| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K021233 |
12/09/2002 |
AAP CANNULATED SCREWS |
AAP IMPLANTATE AG |
CHRISTIAN ABEL |
| K023397 |
12/16/2002 |
ABBOTT ARCHITECT FOLATE |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K024084 |
12/31/2002 |
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 |
ABBOTT LABORATORIES |
FRANK POKROP |
| K023807 |
12/26/2002 |
MODIFICATION TO ALKP |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K022854 |
12/30/2002 |
ACELL UBM HYDRATED WOUND DRESSING |
ACELL, INC |
PATSY J TRISLER |
| K021637 |
12/19/2002 |
ACELL UBM LYOPHILIZED WOUND DRESSING |
ACELL, INC |
PATSY J TRISER |
| K012691 |
12/20/2002 |
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
ACUTRONIC MEDICAL SYSTEMS AG |
TERRY TORZALA |
| K023788 |
12/13/2002 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
| K023411 |
12/19/2002 |
STEELEX STERNUM SET |
AESCULAP, INC. |
GEORG KELLER |
| K023212 |
12/13/2002 |
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS |
AG GARMENTS |
ATHENA SHUDDE |
| K023264 |
12/19/2002 |
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K022693 |
12/09/2002 |
INSTANT-VIEW TCA URINE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K023936 |
12/20/2002 |
MODIFICATION TO MEDIPRIME |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K024102 |
12/18/2002 |
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K023996 |
12/18/2002 |
ALOKA SSD-3500 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
| K023299 |
12/11/2002 |
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM |
ALPHATEC MFG., INC. |
ELLEN A HICKS |
| K023104 |
12/16/2002 |
AMEDICA DRUG SCREEN AMPHETAMINE TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K023101 |
12/16/2002 |
AMEDICA DRUG SCREEN METHAPHETAMINE TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K023109 |
12/16/2002 |
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K023229 |
12/13/2002 |
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE |
AMERICAN MAMMOGRAPHICS, INC. |
ADRIAN PALMER |
| K023276 |
12/09/2002 |
AMSINO TRACHEOSTOMY CARE TRAY |
AMSINO INTERNATIONAL, INC. |
DEAN R GAUF |
| K023161 |
12/10/2002 |
SMARTSTEP SYSTEM |
ANDANTE MEDICAL DEVICE, LTD. |
ORLY MAOR |
| K023173 |
12/18/2002 |
ANDREWS INTRODUCER, MODEL ASI01 |
ANDREWS SURGICAL INNOVATIONS, LTD. |
EMMET ANDREWS |
| K023769 |
12/30/2002 |
PREPARE ADMINISTRATION SET |
APPRO HEALTHCARE, INC. |
JOHN R SEMLER |
| K023405 |
12/16/2002 |
TROJAN MINT TINGLE BRAND LATEX CONDOMS |
ARMKEL, LLC. |
STEPHEN C KOLAKOWSKY |
| K023986 |
12/17/2002 |
ARTHREX OPES ELECTRODES AND ACCESSORIES |
ARTHREX, INC. |
ANN WATERHOUSE |
| K023119 |
12/18/2002 |
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B |
ARTHREX, INC. |
ANN WATERHOUSE |
| K023777 |
12/11/2002 |
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 |
ARTHRONET MEDICAL, INC. |
CAROLINA SCHABER |
| K020683 |
12/17/2002 |
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 |
ATI MEDICAL, INC. |
MICHAEL WIENHOLT |
| K023108 |
12/03/2002 |
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE |
ATLANTIC PRODUCTS, INC. |
MAHBUBUR RAHMAN |
| K021699 |
12/16/2002 |
AUTOLENS CLEANING AND DISINFECTING UNIT |
AUTOLENS INC. |
RICHARD E LIPPMAN |
| K021859 |
12/02/2002 |
WRIST IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K023160 |
12/20/2002 |
DRX5000 |
AXIOM USA. INC |
JIM GIBSON |
| K022640 |
12/02/2002 |
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM |
BACCHUS VASCULAR, INC. |
GREGORY J MATHISON |
| K023514 |
12/02/2002 |
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) |
BACCHUS VASCULAR, INC. |
GREGORY J MATHISON |
| K022773 |
12/13/2002 |
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSON |
| K023341 |
12/23/2002 |
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSON |
| K023340 |
12/23/2002 |
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSOPN |
| K023322 |
12/23/2002 |
