIZER |
TRUDELL MEDICAL INTL. |
JOHN STRAATMAN |
| K053625 |
12/28/2005 |
NASALGUARD |
TRUTEK CORP |
ASHOK WAHL |
| K053656 |
12/30/2005 |
TYRX ANTIMICROBIAL MESH |
TYRX PHARMA INC |
MASON W DIAMOND |
| K050464 |
02/23/2005 |
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 |
ULTI MED, INC. |
CAROLE STAMP |
| K053513 |
12/16/2005 |
T-PIN |
UNION SURGICAL LLC |
AL WEISENBORN |
| K050269 |
02/04/2005 |
U1 HIP SYSTEM - BIPOLAR |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| K050262 |
02/04/2005 |
U2 ACETABULAR COMPONENT |
UNITED ORTHOPEDIC CORP. |
GENE HUANG |
| K050253 |
02/03/2005 |
USGI SHAPELOCK ENDOSCOPIC GUIDE |
USGI MEDICAL |
MARY LOU MOONEY |
| K050364 |
02/14/2005 |
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K053535 |
12/19/2005 |
VIVAWAVE MICROWAVE ABLATION SYSTEM |
VALLEYLAB |
HERBERT VINSON |
| K050321 |
02/09/2005 |
ONTRAK TESTCARD 9 |
VARIAN INC |
LORNA GAMBOA |
| K050479 |
02/24/2005 |
4D INTEGRATED TREATMENT CONSOLE |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K050296 |
02/07/2005 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K050442 |
02/22/2005 |
MILLENNIUM MULTI-LEAF COLLIMATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K053644 |
12/30/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K053503 |
12/16/2005 |
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) |
VAX-D MEDICAL TECHNOLOGIES USA, L.C. |
LAWRENCE DYER |
| K050474 |
02/24/2005 |
VEINNOVATIONS INFILTRATION SYSTEM |
VEINNOVATIONS, LLC |
ROSINA ROBINSON |
| K050245 |
02/02/2005 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K050309 |
02/08/2005 |
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K053648 |
12/30/2005 |
PIONEER TC8080, COMPANION III |
VIASYS NEURO CARE |
Gary Syring |
| K050362 |
02/14/2005 |
VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) |
VIDENT |
BARBARA J LEWANDOWSKI |
| K053560 |
12/21/2005 |
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K053392 |
12/05/2005 |
FUTURABOND NR SINGLE DOSE |
VOCO GMBH |
MICHAEL SUS |
| K053391 |
12/05/2005 |
X-TRA FIL |
VOCO GMBH |
MICHAEL SUS |
| K053364 |
12/02/2005 |
HALUX IRIS EXAMINATION AND SURGICAL LAMP |
WALDMANN LIGHTING |
DANIEL KAMM |
| K050317 |
02/09/2005 |
BURANE XL |
WAVELIGHT LASER TECHNOLOGIE AG |
ALEXANDER POPP |
| K053604 |
12/27/2005 |
WAVELIGHT IDAS |
WAVELIGHT LASER TECHNOLOGIE AG |
THORSTEN CRETER |
| K053381 |
12/05/2005 |
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE |
WELCH ALLYN, INC. |
CHRIS KLACZYK |
| K053498 |
12/16/2005 |
HYPEROX 101 |
WJO, INC |
CHRIS BELLETIERI |
| K053642 |
12/30/2005 |
OSTEOSET DBM PELLETS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K053588 |
12/23/2005 |
PROFEMUR LX HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K053519 |
12/19/2005 |
SAFETY SYRINGE |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARY POND |
| K053433 |
12/09/2005 |
CAUTERY TIP CLEANER, MODEL 30500 |
XODUS MEDICAL, INC. |
BRENDA NIEL |
| K050388 |
02/15/2005 |
REFIX INTERNAL FRACTURE FIXATION SCREWS |
XTREMI-T, LLC |
SHAWAN T HUXEL |
| K053619 |
12/27/2005 |
COLORBITE |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K050417 |
02/18/2005 |
ELITE IMPLANT |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K050455 |
02/22/2005 |
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES |
ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD |
KAREN ABELL |
| K050450 |
02/22/2005 |
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES |
ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD |
KAREN ABELL |
| K053536 |
12/19/2005 |
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS |
ZIMMER GMBH |
LAURA D WILLIAMS |
| K050433 |
02/22/2005 |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM |
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
CINDY J DICKEY |
| K053340 |
12/01/2005 |
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K050411 |
02/17/2005 |
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM |
ZIMMER, INC. |
CINDY J DICKEY |
