| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K023336 |
10/09/2002 |
OCO DENTAL IMPLANT (5.0MM DIAMETER) |
"O" CO., INC. |
DAVID D DALISE |
| K021125 |
10/25/2002 |
SENSUA! |
AAC CONSULTING GROUP, INC. |
EDUARDO MARCH |
| K022941 |
10/28/2002 |
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING |
ABBOTT LABORATORIES |
JOSEPH MAGLIOZZI |
| K022589 |
10/28/2002 |
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K022896 |
10/03/2002 |
CSV12 SOFTWARE VIEWER |
ACUSON CORP. |
BOB LEIKER |
| K022441 |
10/08/2002 |
STERRAD SEALSURE CHEMICAL INDICATOR TAPE |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K023010 |
10/01/2002 |
SNIFF POSITION PILLOWS/POPITZ PILLOWS |
AEOLUS INTERNATIONAL CORPORATION |
MICHAEL D POPITZ |
| K022942 |
10/21/2002 |
CRANIOCUT |
AESCULAP, INC. |
GEORG KELLER |
| K022306 |
10/10/2002 |
AART SILICONE TUBING |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
| K023287 |
10/22/2002 |
DRYSTAR 5500 |
AGFA CORP. |
JEFF JEDLICKA |
| K023249 |
10/18/2002 |
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM |
ALCON LABORATORIES, INC. |
CHRISTY STEVENS |
| K023167 |
10/02/2002 |
BREATHABLE SURGICAL GOWN |
ALLEGIANCE HEALTHCARE CORP. |
SHARON NICHOLS |
| K022765 |
10/11/2002 |
NITRILE POWDER-FREE EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K023170 |
10/09/2002 |
NITRILE POWDER-FREE EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K014071 |
10/01/2002 |
PMX DISPOSABLE BAG MASK RESUSCITATOR |
ALLIED HEALTHCARE PRODUCTS, INC. |
VERNON TRIMBLE |
| K022226 |
10/08/2002 |
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS |
ALTUS MEDICAL, INC. |
KATHY MAYNOR |
| K023079 |
10/30/2002 |
NEW OUTLINE |
ANAXDENT GMBH |
DVORAH RICHMAN |
| K021389 |
10/01/2002 |
BIOLOGICAL SOUND MONITOR (BSM) SENSOR |
ANDROMED, INC. |
GENEVIEVE HAMEL |
| K022298 |
10/01/2002 |
I-STETHOS LINK |
ANDROMED, INC. |
GENEVIEVE HAMEL |
| K022342 |
10/09/2002 |
EZ-SCOPE AN, EZ-SCOPE LIGHT |
ANZAI MEDICAL CO, LTD. |
T. WHIT ATHEY |
| K023368 |
10/28/2002 |
TRUCATH.IP |
AORTECH CRITICAL CARE LTD. |
PAUL BURNS |
| K022666 |
10/09/2002 |
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
CHARLES F ANDREWS |
| K022987 |
10/21/2002 |
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K021210 |
10/28/2002 |
ARTERIA OCCLUSION BALLOON |
ARTERIA MEDICAL SCIENCE, INC. |
ALAN HINTON |
| K022234 |
10/03/2002 |
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B |
ARTHREX, INC. |
ANN WATERHOUSE |
| K022475 |
10/03/2002 |
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K022217 |
10/24/2002 |
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM |
ASEPTICO, INC. |
GRANT RAMALEY |
| K023285 |
10/09/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K022785 |
10/09/2002 |
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K022207 |
10/04/2002 |
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K022398 |
10/11/2002 |
REUSABLE BRONCHIAL BIOPSY FORCEPS |
BALLARD MEDICAL PRODUCTS |
CINDY ELLIS |
| K022668 |
10/15/2002 |
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K020807 |
10/01/2002 |
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K023049 |
10/04/2002 |
SYNCHRON LX I 725 CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K022580 |
10/09/2002 |
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM |
BECTON DICKINSON & CO. |
PETER ZURLO |
| K023092 |
10/18/2002 |
BD K-4000 MICROKERATOME SYSTEM |
BECTON DICKINSON & CO. |
EILEEN T SCHWEIGHARDT |
| K022637 |
10/16/2002 |
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME |
BECTON DICKINSON & CO. |
EILEEN T SCHWEIGHARDT |
| K022581 |
10/09/2002 |
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM |