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSON |
| K023339 |
12/23/2002 |
IMAGETILE |
BARCO NV |
FRANK FERGUSON |
| K013562 |
12/12/2002 |
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K022288 |
12/17/2002 |
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
BAYER CORP. |
KENNETH T EDDS |
| K023841 |
12/24/2002 |
AMMONIA ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
ANDRES HOLLE |
| K022177 |
12/17/2002 |
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K023334 |
12/31/2002 |
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 |
BAYLIS MEDICAL CO., INC. |
AMANDA HARTLEY |
| K023597 |
12/11/2002 |
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY |
BECKMAN COULTER, INC. |
MARA CALER |
| K023480 |
12/20/2002 |
ACCESS TOTAL BHCG |
BECKMAN COULTER, INC. |
DENISE THOMPSON |
| K023369 |
12/09/2002 |
ACCESS TOTAL T4 ASSAY |
BECKMAN COULTER, INC. |
DENISE THOMPSON |
| K022133 |
12/10/2002 |
BD DIRECTIGEN EZ RSV KIT |
BECTON DICKINSON & CO. |
COLLEEN A KISTLER |
| K024109 |
12/30/2002 |
BD ULTRA-FINE III PEN NEEDLE |
BECTON DICKINSON & CO. |
JOHN A SCHALGO |
| K023219 |
12/06/2002 |
BECTON DICKINSON DIABETES SOFTWARE |
BECTON DICKINSON & CO. |
JOHN SCHALAGO |
| K023858 |
12/20/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K023527 |
12/23/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K023634 |
12/24/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K010185 |
12/30/2002 |
6.0 X 5.7MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
| K022660 |
12/19/2002 |
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K022995 |
12/02/2002 |
COLLATEK HYDROGEL |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
AJAY KUMAR |
| K023089 |
12/16/2002 |
GELSPHERES EMBOLIC AGENT |
BIOCURE, INC. |
JOHN GREENBAUM |
| K023063 |
12/13/2002 |
COMPREHENSIVE HUMERAL FRACTURE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K023188 |
12/11/2002 |
PRESS-FIT HEAD RESURFACING DEVICE |
BIOMET ORTHOPEDICS, INC. |
PATRICIA SANDBORN BERES |
| K022952 |
12/02/2002 |
MODULAR HEAD BONE SCREW |
BIOMET, INC. |
KACY ARNOLD |
| K024037 |
12/30/2002 |
NARROW ASCENT INTERLOK FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K023810 |
12/04/2002 |
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
JUDY SOKUA |
| K023803 |
12/11/2002 |
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K023147 |
12/12/2002 |
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 |
BORTEC BIOMEDICAL, LTD. |
CARL YOUNGMAN |
| K023870 |
12/20/2002 |
FLEXIMA BILIARY CATHETER |
BOSTON SCIENTIFIC/MEDI-TECH |
NICHOLAS CONDAKES |
| K023489 |
12/16/2002 |
QUICKTOX MULTIPLE DRUG DIPCARD |
BRANAN MEDICAL CORP. |
CHIA HER |
| K023961 |
12/24/2002 |
SCOUT BOSS |
BURKE, INC. |
DUWAYNE E KRAMER JR. |
| K023374 |
12/18/2002 |
GROSHONG NXT DUAL LUMEN PICC CATHETERS |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K023193 |
12/20/2002 |
CANDELA GENTLE YAG LASER SYSTEM |
CANDELA CORP. |
William McGrail |
| K024058 |
12/30/2002 |
MODIFICATION TO CARDEON AEGIS CATHETER |
CARDEON CORP. |
JANE BEGGS |
| K022584 |
12/30/2002 |
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING |
CARDIOTECH INTL. |
ANDREW M REED |
| K023466 |
12/13/2002 |
TULIP ALGINATE IMPRESSION MATERIAL |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K023328 |
12/12/2002 |
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH |
CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES |
MELISSA MAHALL |
| K023347 |
12/06/2002 |
VITAL STIM |
CHATTANOOGA GROUP |
CHERYL BAGWELL |
| K023370 |
12/24/2002 |
CHEETAH I.V.D.S., MODEL 2002P |
CHEETAH MEDICAL INC. |
ARAVA HACOHEN |
| K023732 |
12/10/2002 |
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
CIBA VISION CORPORATION |
TERRINA WILDER |
| K023661 |
12/06/2002 |
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K023125 |
12/18/2002 |
COALESCENT U-CLIP- AND ACCESSORIES |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K023922 |
12/20/2002 |
