| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K032099 |
10/27/2003 |
SWISS MASTER LIGHT |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
CYNTHIA J M. NOLTE |
| K031263 |
10/07/2003 |
3M LIQUID BANDAGE, MODEL 120-LB |
3M COMPANY |
ANNA E MCRIGHT |
| K031012 |
10/16/2003 |
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK |
3M COMPANY |
CYNTHIA LAMARUCCIOLA |
| K032499 |
10/30/2003 |
A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS |
A & D ENGINEERING, INC. |
JERRY WANG |
| K032458 |
10/06/2003 |
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT |
ABBOTT LABORATORIES |
DENISE FARMER |
| K032929 |
10/22/2003 |
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 |
ABBOTT VASCULAR INC. |
JOANNA KUSKOWSKI |
| K032956 |
10/10/2003 |
ACCUSONIC A-SCAN MODEL, 24-4000 |
ACCUTOME, INC. |
JEFFREY L WRIGHT |
| K032661 |
10/14/2003 |
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K033254 |
10/22/2003 |
FORTE GAMMA CAMERA SYSTEM |
ADAC LABORATORIES |
JOY M SACMAR |
| K032724 |
10/09/2003 |
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
RANDY VADER |
| K032220 |
10/24/2003 |
ADEPT 1064/532 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032218 |
10/24/2003 |
ADEPT 1064/532/755 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032221 |
10/24/2003 |
ADEPT 1064/755 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K032034 |
10/03/2003 |
ANS AXXESS PERCUTANEOUS LEAD |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K032751 |
10/06/2003 |
MODIFICATION TO RENEW LEAD EXTENSION |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K032349 |
10/03/2003 |
PLACER |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K032736 |
10/03/2003 |
HEART 2006 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
| K032210 |
10/02/2003 |
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM |
ALARA, INC. |
DIANE M KING |
| K032801 |
10/17/2003 |
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K030279 |
10/03/2003 |
REPROCESSED ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K033311 |
10/29/2003 |
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
| K030421 |
10/23/2003 |
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM |
ALSIUS CORP. |
KENNETH A COLLINS |
| K031497 |
10/17/2003 |
AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K031501 |
10/16/2003 |
EASYGLUCO, MODEL IGM0002 |
AMERICAN HEALTHCARE INC. |
EDWARD LETCO |
| K032789 |
10/09/2003 |
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 |
AMERICAN I.V. PRODUCTS, INC. |
GREGORY FALK |
| K030120 |
10/29/2003 |
AMSURE FOLEY CATHETER |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K023885 |
10/21/2003 |
COMBI-SCREEN, MODELS 10SL AND 11SL |
ANALYTICON BIOTECHNOLOGIES AG |
DANIEL KAMM |
| K032257 |
10/16/2003 |
MODEL IR 1200 INSULIN PUMP |
ANIMAS CORP. |
MICHAEL J ANDREWS |
| K031523 |
10/01/2003 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
| K033099 |
10/16/2003 |
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 |
APPLIED DIABETES RESEARCH, INCORPORATED |
JIM BARLEY |
| K032889 |
10/02/2003 |
OPTICAL SEPARATOR |
APPLIED MEDICAL RESOURCES |
CHERYL BLAKE |
| K033024 |
10/24/2003 |
MODIFICATION TO SUTURE CLINCH |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
| K032962 |
10/29/2003 |
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE |
ARROW INTL., INC. |
ELIZABETH PRICE |
| K032098 |
10/07/2003 |
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B |
ARTHREX, INC. |
ANN WATERHOUSE |
| K033257 |
10/30/2003 |
ARTHROCARE ENT PLASMA WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K032072 |
10/01/2003 |
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE |
ARTHROTEK, INC. |
TRACY J BICKEL |
| K032686 |
10/22/2003 |
ASCENSION MODULAR RADIAL HEAD |
ASCENSION ORTHOPEDICS, INC. |
PETER STRZEPA |
| K031503 |
10/24/2003 |
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER |
AVITA CORPORATION |
JENNIFER REICH |
| K032144 |
10/01/2003 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
AMY SMITH |
| K032655 |
10/06/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN B POWERS |
| K033126 |
10/29/2003 |
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM |
BEHAVIORAL TECHNOLOGY, INC. |
SUSAN E OLSEN |
| K031909 |
10/07/2003 |
BETEC RETRACTABLE SAFETY SYRINGE (5ML) |
BETEC MEDICAL SCIENCE CO., LTD. |
JENNIFER REICH |
| K032166 |
10/21/2003 |
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 |
BINAX, INC. |
PAMELA ANGELL |
| K031838 |
10/30/2003 |
PROFUSION BONE VOID FILLER KIT |
BIOGENERATION |
BERNARD F GRISONI |
| K032351 |
10/21/2003 |
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON D GREER |
| K030348 |
10/21/2003 |
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE |
BIOLAB EQUIPMENT CANADA LTD. |
JERRY PONIKVAR |
| K030539 |
10/10/2003 |
LASERSMILE |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| K030394 |
