| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K014142 |
02/28/2002 |
UNITE BONDING ADHESIVE |
3M UNITEK |
L. MARLYN SCHEFF |
| K012472 |
02/15/2002 |
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS |
A & D ENGINEERING, INC. |
JERRY WANG |
| K021233 |
12/09/2002 |
AAP CANNULATED SCREWS |
AAP IMPLANTATE AG |
CHRISTIAN ABEL |
| K014201 |
02/25/2002 |
AARON REUSABLE ELECTROSURGICAL ELECTRODE |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
| 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 |
| K012975 |
02/28/2002 |
SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS |
ABBOTT LABORATORIES |
JANET S CONNOLLY |
| K014203 |
02/28/2002 |
ABX MICROS 60 HEMATOLOGY ANALYZER |
ABX DIAGNOSTICS |
TOM M PHILLIPS |
| 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 |
| K013511 |
02/01/2002 |
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) |
ACULUX, INC. |
KIM MARSH |
| K012691 |
12/20/2002 |
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
ACUTRONIC MEDICAL SYSTEMS AG |
TERRY TORZALA |
| K014185 |
02/13/2002 |
AOS CANNULATED BONE SCREW SYSTEM |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K994055 |
02/13/2002 |
STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K013778 |
02/07/2002 |
PEACE OF MIND HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K012694 |
02/04/2002 |
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS |
ADVEN MEDICAL |
MARK W ALDANA |
| K012675 |
02/12/2002 |
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS |
ADVEN MEDICAL |
MARK W ALDANA |
| K012676 |
02/04/2002 |
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS |
ADVEN MEDICAL |
MARK W ALDANA |
| K023788 |
12/13/2002 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
| K023411 |
12/19/2002 |
STEELEX STERNUM SET |
AESCULAP, INC. |
GEORG KELLER |
| K014144 |
02/07/2002 |
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 |
AFP IMAGING CORP. |
DAVID VOZICK |
| K013946 |
02/27/2002 |
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM |
AFX, INC. |
NANCY NORRIS |
| 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 |
| K013893 |
02/01/2002 |
SCANX |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| 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 |
| K014202 |
02/20/2002 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K013479 |
02/11/2002 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
| 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 |
| K014005 |
02/15/2002 |
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
JOHN C PULFORD |
| K014047 |
02/28/2002 |
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
| K023769 |
12/30/2002 |
PREPARE ADMINISTRATION SET |
APPRO HEALTHCARE, INC. |
JOHN R SEMLER |
| K013614 |
02/01/2002 |
TROJAN CRYSTAL CLEAR LIQUID |
ARMKEL LLC |
STEPHEN C KOLAKOWSKY |
| 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 |
| K013940 |
02/26/2002 |
LASER SYSTEM YELLOWSTAR |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
| K020304 |
02/14/2002 |
DISPOSABLE LIGHT HANDLE AND ADAPTOR |
ASPEN SURGICAL PRODUCTS, INC. |
ROY MELLING |
| K011273 |
02/20/2002 |
SI ASCOPE |
ASTRON CLINICA LIMITED |
E.J. Smith |
| K012487 |
02/21/2002 |
SPHYGMOCOR PX MODEL SCOR-PX |
ATCOR MEDICAL PTY. LTD |
KIRSTEN PAULSON |
| 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 |
| K014102 |
02/21/2002 |
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 |
ATOS MEDICAL AB |
EDDY ABERG |
| 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 |
| K013635 |
02/11/2002 |
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) |
BACCHUS VASCULAR, INC. |
GREG 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 |
| K014174 |
02/22/2002 |
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 |
BARNSTEAD/THERMOLYNE CORP. |
MIA M WARE |
| 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 |
| K012357 |
02/28/2002 |
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| 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 |
| K013904 |
02/12/2002 |
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K013919 |
02/22/2002 |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K013862 |
02/21/2002 |
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM |
BCI, INC. |
DONALD ALEXANDER |
| K013719 |
02/05/2002 |
BECKER BAND CRANIAL REMOLDING ORTHOSIS |
BECKER ORTHOPEDIC APPLIANCE CO. |
JAMES H CAMPBELL |
| 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 |
| K014173 |
02/15/2002 |
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| 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 |
| K013971 |
02/01/2002 |
BD VACUTAINER SAFETY COAGULATION TUBE |
BECTON DICKINSON & CO. |
KEITH SMITH |
| 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 |
| K013668 |
02/04/2002 |
BERCHTOLD ELEKTROTOM 106 HITT |
BERCHTOLD CORP. |
MARIKA ANDERSON |
| 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 |
| K013148 |
02/28/2002 |
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) |
BIOGENEX LABORATORIES |
GURVINDER S NANDA |
| K013908 |
02/12/2002 |
WATERLASE MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| 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 |
| K020264 |
02/08/2002 |