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 |
COAPT SYSTEMS, INC. |
SHELLEY TRIMM |
| K023581 |
12/02/2002 |
COMFORT AGILE SCOOTER, LY-EW303 |
COMFORT ORTHOPEDIC CO. LTD. |
JEN KE-MIN |
| K023655 |
12/13/2002 |
ENHANCE HTF MEDIUM WITH HEPES |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
| K023717 |
12/13/2002 |
SPERM WASH MEDIUM WITH GENTAMICIN |
CONCEPTION TECHNOLOGIES |
JOHN CORCORAN |
| K023731 |
12/24/2002 |
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 |
CONSOLIDATED TECHNOLOGY |
CANDICE BETZ |
| K023349 |
12/24/2002 |
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
MARTIN DALSING |
| K023353 |
12/20/2002 |
SYDNEY IVF HYALURONIDASE |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K023379 |
12/11/2002 |
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER |
COOPER SURGICAL |
JOSEPH M AZARY |
| K023383 |
12/13/2002 |
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER |
COOPER SURGICAL |
JOSEPH M AZARY |
| K023382 |
12/20/2002 |
COOPERSURGICAL MALLEABLE SYTLET |
COOPER SURGICAL |
JOSEPH M AZARY |
| K023384 |
12/13/2002 |
COOPERSURGICAL TRIAL TRANSFER CATHETER |
COOPER SURGICAL |
JOSEPH M AZARY |
| K023907 |
12/18/2002 |
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER |
CORDIS CORP. |
DONNA MARSHALL |
| K023327 |
12/02/2002 |
CYNOVAD ZIRKON |
CYNOVAD |
NAOUM ARAJ |
| K023361 |
12/16/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K023541 |
12/13/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K022284 |
12/10/2002 |
SNORE-AID MAX |
DENTAL IMAGINEERS, LLC |
WILLIAM A BELFER |
| K023115 |
12/18/2002 |
ACE VERSANAIL |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN, J.D. |
| K023786 |
12/10/2002 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER |
DEPUY ORTHOPAEDICS, INC. |
KARLA A HAM |
| K021039 |
12/11/2002 |
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM |
DEPUYACROMED |
KAREN F JURCZAK |
| K023330 |
12/11/2002 |
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K022713 |
12/18/2002 |
DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
JAMES L BROWN |
| K023152 |
12/17/2002 |
IMMULITE 2000 ALLERGEN-SPECIFIC IGE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K023304 |
12/09/2002 |
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K023543 |
12/02/2002 |
EVLT KIT AND D15PLUS AND D30PLUS DIODE |
DIOMED, INC. |
SAMUEL D WADE |
| K023233 |
12/13/2002 |
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K023757 |
12/05/2002 |
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 |
ENDOCARE, INC. |
EBEN GORDON |
| K023886 |
12/12/2002 |
ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D |
ERBE USA, INC. |
JOHN TARTAL |
| K023880 |
12/11/2002 |
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER |
ETHICON, INC. |
PETER CECCHINI |
| K022715 |
12/19/2002 |
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE |
ETHICON, INC. |
REY LIBROJO |
| K022933 |
12/02/2002 |
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT |
EVENFLO COMPANY, INC. |
MATTHEW G MCCARTY |
| K023485 |
12/02/2002 |
EXPLORER POWERED WHEELCHAIR |
EVERMED CORP. |
ROBERT S MCQUATE |
| K023993 |
12/27/2002 |
GALAXY SERIES WHEELCHAIR |
EVERMED CORP. |
CALVIN CHANG |
| K024030 |
12/12/2002 |
MILLENNIUM SERIES MANUAL WHEELCHAIRS |
EVERMED CORP. |
CALVIN CHANG |
| K020533 |
12/02/2002 |
EXEL VACULET BLOOD COLLECTION SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K023017 |
12/13/2002 |
TUCKER EMBRYO CATHETER |
FERTILITY TECHNOLOGY RESOURCES, INC. |
THOMAS J ZINNANTI |
| K023362 |
12/09/2002 |
FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN |
FISHER DIAGNOSTICS |
JERALD STEINER |
| K021548 |
12/06/2002 |
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K023241 |
12/24/2002 |
TELEGRAPH HUMERAL NAIL |
FOURNITURES HOSPITALIERES INDUSTRIE |
M. FRANK LEWIS |
| K023574 |
12/04/2002 |
GIZMO |
FREEDOM DESIGNS, INC. |
GINNY S MALOCO |
| K023554 |
12/20/2002 |
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE |
GE LUNAR CORP. |
JAMES P RASKOB |
| K023932 |
12/11/2002 |
GE PHOTON ENERGY RECOVERY (PER) OPTION |
GE MEDICAL SYSTEMS F.I. HAIFA |
HEMY NEUMAN |
| K021726 |
12/12/2002 |
GEBAUER'S INSTANT ICE |
GEBAUER CO. |
SUZANNE B WOJCIK |
| K023380 |
12/03/2002 |
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K023246 |
12/23/2002 |
AMALGA PACS |
GLOBAL CARE SOLUTIONS, S.A. |
CARL ALLETTO |
| K023320 |
12/10/2002 |
AGILTRAC .035 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
MICHELLE GROSSMAN |
| K023007 |
12/05/2002 |
DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
RICHARD D BLISS |
| K021775 |
12/23/2002 |
LTFS230 |
HEALTHTRONICS, INC. |
PETER WEIMAN |
| K023259 |
12/26/2002 |
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 |
HELIX MEDICAL, INC. |
CYNTHIA M ANDERSON |
| K023491 |
12/13/2002 |
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM |
HELP TECHNOLOGIES |
ROBERT J BARD |
| K023784 |
12/24/2002 |
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
| K022690 |
12/23/2002 |
PAROS CRP |
HORIBA LTD. |
IAN GILES |
| K022905 |
12/13/2002 |
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER |
HORIZON MEDICAL PRODUCTS, INC. |
SCOTT MOELLER |
| K022993 |
12/02/2002 |
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS |
HOVEROUND CORP. |
TONY DIGIOVANNI |
| K023087 |
12/16/2002 |
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K024060 |
12/20/2002 |
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K023267 |
12/11/2002 |
T2 SUPRACONDYLAR NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K022928 |
12/11/2002 |
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS |
HUDSON DIAGNOSTIC IMAGING LLC |
MARTIN E WENDELKEN |
| K023938 |
12/13/2002 |
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 |
HUTCHINSON TECHNOLOGY, INC. |
THOMAS A DOLD |
| K022945 |
12/18/2002 |
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA |
HYCOR BIOMEDICAL, INC. |
RANDY WILSON |
| K022944 |
12/18/2002 |
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA |
HYCOR BIOMEDICAL, INC. |
RANDY WILSON |
| K021509 |
12/24/2002 |
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 |
HYGIA HEALTH SERVICES, INC. |
GEOFF M FATZINGER |
| K023883 |
12/20/2002 |
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO |
I-FLOW CORP. |
SHANE NOEHRE |
| K023827 |
12/13/2002 |
PARAGON INFUSION SYSTEM WITH BOLUS |
I-FLOW CORP. |
SHANE NOEHRE |
| K022009 |
12/30/2002 |
3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
| K023242 |
12/04/2002 |
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE |
IMPLANT SCIENCES CORP. |
JEFFREY GIBBS |
| K022377 |
12/10/2002 |
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 |
IMPLEX CORP. |
ROBERT A POGGIE |
| K023067 |
12/03/2002 |
IMTEC SENDAX MDI ORTHO6 AND ORTHO8 |
IMTEC CORP. |
BRAD VANCE |
| K023500 |
12/13/2002 |
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 |
INNOVATECH, INC |
TONY C.S. CHANG |
| K023269 |
12/23/2002 |
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K022979 |
12/18/2002 |
LAPARETTE, MODEL LAP J L S H N |
INSTRUMENTS MEDICAUX G.B., INC. |
MARTIN PAQUETTE |
| K022911 |
12/02/2002 |
MODEL AMI1200 C-ARM |
INTEGRITY PRACTICE MANAGEMENT, INC. |
KEVIN J MEURET |
| K022048 |
12/04/2002 |
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K021915 |
12/19/2002 |
TRANSITIONAL IMPLANTS |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K023222 |
12/26/2002 |
ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 |
INVITROCARE, INC. |
ROBERT E LOVINS |
| K022086 |
12/23/2002 |
AIM-V (R) MEDIUM, MODEL 087-0112 |
INVITROGEN CORPORATION |
KEITH D GITTERMAN |
| K023035 |
12/02/2002 |
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K022147 |
12/20/2002 |
DENTA PORT |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K024036 |
12/20/2002 |
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
| K022762 |
12/16/2002 |
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 |