10/27/2003 |
FLUID SAMPLE RETRIEVAL SYSTEM |
BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING |
SUSAN B FENTRESS |
| K032766 |
10/31/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032738 |
10/31/2003 |
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K032711 |
10/31/2003 |
VITEK GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K031684 |
10/30/2003 |
TOPKIN WOUND DRESSING |
BIOMET MERCK GMBH |
THOMAS KIEWITT |
| K032819 |
10/20/2003 |
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K033217 |
10/31/2003 |
PHERON PTA CATHETER |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K032700 |
10/09/2003 |
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K032930 |
10/23/2003 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K032712 |
10/02/2003 |
VAXCEL PLUS CHRONIC DIALYSIS CATHETER |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K033010 |
10/10/2003 |
BRM2 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
CHRIS MANDER |
| K031928 |
10/24/2003 |
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) |
BRAUN GMBH |
FRED SCHLADOR |
| K030627 |
10/23/2003 |
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 |
C.R. BARD, INC. |
DEBORAH HERRINGTON |
| K032918 |
10/06/2003 |
C.T.M. MOBILITY SCOOTER, MODEL HS-235 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K032919 |
10/15/2003 |
C.T.M. MOBILITY SCOOTER, MODEL HS-250 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K033172 |
10/30/2003 |
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS |
CANDELA CORP. |
LORRAINE CALZETTA-PATROVIC |
| K032388 |
10/31/2003 |
BONE CEMENT RADIO-OPACIFIER |
Cardinal Health |
SHARON NICHOLS |
| K031301 |
10/15/2003 |
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING |
Cardinal Health |
ERICA SETHI |
| K033037 |
10/31/2003 |
MODIFICATION TO GLOBALCARDIO |
CARDIOCOMM SOLUTIONS, INC. |
JANET WAINMAN |
| K031840 |
10/10/2003 |
CAREMATIX WELLNESS SYSTEM |
CAREMATIX INC. |
DANIEL KAMM |
| K032348 |
10/24/2003 |
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP |
CENTERPULSE ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K030923 |
10/03/2003 |
EPSILON DURASUL CONSTRAINED ACETABULAR LINER |
CENTERPULSE ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K031567 |
10/02/2003 |
3D INVIVO BY CSIST |
CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY |
CARL ALLETTO |
| K032978 |
10/20/2003 |
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME |
CIBA VISION CORPORATION |
PENNY NORTHCUTT |
| K033162 |
10/10/2003 |
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K032074 |
10/21/2003 |
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K030910 |
10/10/2003 |
CLUED UP MULTIPURPOSE SOLUTION- NO RUB |
CLUED UP LIMITED |
JENNY KOKSHUN |
| K032698 |
10/23/2003 |
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
| K032770 |
10/08/2003 |
ENDOTINE FOREHEAD DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
| K032100 |
10/02/2003 |
I-BEAM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K032223 |
10/15/2003 |
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
| K031966 |
10/16/2003 |
ENK FIBEROPTIC ATOMIZER SET |
COOK, INC. |
JENNIFER J BOSLEY |
| K032426 |
10/31/2003 |
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET |
COOK, INC. |
JENNIFER J BOSLEY |
| K032931 |
10/22/2003 |
PTA BALLOON CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K032737 |
10/02/2003 |
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA |
CORDIS EUROPA N.V. |
KAREN WILK |
| K032868 |
10/14/2003 |
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 |
CORGENIX, INC. |
NANCI DEXTER |
| K032186 |
10/14/2003 |
AUTOALIGN |
CORTECHS LABS, INC. |
ALLAN GREEN |
| K030737 |
10/10/2003 |
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 |
CTF SYSTEMS (2001), INC. |
DARYL WISDAHL |
| K032565 |
10/22/2003 |
CYNOSURE PHOTOGENICA VL |
CYNOSURE, INC. |
GEORGE CHO |
| K031389 |
10/01/2003 |
CYNOSURE SMART 2940D ER:YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K031125 |
10/09/2003 |
CYNOSURE SMART FILE ND:YAG LASERS |
CYNOSURE, INC. |
GEORGE CHO |
| K031440 |
10/01/2003 |
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K032798 |
10/30/2003 |
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K032574 |
10/06/2003 |
DIMENSION DRUG CALIBRATOR II, MODEL DC49C |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K032564 |
10/31/2003 |
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K032573 |
10/31/2003 |
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K013452 |
10/31/2003 |
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS |
DANMAR PRODUCTS, INC. |
KAREN A LINDNER |
| K031760 |
10/10/2003 |
VIEWPOINT TELEMETRY SYSTEM |
DATASCOPE CORP. |
SUSAN E MANDY |
| K033078 |
10/29/2003 |
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE |
DATEX-OHMEDA |
JOEL KENT |
| K023366 |