BECTON DICKINSON & CO. |
JOHN SCHALAGO |
| K023273 |
10/31/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K023136 |
10/16/2002 |
OLEEVA FABRIC |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K021351 |
10/17/2002 |
BIOSTEON CROSS PIN |
BIOCOMPOSITES LTD. |
J. STEPHEN BRATT |
| K023203 |
10/17/2002 |
OSSTAPLE |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K023488 |
10/31/2002 |
OSSTAPLE, CRANIOFACIAL |
BIOMEDICAL ENTERPRISES, INC |
W. CASEY FOX |
| K023486 |
10/31/2002 |
OSSTAPLE, MAXILLOFACIAL |
BIOMEDICAL ENTERPRISES, INC |
W. CASEY FOX |
| K020810 |
10/03/2002 |
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 |
BIOMERIEUX, INC. |
SANDRA PERREAND |
| K021661 |
10/25/2002 |
RINGLOC CONSTRAINED LINERS |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K023085 |
10/17/2002 |
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K021728 |
10/25/2002 |
RINGLOC CONSTRAINED LINERS II |
BIOMET, INC. |
DALENE T BINKLEY |
| K023022 |
10/04/2002 |
NUGEN FX SCREW |
BIONX IMPLANTS, INC. |
GERARD S CARLOZZI |
| K023032 |
10/08/2002 |
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL |
BIORESOURCE TECHNOLOGY, INC. |
ALAN POSNER |
| K023099 |
10/18/2002 |
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K011208 |
10/02/2002 |
BIOVER |
BIOVER AG |
HEINZ E WICK |
| K022493 |
10/11/2002 |
EMS 400 |
BODY CLOCK HEALTH CARE LTD |
JONATHAN BASH |
| K021630 |
10/25/2002 |
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
TODD KORNMANN |
| K023291 |
10/17/2002 |
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X |
BOSTON SCIENTIFIC CORP. |
ANDREA L RUTH |
| K022357 |
10/16/2002 |
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 |
BOSTON SCIENTIFIC, TARGET |
GEORGE J PRENDERGAST |
| K021306 |
10/25/2002 |
VECTORVISION CT-FREE KNEE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K021835 |
10/17/2002 |
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX |
BRENNEN MEDICAL, INC. |
PHILLIP B LAWIN |
| K014128 |
10/04/2002 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
| K023124 |
10/04/2002 |
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT |
CANON, INC. |
SHIELA DRISCOLL |
| K022373 |
10/07/2002 |
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS |
CANTOR & NISSEL LTD. |
MARTIN DALSING |
| K022210 |
10/04/2002 |
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 |
CARDIAC SCIENCE, INC. |
JOHN CARLINE |
| K022670 |
10/17/2002 |
CARRAKLENZ AND ULTRAKLENZ |
CARRINGTON LABORATORIES, INC. |
MARY MC-NAMARA-CULINANE |
| K022881 |
10/22/2002 |
CEDARA I-SOFTVIEW |
CEDARA SOFTWARE CORP. |
CAROL NAKAGAWA |
| K022615 |
10/29/2002 |
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR |
CENTERPULSE SPINE-TECH, INC. |
ANGELA BYLAND |
| K021390 |
10/04/2002 |
PMX COMPACT RESUCITATOR |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
| K023224 |
10/25/2002 |
INFUSION CATHETER EXTENSION SET |
CHF SOLUTIONS, INC. |
AMY PETERSON |
| K021635 |
10/28/2002 |
KARATS MULTIPURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K022936 |
10/02/2002 |
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K023250 |
10/17/2002 |
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K022867 |
10/02/2002 |
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K022885 |
10/02/2002 |
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K020285 |
10/23/2002 |
CMA CEREBRAL TISSUE MONITORING SYSTEM |
CMA MICRODIALYSIS AB |
SHEILA HEMEON-HEYER |
| K013525 |
10/04/2002 |
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) |
COLOPLAST CORP. |
HARVEY M ARBIT |
| K021910 |
10/11/2002 |
COMFORT DREAMRIDER SCOOTER, LY-EW402 |