JOMED, INC. |
TERRY SCHULTZ |
| K023132 |
12/17/2002 |
JOSTRA MECC SYSTEM |
JOSTRA AG |
KATHLEEN JOHNSON |
| K023853 |
12/13/2002 |
K-ASSAY LP(A) CONTROLS |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K023187 |
12/02/2002 |
KSEA SPINOSCOPE |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| K014277 |
12/11/2002 |
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K023305 |
12/26/2002 |
KEGELMASTER 2000 |
KEGELMASTER 2000 LTD. |
YOLANDA SMITH |
| K021501 |
12/02/2002 |
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
| K021500 |
12/20/2002 |
VACUUM ASSISTED CLOSURE |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
| K023770 |
12/12/2002 |
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) |
KINETIKOS MEDICAL, INC. |
JOHN SPAMPINATO |
| K024025 |
12/18/2002 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
JAMES F LOGAN |
| K023143 |
12/19/2002 |
ECHO SOUNDER, ES-102EX |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K023292 |
12/13/2002 |
APEX HRI DIGITAL RADIOGRAPHY SYSTEM |
KRUGMAN TECHNOLOGIES, INC |
MICHAEL A KRUGMAN |
| K021643 |
12/13/2002 |
HA ORBITAL IMPLANT |
LABORATOIRE VILLANOVA |
ISABELLE DRUBAIX |
| K023832 |
12/13/2002 |
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
JOHN E HUGHES |
| K022888 |
12/11/2002 |
ACUBEAM, SUPER NOVA, DIO |
LIGHT FORCE THERAPY, INC. |
LEWIS WARD |
| K023317 |
12/12/2002 |
METHADONE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K023316 |
12/16/2002 |
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K022723 |
12/26/2002 |
MASTEL 1 FOLDER IMPLANTATION SYSTEM |
MASTEL PRECISION, INC. |
MAUREEN WEINER |
| K023098 |
12/09/2002 |
ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT |
MCKINLEY INFUSER |
JOHN CHAPPELL |
| K023789 |
12/06/2002 |
O.B. TAMPONS |
MCNEIL-PPC, INC. |
DIANA L.B. UHL |
| K023293 |
12/23/2002 |
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 |
MED-TEC,INC. |
DONALD F RIIBE |
| K023084 |
12/16/2002 |
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL |
MEDICAL ADVANCES, INC. |
ANTHONY DIETZLER |
| K023669 |
12/19/2002 |
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K023867 |
12/17/2002 |
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K023928 |
12/11/2002 |
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K023081 |
12/16/2002 |
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K022732 |
12/13/2002 |
INFANT/CHILD REDUCED ENERGY ELECTRODES |
MEDTRONIC PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
| K014296 |
12/10/2002 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K023797 |
12/13/2002 |
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K023415 |
12/13/2002 |
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K024032 |
12/30/2002 |
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY |
MEDTRONIC VASCULAR |
LYNN JENSEN |
| K024035 |
12/30/2002 |
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY |
MEDTRONIC VASCULAR |
LYNN JENSEN |
| K023798 |
12/03/2002 |
MODIFICATION TO ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
| K022661 |
12/13/2002 |
A1CNOW FOR HOME USE |
METRIKA, INC. |
Erika B Ammirati |
| K020482 |
12/16/2002 |
KERATOME BLADE 200200 & 600600 |
MICROSPECIALTIES, INC. |
CHARLES VASSALLO |
| K021953 |
12/20/2002 |
MITEK PDS/PGA STAPLE |
MITEK WORLDWIDE |
PETRA C SMIT |
| K023388 |
12/27/2002 |
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM |
MITEK WORLDWIDE |
PETRA C SMIT |
| K021098 |
12/03/2002 |
DAUM-LECTRIC MRI DRILLING MACHINE |
MRI DEVICES DAUM GMBH |
E. J SMITH |
| K021115 |
12/20/2002 |
GYNEFLEX |
NAISSANCE HOLDINGS, LC |
NANCY E TAYLOR |
| K013113 |
12/20/2002 |
MODIFICATION TO NANMA VACUUM PUMP |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
| K023477 |
12/13/2002 |
BIOLOY |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
| K023962 |
12/24/2002 |
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K023016 |
12/04/2002 |