REPICCI II UNICONDYLAR KNEE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K013923 |
02/25/2002 |
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER |
BIOMET ORTHOPEDICS, INC. |
LONNIE WITHAM |
| 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 |
| K011569 |
02/22/2002 |
BIOSORBFX O/M 2.0/2/4 SYSTEM |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K020088 |
02/08/2002 |
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
CAROL E JONES |
| K023810 |
12/04/2002 |
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
JUDY SOKUA |
| K013803 |
02/13/2002 |
FLOWGUARD DEVICE |
BIOSONIX LTD. |
AHAVA STEIN |
| K020164 |
02/12/2002 |
E-SCAN XQ |
BIOSOUND ESAOTE, INC. |
COLLEEN DENSMORE |
| K023803 |
12/11/2002 |
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K013885 |
02/01/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K014169 |
02/06/2002 |
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
BOB J. JOHNSON & ASSOC., INC |
ROBERT SNYDER |
| K014187 |
02/06/2002 |
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM |
BOEHRINGER LABORATORIES |
JOHN KARPOWICZ |
| K023147 |
12/12/2002 |
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 |
BORTEC BIOMEDICAL, LTD. |
CARL YOUNGMAN |
| K020283 |
02/11/2002 |
BACK-UP MEIER STEERABLE GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| 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 |
| K013717 |
02/06/2002 |
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
| 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 |
| K013748 |
02/11/2002 |
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) |
CANDELA CORP. |
L NELSON |
| K013825 |
02/15/2002 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
| K020197 |
02/21/2002 |
MODIFICATION TO DATACAPTOR |
CAPSULE TECHNOLOGIE |
DANIEL KAMM |
| K013879 |
02/01/2002 |
TM2000, MODEL 1 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K024058 |
12/30/2002 |
MODIFICATION TO CARDEON AEGIS CATHETER |
CARDEON CORP. |
JANE BEGGS |
| K012241 |
02/01/2002 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 |
CARDIONET, INC |
DONALD V CANAL |
| K020018 |
02/21/2002 |
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE |
CARDIOPULMONARY CORP. |
JOHN LAVIOLA |
| K022584 |
12/30/2002 |
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING |
CARDIOTECH INTL. |
ANDREW M REED |
| K014028 |
02/08/2002 |
CARESIDE APTT |
CARESIDE HEMOTOLOGY, INC. |
KENNETH B ASARCH |
| K023466 |
12/13/2002 |
TULIP ALGINATE IMPRESSION MATERIAL |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K011147 |
02/15/2002 |
CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) |
CAVITAT MEDICAL TECHNOLOGIES, INC. |
LARRY R PILOT |
| K023328 |
12/12/2002 |
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH |
CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES |
MELISSA MAHALL |
| K020132 |
02/26/2002 |
CHASE CARDIOVASCULAR PATCH KIT |
CHASE MEDICAL, INC. |
DAVE HERNON |
| K023347 |
12/06/2002 |
VITAL STIM |
CHATTANOOGA GROUP |
CHERYL BAGWELL |
| K013342 |
02/15/2002 |
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. |
CHAY MEDICAL, LLC. |
STEPHEN C PEARSON |
| 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 |
| K020193 |
02/28/2002 |
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
CL MCINTOSH |
RICHARD E LIPPMAN |
| K012601 |
02/06/2002 |
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
| K012621 |
02/06/2002 |
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
| K012616 |
02/06/2002 |
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
| K012606 |
02/06/2002 |
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
| K012612 |
02/06/2002 |
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE |
CLEAR MEDICAL, INC. |
RICHARD RADFORD |
| K013863 |
02/19/2002 |
CRYSTAL MONITOR MODEL 16 |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
| K014048 |
02/11/2002 |
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS |
CLINICON CORP. |
SEAN M CURRY |
| K023661 |
12/06/2002 |
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K014063 |
02/07/2002 |
TASK FORCE MONITOR 3040 |
CNSYSTEMS MEDIZINTECHNIK GMBH |
CHRISTIAN WAGNER |
| 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 |
| K011835 |
02/12/2002 |
COBE REVOLUTION |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| 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 |
| K013216 |
02/27/2002 |
DIODENT DENTAL LASER SYSTEM |
CONTINUUM ELECTRO-OPTICS, INC. |
RONALD KOHLHARDT |
| K014160 |
02/08/2002 |
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K023353 |
12/20/2002 |
SYDNEY IVF HYALURONIDASE |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K013241 |
02/21/2002 |
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
HEIDI MASTEN |
| K013252 |
02/21/2002 |
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
HEIDI MASTEN |
| 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 |
| K020052 |
02/11/2002 |
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K011239 |
02/14/2002 |
GINDA GUARD |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K013975 |
02/22/2002 |
CP-SLEEVE |
CP MEDICAL |
MARY ANN GREENWALT |
| K020107 |
02/07/2002 |
SMARTEPIL |
CYNOSURE, INC. |
GEORGE CHO |
| K023327 |
12/02/2002 |