10/07/2003 |
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS |
DATEX-OHMEDA, INC. |
MICHAEL A CHILBERT |
| K031074 |
10/15/2003 |
DIGITAL AMBULATORY ECG (HOLTER) RECORDER |
DATRIX |
LAUREN M LUHMANN |
| K023509 |
10/30/2003 |
DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
DAVITA CLINICAL RESEARCH (TRRI) |
TRACY L GRAY |
| K032195 |
10/07/2003 |
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT |
DENTAURUM |
JAN A DOORSCHODT |
| K032320 |
10/01/2003 |
APPOLLO 3 ALLOY |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K032904 |
10/14/2003 |
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 |
DENTSPLY INTL. |
JOHN R MILLER |
| K024133 |
10/01/2003 |
CLS-2000 UNIT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K032687 |
10/06/2003 |
ACE NANCY NAIL |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K031408 |
10/15/2003 |
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) |
DEROYAL |
AUDREY DANIELS |
| K032881 |
10/10/2003 |
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K031465 |
10/10/2003 |
MODEL 2100 PULSE OXIMETER |
DOLPHIN MEDICAL INC. |
JON WERNER |
| K032947 |
10/17/2003 |
NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 |
DOLPHIN MEDICAL INC. |
BILL CURNAN |
| K033305 |
10/31/2003 |
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K024072 |
10/06/2003 |
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K031329 |
10/22/2003 |
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) |
DYNATRONICS CORP. |
RON HATCH |
| K031732 |
10/15/2003 |
EBI ACUMEN SURGICAL NAVIGATION SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K032587 |
10/02/2003 |
EDWARDS PERIPHERAL DILATATION CATHETER |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K031769 |
10/14/2003 |
E-STRIP |
EEMSO, INC. |
LARRY R PILOT |
| K033214 |
10/14/2003 |
EKOS PERIPHERAL INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K032996 |
10/23/2003 |
ELEKTA SYNERGY SYSTEM |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
PETER STEGAGNO |
| K032616 |
10/02/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K024361 |
10/09/2003 |
EM PROBE, EM PAD |
EM PROBE INC. |
GLEN A GORDON |
| K032105 |
10/30/2003 |
ENDOHELIX ENDARTERECTOMY DEVICE |
ENDARX, INC. |
SCOTT ADAMS |
| K033211 |
10/30/2003 |
ENSITE SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
KAREN J MCKELVEY |
| K031066 |
10/17/2003 |
VIEWMATE ULTRASOUND IMAGING SYSTEM |
EP MEDSYSTEMS |
JOHN J TALARICO |
| K024023 |
10/01/2003 |
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER |
ESSEX MEDICAL SYSTEMS PLUS |
SUSAN D GOLDSTEIN-FALK |
| K032632 |
10/22/2003 |
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH |
ESTECH, INC. |
ARTHUR BERTOLERO |
| K032307 |
10/24/2003 |
CAP BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
Kristine Canavan |
| K032676 |
10/30/2003 |
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
| K030472 |
10/09/2003 |
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM |
ETHICON ENDO-SURGERY, INC. |
MICHAEL J CRADER |
| K032420 |
10/22/2003 |
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE |
ETHICON, INC. |
REY LIBROJO |
| K031195 |
10/10/2003 |
CUF-COVER (TM) |
ETHOX CORP. |
DANIEL KAMM |
| K032580 |
10/22/2003 |
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM |
EV3 INC |
GLEN D SMYTHE |
| K033140 |
10/29/2003 |
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOR |
| K023209 |
10/10/2003 |
INSIGHT MILLENNIUM III |
FASSTECH |
LEE BRODY |
| K031307 |
10/22/2003 |
FERRIS POLYMEM SILVER WOUND DRESSING |
FERRIS MFG. CORP. |
THEODORE THORSEN |
| K023723 |
10/23/2003 |
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 |
FMS, FINAPRES MEDICAL SYSTEMS BV |
CHRISTINE EMANUEL |
| K031953 |
10/22/2003 |
WEST NILE VIRUS ELISA IGG, MODEL EL0300G |
FOCUS TECHNOLOGIES, INC. |
MICHAEL J WAGNER |
| K031952 |
10/22/2003 |
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M |
FOCUS TECHNOLOGIES, INC. |
MICHAEL J WAGNER |
| K032302 |
10/02/2003 |
XIVE TG ABUTMENTS |
FRIADENT GMBH |
CAROL PATTERSON |
| K032750 |
10/02/2003 |
MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE |
FRIANDENT GMBH |
CAROL PATTERSON |
| K032290 |
10/10/2003 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K033209 |
10/31/2003 |
FUKUDA DENSHI MODEL FF SONIC UF-750XT |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K032289 |
10/20/2003 |
FIT CHECKER II |
GC AMERICA, INC. |
TERRY L JORITZ |
| K032656 |
10/30/2003 |
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X |
GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC |
ALLEN SCHUH |
| K032577 |
10/10/2003 |
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA L MICHELS |
| K032513 |
10/30/2003 |
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DAVID WAHLIG |
| K033244 |
10/16/2003 |
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K032915 |
10/30/2003 |