COMFORT ORTHOPEDIC CO. LTD. |
JEN KE-MIN |
| K022369 |
10/11/2002 |
COMFORT WINDJOY SCOOTER, MODEL LY-EW302 |
COMFORT ORTHOPEDIC CO. LTD. |
JEN KE-MIN |
| K022897 |
10/11/2002 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
CATHY STUPAK |
| K020027 |
10/08/2002 |
FOCUS RADIATION TREATMENT PLANNING SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MICHAEL A PARSONS |
| K021186 |
10/25/2002 |
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, |
CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH |
CAROLANN KOTULA |
| K022351 |
10/16/2002 |
DIODENT DENTAL LASER SYSTEM |
CONTINUUM ELECTRO-OPTICS, INC. |
THOMAS J HANEY |
| K022484 |
10/25/2002 |
COOK INJECTION NEEDLE |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K023116 |
10/18/2002 |
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B |
CORDIS CORP. |
KAREN WILK |
| K023217 |
10/25/2002 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K022194 |
10/29/2002 |
TRAXX ELECTRIC WHEELCHAIR |
CROSSROADS DISTRIBUTION COMPANY, L.L.C. |
Kevin Walls |
| K021854 |
10/25/2002 |
DFV CPG COLPOSCOPE |
D.F. VASCONCELLOS S.A. |
JEAN M BUCHWALD |
| K023065 |
10/16/2002 |
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE PIESTRAK |
| K023202 |
10/23/2002 |
MICROSCAN SYNERGIES PLUS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K022485 |
10/03/2002 |
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE |
DATEX-OHMEDA |
JOEL KENT |
| K021955 |
10/08/2002 |
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES |
DATEX-OHMEDA, INC. |
MICHAEL A CHILBERT |
| K022300 |
10/03/2002 |
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V |
DENTAL VIPI LTDA |
Kevin Walls |
| K020231 |
10/21/2002 |
DIASOL-ADDITIVES |
DIASOL, INC. |
MONICA ABELES |
| K022450 |
10/22/2002 |
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY |
DIDECO S.P.A. |
BARRY SALL |
| K023471 |
10/29/2002 |
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS AG |
DAVID E CHADWICK |
| K020339 |
10/25/2002 |
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
| K012816 |
10/17/2002 |
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 |
DYNAREX CORP. |
JOHN GAGLIARDI |
| K023399 |
10/25/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K023204 |
10/18/2002 |
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K023133 |
10/18/2002 |
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K023324 |
10/18/2002 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K022583 |
10/31/2002 |
FLASH 1 |
EMED, INC. |
KENNETH KARASIUK |
| K022199 |
10/02/2002 |
ENDIUS ATAVI SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ NASSIF |
| K022613 |
10/25/2002 |
HELIX HYDRO-JET |
ERBE USA, INC. |
JOHN TARTAL |
| K021087 |
10/11/2002 |
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE |
ERECORDS LIMITED |
ED GOSS |
| K023182 |
10/24/2002 |
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS |
ETHICON ENDO-SURGERY, INC. |
CAROL SPRINKLE |
| K020750 |
10/31/2002 |
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K020749 |
10/31/2002 |
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K023186 |
10/17/2002 |
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY |
EXACTECH, INC. |
MARTIN SPRUNCH |
| K022276 |
10/04/2002 |
KOKOMATE |
FERRARIS RESPIRATORY, INC. |
JIM LEWIS |
| K023314 |
10/18/2002 |
MICROFIX |
FIXANO SA |
FRANK FERGUSON |
| K021142 |
10/01/2002 |
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 |
FORTUNE MEDICAL INSTRUMENT CORP. |
TYLER WANG |
| K022536 |
10/30/2002 |
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR |
FRESENIUS MEDICAL CARE |
ART EILINSFELD |
| K021238 |
10/09/2002 |
FRYE ADJUSTING INSTRUMENT |