CYNOVAD ZIRKON |
CYNOVAD |
NAOUM ARAJ |
| K020249 |
02/06/2002 |
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020185 |
02/06/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020209 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020328 |
02/19/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| 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 |
| K020246 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K023541 |
12/13/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K020182 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020173 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020168 |
02/06/2002 |
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K020023 |
02/28/2002 |
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING |
DAKO CORP. |
GRETCHEN M MURRAY |
| K011540 |
02/06/2002 |
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 |
DATASCOPE CORP. |
SUSAN E MANDY |
| K014249 |
02/19/2002 |
JETPOLISHER |
DELDENT LTD. |
ALAN EDEL |
| K014252 |
02/19/2002 |
JETSTREAM |
DELDENT LTD. |
ALAN EDEL |
| K022284 |
12/10/2002 |
SNORE-AID MAX |
DENTAL IMAGINEERS, LLC |
WILLIAM A BELFER |
| K020412 |
02/22/2002 |
DEPILASE TWIN LASE LASER SYSTEM |
DEPILASE GROUP LTD. |
MARIO RUSSO |
| K020463 |
02/27/2002 |
DEPILASE YAG LASE PLUS LASER SYSTEM |
DEPILASE GROUP LTD. |
MARIO LUCA RUSSO |
| 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 |
| K020080 |
02/19/2002 |
BONART ART-E1 ELECTROSURGERY UNIT |
DIAGNOSTIC DATA, INC. |
ROBERT E JOHNSON |
| 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 |
| K014120 |
02/08/2002 |
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) |
DIAGNOSTICS BIOCHEM CANADA, INC. |
G. R. DUMONT |
| K020351 |
02/26/2002 |
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K023543 |
12/02/2002 |
EVLT KIT AND D15PLUS AND D30PLUS DIODE |
DIOMED, INC. |
SAMUEL D WADE |
| K012003 |
02/12/2002 |
DRG REACTION CHAMBER/SAFETY TIP |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K020075 |
02/08/2002 |
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER |
DOLPHIN MEDICAL INC. |
JON WERNER |
| K011404 |
02/22/2002 |
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS |
DRAEGER MEDICAL, INC. |
MICHAIL A KELHART |
| K013361 |
02/26/2002 |
WIN-2 TANGO ELITE NP |
DURABLE MEDICAL EQUIPMENT, INC. |
ROBERT S MCQUATE |
| K013219 |
02/19/2002 |
PROTOCO2L INSUFFLATOR MODEL 6400 |
E-Z-EM, INC. |
ROBERT WILLIAMS |
| K023233 |
12/13/2002 |
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K020141 |
02/05/2002 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
| K013990 |
02/27/2002 |
LIFESTITCH SUTURING DEVICE |
EDWARDS LIFESCIENCES, LLC. |
LUCINDA STOCKERT |
| K012958 |
02/22/2002 |
BREATHING CIRCUIT FILTER |
EMERGENCY FILTRATION PRODUCTS, INC. |
DOUGLAS K BEPLATE |
| K020170 |
02/11/2002 |
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K020236 |
02/14/2002 |
MODIFICATION TO PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K014107 |
02/13/2002 |
ENDIUS CERVICAL PLATE SYSTEM |
ENDIUS, INC. |
GENE DIPOTO |
| K023757 |
12/05/2002 |
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 |
ENDOCARE, INC. |
EBEN GORDON |
| K020082 |
02/05/2002 |
ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM |
ENDOCARE, INC. |
CHRIS HADLAND |
| K020214 |
02/26/2002 |
MEDIAL ROTATION KNEE SYSTEM |
ENGINEERING CONSULTING SERVICES, INC. |
AL LIPPINCOTT |
| K023886 |
12/12/2002 |
ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D |
ERBE USA, INC. |
JOHN TARTAL |
| K013749 |
02/11/2002 |
ENDOANCHOR AND OPENANCHOR |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
| 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 |
| K012463 |
02/05/2002 |
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
ROBERT TU |
| K020291 |
02/27/2002 |
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER |
EXACTECH, INC. |
ROBERT PAXTON |
| 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 |
| K013397 |
02/15/2002 |
PACIFIC HEMOSTASIS REFERENCE EMULSION |
FISHER DIAGNOSTICS |
JERALD P STEINER |
| K020127 |
02/14/2002 |
SMARTFLOW PULSE TRANSMISSION COEFFICIENT |
FLORENCE MEDICAL LTD. |
ORLY MAOR |
| K014284 |
02/15/2002 |
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE |
FORMOSA GLOVE INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| K014285 |
02/14/2002 |
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE |
FORMOSA GLOVE INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| 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 |
| K020084 |
02/06/2002 |
FUKUDA DENSHI DYNASCOPE MODEL DS-5700 |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K020117 |
02/28/2002 |
GC FUJI LINING LC PASTE PAK |
GC AMERICA, INC. |
TERRY L JORITZ |
| K013997 |
02/20/2002 |
UNIFIL BOND |
GC AMERICA, INC. |
TERRY L JORITZ |
| K020138 |
02/11/2002 |
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 |
GDS TECHNOLOGY |
RICHARD TYHACH |
| K023554 |
12/20/2002 |
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE |
GE LUNAR CORP. |
JAMES P RASKOB |
| K020483 |
02/28/2002 |
ADVANTAGE WORKSTATION 4.1 |
GE MEDICAL SYSTEMS |
SCOTT R EVANS |
| K023932 |
12/11/2002 |
GE PHOTON ENERGY RECOVERY (PER) OPTION |
GE MEDICAL SYSTEMS F.I. HAIFA |
