| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K033022 |
11/21/2003 |
PROTEMP 3 GARANT |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K023640 |
01/24/2003 |
PICCOLO HDL TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K023642 |
01/24/2003 |
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K023639 |
01/24/2003 |
PICCOLO TRIGLYCERIDES TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K024239 |
01/13/2003 |
CHEMO DISPENSING PIN, MODEL 12495 |
ABBOTT LABORATORIES |
NICOHL R WILDING |
| K024126 |
01/14/2003 |
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT |
ABBOTT LABORATORIES |
NICOHL R WILDING |
| K030002 |
01/27/2003 |
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. |
ABBOTT LABORATORIES |
NOCOHL R WILDING |
| K024067 |
01/15/2003 |
RHEUMATOID FACTOR (RF) |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K030144 |
01/31/2003 |
MODIFICATION TO PENTRA 60 AND PENTRA 60C+ |
ABX DIAGNOSTICS |
TIM LAWTON |
| K024002 |
01/03/2003 |
PENTRA 80 |
ABX DIAGNOSTICS |
TIM LAWTON |
| K030031 |
01/28/2003 |
SOFT TISSUE ANCHORING WASHERS |
ACCU-SPEED, INCORPORATED |
ROBERT W SECOVICH |
| K020892 |
01/27/2003 |
ACIST GENTOO CONTRAST INJECTION SYSTEM |
ACIST MEDICAL SYSTEMS |
CARL M BEAURLINE |
| K023358 |
01/03/2003 |
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 |
ACMI CORPORATION |
TERRENCE SULLIVAN |
| K033041 |
11/21/2003 |
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K032879 |
11/13/2003 |
NAVIGATOR I |
ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. |
JOAN JOHNSON |
| K033401 |
11/20/2003 |
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER |
ADVANCED CIRCULATORY SYSTEMS, INC. |
Gary Syring |
| K023981 |
01/31/2003 |
AHL GENERIC GLASS IONOMER LUTING CEMENT |
ADVANCED HEALTHCARE LTD. |
BILL ETTINGER |
| K033597 |
11/25/2003 |
ATR 5000, LC 5000, IMPLANT SYSTEM |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
DANIELE POLI |
| K032481 |
11/04/2003 |
THERATEARS CONTACT LENS COMFORT DROPS |
ADVANCED VISION RESEARCH, INC. |
BEVERLEY D VENUTI |
| K023712 |
01/31/2003 |
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST |
ADVANTAGE DIAGNOSTICS CORP |
JANIS FREESTONE |
| K032849 |
11/21/2003 |
AERONEB GO NEBULIZER, MODEL AG-AG2000 |
AEROGEN, INC. |
Nancy E Isaac |
| K023678 |
01/23/2003 |
DIMISIL SCAR GEL |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
| K033013 |
11/25/2003 |
MDIFICATION TO MEDIPRIME |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K024292 |
01/09/2003 |
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K024120 |
01/15/2003 |
MODIFICATION TO TEMNO BIOPSY NEEDLES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON NICHOLS |
| K023613 |
01/23/2003 |
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 |
ALPHATEK CORP. |
PAUL M KUPSCO |
| K032744 |
11/13/2003 |
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC. |
HOWARD L SCHRAYER |
| K033345 |
11/19/2003 |
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS |
ANALOGIC CORP. |
MARVIN ROSENBAUM |
| K033443 |
11/19/2003 |
SPEEDLYSER INFUSION CATHETER KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K023213 |
01/16/2003 |
RDH-2000 |
ANODIA SYSTEMS |
THAD OVERMYER |
| K031385 |
11/10/2003 |
ANZAI AZ-733 RESPIRATORY GATING SYSTEM |
ANZAI MEDICAL CO, LTD. |
T. WHIT ATHEY |
| K033333 |
11/14/2003 |
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
| K024056 |
01/17/2003 |
SURESET 3.0 ML RESERVOIR, MODEL 24-103 |
APPLIED DIABETES RESEARCH, INCORPORATED |
JAMES BARLEY |
| K031553 |
11/18/2003 |
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES |
ARCADIA MEDICAL CORPORATION |
ARTHUR WARD |
| K023609 |
01/17/2003 |
SILVERLON ADHESIVE STRIP |
ARGENTUM INTERNATIONAL LLC. |
BART FLICK |
| K023612 |
01/24/2003 |
SILVERLON CONTACT WOUND DRESSING |
ARGENTUM INTERNATIONAL LLC. |
BART FLICK |
| K031153 |
11/25/2003 |
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 |
ARROW INTL., INC. |
WILLIAM G MCLAIN |
| K031666 |
11/18/2003 |
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS |
ARTHREX, INC. |
ANN WATERHOUSE |
| K033584 |
11/28/2003 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K032160 |
11/17/2003 |
ARTELON SURGICAL SUTURE |
ARTIMPLANT AB |
RUSS PAGANO |
| DEN020001 |
01/31/2003 |
BREASTVIEW VISUAL MAPPING SYSTEM |
ASSURANCE MEDICAL |
HOWARD M HOLSTEIN |
| K023004 |
01/28/2003 |
LFRE INDIRECT LARYNGOSCOPE |
ASTRALITE CORP. |
DORIAN SWARTZ |
| K023686 |
01/29/2003 |
AURORA MR-GUIDED INTERVENTIONAL SYSTEM |
AURORA IMAGING TECHNOLOGY, INC. |
ALAN OSLAN |
| K023653 |
01/17/2003 |
MAXONE IV FLUID/BLOOD WARMER, MODEL 102 |
AUTOMATIC MEDICAL TECHNOLOGIES, INC. |
CINDY MARTIN |
| K023934 |
01/23/2003 |
RAPID THERMAL EXCHANGE SYSTEM |
AVACORE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K024018 |
01/17/2003 |
AVANT GUARDIAN 101 |
AVANT MEDICAL CORPORATION |
JOHN B SLATE |
| K033015 |
11/25/2003 |
AXIOM BIOLASER LLLT SERIES-3 |
AXIOM USA. INC |
JIM GIBSON |
| K022602 |
01/23/2003 |
DRX3000 |
AXIOM USA. INC |
JIM GIBSON |
| K024236 |
01/17/2003 |
ULTRASOUND SCANNER, TYPE 2400 |
B-K MEDICAL A/S |
VILLY BRAENDER |
| K023533 |
01/17/2003 |
BARCO MEDIS 5MP2 AURA |
BARCO NV |
FRANK FERGUSON |
| K031646 |
11/14/2003 |
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K031676 |
11/20/2003 |
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K024234 |
01/23/2003 |
ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL |
BAYER CORP. |
GEORGE M TANCOS |
| K024017 |
01/30/2003 |
BAYER ADVIA CENTAUR HER-2/NEU ASSAY |
BAYER CORP. |
KENNETH T EDDS |
| K023840 |
01/07/2003 |
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
ANDRES HOLLE |
| K033007 |
11/14/2003 |
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K030102 |
01/24/2003 |
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K030169 |
01/31/2003 |
SETPOINT CHEMISTRY CALIBRATOR |
BAYER HEALTHCARE, LLC |
KENNETH T EDDS |
| K030012 |
01/17/2003 |
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K023764 |
01/28/2003 |
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K024112 |
01/09/2003 |
BD INSULIN SYRINGE |
BECTON DICKINSON & CO. |
JOHN A SCHALAGO |
| K033350 |
11/18/2003 |
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER |
BECTON DICKINSON & CO. |
M. WENDY BALLESTEROS |
| K023568 |
01/24/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K023895 |
01/08/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K024152 |
01/31/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K023703 |
01/30/2003 |
BI-OSTETIC |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K022622 |
01/09/2003 |
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K031375 |
11/20/2003 |
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 |
BESMED HEALTH BUSINESS CORP. |
DR. JEN KE MIN |
| K031374 |
11/28/2003 |
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 |
BESMED HEALTH BUSINESS CORP. |
DR. JEN KE MIN |
| K023705 |
01/29/2003 |
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM |
BICON, INC. |
VINCENT J MORGAN |
| K024222 |
01/15/2003 |