FRYE HEALTH SYSTEMS |
DEBORAH F KONENMAN |
| K023323 |
10/29/2002 |
1CC FUTURA SAFETY SYRINGE |
FUTURA MEDICAL TECHNOLOGY |
DAVID OLMSTEAD |
| K021742 |
10/25/2002 |
GALEMED NEB-EASY NEBULIZER |
GALEMED CORP. |
TOM SHANKS |
| K022430 |
10/18/2002 |
ISO FUNCTIONAL |
GC AMERICA, INC. |
TERRY L JORITZ |
| K022794 |
10/11/2002 |
E-SPEED EBT SCANNER SYSTEM |
GE IMATRON |
KERRY A SPEAR |
| K023332 |
10/23/2002 |
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K022322 |
10/08/2002 |
INNOVA AND INNOVA 2000 S |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K023100 |
10/11/2002 |
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LISA LEE MICHELS |
| K021454 |
10/01/2002 |
UNITY NETWORK ID |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
JOELLE NEIDER |
| K022495 |
10/08/2002 |
GETTIG DISPOSABLE SYRINGES |
GETTIG PHARMACEUTICAL INSTRUMENT CO. |
JAMES A BENZ |
| K023300 |
10/28/2002 |
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J |
GUIDANT CORP. |
JANELL A COLLEY |
| K021595 |
10/24/2002 |
GYRUS ENT NERVE STIMULATOR |
GYRUS ENT L.L.C. |
GREG SREDIN |
| K021250 |
10/24/2002 |
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) |
HANDPIECE UNLIMITED |
MARTINA GUNDEROTH |
| K023005 |
10/18/2002 |
AQUILLA MODULAR WHEELCHAIR |
HAYWOOD VOCATIONAL OPPORTUNITIES |
RICHARD O WOOD |
| K022667 |
10/22/2002 |
HCMI X-RAY |
HEALTH CARE MFG., INC. |
DANIEL KAMM |
| K022737 |
10/22/2002 |
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC |
HEALTH CARE MFG., INC. |
DANIEL KAMM |
| K022757 |
10/11/2002 |
SPIFE CK KIT, MODEL 3332, 3333 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K022455 |
10/01/2002 |
SPIFE LD-12 KIT, MODEL 3338 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K021923 |
10/24/2002 |
INRATIO SELF-TEST |
HEMOSENSE, INC. |
Judith Blunt |
| K022612 |
10/28/2002 |
IBOND GLUMA INSIDE |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K022390 |
10/11/2002 |
HITACHI ALTAIRE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K022665 |
10/09/2002 |
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE |
HOHENSTEIN ENTERPRISES, INC. |
L. FRANKLIN BOST |
| K022243 |
10/25/2002 |
HORIZONS REUSABLE HOT BIOPSY FORCEPS |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K022268 |
10/25/2002 |
HORIZONS REUSABLE POLYPECTOMY SNARES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K023102 |
10/09/2002 |
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K023294 |
10/09/2002 |
BOSWORTH CORACO-CLAVICULAR SCREW |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K021451 |
10/18/2002 |
DURACON CS TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K022403 |
10/17/2002 |
GMRS PRESS FIT STEMS WITH PUREFIX HA |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K022651 |
10/17/2002 |
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K022545 |
10/11/2002 |
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K023318 |
10/18/2002 |
I-FLOW ELASTOMERIC PUMP WITH BOLUS |
I-FLOW CORP. |
SHANE NOEHRE |
| K021608 |
10/22/2002 |
SMITHWICK CAROTID SHUNT |
IMPLANTABLE DEVICES |
WILLIAM E MCPHERSON |
| K022966 |
10/02/2002 |
PROXILOCK HIP PROSTHESIS; SIZE 12/36 |
IMPLEX CORP. |
MARCI HALEVI |
| K012271 |
10/04/2002 |
ACUTEVENTILATOR |
IMPOEX INTERNATIONAL, LTD. |
SIVERT CLAESSON |
| K022781 |
10/08/2002 |
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
| K022630 |
10/09/2002 |
MODIFICATION TO FOCUS |
INSTRUMENTARIUM CORP. |
MARK MASON |
| K022940 |
10/11/2002 |
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 |
INTELLIGENT IMAGES SRL |
MAURIZIO PIAGGIO |
| K022728 |
10/11/2002 |
AUDIOTRAVELLER, MODEL AA222 |
INTERACOUSTICS A/S, ASSENS |