HEMY NEUMAN |
| K020022 |
02/01/2002 |
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
THOMAS ENGLISH |
| K021726 |
12/12/2002 |
GEBAUER'S INSTANT ICE |
GEBAUER CO. |
SUZANNE B WOJCIK |
| K020263 |
02/06/2002 |
LOGIQ 3 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K012467 |
02/11/2002 |
SOLAR 8000M SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K023380 |
12/03/2002 |
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K002102 |
02/06/2002 |
GENTLE COLONICS IRRIGATION SYSTEM |
GENTLE COLONICS, INC. |
GRACE HOLLAND |
| K023246 |
12/23/2002 |
AMALGA PACS |
GLOBAL CARE SOLUTIONS, S.A. |
CARL ALLETTO |
| K013707 |
02/01/2002 |
SOFTIQUE, MODEL GI 11001 |
GLOBAL TV CONCEPTS, LTD. |
LAURIE BRADEN |
| K012976 |
02/12/2002 |
TWIN PLUS |
GRASS-TELEFACTOR DIVISON |
JOHN B CHATTEN |
| K014104 |
02/01/2002 |
VACUETTE EDTA K2 TUBES |
GREINER VACUETTE NORTH AMERICA, INC. |
Judi Smith |
| K020161 |
02/22/2002 |
AGILTRAC .018 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
CURTIS TRUESDALE |
| K023320 |
12/10/2002 |
AGILTRAC .035 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
MICHELLE GROSSMAN |
| K020143 |
02/20/2002 |
VASOVIEW 5 HARVESTING CANNULA |
GUIDANT CORPORATION, CARDIAC SURGERY |
ANNE SCHLAGENHAFT |
| K013692 |
02/05/2002 |
TRAPSYSTEM SET |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
| K023007 |
12/05/2002 |
DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
RICHARD D BLISS |
| K021775 |
12/23/2002 |
LTFS230 |
HEALTHTRONICS, INC. |
PETER WEIMAN |
| K012549 |
02/04/2002 |
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM |
HEALTHWAY PRODUCTS, INC. |
DICK BRIGGS |
| 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 |
| K013611 |
02/01/2002 |
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
| K003744 |
02/20/2002 |
ENRAF-NONIUS ENDOMED 182 SYSTEM |
HENLEY HEALTHCARE, INC. |
REBECCA STOUT |
| K020131 |
02/28/2002 |
VENUS UNIVERSAL LIGHT CURING COMPOSITE |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K013723 |
02/06/2002 |
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
| K013722 |
02/11/2002 |
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
| 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 |
| K020293 |
02/14/2002 |
OSTEONICS SPINAL 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 |
| K012811 |
02/11/2002 |
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
CINDY SHOWALTER |
| 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 |
| K020232 |
02/12/2002 |
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K023883 |
12/20/2002 |
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO |
I-FLOW CORP. |
SHANE NOEHRE |
| K020251 |
02/15/2002 |
PARAGON INFUSION SYSTEM |
I-FLOW CORP. |
SHANE NOEHRE |
| K023827 |
12/13/2002 |
PARAGON INFUSION SYSTEM WITH BOLUS |
I-FLOW CORP. |
SHANE NOEHRE |
| K013755 |
02/08/2002 |
CONCERT RADIOPAQUE BONE CEMENT |
IMMEDICA, INC. |
RUSSELL PAGANO |
| 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 |
| K013732 |
02/07/2002 |
GELZONE |
IMPLANTECH ASSOCIATES, INC. |
STEPHEN MEADE |
| K020295 |
02/12/2002 |
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 |
IMPLEX CORP. |
LES HEIMANN |
| 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 |
| K012490 |
02/12/2002 |
ORION DIGITAL IMAGING SYSTEM |
INFIMED, INC. |
RALPH J FLATAU |
| K020266 |
02/22/2002 |
INION CPS BSSO SCREW |
INION LTD. |
HANNA MARTTILA |
| K023500 |
12/13/2002 |
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 |
INNOVATECH, INC |
TONY C.S. CHANG |
| K013889 |
02/07/2002 |
ENDOSCOPIC MULTI-FIRE CLIP APPLIER |
INSCOPE, LLC. |
BRUCE WEBER |
| K020096 |
02/08/2002 |
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| K013891 |
02/05/2002 |
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| 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 |
| K014239 |
02/19/2002 |
MEDSURG EQUIPMENT COVERS |
INTERNATIONAL MEDSURG CONNECTION |
MICHELE H VOVOLKA |
| K022048 |
12/04/2002 |
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K020048 |
02/06/2002 |
MODIFICATION TO GEO STRUCTURE |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K020204 |
02/21/2002 |
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K013651 |
02/27/2002 |
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS |
INTERVASCULAR |
Amy Aulwes |
| K021915 |
12/19/2002 |
TRANSITIONAL IMPLANTS |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K013941 |
02/27/2002 |
PULSION FS LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K013952 |
02/28/2002 |
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUL |
| K014079 |
02/22/2002 |
DR. HAYS BITE GUARD |
INVENTIVE RESOURCES, INC. |
DAVID W SCHLERF |
| 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 |
| K002604 |
02/07/2002 |
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM |
INVIVO RESEARCH, INC. |
FRANCIS X CASEY |
| K013809 |
02/07/2002 |
D.SIGN 59 |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
| K014042 |
02/22/2002 |
D.SIGN 84 |
IVOCLAR VIVADENT, INC. |
ANDERJEET S GULATI |
| K013929 |
02/07/2002 |
HELIOMOLAR HB TRANSLUCENT SHADES |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| 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 |
| K013955 |