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 |
BIO-RAD |
Yvette Lloyd |
| K024221 |
01/15/2003 |
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 |
BIO-RAD |
Yvette Lloyd |
| K024230 |
01/15/2003 |
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 |
BIO-RAD |
Yvette Lloyd |
| K024229 |
01/15/2003 |
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 |
BIO-RAD |
Yvette Lloyd |
| K024217 |
01/15/2003 |
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 |
BIO-RAD |
Yvette Lloyd |
| K024227 |
01/15/2003 |
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 |
BIO-RAD |
Yvette Lloyd |
| K024231 |
01/13/2003 |
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 |
BIO-RAD |
Yvette Lloyd |
| K024225 |
01/15/2003 |
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 |
BIO-RAD |
Yvette Lloyd |
| K024223 |
01/13/2003 |
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 |
BIO-RAD |
Yvette Lloyd |
| K024226 |
01/10/2003 |
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 |
BIO-RAD |
Yvette Lloyd |
| K024219 |
01/15/2003 |
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 |
BIO-RAD |
Yvette Lloyd |
| K024224 |
01/15/2003 |
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 |
BIO-RAD |
Yvette Lloyd |
| K024218 |
01/17/2003 |
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 |
BIO-RAD |
Yvette Lloyd |
| K024232 |
01/17/2003 |
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 |
BIO-RAD |
Yvette Lloyd |
| K024220 |
01/17/2003 |
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 |
BIO-RAD |
Yvette Lloyd |
| K032874 |
11/24/2003 |
HBA SPERM-HYALURONAN BINDING ASSAY |
BIOCOAT, INC. |
JAMES B JOHNSTON |
| K020586 |
01/24/2003 |
GOOD LUBRICATIONS |
BIOFILM, INC. |
ROBERT L DE ARMOND |
| K032425 |
11/05/2003 |
INVISIJECT RESUSABLE AUTO-INJECTOR |
BIOGEN |
Michael Poirier |
| K024088 |
01/02/2003 |
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K032788 |
11/04/2003 |
VITEK 2 GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032861 |
11/12/2003 |
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032286 |
11/20/2003 |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
| K024086 |
01/09/2003 |
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM |
BIOMET ORTHOPEDICS, INC. |
KACY ARNOLD |
| K032895 |
11/20/2003 |
BI-ANGULAR SHOULDER SYSTEM |
BIOMET, INC. |
PATRICIA S BERES |
| K021992 |
01/14/2003 |
DHS DISPOSABLE HOOD SYSTEM |
BIOMET, INC. |
KACY ARNOLD |
| K030047 |
01/23/2003 |
FREEDOM CONSTRAINED LINERS |
BIOMET, INC. |
MAX T HEBEL |
| K033233 |
11/05/2003 |
LACTOSORB TIBIAL L-15 SCREW AND WASHER |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K023546 |
01/17/2003 |
MAXIM ACCEL KNEE SYSTEM |
BIOMET, INC. |
TRACY J BICKEL |
| K024022 |
01/23/2003 |
OSTEO-CABLE SLEEVE |
BIOMET, INC. |
KACY ARNOLD |
| K020863 |
01/09/2003 |
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
WILLIAM WELCH |
| K030088 |
01/17/2003 |
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K030089 |
01/23/2003 |
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K032992 |
11/21/2003 |
UNIMARK HOME PREGNANCY TEST DEVICE |
BIOTECH ATLANTIC, INC. |
FRANCIS L DENG |
| K022360 |
01/27/2003 |
ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K033320 |
11/19/2003 |
SCOUT PRO |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K032597 |
11/04/2003 |
BISCEM GI |
BISCO, INC. |
KATHY JOUNG |
| K024165 |
01/10/2003 |
DUAL-LUMEN CATHETER |
BISTECH, INC. |
PAMELA PAPINEAU |
| K023721 |
01/10/2003 |
BONART ART-L2 LIGHT CURING UNIT |
BONART CO. LTD. |
ERIC L ONG |
| K032713 |
11/24/2003 |
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K033441 |
11/21/2003 |
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER |
BOSTON SCIENTIFIC CORP. |
HEIDI M ERICKSON |
| K030083 |
01/28/2003 |
VAXCEL WITH PASV PORT |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K024048 |
01/06/2003 |
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
TODD KORNMANN |
| K032940 |
11/20/2003 |
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K032938 |
11/20/2003 |
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K033438 |
11/20/2003 |
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD KELLER |
| K021994 |
01/02/2003 |
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM |
C.R. BARD, INC. |
AYMEE BERRY |
| K032521 |
11/14/2003 |
BARD DUAL LUMEN URETERAL CATHETER |
C.R. BARD, INC. |
FRANCES HARRISON |
| K030792 |
11/14/2003 |
BARD ENDOTRACHEAL TUBE, CUFFED |
C.R. BARD, INC. |
FRANCES E HARRISON |
| K022447 |
01/23/2003 |
BARD ER URETERAL STENT WITH SUTURE |
C.R. BARD, INC. |
DONNA J WILSON |
| K033245 |
11/06/2003 |
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U |
C.R. BARD, INC. |
MICHAEL A PATZ |
| K033294 |
11/26/2003 |
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER |
C.R. BARD, INC. |
GLENN NORTON |
| K022951 |
01/27/2003 |
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG |
CANDELA CORP. |
LORRAINE NELSON |
| K022884 |
01/22/2003 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORAINE NELSON |
| K023728 |
01/07/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
CANOPUS MEDICAL SUPPLY CO., LTD. |
RUBY LIN |
| K023452 |
11/20/2003 |
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E |
CANOPUS MEDICAL SUPPLY CO., LTD. |
RUBY LIN |
| K023689 |
01/17/2003 |
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K023356 |
01/16/2003 |
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K024365 |
01/15/2003 |
TM2005 PERSONAL MEDICAL PHONE CENTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K022929 |
01/27/2003 |
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 |
CARDIAC SCIENCE, INC. |
JOHN CARLINE |
| K022008 |
01/29/2003 |
CARDIMA ABLATION SYSTEM |
CARDIMA, INC. |
ROBERT A CHIN |
| K032444 |
11/13/2003 |
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY |
Cardinal Health |
ERICA SETHI |
| K023427 |
01/07/2003 |
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 |
CARDIOMEDICS, INC. |
GARY CLARK |
| K021694 |
01/08/2003 |
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 |
CARDIOVENTION, INC. |
TESSA YAMUT |
| K021594 |
11/13/2003 |
COPC BAND |
CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC |
JOSEPH TERPENNING |
| K023528 |
01/17/2003 |
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE |
CENTERPLUS ORTHOPEDICS, INC |
MITCHELL A DHORITY |
| K023874 |
11/20/2003 |
SYSTEM 100 ULTRAFILTRATION CATHETER |
CHF SOLUTIONS, INC. |
AMY PETERSON |
| K033593 |
11/20/2003 |
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
| K031042 |
11/03/2003 |
ATAC HEMOGLOBIN A1C REAGENT KIT |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K024173 |
01/14/2003 |
CDS 3-PD HEMATOLOGY CONTROLS |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
ANDREW C SWANSON |
| K022023 |
01/07/2003 |
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 |
CLINICAL INNOVATIONS, INC. |
WILLIAM DEAN WALLACE |
| K030074 |
01/21/2003 |
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K030150 |