ADVANTAGE 4D OPTION |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K032795 |
10/08/2003 |
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K033168 |
10/10/2003 |
GE 0.2T SIGNA PROFILE/I MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
| K032974 |
10/21/2003 |
GE LOGIQ 5 PRO OR EXPERT |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K032477 |
10/22/2003 |
GE LOGIQ BOOK |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K033139 |
10/23/2003 |
GE MARLIN ULTRASOUND |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K032620 |
10/10/2003 |
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K032002 |
10/30/2003 |
FERTELL FEMALE FERTILITY TEST |
GENOSIS, INC. |
SHARON A SEGAL |
| K032723 |
10/01/2003 |
BIOSIGN STEAM-24 BIOLOGICAL INDICATOR |
GETINGE USA, INC |
KARLA BYRNE |
| K032405 |
10/29/2003 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K032385 |
10/30/2003 |
GLOBAL PRESS-FIT STEM |
GLOBAL MEDICAL CO. |
J.D. WEBB |
| K032608 |
10/21/2003 |
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER |
GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB |
THOMAS BOCK |
| K031446 |
10/31/2003 |
JABES ELECTRONIC STETHOSCOPE |
GS TECHNOLOGY CO., LTD. |
DANIEL KAMM |
| K032530 |
10/23/2003 |
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM |
GUIDANT CORPORATION |
MICHELLE GROSSMAN |
| K022679 |
10/22/2003 |
RAPHAEL |
HAMILTON MEDICAL AG |
DAVID THOMPSON |
| K032705 |
10/01/2003 |
DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
AL WEISENBORN |
| K033125 |
10/30/2003 |
HANDIVIPP |
HANDINOR USA, INC. |
BARBARA CHIPONIS |
| K031439 |
10/02/2003 |
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K032913 |
10/02/2003 |
HL888 AF |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K032839 |
10/10/2003 |
HL888BA |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K032695 |
10/02/2003 |
HL888BF |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K032837 |
10/10/2003 |
HL888BM |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K033043 |
10/10/2003 |
MODIFICATION TO HL168 |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K030998 |
10/10/2003 |
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 |
HEALTHONICS, INC. |
JAMES W KRONBERG |
| K032337 |
10/21/2003 |
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
| K032772 |
10/08/2003 |
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM |
HILL-ROM MANUFACTURING, INC. |
CINDY L CROSBY |
| K033248 |
10/20/2003 |
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K032985 |
10/21/2003 |
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM |
HMD BIOMEDICAL, INC. |
JEFFREY FLEISHMAN |
| K032546 |
10/16/2003 |
HOLOGIC DR IMAGEPRO |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K023000 |
10/29/2003 |
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES |
HOME CARE TECHNOLOGY CO., LTD. |
SHU-CHEN CHENG |
| K032300 |
10/09/2003 |
ACCOLADE-J HIP STEM SERIES |
HOWMEDICA OSTEONICS CORP. |
LORRAINE MONTEMURRO |
| K032581 |
10/09/2003 |
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K032523 |
10/22/2003 |
T2 NAILING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K032898 |
10/09/2003 |
T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K031873 |
10/07/2003 |
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET |
I-STAT CORPORATION |
GREGORY W SHIPP |
| K032324 |
10/02/2003 |
ECHOENCODER |
ICARDIOGRAM, INCORPORATED |
JAMES LOEHR |
| K033283 |
10/27/2003 |
CENTRA VIEW DEVICE LINK SYSTEM |
ICU DATASYSTEMS, INC. |
SAMUEL W COONS |
| K032527 |
10/31/2003 |
HEDROCEL VERTEBRAL BODY REPLACEMENT |
IMPLEX CORP. |
MARCI HALEVI |
| K032344 |
10/02/2003 |
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 |
IMPLEX CORP. |
MARCI HALEVI |
| K033194 |
10/30/2003 |
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K030081 |
10/06/2003 |
CSF400 AND CSF600 |
INMED LTDA. |
JAY MANSOUR |
| K032140 |
10/02/2003 |
5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD M HOLSTEIN |
| K032704 |
10/24/2003 |
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 |
INNOVATECH SURGICAL INC. |
MICHAEL J MCGOWAN |
| K032703 |
10/24/2003 |
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 |
INNOVATECH SURGICAL INC. |
MICHAEL J MCGOWAN |
| K032145 |
10/31/2003 |
AUDICOR UPGRADE SYSTEM |
INOVISE MEDICAL, INC. |
STEVE HESLER |
| K032419 |
10/24/2003 |
QUANTEX D-DIMER |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K032817 |
10/06/2003 |
EXTERNAL DRAINAGE SET |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JUDITH E O'GRADY |
| K032533 |
10/16/2003 |
INTELEPACS |
INTELERAD MEDICAL SYSTEMS INC. |
CARL ALLETTO |
| K031875 |
10/22/2003 |
INTER-OS LIMB LENGTHENER |
INTER-OS TECHNOLOGIES |
RANDOLPH C ROBINSON |
| K031473 |
10/30/2003 |
RATIONAL IMAGING PACS |
INTUITIVE IMAGING INFORMATICS, LLC |
DONALD MUNDT |
| K032793 |
10/09/2003 |
US-100 PORTABLE ULTRASOUND THERAPY UNIT |