02/04/2002 |
VERAVIEWEPOCS, MODEL VE |
J. MORITA USA, INC. |
WILLIAM D HARE |
| K012502 |
02/04/2002 |
MEDIGROUP CATHETER EXTENDER/REPAIR KIT |
JANIN GROUP, INC. |
JOHN A NAVIS |
| K020282 |
02/28/2002 |
JAS AMYLASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
DAVID JOHNSON |
| K013543 |
02/22/2002 |
BOND-1 C & B |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K013542 |
02/14/2002 |
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K024036 |
12/20/2002 |
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
| K014129 |
02/14/2002 |
PROMOGRAN MATRIX WOUND DRESSING |
JOHNSON & JOHNSON MEDICAL, LTD. |
SERGIO J GADALETA |
| K022762 |
12/16/2002 |
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 |
JOMED, INC. |
TERRY SCHULTZ |
| K013944 |
02/11/2002 |
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
| K023132 |
12/17/2002 |
JOSTRA MECC SYSTEM |
JOSTRA AG |
KATHLEEN JOHNSON |
| K014293 |
02/19/2002 |
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K023853 |
12/13/2002 |
K-ASSAY LP(A) CONTROLS |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K013914 |
02/06/2002 |
POWDERFREE LATEX SURGEON'S GLOVES |
KANAM LATEX INDUSTRIES PVT. LTD. |
RAVI ABRAHAM |
| K013107 |
02/26/2002 |
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| 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 |
| K014179 |
02/04/2002 |
DEMETRON LC |
KERR CORP. |
COLLEEN BOSWELL |
| K014027 |
02/22/2002 |
OPTIBOND SOLO PLUS 4 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K020092 |
02/22/2002 |
TEMPHASE |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| 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 |
| K013994 |
02/01/2002 |
MODIFICATION TO VIEWSEND MEDICAL |
KLT TELECOM, INC. |
KEN LOGSDON, JR. |
| K024025 |
12/18/2002 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
JAMES F LOGAN |
| K010452 |
02/12/2002 |
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| 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 |
| K013259 |
02/20/2002 |
PORTABLE NON-CONTACT TONOMETER, MODEL PT100 |
LEICA MICROSYSTEMS, INC. O.I.D. |
FRANK J DREXELIUS |
| 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 |
| K013223 |
02/11/2002 |
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS) |
LITTON SYSTEMS, INC. |
GARY BYRD |
| K013284 |
02/11/2002 |
LUMEND FRONTRUNNER CTO CORONARY CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K013985 |
02/01/2002 |
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX |
MACHNET BV |
DANIEL KAMM |
| 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 |
| K012562 |
02/08/2002 |
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER |
MEDICAL COMPONENTS, INC. |
FLORENCE A CAIKOSKI |
| K012640 |
02/28/2002 |
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
| K014036 |
02/14/2002 |
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K022732 |
12/13/2002 |
INFANT/CHILD REDUCED ENERGY ELECTRODES |
MEDTRONIC PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
| K012274 |
02/05/2002 |
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER |
MEDTRONIC PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
| K012052 |
02/11/2002 |
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 |
MEDTRONIC PS MEDICAL |
JEFF HENDERSON |
| K014296 |
12/10/2002 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K020155 |
02/05/2002 |
DYNA-LOK CLASSIC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD 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 |
| K020426 |
02/26/2002 |
MSD WIRE SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K020338 |
02/27/2002 |
STEALTHSTATION WITH FLUOROMERGE SOFTWARE |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| 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 |
| K013963 |
02/28/2002 |
MODEL 9210 DELIVERY CATHETER, MODEL 9210 |
MEDTRONIC VASCULAR |
MARY E BEST |
| K023798 |
12/03/2002 |
MODIFICATION TO ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
| K014301 |
02/11/2002 |
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS CO., LTD. |
Lee Leichter |
| K020062 |
02/14/2002 |
XERAFIT |
METALOR TECHNOLOGIES USA |
BRUCE A BARTON |
| K022661 |
12/13/2002 |
A1CNOW FOR HOME USE |
METRIKA, INC. |
Erika B Ammirati |
| K020235 |
02/15/2002 |
A1CNOW FOR PROFESSIONAL USE |
METRIKA, INC. |
ERIKA AMMIRATI |
| K020234 |
02/15/2002 |
A1CNOW FOR RX HOME USE |
METRIKA, INC. |
ERIKA AMMIRATI |
| K010175 |
02/06/2002 |
MICROLIGHT 830 LASER SYSTEM |
MICROLIGHT CORPORATION OF AMERICA |
MICHAEL BARBOUR |
| K020482 |
12/16/2002 |
KERATOME BLADE 200200 & 600600 |
MICROSPECIALTIES, INC. |
CHARLES VASSALLO |
| K020122 |
02/15/2002 |
MB 102 MILLENNIUM BLADES |
MILLENNIUM BIOMEDICAL, INC. |
JERRY KAENI |
| K011833 |
02/15/2002 |
MB 103 MILLENNIUM BLADES |
MILLENNIUM BIOMEDICAL, INC. |
JERRY KAENI |
| K014016 |
02/01/2002 |
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER |
MINNTECH CORP. |
LYNN LUCDERS |
| K013781 |
02/06/2002 |
RIDIDFIX 2.7MM BTB CROSS PIN KIT |
MITEK PRODUCTS |
JENNIFER JOHNSON |
| 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 |
| K020036 |
02/01/2002 |
EXS-63 SMALL EXTREMITY ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| 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 |