01/28/2003 |
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K022596 |
01/31/2003 |
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) |
CLOVER HI-TECH INC. |
CECILIA L YU |
| K024366 |
01/17/2003 |
COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K023254 |
01/27/2003 |
SPEEDICATH |
COLOPLAST CORP. |
ELIZABETH BOOTS |
| K032662 |
11/03/2003 |
GUTTAFLOW |
COLTENE/WHALEDENT GMBH & CO. KG |
HENRY J VOGELSTEIN |
| K021176 |
01/21/2003 |
COMPUMEDICS SOMTE SYSTEM |
COMPUMEDICS LIMITED |
CONSTANCE G BUNDY |
| K024294 |
01/08/2003 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
CATHY STUPAK |
| K031007 |
11/14/2003 |
KWIKEZE MALE CONDOM APPLICATOR |
CONDAX LLC. |
ELI J CARTER |
| K033093 |
11/05/2003 |
ECHOCONNEX COMMUNICATOR |
CONNEXMD |
CURTIS LEBLEU |
| K024028 |
01/24/2003 |
SHARP VIEW IMAGE ENHANCEMENT SYSTEM |
CONTEXT VISION AB |
KENT STRANDLUND |
| K023850 |
01/22/2003 |
SYDNEY IVF EMBRYO BIOPSY MEDIUM |
COOK OB/GYN |
DEBBIE SCHMITT |
| K032869 |
11/19/2003 |
COOK CODA BALLOON CATHETER |
COOK, INC. |
Theodore Heise |
| K031494 |
11/12/2003 |
DOC'S BEST WHITE COPPER CEMENT |
COOLEY & COOLEY, LTD. |
M. JOYCE HEINRICH |
| K032873 |
11/07/2003 |
PROCLEAR COMPATIBLES MULTIFOCAL |
COOPER VISION, INC. |
LISA HAHN |
| K023930 |
01/22/2003 |
COOPERSURGICAL OOCYTE RECOVERY NEEDLES |
COOPERSURGICAL, INC. |
JOSEPH M AZARY |
| K024195 |
01/03/2003 |
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K024196 |
01/03/2003 |
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K020745 |
01/02/2003 |
COSMED MICROQUARK |
COSMED S.R.L. |
ROBERT SCHIFF |
| K023710 |
01/17/2003 |
VISORB SWIFT |
CP MEDICAL |
MARY ANN GREENAWALT |
| K022807 |
01/29/2003 |
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA |
CREATIVE TECHNOLOGIES, INC. |
ELIZABETH P NOBLE |
| K033431 |
11/20/2003 |
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K032383 |
11/28/2003 |
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM |
CURELIGHT LTD |
JONATHAN S KAHAN |
| K032539 |
11/17/2003 |
CYNOSURE PHOTOGENICA SV LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K032697 |
11/07/2003 |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K033482 |
11/26/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K023141 |
01/16/2003 |
MODIFICATION TO STANDARD HUMAN PLASMA |
DADE BEHRING, INC. |
DONNA A WOLF |
| K022976 |
01/16/2003 |
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K033281 |
11/26/2003 |
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE |
DATEX-OHMEDA |
JOEL KENT |
| K023459 |
01/13/2003 |
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
| K033144 |
11/13/2003 |
DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES |
DEFIBTECH, LLC |
JOHN L ROGERS |
| K022221 |
01/30/2003 |
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS |
DELTEC, INC. |
LISA STONE |
| K031793 |
11/13/2003 |
DENTATUS OSCIOMAT |
DENTATUS USA, LTD. |
RICHARD C LANZILLOTTO |
| K030644 |
11/21/2003 |
CONTEC DUO, CONTEC LC, CONTEC LCR |
DENTAURUM |
JAN W A DOORSCHODT |
| K023776 |
01/23/2003 |
XENO III DENTAL ADHESIVE |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K023835 |
01/29/2003 |
DEVEX MESH SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K024348 |
01/28/2003 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
LISA GILMAN |
| K023804 |
01/23/2003 |
MOSS MIAMI SPINAL SYSTEM PIN NUT |
DEPUY ACROMED |
LISA GILMAN |
| K021478 |
11/18/2003 |
DELTA SHOULDER |
DEPUY, INC. |
JANET G JOHNSON |
| K033329 |
11/14/2003 |
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS |
DEPUY, INC. |
RHONDA MYER |
| K033057 |
11/20/2003 |
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE |
DEROYAL |
SHARON COOK |
| K033385 |
11/07/2003 |
DGH 55 HANDHELD PACHYMETER (PACHMATE) |
DGH TECHNOLOGY, INC. |
M. LUTHER DETWEILER |
| K023739 |
01/17/2003 |
GLUCOSE-SL-C ASSAY, MODEL 257-30 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K033061 |
11/07/2003 |
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
| K021338 |
01/07/2003 |
ACCULEAF |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K023535 |
01/17/2003 |
TRIPTER X-1 COMPACT DUET |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K023748 |
01/17/2003 |
FLASH-LITE II LED DENTAL CURING LIGHT |
DISCUS DENTAL, INC. |
GARY L HOLLAR |
| K023649 |
01/17/2003 |
VITIQUE SYSTEM |
DMG USA, INC. |
PAMELA PAPINEAU |
| K020924 |
01/06/2003 |
CUSTODIOL HTK SOLUTION |
DR. FRANZ KOHLER CHEMIE GMBH |
T. WHIT ATHEY |
| K032537 |
11/25/2003 |
DRAEGER MICRO2+ AND MASIMO MINISAT |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K023289 |
01/15/2003 |
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 |
DRAGER MEDIZINTECHNIK GMBH |
JAMES J BRENNAN |
| K031132 |
11/26/2003 |
CONSULTIVA CASE INPUT STATION, MODEL CIS-1 |
EASTMAN KODAK COMPANY |
WIDO MENHARDT |
| K024129 |
01/15/2003 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K024248 |
01/22/2003 |
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K012423 |
01/24/2003 |
MUCOGRAFT |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K031946 |
11/03/2003 |
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE |
EDWARDS LIFESCIENCES, LLC. |
JEAN CHANG |
| K032935 |
11/20/2003 |
EPI-SCAN, MODEL P 100 |
EDX EPI-SCAN, INC. |
GREG HOLLAND |
| K023394 |
01/07/2003 |
UNISIGHT SYSTEM WITH UNIGATE |
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) |
DAVID LIN |
| K024373 |
01/28/2003 |
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 |
ELLTEC CO., LTD. |
RIEKO SO |
| K023148 |
01/24/2003 |
EPW POWERED WHEELCHAIR, GP-201 |
EMG TECHNOLOGY CO., LTD. |
Ke-Min Jen |
| K033204 |
11/12/2003 |
ESG 4-WHEEL SCOOTER, ESG-03 |
EMG TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| K024047 |
01/08/2003 |
ERBE VIO APC WITH ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K023120 |
11/12/2003 |
OXYCON MOBILE |
ERICH JAEGER GMBH |
EARL DRAPER |
| K024021 |
01/24/2003 |
NITREX NITINOL GUIDEWIRE |
EV3 CORPORATION |
PHIL NEURURER |
| K033134 |
11/17/2003 |
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
| K033314 |
11/21/2003 |
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
| K032964 |
11/13/2003 |
EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS |
EXACTECH, INC. |
GARY J MILLER |
| K011754 |
01/22/2003 |
EXEL SECURETOUCH PTP SYRINGE |
EXELINT INTL. CO. |
ARMAND HAMID |
| K021340 |
01/30/2003 |
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE |
EXTERNAL COUNTERPULSATION LAB |
DAWEI CAI |
| K033452 |
11/28/2003 |
CWAS 1000 |
FASSTECH |
LEE BRODY |
| K033368 |
11/26/2003 |
FOSSA URETERAL OPEN LUMEN STENT |
FOSSA MEDICAL, INC. |
GLORIA KOLB |
| K033370 |
11/28/2003 |
POWERED WHEELCHAIR, MODEL FR168W |
FREERIDER, CORP. |
ROBERT S MCQUATE |
| K033561 |
11/26/2003 |
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FRANK GIANELLI |
| K023751 |
01/22/2003 |
EXAJET |
GC AMERICA, INC. |
TERRY L JORITZ |
| K023814 |
01/30/2003 |
GRADIA DIRECT |
GC AMERICA, INC. |
TERRY L JORITZ |
| K023727 |
01/16/2003 |
TEMPORARY CEMENT-DC010002 |
GC AMERICA, INC. |
TERRY L JORITZ |