ITO CO., LTD. |
T. WHIT ATHEY |
| K030922 |
10/17/2003 |
VIVASENS |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K032340 |
10/16/2003 |
VISTAKON (GALYFILCON A) SOFT CONTACT LENS |
JOHNSON & JOHNSON VISION CARE, INC. |
JACQUELINE ZIMOVAN |
| K032411 |
10/07/2003 |
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE |
JS VASCULAR, INC. |
MICHAEL A DANIEL |
| K033221 |
10/28/2003 |
KAVO EVEREST ZH-BLANK |
KAVO AMERICA CORPORATION |
DANIEL KAMM |
| K031750 |
10/24/2003 |
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K030256 |
10/21/2003 |
ISO-ELASTIC CERCLAGE SYSTEM |
KINAMED, INC. |
VINEET SARIN |
| K032310 |
10/10/2003 |
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS |
KINETIC CONCEPTS, INC. |
JUDITH HARBOUR |
| K032630 |
10/03/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
KINGSWELL INTERNATIONAL INC. |
D.C. CHANG |
| K032668 |
10/06/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES |
KINGSWELL INTERNATIONAL INC. |
D.C. CHANG |
| K032442 |
10/29/2003 |
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K032413 |
10/10/2003 |
KLS-MARTIN STERNAL PLATING SYSTEM |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K030358 |
10/31/2003 |
KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K031386 |
10/06/2003 |
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX |
LALAN GLOVES (PVT) LTD. |
UPUL GUNASINGHE |
| K032004 |
10/02/2003 |
AQUABOSS ECORO DIA 50 |
LAUER LTD., HONG KONG |
STEPHAN KRIETEMEYER |
| K032461 |
10/03/2003 |
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
Lin-Zhi International, Inc. |
CHENG I LIN |
| K031797 |
10/10/2003 |
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K032323 |
10/07/2003 |
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
LONG FIRST (XIAMEN) PLASTICS CO., LTD. |
CHIEN LIN |
| K032357 |
10/09/2003 |
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES |
LUMENIS, INC. |
KAREN BAKER |
| K032714 |
10/22/2003 |
CARDICARE MODEL MT-301F & MT-301C |
LUMISCOPE CO., INC. |
MARIO MANZANO |
| K030857 |
10/16/2003 |
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES |
MAHE INTL., INC. |
PAUL CART |
| K032501 |
10/17/2003 |
MAXTER STERILE POWDER FREE SURGICAL GLOVES |
MAXTER GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K032467 |
10/10/2003 |
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES |
MAXTER GLOVE MANUFACTURING SDN BHD |
PRISCILLA WEE |
| K033039 |
10/07/2003 |
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS |
MCKINLEY, INC. |
ANDREW N LAMBORNE |
| K024322 |
10/27/2003 |
EMBLA N7000 |
MEDCARE FLAGA |
KUMAR KULKARNI |
| K033179 |
10/15/2003 |
MEDELA CLARIO HOME CARE PUMP |
MEDELA AG |
WERNER FREI |
| K032826 |
10/09/2003 |
MAS PAR TDM |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K032055 |
10/03/2003 |
MEDS-4-INF+ |
MEDICAL EQUIPMENT DEVICE SPECIALISTS |
C. A. TEKLINSKI |
| K032599 |
10/29/2003 |
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES, LLC |
MARK ROHRER |
| K031564 |
10/07/2003 |
CSS |
MEDICAL SCIENTIFIC, INC. |
PAUL NARDELLA |
| K032989 |
10/22/2003 |
MEDI-HEAT INFANT HEEL WARMER |
MEDIHEAT, INC. |
UMA RAMACHANDRAN |
| K032768 |
10/09/2003 |
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) |
MEDTRONIC AVE, INC. |
SARAH SHEPHARD |
| K032164 |
10/23/2003 |
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 |
MEDTRONIC MINIMED |
GERDA P RESCH |
| K032485 |
10/28/2003 |
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 |
MEDTRONIC MINIMED |
MIRIELLE MENGOTTO |
| K032484 |
10/28/2003 |
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 |
MEDTRONIC MINIMED |
MIRIELLE MENGOTTO |
| K033016 |
10/30/2003 |
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 |
MEDTRONIC NEUROLOGICAL |
PAM SCHAUB |
| K033264 |
10/31/2003 |
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K032312 |
10/21/2003 |
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
MEDTRONIC VASCULAR |
KRISTINA MOLLNER |
| K032926 |
10/15/2003 |
EKG SPEAKS |
MEDTRONIC VASCULAR |
KRISTYN BENSON |
| K032138 |
10/09/2003 |
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER |
MEDTRONIC VASCULAR |
DEBORAH KIDDER |
| K032231 |
10/03/2003 |
MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K032997 |
10/15/2003 |
MODIFICATION TO: HORIZON 9000WS |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
| K031369 |
10/31/2003 |
MERCATOR HEALTHCARE MALE LATEX CONDOM |
MERCATOR HEALTHCARE LTD. |
ELI J CARTER |
| K032427 |
10/09/2003 |
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM |
MERIDAN MEDICAL |
GREG HOLLAND |
| K031922 |
10/01/2003 |
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W |
MERIT MEDICAL SYSTEMS, INC. |
JOHN W NICHOLSON |
| K032605 |
10/08/2003 |
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING |
META BIOMED CO., LTD. |
JENNY SHON |
| K032603 |
10/07/2003 |
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING |
META BIOMED CO., LTD. |
JENNY SHON |
| K033253 |
10/21/2003 |
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR |
MICRO CURRENT TECHNOLOGY, INC. |
DAVID SUZUKI |
| K032842 |
10/17/2003 |
MICROGENICS CYCLOSPORINE CONTROL KIT |
MICROGENICS CORP. |
DAVID CASAL |
| K032590 |
10/22/2003 |
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K032449 |
10/22/2003 |
THERMASSAGE ENERGY PRODUCT, MODEL HY5000 |
MIGUN MEDICAL INSTRUMENT CO. LTD. |
EDWARD A KROLL |
| K032175 |
10/09/2003 |
DESENS-IONOMER |
MILTON HODOSH, M.D. |
MILTON HODOSH |
| K032167 |
10/15/2003 |
BIO-INTRAFIX TIBIAL SCREW AND SHEATH |
MITEK WORLDWIDE |
KAREN K SYLVIA |
| K032234 |
10/02/2003 |
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K |
MK-DENT GMBH |
MARTINA GUNDEROTH |
| K031863 |
10/10/2003 |
CARESTATION 126S VIDEOPHONE |
MOTION MEDIA TECHNOLOGY INC. |
STUART R ROSS |
| K032576 |
10/23/2003 |
BIOPSY BREAST COIL, MODEL BBC |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K033152 |
10/10/2003 |
HAC-12 AND HAC-30 HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K033151 |
10/10/2003 |
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K031819 |
10/30/2003 |
DIO-DENT 10 DENTAL DIODE LASER |
MSQ (M2) LTD. |
ARAVA HACOHEN |
| K032395 |
10/17/2003 |
PROPHY-MATE |
NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K032820 |
10/23/2003 |
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM |
NDO SURGICAL, INC. |
ERIC BANNON |
| K033315 |
10/29/2003 |
SUPEROPEN 0.23T, MODEL NAM-P023A |
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. |
WANG ZHIQIANG |
| K032196 |
10/09/2003 |
NBD DISPOSABLE RF CANNULAE |
NEW BUSINESS DEVELOPMENT, LLC |
TIMOTHY B LUSBY |
| K032085 |
10/03/2003 |
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 |
NIDEK, INC. |
CAROL PATTERSON |
| K030683 |
10/31/2003 |
NIPRO DISPOSABLE SYRINGES |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
| K030668 |
10/17/2003 |
MODEL 3100 WRISTOX PULSE OXIMETER |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K033049 |
10/24/2003 |
CZR PRESS |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K022505 |
10/01/2003 |
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, |
NOUVAG AG |
ERICH FORSTER |
| K033295 |
10/28/2003 |
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN |
NOVAMIN TECHNOLOGY, INC. |
DAVID C GREENSPAN |
| K032634 |
10/06/2003 |
NORMED COMPRESSION BONE SCREW SYSTEM |
NOVIACE CORPORATION |
ALBERT ENAYATI |
| K032180 |
10/07/2003 |
NUVASIVE CEMENT RESTRICTOR |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K032083 |
10/24/2003 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K032356 |
10/28/2003 |
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K033225 |
10/16/2003 |
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS OPTICAL CO., LTD. |
TINA STEFFANIE-OAK |
| K032177 |
10/02/2003 |
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TINA STEFFANIE-OAK |
| K033212 |
10/30/2003 |
LIFESTENT SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
| K032654 |
10/09/2003 |
PORT CASSETTE |
OREX COMPUTED RADIOGRAPHY LTD |
MARY MCNAMARA-CULLINANE |
| K031607 |
10/10/2003 |
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL |
ORION DIAGNOSTICA, DIV. ORION CORP. |
ANNIKKA RANTAMA |
| K033127 |
10/31/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
SARAH PARSONS |
| K032993 |
10/31/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
SARAH PARSONS |
| K032682 |
10/22/2003 |
STS SCREW |
ORTHO-PRO LLC |
J.D. WEBB |
| K031474 |
10/15/2003 |
SC TOTAL HIP SYSTEM |
ORTHOPEDIC ALLIANCE LLC |
ROGER WILLIAMS |
| K032917 |
10/21/2003 |
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K031471 |
10/10/2003 |
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K032392 |
10/22/2003 |
MORALES PROTRACTION FACEMASK |
ORTOSIM, S.A. DE C.V. |
Kevin Walls |
| K032673 |
10/02/2003 |
IMMIX PLASTIFILM |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER |
| K033130 |
10/31/2003 |
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR |
OSYPKA MEDICAL, INC. |
MARKUS J OSYPKA |
| K033141 |
10/30/2003 |
MECHANICAL WHEEHCHAIR |
PACIFIC MEDICAL SUPPLIERS, INC. |
STEPHEN T MLCOCH |
| K032119 |
10/29/2003 |
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS |
PARAGON MEDICAL, INC. |
DAVID C FURR |
| K032374 |
10/22/2003 |
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K032201 |
10/10/2003 |
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
| K033326 |
10/29/2003 |
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
ROBERT L TUROCY |
| K032858 |
10/10/2003 |
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
HAUKE SCHIK |
| K030468 |
10/15/2003 |
ACURA ELITE GRAVITY COMPENSATING RESERVOIR |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K032115 |
10/10/2003 |
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 |
Polyganics BV |