| K013212 |
02/25/2002 |
WAVELENGHT ULTRASOUND LOTION |
NATIONAL THERAPY PRODUCTS INC. |
PAUL L HOOEY |
| K023477 |
12/13/2002 |
BIOLOY |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
| K012861 |
02/05/2002 |
VASCUPUNCTURE ACCESS WIRE |
NEO METRICS, INC. |
GENE CHAMPEAU |
| K013360 |
02/20/2002 |
DFINER UROLOGICAL CATHETER |
NEOSEED TECHNOLOGY,LLC |
MARK KIERAS |
| 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 |
| K013760 |
02/11/2002 |
DC-3300 LASER DIODE PHOTOCOAGULATOR |
NIDEK, INC. |
CAROL PATTERSON |
| K013864 |
02/08/2002 |
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 |
NIDEK, INC. |
CAROL PATTERSON |
| K023702 |
12/18/2002 |
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE |
NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K014295 |
02/28/2002 |
STAT PROFILE PHOX ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MAC DONALD |
| K023567 |
12/20/2002 |
STAT PROFILE PHOX PLUS L ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K010694 |
02/11/2002 |
INCLUDER CLAMP |
NOVARE SURGICAL SYSTEMS, INC. |
TERRY BUELNA |
| K013730 |
02/06/2002 |
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES |
NOVASYS MEDICAL, INC. |
THOMAS C WEHMAN |
| K013930 |
02/20/2002 |
NEUROSENSOR |
NOVUS MONITORING LTD |
PETER F GIBSON |
| K014152 |
12/11/2002 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K013655 |
02/04/2002 |
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 |
NXSTAGE MEDICAL, INC. |
KAREN ST. ONGE |
| 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 |
| K014015 |
02/08/2002 |
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K014032 |
02/08/2002 |
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| 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 |
| K020362 |
02/12/2002 |
P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM |
ON SITE GAS SYSTEMS INC. |
C. BARTON GULLONG |
| 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 |
| K013006 |
02/06/2002 |
OVUS CAPLESS SAFETY NEEDLE |
OVUS SYSTEMS |
T. WHIT ATHEY |
| K020288 |
02/27/2002 |
PADPRO, MODEL 2603 |
PADPRO LLC. |
DANIEL KAMM |
| K011106 |
02/11/2002 |
STONELITH, MODEL V5 |
PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD |
CENGIZ KABAKCI |
| K013640 |
02/04/2002 |
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| 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 |
| K020494 |
02/21/2002 |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
MIKE HUDON |
| K014261 |
02/12/2002 |
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K023877 |
12/23/2002 |
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN |
PHILIPS ULTRASOUND, INC. |
LYNN HARMER |
| K020129 |
02/01/2002 |
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
| K020148 |
02/04/2002 |
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
| 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 |
| K020240 |
02/22/2002 |
SLIM GLIDING NAIL SYSTEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K013547 |
02/20/2002 |
BABYCOM |
PMG MEDICA LTD. |
ELI M ORBACH |
| 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 |
| K014167 |
02/19/2002 |
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM |
POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] |
PATRICIA COLLINS |
| K023251 |
12/04/2002 |
PEDIATRIC ARTERIAL CANNULA |
POLYSTAN A/S |
DANA OLSEN |
| K014115 |
02/27/2002 |
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
PORTEX, INC. |
TIMOTHY J TALCOTT |
| K014073 |
02/13/2002 |
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE |
PORTEX, INC. |
BRAIN E FARIAS |
| 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 |
| K013700 |
02/05/2002 |
ORTHOSIS HELMET MOLDING |
PRECISION PROSTHETICS & ORTHOTICS, INC. |
CONNIE FICKLIN |
| 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 |
| K013970 |
02/19/2002 |
PRIME-DENT HEMA DESENSITIZER |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K020044 |
02/26/2002 |
VINYL EXAMINATION GLOVES STERILE POWEDERED |
PRIMUS GLOVES PRIVATE LTD. |
JOSEPH J E PEREIRA |
| K023112 |
12/17/2002 |
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 |
PROBLEM SOLVING CONCEPTS, INC. |
THOMAS M MCCLELLAND |
| K020070 |
02/01/2002 |
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 |
PROGENY, INC. |
ALAN KREMA |
| 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 |
| K011275 |
02/11/2002 |
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY |
PSYCHEMEDICS CORP. |
THOMAS CAIRNS |
| K013996 |
02/26/2002 |
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE |
PT. MAJA AGUNG LATEXINDO |
EMMY T JOENG |
| K020115 |
02/28/2002 |
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM |
PULPDENT CORP. |
KENNETH J BERK |
| K014059 |
02/27/2002 |
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE |
PULPDENT CORP. |
KENNETH J BERK |
| 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 |
| K020229 |
02/06/2002 |
R & D BODY FLUID CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K012439 |
02/06/2002 |
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM |
RADCO DATA AB |
DANIEL KAMM |
| K024107 |
12/24/2002 |
FEMOSTOP FEMORAL COMPRESSION SYSTEM |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K020504 |