| K033365 |
11/06/2003 |
APEXPRO FH TELEMETRY SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K033304 |
11/12/2003 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K033492 |
11/24/2003 |
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA LEE MICHELS |
| K024200 |
01/16/2003 |
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K024137 |
01/15/2003 |
JUPITER PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K033502 |
11/20/2003 |
LIGHTSPEED 6.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
JOHN W JAECKLE |
| K033504 |
11/25/2003 |
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER, PH.D. |
| K024174 |
01/28/2003 |
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES |
GENERAL GLOVES CORP. |
JOHN CHEN |
| K023544 |
01/16/2003 |
GENZYME CONTRAST II HCG URINE/SERUM TEST |
GENZYME CORP. |
E.V. GOORCHENKO |
| K023971 |
01/27/2003 |
VACUETTE TRACE ELEMENTS TUBES |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
Judi Smith |
| K033393 |
11/10/2003 |
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM |
GUIDANT CORP. |
KELLY PIKE |
| K030019 |
01/24/2003 |
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE |
GUIDANT CORP. |
KRISTINE M TEICH |
| K023373 |
01/03/2003 |
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 |
GVI TECHNOLOGY PARTNERS |
KEVIN M NURROCK |
| K033554 |
11/24/2003 |
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS |
GYRUS ENT L.L.C. |
GREGORY SREDIN |
| K024286 |
11/17/2003 |
GYRUS OPEN FORCEPS |
GYRUS MEDICAL, INC. |
MARK JENSEN |
| K033112 |
11/05/2003 |
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS |
HAND BIOMECHANICS LAB, INC. |
TIMOTHY R STALLINGS |
| K023834 |
01/14/2003 |
HL888 |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K032802 |
11/19/2003 |
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III |
HK SURGICAL, INC. |
SALLY M BOWDON |
| K033224 |
11/05/2003 |
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K033473 |
11/18/2003 |
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT |
HORIZON MEDICAL PRODUCTS, INC. |
SCOTT MOELLER |
| K023901 |
01/28/2003 |
ALUMINA V40 FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K033145 |
11/05/2003 |
HOFFMANN II PELVIC CLAMP |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K030978 |
11/20/2003 |
SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
DENISE DUCHENE |
| K023138 |
01/17/2003 |
HYDROFERA BACTERIOSTATIC WOUND DRESSING |
HYDROFERA, LLC. |
HEATHER S BOND |
| K033188 |
11/19/2003 |
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 |
IDEV TECHNOLOGIES, INC. |
LYNNE A DAVIES |
| K033292 |
11/26/2003 |
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 |
IGC-MEDICAL ADVANCES, INC. |
ANTHONY DIETZLER |
| K023575 |
01/22/2003 |
CONCERT CRANIOPLAST |
IMMEDICA, INC. |
RUSSELL PAGANO |
| K030263 |
11/24/2003 |
IMMUNICON CELLTRACKS ANALYZER |
IMMUNICON CORP. |
PETER SCOTT |
| K033430 |
11/07/2003 |
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 |
IMPLANT INNOVATIONS, INC. |
TAMARA NELSON |
| K024161 |
01/15/2003 |
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS |
IMPLEX CORP. |
MARCI HALEVI |
| K033384 |
11/19/2003 |
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ |
IMPLEX CORP. |
MARCI HALEVI |
| K023638 |
01/03/2003 |
CASSETTE/URINE HCG |
IND DIAGNOSTIC INC. |
DAVID LEE |
| K024103 |
01/24/2003 |
IVUS PLUS |
INDEC SYSTEMS, INC. |
CAROL HUBLER |
| K022366 |
01/27/2003 |
CELSIUS CONTROL SYSTEM |
INNERCOOL THERAPIES |
STEVE REITZLER |
| K030802 |
11/25/2003 |
CAPHOSOL |
INPHARMA A.S. |
BRUCE MANNING |
| K023864 |
01/09/2003 |
PERFORMA STEREO |
INSTRUMENTARIUM CORP. IMAGING DIVISION |
BRIAN BRONCATTI |
| K023839 |
01/14/2003 |
HEMOSIL FACTOR V DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K023859 |
01/08/2003 |
SMARTTROAE |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K033187 |
11/19/2003 |
INTERLAB IMMUNOFIXATION TEST(S) |
INTERLAB S.R.L. |
Gary Lehnus |
| K023561 |
01/31/2003 |
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
| K022143 |
01/23/2003 |
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K032784 |
11/18/2003 |
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K031842 |
11/21/2003 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K033199 |
11/12/2003 |
COMPACT DIGITAL CARDIAC CAMERA (CDCC) |
IS2 MEDICAL SYSTEMS, INC. |
VICTOR WOODBURN |
| K032519 |
11/12/2003 |
ENDO PAT 2000 |
ITAMAR MEDICAL |
DORIT WINITZ |
| K022846 |
01/28/2003 |
SW-180 SHORTWAVE THERAPY UNIT |
ITO CO., LTD. |
T. WHIT ATHEY |
| K032470 |
11/05/2003 |
MULTILINK |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K031722 |
11/25/2003 |
JSA REPROCESSED COMPRESSION SLEEVE DEVICES |
JACK SPEER AND ASSOC., INC. |
JACK SPEER |
| K021750 |
01/27/2003 |
LID CHAIN EYELID WEIGHTS |
JEDMED INSTRUMENT CO. |
CRAIG R PARKS |
| K024177 |
01/22/2003 |
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER |
JOHNSON & JOHNSON VISION CARE, INC. |
JAMES W PARZIALE |
| K020784 |
01/09/2003 |
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS |
JOSTRA AG |
KATHLEEN JOHNSON |
| K021547 |
01/24/2003 |
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT |
JOTEC GMBH |
JOE SHARBER |
| K023704 |
01/30/2003 |
KSEA SCB ACC CONTROL |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K032087 |
11/26/2003 |
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 |
KEELER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K033021 |
11/12/2003 |
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K021634 |
01/09/2003 |
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 |
KING SYSTEMS CORP. |
TOM MCGRAIL |
| K032670 |
11/14/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR |
KINGSWELL INTERNATIONAL INC. |
D.C. CHANG |
| K023482 |
01/15/2003 |
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN P PRARIO |
| K023866 |
01/24/2003 |
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES |
KL-KEPONG RUBBER PRODUCTS SDN. BHD. |
YIM HOON PUNG |
| K030359 |
11/06/2003 |
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K021490 |
01/02/2003 |
REEVUE INDIRECT CALORIMETER, MODEL#8100 |
KORR MEDICAL TECHNOLOGIES, INC. |
SCOTT A KOFOED |
| K032455 |
11/07/2003 |
PANAVIA F 2.0 |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
| K031419 |
11/24/2003 |
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K032871 |
11/10/2003 |
PLANET MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K032867 |
11/10/2003 |
STAR (LUNAR SERIES) MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K024206 |
11/17/2003 |
AURA ISURGICAL LASER SYSTEM & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
| K023688 |
01/30/2003 |
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER |
LEMAITRE VASCULAR, INC. |
JAMES ASHBY |
| K022145 |
01/14/2003 |
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 |
LEMAITRE VASCULAR, INC. |
JAMES ASHBY |
| K024264 |
01/16/2003 |
SKINTACT |
LEONHARD LANG CO. |
ELAINE DUNCAN |
| K023920 |
01/16/2003 |
SKINTACT |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K024247 |