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE |
NICORE EQUIPMENT & LEASING, INC. |
JEFF MOGILEWICZ |
| K023719 |
12/23/2002 |
MP-1 MICRO PERIMETER |
NIDEK TECHNOLOGIES SRL |
ALDO COCCHIGLIA |
| K023702 |
12/18/2002 |
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE |
NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K023567 |
12/20/2002 |
STAT PROFILE PHOX PLUS L ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K014152 |
12/11/2002 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K023077 |
12/10/2002 |
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) |
OCU-EASE OPTICAL PRODUCTS, INC. |
DEANNA WERBER |
| K023280 |
12/19/2002 |
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K024033 |
12/20/2002 |
XTJF-160AF DUODENOVIDEOSCOPE |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K021682 |
12/12/2002 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K023372 |
12/27/2002 |
NON-BIOABSORBABLE STAPLE |
ONUX MEDICAL, INC. |
RUTHANN DEPIETRO |
| K022176 |
12/03/2002 |
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 |
ORION DIAGNOSTICA, DIV. ORION CORP. |
ANNIKKA RANTAMA |
| K023875 |
12/10/2002 |
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K023876 |
12/10/2002 |
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K023501 |
12/18/2002 |
GOLD CORE 35 |
PENTRON LABORATORY TECHNOLOGIES |
GREG JIMMIE |
| K023502 |
12/18/2002 |
JEWEL CAST PLUS |
PENTRON LABORATORY TECHNOLOGIES |
GREG JIMMIE |
| K023871 |
12/04/2002 |
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K023137 |
12/19/2002 |
PHILIPS EASYVISION WORKSTATION RELEASE 6 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K023877 |
12/23/2002 |
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN |
PHILIPS ULTRASOUND, INC. |
LYNN HARMER |
| K011723 |
12/18/2002 |
ANTI-SNORING DEVICE OR ASD |
PI MEDICAL |
LINDA S ALEXANDER |
| K023667 |
12/24/2002 |
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K020899 |
12/13/2002 |
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D |
PNEU PAC, LTD. |
DONALD ALEXANDER |
| K023396 |
12/23/2002 |
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K023251 |
12/04/2002 |
PEDIATRIC ARTERIAL CANNULA |
POLYSTAN A/S |
DANA OLSEN |
| K022313 |
12/09/2002 |
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K023700 |
12/04/2002 |
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE |
PRECISION VASCULAR SYSTEMS, INC. |
RICK GAYKOWSKI |
| K022607 |
12/20/2002 |
SPECTRAPULSE |
PRIMARY TECHNOLOGY, LLC. |
STEPHEN ALMEIDA |
| K023112 |
12/17/2002 |
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 |
PROBLEM SOLVING CONCEPTS, INC. |
THOMAS M MCCLELLAND |
| K023450 |
12/19/2002 |
BIOPSY SITE TISSUE MARKER DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K023051 |
12/12/2002 |
INTRAUTERINE DELIVERY SYSTEM - INJECTOR |
PROSURG, INC. |
ASHVIN DESAI |
| K023225 |
12/18/2002 |
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE |
PURITAN BENNETT CORP. |
GINA TO |
| K023094 |
12/17/2002 |
IRIDIS OPHTHALMIC PHOTOCOAGULATOR |
QUANTEL MEDICAL |
ROGER W BARNES |
| K024107 |
12/24/2002 |
FEMOSTOP FEMORAL COMPRESSION SYSTEM |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K022914 |
12/20/2002 |
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES |
RHYTHMLINK INTERNATIONAL, LLC |
BRETT L NETHERTON |
| K023846 |
12/06/2002 |
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY |
RITA MEDICAL SYSTEMS |
KAREN FRISCHMEYER |
| K022494 |
12/02/2002 |
HOME CARE JELLY |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
SHU-CHEN CHENG |
| K022518 |
12/02/2002 |
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
SHU-CHEN CHENG |
| K024098 |
12/19/2002 |
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K023281 |
12/06/2002 |
ONLINE DAT II COCAINE II |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K022500 |
12/23/2002 |
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
DONALD DANALD |
| K023545 |
12/30/2002 |