JAN BART HAK |
| K022809 |
10/17/2003 |
EZ SPLINT & EZ SPLINT PM |
POWER PRODUCTS, INC.-SPLINTEK |
CAROLANN KOTULA |
| K032456 |
10/16/2003 |
PROWESS |
PROWESS, INC. |
W. JAMES BISHOP |
| K032226 |
10/16/2003 |
LTV-1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K032791 |
10/30/2003 |
GLYCOHEMOSURE HBA1C CONTROL |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
| K033181 |
10/24/2003 |
SPR SYSTEM |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K032899 |
10/17/2003 |
RADIUS COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
| K032200 |
10/03/2003 |
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH |
REMCO ITALIA S.P.A. |
DANIEL KAMM |
| K032480 |
10/16/2003 |
AUTOSET SPIRIT SYSTEM |
RESMED LTD. |
DAVID D'CRUZ |
| K032433 |
10/24/2003 |
NASAL JACKS MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K030886 |
10/07/2003 |
NICO WITH MARS, MODEL 7300 |
RESPIRONICS NOVAMETRIX, INC. |
MICHAEL MALIS |
| K032403 |
10/27/2003 |
SMARTMONITOR 2 PROFESSIONAL SERIES (PS) |
RESPIRONICS, INC. |
ZITA A YURKO |
| K032941 |
10/22/2003 |
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE |
RICH-MAR CORP. |
DAVID RICHARDS |
| K030082 |
10/30/2003 |
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K032437 |
10/08/2003 |
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K033185 |
10/14/2003 |
COBAS INTEGRA ALP IFCC GEN.2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032279 |
10/10/2003 |
ONLINE TDM AMIKA |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K033165 |
10/14/2003 |
PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K033009 |
10/16/2003 |
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K032311 |
10/17/2003 |
ROCHE DIAGNOSTICS OMNI S ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K032506 |
10/09/2003 |
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K032465 |
10/21/2003 |
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI |
SATELEC |
JACQUELINE E MASSE |
| K032368 |
10/09/2003 |
SONOMA ANTERIOR CERVICAL PLATE SYSTEM |
SEASPINE |
DIANA SMITH |
| K033088 |
10/29/2003 |
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 |
SECTRA AB |
CARL ALLETTO |
| K031590 |
10/02/2003 |
SECTRA ORTHOPEDIC PACKAGE |
SECTRA-IMTEC AB |
CARL ALLETTO |
| K032071 |
10/10/2003 |
POWDER FREE VINYL EXAMINATION GLOVE |
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. |
WILLIAM E HARRIS |
| K032746 |
10/17/2003 |
SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES |
SHANGHAI GIANTMAX PLASTIC PRODUCT CORP. |
SUSAN D GOLDSTEIN-FALK |
| K032745 |
10/17/2003 |
SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES |
SHANGHAI GIANTMAX PLASTIC PRODUCT CORP. |
SUSAN D GOLDSTEIN-FALK |
| K032792 |
10/15/2003 |
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW |
SHANGHAI JIAWANG INDUSTRIAL CO. LTD. |
JANNA P TUCKER |
| K032024 |
10/29/2003 |
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
SHEN WEI (USA), INC. |
BELLE M CHOU |
| K032084 |
10/29/2003 |
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR |
SHEN WEI (USA), INC. |
BELLE CHOU |
| K032178 |
10/15/2003 |
RHYTHM TOUCH Q 2-WAY |
SHOCKIM ENTERPRISES, LTD. |
GREG HOLLAND |
| K032428 |
10/16/2003 |
MAGNETOM AVANTO MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NEALIE HARTMAN |
| K032790 |
10/02/2003 |
MICROMLC |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KEN NEHMER |
| K033196 |
10/16/2003 |
SONOLINE ANTARES WITH CLARIFY VE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDI HOFFMAN |
| K031455 |
10/22/2003 |
CONKLUSION PEDICLE SCREW SYSTEM |
SIGNUS MEDICAL LLC. |
THOMAS HOGHAUG |
| K033073 |
10/10/2003 |
ORTHOPHOS XG DS/CEPH |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA M HEMEON |
| K032683 |
10/15/2003 |
GENESIS II POROUS PLUS HA KNEE SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON-AKIL |
| K032722 |
10/01/2003 |
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
| K032387 |
10/29/2003 |
TRIVEX SYSTEM |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
| K032093 |
10/22/2003 |
PARIEFIX |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
| K031265 |
10/09/2003 |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
SPINE NEXT SA |
DIANE JOHNSON |
| K031862 |
10/31/2003 |
SPINERX-LDM |
SPINERX TECHNOLOGY |
HUGHIE WATSON |
| K032398 |
10/31/2003 |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
SPINEVISION, INC. |
LYNETTE WHITAKER |
| K032482 |
10/24/2003 |
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
STANBIO LABORATORY |
KIRK JOHNSON |
| K031901 |
10/10/2003 |
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT |
STELKAST COMPANY |
DONALD A STEVENS |
| K032721 |
10/06/2003 |
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) |
STELLARTECH RESEARCH CORP. |
GARY A SEEGER |
| K031681 |
10/30/2003 |
STERISIL ANTIMICROBIAL TUBING AND BOTTLE |
STERISIL |
BRAD DOWNS |
| K031341 |
10/29/2003 |