01/16/2003 |
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K023960 |
01/09/2003 |
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 |
LIDCO LTD. |
GREGORY SPELLER |
| K032774 |
11/26/2003 |
RENOVA INTERNAL HEX IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
Diane Brinza |
| K021739 |
01/10/2003 |
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 |
LIMERICK, INC. |
PATRICIA KELLY |
| K032764 |
11/03/2003 |
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K023795 |
01/21/2003 |
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K032607 |
11/10/2003 |
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 |
LINVATEC CORP. |
LAURA KREJCI |
| K023701 |
01/30/2003 |
ANGIONEW-IV |
LIVING DATA TECHNOLOGIES CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K033565 |
11/21/2003 |
LMT NOMAG IC 1,5 |
LMT LAMMERS MEDICAL TECHNOLOGY GMBH |
THOMAS M BOHNEN |
| K031170 |
11/13/2003 |
POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS |
LONG FIRST (XIAMEN) CO.,LTD. |
STONE CHEN |
| K023114 |
01/23/2003 |
LUMEND FRONTRUNNER CTO CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K023410 |
01/06/2003 |
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K031997 |
11/25/2003 |
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM |
MALLINCKRODT DAR S.R.L. |
GIUSEPPE TOMASINI |
| K031463 |
11/18/2003 |
MARINA MEDICAL SILICONE PESSARY |
MARINA MEDICAL INSTRUMENTS, INC. |
JAY MANSOUR |
| K022961 |
01/31/2003 |
RTDOSEPLAN |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K013582 |
01/16/2003 |
MAYBE?MOM MINI OVULATION MICROSCOPE |
MAYBE?MOM |
TONI MILLERVA |
| K031876 |
11/21/2003 |
ELECTRO FLO PERCUSSOR, MODEL 5000 |
MED SYSTEMS |
DANIEL KAMM |
| K010714 |
01/21/2003 |
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 |
MEDI-GLOBE CORP. |
GERHARDT SEIWERTH |
| K011261 |
11/17/2003 |
STONE EXTRACTOR BALLOON CATHETER |
MEDI-GLOBE CORP. |
SCOTT KARLER |
| K023443 |
01/13/2003 |
MEDS-3 NEUROMUSCULAR STIMULATOR |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
DARREL BLOMBERG |
| K023446 |
01/13/2003 |
MEDS-3 NEUROMUSCULAR STIMULATOR |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
DARREL BLOMBERG |
| K023435 |
01/13/2003 |
MEDS-4 NEUROMUSCULAR STIMULATOR |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
C. A. TEKLINSKI |
| K023439 |
01/13/2003 |
MEDS-4 NEUROMUSCULAR STIMULATOR |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
DARREL BLOMBERG |
| K023460 |
01/09/2003 |
PACSPLUS |
MEDICAL STANDARD CO., LTD. |
CARL ALLETTO |
| K032094 |
11/14/2003 |
PASSMED SPINAL SYSTEM |
MEDICREA |
J.D. WEBB |
| K033102 |
11/05/2003 |
MEDIC COLON MODEL, RELEASE 1 |
MEDICSIGHT |
CAROL MACDONALD |
| K032823 |
11/10/2003 |
MEDICHEART, MODEL RELEASE 1 |
MEDICSIGHT |
CAROL MACDONALD |
| K023970 |
01/24/2003 |
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J I HOLLANDER |
| K032308 |
11/10/2003 |
BLOOD PRESSURE MONITOR, MODEL M100 |
MEDITEK TECHNOLOGY, INC. |
TONY C.S. CHANG |
| K023163 |
01/13/2003 |
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 |
MEDLOGIC GLOBAL LIMITED |
HOWARD BEAUMONT |
| K033247 |
11/05/2003 |
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
MEDRAD, INC. |
TROY A JACK |
| K023183 |
01/10/2003 |
MEDRAD STELLANT CT INJECTOR SYSTEM |
MEDRAD, INC. |
FRANK W PELC III |
| K033334 |
11/10/2003 |
PROFILE -ER |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K022272 |
01/08/2003 |
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
ROGER BRINK |
| K033468 |
11/14/2003 |
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE |
MEDTRONIC PERFUSION SYSTEMS |
MICHELE PYFFEROEN |
| K033416 |
11/05/2003 |
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K033275 |
11/06/2003 |
LIFEPAK 12, 20, 500, CR PLUS |
MEDTRONIC PHYSIO-CONTROL CORP. |
MICHELLE ACKERMANN |
| K033271 |
11/06/2003 |
DYNALOK CLASSIC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K022126 |
01/03/2003 |
CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K023878 |
01/24/2003 |
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K024069 |
01/08/2003 |
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 |
MEDTRONIC VASCULAR |
RONALD W BENNETT |
| K024316 |
01/06/2003 |
NIM-PRS |
MEDTRONIC XOMED, INC. |
MARTIN SARGENT |
| K023599 |
01/03/2003 |
IMMUNOCARD STAT! E. COLI O157 PLUS |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K032811 |
11/24/2003 |
CEDIA VANCOMYCIN ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
| K031024 |
11/14/2003 |
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K032995 |
11/20/2003 |
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) |
MICRON CORP. |
TAKASHI TERUI |
| K023481 |
01/08/2003 |
MICROVISION SCLERAL BUCKLING COMPONENTS |
MICROVISION, INC. |
SHEILA HEMEON-HEYER, JD, RAC |
| K033390 |
11/04/2003 |
COLIBRI DISPOSABLE VITRECTOMY CUTTER |
MICROWORLD MEDICAL INSTRUMENTS, INC. |
SEMYON GAMBARIN |
| K032872 |
11/28/2003 |
MICRUS MICROCOIL SYSTEM |
MICRUS CORP. |
MARGARET WEBBER |
| K031799 |
11/12/2003 |
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 |
MIELE, INC. |
STEVE POLINSKI |
| K023892 |
01/17/2003 |
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS |
MILLIPORE CORP. |
THOMAS BORROWS |
| K031541 |
11/18/2003 |
PARADIGMPAL, MODEL MMT-7330 |
MINIMED, INC. |
GERDA P RESCH |
| K033277 |
11/04/2003 |
HYDRAGEL CSF ISOFOCUSING KITS |
MORAX |
BOREK JANIK |
| K022636 |
01/13/2003 |
BODY BOX 5500 |
MORGAN SCIENTIFIC, INC. |
PATRICK F MORGAN |
| K032934 |
11/13/2003 |
MPS ACACIA SAFEGUARD HUBER DEVICE |
MPS ACACIA |
FERGIE F FERGUSON |
| K024352 |
01/09/2003 |
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K033567 |
11/25/2003 |
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K024208 |
01/07/2003 |
OBC-250-PAN BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K024354 |
01/09/2003 |
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K024209 |
01/09/2003 |
QWH-250-PAN WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K031820 |
11/12/2003 |
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 |
MULTINATIONAL |
GRACE HOLLAND |
| K030787 |
11/14/2003 |
SHILEY FLEXTRA TRACHEOSTOMY TUBE |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K033321 |
11/05/2003 |
SELECTIVA SB GUIDEWIRE |
NEO METRICS, INC. |
MARK PEDERSON |
| K033427 |
11/10/2003 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
| K023462 |
01/13/2003 |
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003 |
NEUROMECHANICAL INNOVATIONS, LLC |
CHRISTOPHER J COLLOCA |
| K023536 |
01/15/2003 |
NUAMPS |
NEUROSCAN |
ELVIRA GARCIA |
| K023531 |
01/17/2003 |
LESSER METATARSAL PHALANGEAL JOINT IMPLANT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K022909 |
01/09/2003 |
NIKOMED TRACE 1 ECG ELECTRODES |
NIKOMED U.S.A., INC. |
ELAINE DUNCAN |
| K032777 |
11/14/2003 |
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
RICHARD D BLISS |
| K023952 |
01/16/2003 |
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE |
NOBEL BIOCARE UAS INC |
KATHELEEN DRAGOVICH |
| K022052 |
01/24/2003 |