02/28/2002 |
INFRARED EAR THERMOMETER, MODELS TH88 SERIES |
RADIANT INNOVATION, INC. |
SUSAN D GOLDSTEIN-FALK |
| K012633 |
02/28/2002 |
RESPIRONICS HEATED HUMIDIFIER |
RESPIRONICS, INC. |
DAVID J VANELLA |
| 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 |
| K020050 |
02/14/2002 |
ENAMEL BONDING SYSTEM |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
| 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 |
| K012966 |
02/01/2002 |
ROCHE COBAS TAQMAN ANALYZER |
ROCHE MOLECULAR SYSTEMS, INC. |
GARY S RIORDAN |
| 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 |
| K010798 |
02/26/2002 |
RUSCH CANTOR TUBE |
RUSCH INTL. |
JULIE A BEAUMONT |
| K013872 |
02/12/2002 |
RUSCH MEMORY BAG |
RUSCH INTL. |
RICK LYKINS |
| K023964 |
12/23/2002 |
RUSCH MICROLARYNGEAL TUBE |
RUSCH INTL. |
RICK LYKINS |
| K010797 |
02/26/2002 |
RUSCH MILLER-ABBOTT TUBE |
RUSCH INTL. |
JULIE A BEAUMONT |
| 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 |
| K014056 |
02/01/2002 |
SALTER LABS MODIFIED NEBUTECH NEBULIZER |
SALTER LABS |
DUANE KAZAL |
| K013951 |
02/28/2002 |
SANDHILL SCIENTIFIC PEDIATEC PH PROBE |
SANDHILL SCIENTIFIC, INC. |
LEWIS WARD |
| K020245 |
02/01/2002 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
| K022466 |
12/31/2002 |
PROFILE 1320 LASER SYSTEM |
SCITON, INC. |
JAY M PATAL |
| K013812 |
02/11/2002 |
SPIROLAB II, MODEL 29 |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
| K020436 |
02/22/2002 |
PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 |
SEDECAL S.A. |
DANIEL KAMM |
| K023923 |
12/11/2002 |
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE |
SENORX, INC. |
AMY BOUCLY |
| K011974 |
02/12/2002 |
SENSAID |
SENSIDYNE, INC. |
GEORGE MASON |
| K014038 |
02/08/2002 |
PYLORITEK VP TEST KIT 5140VP |
SERIM RESEARCH CORP. |
PATRICIA RUPUCHOCK |
| K013276 |
02/15/2002 |
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) |
SEWOON MEDICAL CO., LTD. |
DANIEL KAMM |
| K020317 |
02/14/2002 |
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE |
SGMP CO., LTD. |
JANNA TUCKER |
| 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 |
| K013998 |
02/13/2002 |
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES |
SHEEN MORE ENT. CO., LTD. |
JANNA P TUCKER |
| K014077 |
02/04/2002 |
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| 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 |
| K014112 |
02/28/2002 |
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E |
SIAM SEMPERMED CORP. LTD. |
JAY MANSOUR |
| K014110 |
02/28/2002 |
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT |
SIAM SEMPERMED CORP. LTD. |
JAY MANSOUR |
| K020144 |
02/15/2002 |
SIEMENS INFINITY SC 6002XL MODIFICATIONS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K020277 |
02/19/2002 |
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K024108 |
12/18/2002 |
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K013826 |
02/01/2002 |
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) |
SIEMENS MEDICAL SYSTEMS, INC. |
SANDRA ROBINSON |
| K020440 |
12/03/2002 |
NEWCOR |
SIEMENS MEDICAL SYSTEMS, INC. |
KATHLEEN RUTHERFORD |
| K020353 |
02/13/2002 |
OMNIA X/XS ULTRASOUND SYSTEM |
SIEMENS MEDICAL SYSTEMS, INC. |
JUDI HOFFMAN |
| K013819 |
02/28/2002 |
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM |
SIERRA DIAGNOSTIC, L.L.C. |
DONALD R STONE |
| K020109 |
02/06/2002 |
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K013751 |
02/06/2002 |
HANDHELD GAMMA FINDER (HGF) |
SILICON INSTRUMENTS GMHB |
THOMAS GOEBEL |
| K012277 |
02/11/2002 |
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE |
SIMS PORTEX LTD. |
STEVEN OGILVIE |
| 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 |
| K012314 |
02/01/2002 |
DYONICS ELECTROBLADE RESECTOR |
SMITH & NEPHEW, INC. |
TIM CRABTREE |
| 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 |
| K012938 |
02/08/2002 |
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS |
SMITH & NEPHEW, INC. |
TRUDE C NAFF |
| K023957 |
12/12/2002 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K013701 |
02/04/2002 |
ENDO-GLIDE |
SONOTECH, INC. |
MARGARET J LARSON |
| K023633 |
12/31/2002 |
SOVIS OPTIQUE'S ENDOSCOPIC CABLE |
SOVIS OPTIQUE |
FRANCES K WU |
| K014105 |
02/01/2002 |
SPECTRAL'S TROPONIN I |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
| K013887 |
02/12/2002 |
BACFIX SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOPPER |
| K013979 |
02/13/2002 |
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K022997 |
12/06/2002 |
SPECTRUM CERVICAL SPINAL SYSTEM |
SPINAL INNOVATIONS, LLC. |
JOSEPH S CLIFT |
| K013312 |
02/13/2002 |
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
| K013301 |
02/13/2002 |
UNI-T SPINAL SYSTEM |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
| K023716 |
12/05/2002 |
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K013993 |
02/22/2002 |
NEOCALEX |
STEPHEN M KORAL, DMD |
STEPHEN M KORAL |
| K012685 |
02/14/2002 |
REPROCESSED ENDOSCOPIC ELECTRODES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012581 |
02/14/2002 |
REPROCESSED STONE RETRIEVAL BASKETS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012597 |
02/11/2002 |