DANIEL EGGAN |
| K022774 |
10/21/2002 |
IQ 200 SYSTEM |
INTL. REMOTE IMAGING SYSTEMS |
HARVEY L KASDAN |
| K022228 |
10/08/2002 |
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES |
IRIDEX CORP. |
JOHN D'ANGELO |
| K022384 |
10/18/2002 |
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP |
ISOLUX AMERICA |
NIKOLAOS ANDREOULAKIS |
| K022969 |
10/18/2002 |
UNIVERSAL CERAMIC SOLDER |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
| K022811 |
10/09/2002 |
W-5 |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
| K020334 |
10/03/2002 |
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC |
JAC-CELL MEDIC CORPORATION |
JOHN GAGLIARDI |
| K023360 |
10/25/2002 |
LEFORTE SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
DANIEL KAMM |
| K022862 |
10/18/2002 |
TRANSCURE, MODEL 2910 |
KINETIC INSTRUMENTS, INC. |
WILLIAM J BECKER |
| K023061 |
10/11/2002 |
KONICA DIRECT DIGITIZER REGIUS, MODEL 170 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
KOJI KUBO |
| K013805 |
10/11/2002 |
KOWA AUTOMATED TONOMETER KT-500 |
KOWA OPTIMED, INC. |
FRANCES K WU |
| K023002 |
10/25/2002 |
CLEARFIL AP-X PLT |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
| K022999 |
10/24/2002 |
CLEARFIL AP-X PLT INTRO KIT |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
| K022346 |
10/18/2002 |
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES |
LATEXX MANUFACTURING SDN.BHD. |
TEOH CHOH SHEE |
| K023194 |
10/24/2002 |
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM |
LIFESCAN, INC. |
JOJN E HUGHES |
| K021752 |
10/11/2002 |
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL |
LUCID KOREA CO., LTD |
DONG KUN LEE |
| K023223 |
10/24/2002 |
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
| K022060 |
10/30/2002 |
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES |
LUMENIS, INC. |
ANNE WORDEN |
| K022327 |
10/16/2002 |
NOVUS SPECTRA |
LUMENIS, INC. |
KELLY MOHROR |
| K022181 |
10/01/2002 |
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES |
LUMENIS, INC. |
KAREN L BAKER |
| K020839 |
10/11/2002 |
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL |
LUMENIS, INC. |
ALAN L VOSS |
| K022716 |
10/11/2002 |
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB |
MED-LOGICS, INC. |
MARK MOYER |
| K022219 |
10/07/2002 |
EXOMIO, MODEL 1.1 |
MEDCOM GMBH |
IOANNIS NOMIKOS |
| K020936 |
10/11/2002 |
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K022570 |
10/31/2002 |
MEDCOMP REPAIR KIT, MODEL ASPCRPK |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K022513 |
10/25/2002 |
MEDCOMP VASCU-SHEATH INTRODUCER SET |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K022043 |
10/18/2002 |
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 |
MEDENNIUM, INC. |
JULIAN ABADIA |
| K023307 |
10/31/2002 |
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K022378 |
10/18/2002 |
PLASMALITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K022895 |
10/18/2002 |
ELCAM STOPCOCKS AND MANIFOLDS |
MEDICAL DEVICE CONSULTANTS, INC. |
DANIEL J DILLON |
| K022743 |
10/09/2002 |
REPROCESSED DISPOSABLE TROCARS |
MEDICAL DEVICE SERVICES |
MARK ALDANA |
| K022748 |
10/09/2002 |
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS |
MEDICAL DEVICE SERVICES |
MARK ALDANA |
| K023420 |
10/25/2002 |
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K022585 |
10/11/2002 |
KIMAX QMA |
MEDICAL METRICS, INC. |
MARK LAMP |
| K023069 |
10/18/2002 |
TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER |
MEDPORT, INC. |
FRAN WHITE |
| K023303 |
10/29/2002 |
EXPORT ASPIRATION CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K022238 |