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K021222 |
01/08/2003 |
LAD, MODEL LAD-01 |
NORWOOD ABBEY , LTD. |
ROBERT HANDREN |
| K031073 |
11/05/2003 |
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
| K023682 |
01/16/2003 |
ENCLOSE ANASTOMOSIS ASSIST DEVICE |
NOVARE SURGICAL SYSTEMS, INC. |
DAVID W SCHLERF |
| K033486 |
11/19/2003 |
GE PRECISION MPI |
NRT-NORDISK RONTGEN TEKNIK A/S |
JAN MALLING |
| K032476 |
11/13/2003 |
NUVASIVE MESH |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K033386 |
11/26/2003 |
NXSTAGE PUREFLOW SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K022304 |
11/14/2003 |
ACCUMAP AUTOMATIC PERIMETER |
OBJECTIVISION PTY LTD. |
FRED HENRY |
| K031380 |
11/14/2003 |
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K032665 |
11/21/2003 |
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K022445 |
01/24/2003 |
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K024114 |
01/10/2003 |
A-SCAN 100 |
OPHTHALMIC TECHNOLOGIES, INC. |
GEORGE H MYERS |
| K030067 |
01/17/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
SARAH PARSONS |
| K033300 |
11/05/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
CHARLOTTE BAKER |
| K030958 |
11/20/2003 |
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K032130 |
11/05/2003 |
VITOSS-FILLED CARTRIDGE |
ORTHOVITA, INC. |
ANDREINA ANGIE IDE |
| K024156 |
01/14/2003 |
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR |
Oscor Inc. |
MILA DOSKOCIL |
| K024053 |
01/31/2003 |
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB |
Oscor Inc. |
MILA DOSKOCIL |
| K023677 |
01/29/2003 |
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) |
OSMETECH |
ANDREW TUMMON |
| K031708 |
11/03/2003 |
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDERMAN |
| K022035 |
01/17/2003 |
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB |
OSTEOMEDICS, INC. |
ALBERT ENYATI |
| K023618 |
01/22/2003 |
SONICAID ONE |
OXFORD INSTRUMENTS MEDICAL LTD. |
MICHAEL EDWARDS |
| K023967 |
01/27/2003 |
PALOMAR Q-YAG ND:YAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K033119 |
11/18/2003 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA E DILLON |
| K023499 |
01/13/2003 |
GOLD CORE PLUS |
PENTRON LABORATORY TECHNOLOGIES |
ANNMARIE TENERO |
| K023742 |
01/17/2003 |
SCULPTURE PLUS NANO-HYBRID COMPOSITE |
PENTRON LABORATORY TECHNOLOGIES |
ANNMARIE TENERO |
| K032753 |
11/18/2003 |
GLUCOSE TOLERANCE BEVERAGE |
PERK SCIENTIFIC, INC. |
MARK BARTOSH |
| K024184 |
01/14/2003 |
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K032613 |
11/20/2003 |
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE |
PETER M. ROTHENBERG, M.D. |
PETER M ROTHENBERG |
| K033444 |
11/21/2003 |
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER |
PHILIPS MEDICAL SYSTEMS |
TAPAN D SHAH |
| K024040 |
01/27/2003 |
ACCURA ELITE SHUNT SYSTEM |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K024101 |
01/27/2003 |
PHOENIX UNIVERSAL SHUNT SYSTEM |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K023512 |
01/24/2003 |
PICUS ULTRASOUND IMAGING SYSTEMS |
PIE MEDICAL |
COLLEEN DENSMORE |
| K032636 |
11/14/2003 |
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) |
PLAYTEX PRODUCTS, INC. |
KAREN A COSTA |
| K024134 |
01/15/2003 |
UNI HIP STEM |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K032716 |
11/28/2003 |
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) |
PORTEX LTD. |
STEVE OGILVIE |
| K023851 |
01/28/2003 |
PRECIMED HIP SCREW SYSTEM |
PRECIMED, INC. |
BARBARA LYONS |
| K023790 |
01/21/2003 |
UCC DENTAL MATERIAL |
PRECIOUS CHEMICALS U.S.A., INC. |
EUGENE LIEBERSTEIN |
| K023831 |
01/24/2003 |
UCP DENTAL MATERIAL |
PRECIOUS CHEMICALS U.S.A., INC. |
EUGENE LIEBERSTEIN |
| K032804 |
11/03/2003 |
CRYOCHECK WEAK LUPUS POSITIVE CONTROL |
PRECISION BIOLOGIC |
STEPHEN DUFF |
| K032331 |
11/20/2003 |
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) |
PRO-MED INSTRUMENTS GMBH |
JIM BAZZINOTTI |
| K023579 |
01/28/2003 |
GAS SAMPLING LINES |
PROMEDIC, INC. |
PAUL DRYDEN |
| K032260 |
11/20/2003 |
ARAMIS II DERMATOLOGICAL LASER |
QUANTEL MEDICAL |
ROGER W BARNES |
| K023464 |
01/13/2003 |
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR |
QUANTEL MEDICAL |
ROGER W BARNES |
| K032379 |
11/20/2003 |
QUASAR, MODEL MD21 |
QUANTUM SKINCARE, INC. |
J. HARVEY KNAUSS |
| K023592 |
01/06/2003 |
SERAQUEST ANTI-THYROGLOBULIN |
QUEST INTL., INC. |
ROBERT A CORT |
| K022326 |
01/31/2003 |
RADIOMED MARKER |
RADIOMED CORPORATION |
GORDON ROBERTS |
| K023519 |
01/16/2003 |
RADIONICS VARILINK 2 |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K023763 |
01/13/2003 |
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS |
RANDOX LABORATORIES, LTD. |
LYNNE HAMILTON |
| K023572 |
01/13/2003 |
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET |
REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED |
LYNN D FLEISHER |
| K031795 |
11/10/2003 |
RELIANT LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K023652 |
01/09/2003 |
REMECURE MODEL CL 15E |
REMEDENT NV |
ED FIRST |
| K031965 |
11/14/2003 |
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 |
REMEL INC |
RICHARD TYSON |
| K031942 |
11/18/2003 |
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 |
REMEL INC |
RICHARD TYSON |
| K031834 |
11/10/2003 |
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY |
REMEL INC |
EARLEEN C PARKS |
| K031559 |
11/12/2003 |
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES |
RENU MEDICAL, INC. |
L. BRUCE PIERSON |
| K022750 |
11/20/2003 |
PLV CONTINUUM VENTILATOR, MODEL P1000 |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
| K032809 |
11/13/2003 |
HOSPITAL SPACER |
RESPIRONICS HEALTHSCAN, INC. |
SUSAN D GOLDSTEIN-FALK |
| K030090 |
01/24/2003 |
H2 HEATED HUMIDIFIER |
RESPIRONICS, INC. |
ZITA A YURKO |
| K023135 |
01/03/2003 |
IMAGE3 SE DISPOSABLE FULL FACE MASK |
RESPIRONICS, INC. |
ZITA A YURKO |
| K032852 |
11/12/2003 |
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 |
REVIVANT CORP. |
BOB H KATZ |
| K022170 |
01/21/2003 |
INNER-LOCK LOCKING INTRODUCER SHEATHS |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K023659 |
01/29/2003 |
1-CCD ENDOCAM 5520 SYSTEM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K023813 |
01/17/2003 |
BIPOLAR FORCEPS |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K032646 |
11/12/2003 |
ELECSYS PROBNP IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K033501 |
11/20/2003 |
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K033548 |
11/24/2003 |
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K022521 |
01/03/2003 |
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
DONALD DANALD |
| K030049 |
01/29/2003 |
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K022845 |
01/29/2003 |
SAS RSV TEST |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K024081 |
01/28/2003 |
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
SAFEHEALTH MEDICAL SUPPLY CORP. |
P.M. YEH |
| K022433 |
01/24/2003 |
NEOGENESYS 2K |