ULTRA-LITE 200E LIGHT CURE UNIT |
ROLENCE ENT. INC. |
STERLING CHENG |
| K020130 |
12/02/2002 |
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M |
ROLOR ELECTRONICS CORP. |
JEN KE-MIN |
| K021430 |
12/02/2002 |
SANIDAD TENS-DUO MODE GP8016N |
ROLOR ELECTRONICS CORP. |
Ke-Min Jen |
| K023964 |
12/23/2002 |
RUSCH MICROLARYNGEAL TUBE |
RUSCH INTL. |
RICK LYKINS |
| K021987 |
12/27/2002 |
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY |
S&S PAR SCIENTIFIC |
SUSAN D GOLDSTEIN-FALK |
| K022683 |
12/16/2002 |
SAS BLOOD/SERUM/URINE/URINE HCG |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K022466 |
12/31/2002 |
PROFILE 1320 LASER SYSTEM |
SCITON, INC. |
JAY M PATAL |
| K023923 |
12/11/2002 |
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE |
SENORX, INC. |
AMY BOUCLY |
| K020837 |
12/02/2002 |
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
TONY T.K. CHENG |
| K023560 |
12/17/2002 |
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K024026 |
12/18/2002 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
SHANGHAI PM PLASTICS ENTERISE CO., LTD. |
CHANG TE SUN |
| K024121 |
12/20/2002 |
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K024106 |
12/20/2002 |
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K024108 |
12/18/2002 |
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K020440 |
12/03/2002 |
NEWCOR |
SIEMENS MEDICAL SYSTEMS, INC. |
KATHLEEN RUTHERFORD |
| K023046 |
12/02/2002 |
SST SALIVA SUPPORTING TABLETS |
SINCLAIR PHARMACEUTICALS, LTD. |
DENISE SWIFT |
| K020085 |
12/10/2002 |
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X |
SINTEA BIOTECH, INC. |
MARIANNE GRUNWALDT |
| K023232 |
12/11/2002 |
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE |
SMART PRACTICE |
KIM SULLIVAN |
| K021803 |
12/19/2002 |
REFLECTION CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K021798 |
12/09/2002 |
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS |
SMITH & NEPHEW, INC. |
GINO J ROUSS |
| K023957 |
12/12/2002 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K023633 |
12/31/2002 |
SOVIS OPTIQUE'S ENDOSCOPIC CABLE |
SOVIS OPTIQUE |
FRANCES K WU |
| K022997 |
12/06/2002 |
SPECTRUM CERVICAL SPINAL SYSTEM |
SPINAL INNOVATIONS, LLC. |
JOSEPH S CLIFT |
| K023716 |
12/05/2002 |
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K023656 |
12/30/2002 |
SICKLE-CHEX SOLUBILITY KIT |
STRECK LABORATORIES, INC. |
CAROL THOMPSON |
| K022185 |
12/17/2002 |
UNIVERSAL CMF SYSTEM |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
| K023185 |
12/17/2002 |
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 |
SULZER CARBOMEDICS, INC. |
TEFFANY HANKINSON |
| K023243 |
12/13/2002 |
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K022985 |
12/05/2002 |
ASCENDENT ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
| K024011 |
12/19/2002 |
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
MARY ANN BARKER |
| K023862 |
12/19/2002 |
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K022091 |
12/30/2002 |
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES |
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. |
DAVID HU |
| K023261 |
12/13/2002 |
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 |
TAUT, INC. |
MAX CLOAT |
| K022698 |
12/02/2002 |
SCOOTER MARS SERIES, MODEL TL-588 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
| K022249 |
12/31/2002 |
NIGHTRON POLYSOMNOGRAPHY SYSTEM |
TELEDIAGNOSTIC SYSTEMS, INC. |
LARRY WOODARD |
| K023271 |
12/18/2002 |
TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
SANDI LARTKA |
| K023272 |
12/23/2002 |
DISPOSABLE ASPIRATION NEEDLE NA-200H |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K024055 |
12/20/2002 |
TILITE EVO |
TISPORT, LLC |
RICHARD S FOREMAN |
| K023239 |
12/23/2002 |
AIA-PACK CA 19-9 |
TOSOH CORP. |
JUDITH E LOEBEL |
| K023240 |
12/23/2002 |
ST AIA-PACK CA 19-9 |
TOSOH CORP. |
JUDITH E LOEBEL |
| K023894 |
12/17/2002 |