10/09/2002 |
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 |
MEDTRONIC VASCULAR |
MARY ELLEN BEST |
| K022370 |
10/18/2002 |
FRAMELOCK; FRAMELOCK ACCESSORIES |
MEDTRONIC XOMED, INC. |
B.L. MCDERMOTT |
| K011493 |
10/01/2002 |
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY |
MENTOR CORP. |
GEORGE HOEDEMAN |
| K022117 |
10/11/2002 |
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE A ERSKINE |
| K022692 |
10/11/2002 |
VOXELPLUS PACS |
MEVISYS CO. LTD |
CARL ALLETTO |
| K023208 |
10/24/2002 |
CEDIA CYCLOSPORINE PLUS ASSAY |
MICROGENICS CORP. |
MARK HAMILTON SMITH |
| K022535 |
10/22/2002 |
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 |
MICROTECH |
GRACE HOLLAND |
| K022420 |
10/22/2002 |
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 |
MICRUS CORP. |
MARGARET WEBBER |
| K020689 |
10/31/2002 |
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM |
MIDI, INC. |
WILLIAMS STIMSON |
| K021936 |
10/16/2002 |
MOIST PUNCTAL PLUG SYSTEM |
MOIST MEDICAL INC. |
GEORGE W MURRAY |
| K021200 |
10/18/2002 |
COMPAS |
MORGAN SCIENTIFIC, INC. |
PATRICK F MORGAN |
| K022307 |
10/08/2002 |
KONRAD, MODEL V.2.0 |
MRC SYSTEMS GMBH |
MARK-ALEKSI KELLER-REICHENBECHER |
| K023164 |
10/11/2002 |
BBC-63-GE BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K023130 |
10/11/2002 |
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM |
MRI DEVICES CORP. |
WILLIAM J DINEHART |
| K022910 |
10/03/2002 |
QSC-63-INT SHOULDER ARRAY COIL SET |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K020934 |
10/25/2002 |
DR. JAPAN FACIL POINT SPINAL NEEDLE |
MYCO MEDICAL, INC. |
SAM KUMAR |
| K020964 |
10/11/2002 |
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER |
NEICH MEDICAL(SHENZHEN)COMPANY, LTD. |
HUANG JIN |
| K022638 |
10/31/2002 |
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT |
NEURORECOVERY, INC. |
ROSINA ROBINSON |
| K021788 |
10/04/2002 |
NBD CEMENT RESTRICTOR DEVICE |
NEW BUSINESS DEVELOPMENT, LLC |
TIM B LUSBY |
| K022599 |
10/30/2002 |
NEWDEAL K WIRE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K023086 |
10/04/2002 |
CLASSIC GREAT TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K022356 |
10/25/2002 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
JAMES A RYBSKI |
| K022472 |
10/09/2002 |
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K023475 |
10/24/2002 |
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K022756 |
10/18/2002 |
NIPRO BIO-FLEX CATHETER |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
| K022562 |
10/11/2002 |
VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION |
NOBEL BIOCARE AB |
KATHLEEN DRAGOVICH |
| K022739 |
10/25/2002 |
REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K022741 |
10/24/2002 |
SPOT PRO (220V), MODEL 131.099 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K022913 |
10/21/2002 |
NXSTAGE PREMIXED DIALYSATE |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K021688 |
10/18/2002 |
NICALERT |
NYMOX PHARMACEUTICAL CORPORATION |
MICHAEL MUNZAR |
| K022205 |
10/03/2002 |
DISPOSABLE N-PE MICROKERATOME BLADES |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
| K021446 |
10/11/2002 |
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR |
OEMEDIC INTERNATIONAL, INC. |
Kevin Walls |
| K020507 |
10/08/2002 |
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
| K022338 |
10/16/2002 |
OPTICAL INTEGRITY GENERAL SHAPED FIBER |
OPTICAL INTEGRITY, INC. |
JOE D BROWN |
| K022391 |
10/21/2002 |
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION |
ORGAN RECOVERY SYSTEMS, INC. |
STANLEY HARRIS |
| K023260 |
10/18/2002 |
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K022939 |