SANEXAS INTL. GMBH |
GENE KELLY |
| K023515 |
01/16/2003 |
PRE-POWDERED LATEX SURGEON'S GLOVES |
SANREA HEALTHCARE PRIVATE LIMITED |
JOSE PAUL M |
| K031236 |
11/14/2003 |
AUTO-BAND LIGATOR |
SCANDIMED. A.S. |
KRISTIAN K JENSEN |
| K021963 |
01/28/2003 |
BIOSORB RESORBABLE VOID FILLER |
SCIENCES ET BIO MATERIAUX (SBM) |
DENIS CLEMENT |
| K032460 |
11/13/2003 |
PROFILE BBL SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K032739 |
11/20/2003 |
UCR SPINAL SYSTEM |
SEASPINE |
DIANA SMITH |
| K023745 |
01/17/2003 |
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G |
SECHRIST INDUSTRIES, INC. |
GREG GODFREY |
| K023128 |
01/22/2003 |
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
SECURE SCIENTIFIC SDN BHD |
CHONG NGIT-HENG |
| K022192 |
01/24/2003 |
PEGASUS NASAL CPAP SYSTEM |
SENSORMEDICS CORP. |
PAUL L KITTINGER |
| K032708 |
11/20/2003 |
PLASTALGIN AND PLASTALGIN ORTHO |
SEPTODONT |
WAYNE H MATELSKI, ESQ. |
| K023976 |
01/30/2003 |
ACROSEAL ROOT CANAL OR APICAL SEALER |
SEPTODONT S.A.S. |
WAYNE H MATELSKI |
| K023537 |
11/20/2003 |
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K024154 |
01/06/2003 |
SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES |
SHANGHAI HUAMAO GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K030583 |
11/10/2003 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K032908 |
11/20/2003 |
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
CHEN YUHONG |
| K032907 |
11/20/2003 |
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD. |
CHEN YUHONG |
| K033374 |
11/06/2003 |
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
SIEMENS AG, MEDICAL SOLUTIONS |
RUDIGER KORNER |
| K033335 |
11/25/2003 |
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DEBBIE PEACOCK |
| K031340 |
11/25/2003 |
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K032536 |
11/10/2003 |
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE K HARTMAN |
| K032475 |
11/10/2003 |
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
| K033238 |
11/14/2003 |
MOBILETTE XP AND MOBILETT XPHYBRID |
SIEMENS MEDICAL SYSTEMS, INC. |
NEALIE HARTMAN |
| K031546 |
11/13/2003 |
RAINBOW GT-4A PAIN RELIEF MACHINE |
SINO-US INFORMATION, INC |
YITANG SHENG |
| K032543 |
11/14/2003 |
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K033509 |
11/28/2003 |
MODIFICATION TO VERSABOND BONE CEMENT |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K033442 |
11/26/2003 |
REFLECTION CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
KANU VADODARIA |
| K023743 |
01/23/2003 |
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
| K032967 |
11/14/2003 |
PASCAL DYNAMIC CONTOUR TONOMETER |
SMT SWISS MICROTECHNOLOGY AG |
Kevin Walls |
| K023070 |
01/28/2003 |
SODEM HIGH SPEED SYSTEM (PNEUMATIC) |
SODEM SYSTEMS |
CAROLE BURNIER |
| K023791 |
01/10/2003 |
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR |
SOFTFOCAL COMPANY, INC. |
ROBERT B MANDELL |
| K023467 |
01/07/2003 |
HCP DICOM NET |
SOFTLINK INTERNATIONAL INC. |
SUSAN D GOLDSTEIN-FALK |
| K022078 |
01/10/2003 |
SOLA, COUNTER-PULSATION, MODEL SECP-S |
SOLA MEDICAL DEVICES, LLC |
GREG HOLLAND |
| K030064 |
01/22/2003 |
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K033367 |
11/05/2003 |
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K033325 |
11/06/2003 |
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K033425 |
11/06/2003 |
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K030028 |
01/17/2003 |
CPC BY SORING GMBH |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
| K024059 |
01/08/2003 |
MBC SERIES |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
| K021130 |
01/07/2003 |
SPECATH CENTRAL VENOUS CATHETER KITS |
SPECIAL MEDICAL CO. LTD. |
SUSAN D GOLDSTEIN-FALK |
| K032787 |
11/20/2003 |
NEUROLASE, MODELS 150V, 150C, 1064 |
SPECTRUM LASER & TECHNOLOGIES |
THOMAS R RADEBAUGH |
| K024326 |
01/23/2003 |
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K014200 |
11/26/2003 |
OPTIMESH |
SPINEOLOGY, INC. |
PAMELA R SNYDER |
| K031798 |
11/12/2003 |
GOOD MORNING TEST |
STANDARD DIAGNOSTICS, INC. |
RICHARD C LANZILLOTTO |
| K023978 |
01/24/2003 |
NITRILE EXAMINATION GLOVES, POWDER FREE |
STARMATRIX SDN BHD |
NGAN BOON SENG |
| K023979 |
01/24/2003 |
NITRILE EXAMINATION GLOVES, PRE-POWDERED |
STARMATRIX SDN BHD |
NGAN GOON SENG |
| K023977 |
01/24/2003 |
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM |
STARMATRIX SDN BHD |
NGAN BOON SENG |
| K032824 |
11/13/2003 |
STELKAST UNICONDYLAR KNEE SYSTEM |
STELKAST COMPANY |
DONALD STEVENS |
| K021555 |
01/15/2003 |
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM |
STEREOTAXIS, INC. |
PETER A TAKES |
| K023580 |
01/17/2003 |
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM |
STERNGOLD |
PAMELA PAPINEAU |
| K033252 |
11/13/2003 |
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K032473 |
11/07/2003 |
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| K022365 |
01/22/2003 |
STRYKER NAVIGATION SYSTEM - HIP MODULE |
STRYKER INSTRUMENTS |
KELLI BITTERBURG |
| K023449 |
01/13/2003 |
NON-INVASIVE PATIENT FIXATION SYSTEM |
STRYKER LEIBINGER |
KELLI J BITTERBURG |
| K024197 |
01/03/2003 |
LIFEDOP DOPPLER |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K032880 |
11/10/2003 |
SUMMIT STAIRWAY LIFT |
SUMMIT LIFTS, INC. |
KENT PERRY |
| K024083 |
01/10/2003 |
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K030179 |
01/24/2003 |
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
MARY ANN BARKER |
| K023624 |
01/27/2003 |
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 |
SURGICAL LASER TECHNOLOGIES, INC. |
DAVIS WOODWARD |
| K033358 |
11/14/2003 |
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 |
SURGITECH, INC. |
CHRISTOPHER CROWELL |
| K032921 |
11/13/2003 |
PREMISE |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K032598 |
11/24/2003 |
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE |
SYNERGETICS, INC. |
DAN REGAN |
| K023826 |
01/24/2003 |
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
| K031175 |
11/14/2003 |
CLICK'X MONOAXIAL SCREWS AND HOOKS |
SYNTHES (USA) |
JOHN WALSH |
| K033071 |
11/05/2003 |
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K033411 |
11/26/2003 |
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS |
SYNTHES (USA) |
BONNIE SMITH |
| K023802 |
01/28/2003 |
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K033158 |
11/05/2003 |
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES |
SYNTHES (USA) |
ANGLELA J SILVESTRI |
| K022844 |
01/07/2003 |
SYNTHES RESORBABLE CONTOURABLE MESH |
SYNTHES (USA) |
MATTHEW M HULL |
| K023941 |
01/23/2003 |
SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K033097 |
11/12/2003 |
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02 |
TAIWAN KING STRONG CO., LTD. |
JEN KE-MIN |
| K021794 |
01/13/2003 |
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING) |
TATUNG CO. |
JENNIFER REICH |
| K033274 |
11/04/2003 |
GIARDIA II |
TECHLAB, INC. |
DAVID M LYERLY |
| K022697 |
01/24/2003 |