STERILMED REPROCESSED COMPRESSION SLEEVES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K011838 |
02/05/2002 |
CENTRIFUGAL PUMP |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
| 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 |
| K020196 |
02/15/2002 |
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM |
SULZER SPINE-TECH |
KRISTYN M BENSON |
| K013953 |
02/26/2002 |
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| 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 |
| K011901 |
02/01/2002 |
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 |
SURVIVALINK CORP. |
JOHN CARLINE |
| K013895 |
02/04/2002 |
TEMPFIL |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K014033 |
02/22/2002 |
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
| K020493 |
02/26/2002 |
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
| K012589 |
02/07/2002 |
FAST SET PUTTY |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K023862 |
12/19/2002 |
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER |
SYNTHES (USA) |
VIKKI M HOFFMAN |
| K020087 |
02/20/2002 |
SYNTHES CRANIAL PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
| K013806 |
02/08/2002 |
SYNTHES METALLIC SPIKED WASHERS |
SYNTHES (USA) |
MATTHEW M HULL |
| K014198 |
02/01/2002 |
BIOTECH B990K VIVI WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K020284 |
02/08/2002 |
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
Ke-Min Jen |
| 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 |
| K013307 |
02/08/2002 |
OMEGATRAC, MODEL Z105 |
TEFTEC CORP. |
THOMAS E FINCH, III |
| K022698 |
12/02/2002 |
SCOOTER MARS SERIES, MODEL TL-588 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
| K013747 |
02/11/2002 |
TEKNO-MEDICAL OBSTETRICAL FORCEPS |
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. |
MARKUS DENK |
| 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 |
| K020090 |
02/11/2002 |
MODIFICATION TO TRANSSEPTAL INTRODUCER SET |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K024055 |
12/20/2002 |
TILITE EVO |
TISPORT, LLC |
RICHARD S FOREMAN |
| K013254 |
02/04/2002 |
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
TOP QUALITY MFG., INC. |
ART WARD |
| K020385 |
02/15/2002 |
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| 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 |
| K014258 |
02/19/2002 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K012368 |
02/12/2002 |
AEROPEP |
TRUDELL MEDICAL INTL. |
TOM HOLBROOK |
| K011488 |
02/22/2002 |
SPIRABRUSH CX BIOPSY INSTRUMENT |
TRYLON CORP. |
MARTIN LONKY |
| K023595 |
12/18/2002 |
BURETTE-IN LINE (150 ML) |
TUTA HEALTHCARE PTY LIMITED |
OMID SOURESRAFIL |
| K020083 |
02/12/2002 |
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 |
TUTA HEALTHCARE PTY LIMITED |
OMID SOURESRAFIL |
| K022517 |
12/24/2002 |
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
| K020009 |
02/11/2002 |
BRACE EZE |
UDENT, INC. |
MANAR JAMAL |
| 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 |
| K013874 |
02/19/2002 |
CLEARPLANE EASY OVULATION TEST |
UNIPATH LTD. |
STEVEN H ARMSTRONG |
| K020352 |
02/26/2002 |
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE |
UNITED STATES SURGICAL |
TINA RIDEOUT |
| K023247 |
12/23/2002 |
CHAMPION 5000 PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K014086 |
02/05/2002 |
CTL BODY / SPINE ARRAY COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K013854 |
02/06/2002 |
MARK 5000 QUADRATURE SHOULDER COIL |
USA INSTRUMENTS, INC. |
TORI MASIELLA |
| 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 |
| K011863 |
02/15/2002 |
VCS-A SERIES CLAMP |
VASCULAR CONTROL SYSTEMS, INC |
AL MEMMOLO |
| 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 |
| K014011 |
02/05/2002 |
CANVAS N-VAS-D 2.0 |
VASSOL, INC. |
LYNETTE L HOWARD |
| K020281 |
02/11/2002 |
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM |
VENTLAB CORP. |
MARGE WALLS-WALKER |
| K023469 |
12/10/2002 |
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 |
VICTUS, INC. |
ILEANA YANES |
| K020301 |
02/12/2002 |
MODIFICATION TO VISTA STEREOSCOPE SYSTEM |
VISTA MEDICAL TECHNOLOGIES, INC. |
GRAHAM BAILLIE |
| K013973 |
02/26/2002 |
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC |
VISTAKON |
JAMES W PARZIALE |
| 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 |
| K013785 |
02/08/2002 |
UROVYSION BLADDER CANCER RECURRENCE KIT |
VYSIS |
RUSSEL K ENNS |
| 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 |
| K020407 |
02/22/2002 |
LORENZ BLUE DEVICE |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K013954 |
02/28/2002 |
LORENZ SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K023718 |
12/04/2002 |
QUICKSET MIMIX BONE VOID FILLER |
WALTER LORENZ SURGICAL, INC. |
KACY ARNOLD |
| K011708 |
02/20/2002 |
MODIFICATION TO WARTNER WART REMOVAL SYSTEM |
WARTNER MEDICAL PRODUCTS |
NANCY LUM-WILSON |
| 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 |
| K020274 |
02/22/2002 |
WMT MODULAR ULNAR HEAD IMPLANT |
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 |
| K014288 |
02/13/2002 |
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD H HUSSEIN |
| 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 |