ST AIA-PACK AFP ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
| K023891 |
12/06/2002 |
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
| K023893 |
12/18/2002 |
ST AIA-PACK CEA ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
| K023091 |
12/17/2002 |
ST AIA-PACK TESTOSTERONE ASSAY |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
| K022963 |
12/04/2002 |
TRANSONIC SYRINGE WARMER, MODEL SYR-1000 |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K023595 |
12/18/2002 |
BURETTE-IN LINE (150 ML) |
TUTA HEALTHCARE PTY LIMITED |
OMID SOURESRAFIL |
| K022517 |
12/24/2002 |
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
| K023176 |
12/13/2002 |
UNDUS MALE LATEX CONDOM (WITH FLAVORING) |
UNIDUS CORP. |
ELI J CARTER |
| K023059 |
12/12/2002 |
UNIDUS MALE LATEX CONDOM |
UNIDUS CORP. |
ELI J CARTER |
| K023175 |
12/13/2002 |
UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) |
UNIDUS CORP. |
ELI J CARTER |
| K023129 |
12/13/2002 |
UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) |
UNIDUS CORP. |
ELI J CARTER |
| K023247 |
12/23/2002 |
CHAMPION 5000 PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K023539 |
12/17/2002 |
STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW |
VALUMED |
THOMAS E COTTONE |
| K023180 |
12/12/2002 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K023154 |
12/20/2002 |
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 |
VASCULAR CONTROL SYSTEMS, INC |
AL MEMMOLO |
| K022028 |
12/17/2002 |
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER |
VASCULAR ONE, INC. |
SUSAN D GOLDSTEIN-FALK |
| K023469 |
12/10/2002 |
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 |
VICTUS, INC. |
ILEANA YANES |
| K023403 |
12/13/2002 |
SPERMGRAD, MODELS 10022/10063 |
VITROLIFE SWEDEN AB |
NINA ARVIDSSON |
| K023019 |
12/10/2002 |
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 |
VOMED VOLZER MEDIZINTECHNIK GMBH & CO. |
DAGMAR MASER |
| K023811 |
12/10/2002 |
MODIFICATION TO VIABAHN ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYNN |
| K014215 |
12/19/2002 |
VIABIL BILIARY ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
| K023041 |
12/11/2002 |
W.O.M. LASER U100 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K023718 |
12/04/2002 |
QUICKSET MIMIX BONE VOID FILLER |
WALTER LORENZ SURGICAL, INC. |
KACY ARNOLD |
| K020020 |
12/30/2002 |
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) |
WELL-LIFE HEALTHCARE, INC. |
TONY C CHANG |
| K023392 |
12/06/2002 |
AGC SPECIAL ALLOY |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K023391 |
12/10/2002 |
BIOPORTA G |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K023389 |
12/06/2002 |
PORTA GEO TI |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
RUDOLF WAGNER |
| K023395 |
12/11/2002 |
PORTADUR P2 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K023549 |
12/09/2002 |
WIENER LAB AMILASA 405 AA LIQUIDA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K023551 |
12/09/2002 |
WIENER LAB GOT (AST) UV AA LIQUIDA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K023550 |
12/09/2002 |
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K021489 |
12/04/2002 |
REPIPHYSIS LIMB SALVAGE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K023517 |
12/02/2002 |
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K024130 |
12/30/2002 |
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIN |
| K023027 |
12/16/2002 |
PREG-Q EARLY PREGNANCY TEST |
YD DIAGNOSTICS |
ART BEACH |
| K023577 |
12/06/2002 |
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K023975 |
12/20/2002 |
VOYAGER LINUX |
Z-KAT, INC. |
CHRISTINA VANCE |
| K024034 |
12/18/2002 |
OCCLUFAST ROCK |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K024041 |
12/18/2002 |
ZETAPLUS SOFT |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K021826 |
12/20/2002 |
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES |
ZIMMER, INC. |
KAREN CAIN |