TEH LIN JUPITER POWER CHAIR, MODEL TL-320 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
| K032520 |
11/12/2003 |
ORTRAUTEK TRAUMA SYSTEM |
TEKKA |
FAYYAZ MEMON |
| K032685 |
11/26/2003 |
CEMSTOP CEMENT RESTRICTOR |
TEKNIMED SA |
J.D. WEBB |
| K031826 |
11/28/2003 |
TRIHA + |
TEKNIMED SA |
J. D WEBB |
| K033115 |
11/17/2003 |
ORTHODEK |
TELEFLEX MEDICAL |
STEPHEN PAGE |
| K022341 |
01/27/2003 |
TERABYTE 2000 HAIR REMOVER |
TERABYTE CO. |
WILLIAM A OLSON |
| K030191 |
01/29/2003 |
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM |
TERATECH CORP. |
CHARLES F HOTTINGER |
| K023935 |
01/28/2003 |
TRILUMINA THERAPEUTIC LASER SYSTEM |
TEXAS APPLIED BIOMEDICAL SERVICES |
M. JOYCE HEINRICH |
| K023009 |
01/21/2003 |
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K023131 |
01/21/2003 |
FREELITE HUMAN LAMBDA FREE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K023984 |
01/31/2003 |
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K024020 |
01/17/2003 |
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM |
THERALIGHT, INC. |
KEVIN E DALY |
| K023779 |
01/14/2003 |
RSV OIA |
THERMO BIOSTAR, INC. |
JOHN G ADAMS |
| K023792 |
01/31/2003 |
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S |
THERMO ORION |
PATRICK K CHIU |
| K032230 |
11/26/2003 |
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE |
THINKLABS INC. |
RICHARD LANZILLOTTO |
| K033346 |
11/03/2003 |
SPI EASY DENTAL IMPLANT PROTECTIVE CAP |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K033035 |
11/20/2003 |
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS |
TLC MARKETING, INC. |
ROBERT MAZZAFERRO |
| K033347 |
11/12/2003 |
MODIFICATION TO: HI-ART SYSTEM |
TOMOTHERAPY INCORPORATED |
KENNETH D BUROKER |
| K033418 |
11/10/2003 |
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K033083 |
11/26/2003 |
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033070 |
11/26/2003 |
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033079 |
11/26/2003 |
CHLAMYDIA IGG ELISA TEST SYSTEM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033051 |
11/26/2003 |
LEGIONELLA PNEUMOPHILA IGG/IGM |
TRINITY BIOTECH USA |
BONNIE DEJOY |
| K033064 |
11/26/2003 |
MYCOPLASMA IGG |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033067 |
11/26/2003 |
PYLORI IGG |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K033059 |
11/26/2003 |
HERPES GROUP IGG |
TRINITY BIOTECH, INC. |
BONNIE DEJOY |
| K023346 |
01/03/2003 |
TROPHYPAN |
TROPHY RADIOLOGIE |
MARIE-PIERRE LABAT-CAMY |
| K033241 |
11/10/2003 |
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 |
TUNG KENG ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K033239 |
11/12/2003 |
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 |
TUNG KENG ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K033219 |
11/12/2003 |
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 |
TUNG KENG ENTERPRISE CO., LTD. |
JEN KE-MIN |
| K033373 |
11/13/2003 |
MONOJECT INSULIN SYRINGE |
TYCO HEALTHCARE |
DAVID OLSON |
| K032627 |
11/12/2003 |
ULTRADENT CITRIC ACID 10% SOLUTION |
ULTRADENT PRODUCTS, INC. |
PETER ALLRED |
| K023706 |
01/14/2003 |
ULTROID HEMORRHOID MANAGEMENT SYSTEM |
ULTROID, LLC |
RONALD R NEWTON |
| K032586 |
11/17/2003 |
CAPROSYN ABSORBABLE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ROBERT ZOTT |
| K023476 |
01/07/2003 |
UNIPACS WORKSTATION |
UNIVERSAL PACS, INC. |
JOHN M TYLER |
| K031493 |
11/20/2003 |
GROWTH GUIDANCE PLATE |
UNIVERSITY OF UTAH/SCHOOL OF MEDICINE |
PETER M STEVENS |
| K032987 |
11/17/2003 |
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 |
UNOTECH DIAGNOSTICS, INC. |
KEN WU |
| K023650 |
01/24/2003 |
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K033353 |
11/14/2003 |
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K033499 |
11/28/2003 |
MALIS IRRIGATION MODULE 1000 |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K031524 |
11/26/2003 |
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K030078 |
01/24/2003 |
BURBANK TENACULUM, MODEL 09-0011-01 |
VASCULAR CONTROL SYSTEMS, INC |
AL MEMMOLO |
| K033237 |
11/20/2003 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
DEBORAH L JENSEN |
| K031515 |
11/14/2003 |
SPIROPRO SPO2 |
VIASYS HEALTHCARE GMBH |
EARL DRAPER |
| K033361 |
11/05/2003 |
VIATRONIX V3D VASCULAR, REVISION 1.0 |
VIATRONIX, INC. |
FRANK DACHILLE |
| K024095 |
01/09/2003 |
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K030419 |
11/06/2003 |
VITERION 100 TELEHEALTH MONITOR |
VITERION TELEHEALTHCARE LLC |
THUY NGUYEN |
| K033117 |
11/25/2003 |
GRANDIO FLOW |
VOCO GMBH |
GERALD W SHIPPS |
| K013884 |
01/21/2003 |
BOUSSIGNAC C.P.A.P. DEVICE |
VYGON S A |
LAETITIA BERNARD |
| K032865 |
11/28/2003 |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W. L. GORE & ASSOCIATES, INC. |
MIKE JOHNSON |
| K030206 |
01/29/2003 |
APEX 90 |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K033446 |
11/13/2003 |
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K033434 |
11/12/2003 |
BESTALOY |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K033435 |
11/12/2003 |
E-SARANG 86, DM78, DM55 |
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. |
RONALD D ARKIN |
| K023744 |
01/03/2003 |
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K023468 |
01/14/2003 |
ENDOSCOPIC LIGHT SOURCE XL180/L3 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K030319 |
11/26/2003 |
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| K032647 |
11/07/2003 |
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K023490 |
01/16/2003 |
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K033032 |
11/10/2003 |
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR |
WU'S TECH CO., LTD. |
Ke-Min Jen |
| K023040 |
01/24/2003 |
WU'S 3-WHEELED NEO SCOOTER, WT-L3 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K023166 |
01/24/2003 |
WU'S 3-WHEELED NEO SCOOTER, WT-M4 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K023168 |
01/24/2003 |
WU'S 3-WHEELED NEO SCOOTER, WT-T3B |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K032617 |
11/12/2003 |
WU'S 4-WHEELED SCOOTER, WT-L4JR |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K033066 |
11/12/2003 |
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM |
XITEC HOLDINGS LLC. |
DANIEL J DILLON |
| K032512 |
11/12/2003 |
Y.E.S POWERED WHEELCHAIR. T180 |
YEOU EIR SHUEN MACHINERY CO., LTD. |
JEN KE-MIN |
| K032669 |
11/12/2003 |
Y.E.S. POWERED WHEELCHAIR, MODEL T200 |
YEOU EIR SHUEN MACHINERY CO., LTD. |
Ke-Min Jen |
| K032781 |
11/13/2003 |
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHEN YUHONG |
| K032783 |
11/13/2003 |
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHEN YUHONG |
| K033034 |
11/05/2003 |
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS |
ZIMMER, INC. |
KAREN CAIN |
| K032691 |
11/13/2003 |
ZOLL AUTOCLAVABLE INTERNAL HANDLES |
ZOLL MEDICAL CORP. |
PAUL DIAS |
| K032439 |
11/05/2003 |
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) |
ZOLL MEDICAL CORP. |
SCOTT AUGUST |