STICK FLOW |
STICK TECH LTD. |
WILLIAM TROETEL |
| K033243 |
10/20/2003 |
ITI SYNOCTA MESO ABUTMENTS |
STRAUMANN USA |
LINDA JALBERT |
| K031278 |
10/16/2003 |
STRYKER FLEXIBLE URETEROSCOPE |
Stryker Endoscopy |
CHRISTOPHER L COOK |
| K032366 |
10/30/2003 |
BONESOURCE HAC FAST SETTING CEMENT |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
| K024013 |
10/31/2003 |
SUN-RAIN ULTRASONIC THERAPY, SU-100 |
SUN-RAIN SYSTEM CORP. |
R. JEN KE-MIN |
| K032408 |
10/15/2003 |
DAMON FT |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K032407 |
10/06/2003 |
OPTIBAND LC |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K033121 |
10/20/2003 |
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K033065 |
10/29/2003 |
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES |
SYNTHES (USA) |
BONNIE SMITH |
| K032559 |
10/22/2003 |
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS |
SYNTHES (USA) |
LISA M BOYLE |
| K033160 |
10/09/2003 |
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K031335 |
10/16/2003 |
POWDER FREE LATEX EXAM GLOVES |
TAN SIN LIAN INDUSTRIES SDN. BHD. |
LEE TAN |
| K031989 |
10/28/2003 |
ORTRAUTEK ORTHOGNATHIC SYSTEM |
TEKKA |
FAYYAZ MEMON |
| K033069 |
10/24/2003 |
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205 |
TENGHI CO. LTD |
LIN HEIAO-FENG |
| K033131 |
10/30/2003 |
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 |
THE FIRST YEARS, INC. |
ROBIN C CONNER |
| K032066 |
10/03/2003 |
SONOSURG SYSTEM |
THE OLYMPUS OPTICAL CO. |
TINA STEFFANIE-OAK |
| K032725 |
10/03/2003 |
MOSFET AUTOSENSE WIRELESS |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MARY HERBERT |
| K032471 |
10/10/2003 |
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM |
TITRONICS RESEARCH & DEVELOPMENT CO. |
JOSEPH R TITONE |
| K032079 |
10/02/2003 |
HLS NOETOS SYSTEM |
TORNIER |
Mireille Lemery |
| K033263 |
10/31/2003 |
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT |
TRACK CORPORATION |
JON EMERY |
| K032731 |
10/30/2003 |
MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS |
TURBO WHEELCHAIR CO., INC. |
JANE HERMES |
| K032532 |
10/22/2003 |
TARAS THREADED FIXATION PIN |
UNION SURGICAL LLC |
AL WEISENBORN |
| K032939 |
10/20/2003 |
EPT CERTAINTY PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K031189 |
10/16/2003 |
UUHC REPROCESSED COMPRESSION SLEEVE DEVICES |
UNIVERSITY OF UTAH HOSPITALS AND CLINICS |
JACK SPEER |
| K032854 |
10/09/2003 |
UNOMEDICAL MONICA INFUSION SET |
UNOMEDICAL A/S |
JOHN M LINDSKOG |
| K032776 |
10/03/2003 |
VACURECT VACUUM CONSTRICTION DEVICE |
VACURECT MANUFACTURING (PTY) LTD. |
MARY MCNAMARA-CULLINANE |
| K023139 |
10/22/2003 |
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE |
VAN OOSTVEEN MEDICAL B.V. |
M.J. VAN OOSTVEEN |
| K032805 |
10/01/2003 |
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
DEBORAH JENSEN |
| K031413 |
10/07/2003 |
VIGORMIST COMPRESSOR NEBULIZER |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K024105 |
10/09/2003 |
VELOPEX AQUACUT FLUID ABRASION UNIT |
VELOPEX INTERNATIONAL, INC. |
TONY URELLA |
| K032748 |
10/29/2003 |
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
STEPHEN S ANDERSON |
| K030985 |
10/15/2003 |
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I |
VITAL SIGNS, INC. |
ANTHONY P MARTINO |
| K022730 |
10/27/2003 |
PERFADEX SOLUTION FOR LUNG PRESERVATION |
VITROLIFE AB |
KARL A POSSELT |
| K032702 |
10/03/2003 |
VIVATIP MICROWAVE ABLATION PROBE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K033108 |
10/27/2003 |
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER |
VIVOSONIC, INC. |
YURI SOKOLOV |
| K033068 |
10/31/2003 |
IONOFIL COLOR AC |
VOCO GMBH |
GERALD W SHIPPS |
| K032924 |
10/10/2003 |
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 |
VOLUME INTERACTIONS PTE LTD |
JOHN BABY |
| K032023 |
10/01/2003 |
W.O.M. LASER U100PLUS |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K030756 |
10/06/2003 |
COACH 777-3 |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K030757 |
10/06/2003 |
COACH 777-4 |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K032441 |
10/06/2003 |
F-10 FOLDING POWER CHAIR |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K032960 |
10/08/2003 |
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A |
WIDE CORPORATION |
CARL ALLETTO |
| K031963 |
10/31/2003 |
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| K032243 |
10/02/2003 |
MINICAT DENTOCAT |
XORAN TECHNOLOGIES, INC. |
PREDRAG SUKOVIC |
| K032660 |
10/29/2003 |
XTRAK SUPPORT CATHETER |
XTRAK MEDICAL INC. |
DEBBIE IAMPIETRO |
| K031061 |
10/09/2003 |
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS |
ZIMMER, INC. |
STEPHEN MCKELVEY |
| K032726 |
10/22/2003 |
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K032363 |
10/31/2003 |
ZOLL M SERIES NIBP OPTION |
ZOLL MEDICAL CORP. |
SEAN REYNOLDS |