10/03/2002 |
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES |
OSYPKA MEDICAL, INC. |
MARKUS J OSYPKA |
| K022924 |
10/17/2002 |
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR) |
OTTO BACK HEALTHCARE, LP |
E.P. (BERT) HARMAN |
| K021690 |
10/24/2002 |
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 |
PAN-AMERICA HYPERBARICS, INC. |
W.T. WORKMAN |
| K021693 |
10/24/2002 |
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 |
PAN-AMERICA HYPERBARICS, INC. |
W.T. WORKMAN |
| K021689 |
10/24/2002 |
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 |
PAN-AMERICA HYPERBARICS, INC. |
W. T WORKMAN |
| K023245 |
10/21/2002 |
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 |
PARADIGM MEDICAL INDUSTRIES, INC. |
DAVID M SILVER |
| K023376 |
10/16/2002 |
EB-1830T3, VIDEO BRONCHOSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K021541 |
10/28/2002 |
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT |
PERKINELMER LIFE SCIENCES |
HANK JUSKE |
| K023262 |
10/28/2002 |
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHANG |
| K023440 |
10/30/2002 |
PHILIPS DIGITAL IMAGING OPTION RELEASE 1 |
PHILIPS MEDICAL SYSTEMS |
LYNN HARMER |
| K023441 |
10/30/2002 |
PHILIPS MULTIDIAGNOST ELEVA |
PHILIPS MEDICAL SYSTEMS |
LYNN HARMER |
| K022788 |
10/25/2002 |
PHILIPS HARMONY RELEASE 1 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
| K020670 |
10/08/2002 |
MODEL 4310 PSARRAY2 EEG ELECTRODE |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K020671 |
10/04/2002 |
PSA4000 EEG MONITOR WITH FRONTAL PSI |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K021495 |
10/01/2002 |
QIVA |
PIE MEDICAL IMAGING B.V. |
COLLEEN DENSMORE |
| K022204 |
10/18/2002 |
VKS KNEE SYSTEM |
PLUS ORTHOPEDICS |
LOUISE M FOCHT |
| K021716 |
10/08/2002 |
SIMPLIFY COMPACT RESUSCITATOR |
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. |
SHAN HUA YING |
| K013921 |
10/17/2002 |
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X |
PORGES S.A. |
BERNARD ISMAEL |
| K021856 |
10/17/2002 |
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX |
PORGES S.A. |
BERNARD ISMAEL |
| K022826 |
10/09/2002 |
CLEAR-IT ANTI-FOG, MODEL PS003 |
PRESERVATION SOLUTIONS, INC. |
JOHN R DALPEE |
| K022946 |
10/08/2002 |
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K023375 |
10/25/2002 |
MODIFICATION TO ESOP CO-CR FEMORAL HEADS |
PRO-ACTIVE HEALTHCARE |
ANDRE WEITH |
| K021443 |
10/21/2002 |
56 SERIES JET NEBULIZER |
PROJECT MARKETING |
TERRY O'BRIEN |
| K022734 |
10/07/2002 |
PULPDENT CALCIUM HYDROXIDE PREPARATION |
PULPDENT CORPORATION |
KENNETH J BERK |
| K022492 |
10/11/2002 |
PULPDENT SEMI-GEL ETCH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K022566 |
10/15/2002 |
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
| K022188 |
10/03/2002 |
RADIANALYZER, MODEL 12710 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K022810 |
10/11/2002 |
COBRASCAN CR-1 FILMLESS |
RADIOGRAPHIC DIGITAL IMAGING, INC. |
ANALEI SAMASEIA |
| K023158 |
10/24/2002 |
RANDOX APOLIPOPROTEIN CALIBRATOR |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K022626 |
10/29/2002 |
MOISTURESTAY (REVLON) |
RAYMOND INDUSTRIAL, LTD. |
ROBERT T WAGNER |
| K022311 |
10/04/2002 |
RHINOSTREAM RHINOMANOMETER MODULE |
RHINOMETRICS A/S |
DAN EGGAN |
| K021329 |
10/09/2002 |
RITA SYSTEM |
RITA MEDICAL SYSTEMS |
ERIN MAZZONE |
| K020831 |
10/24/2002 |
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K021190 |
10/25/2002 |
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K022540 |
10/24/2002 |
CARDIO ID+(RZ153+) |
ROZINN ELECTRONICS, INC. |
MARK ROSOFF |
| K022299 |
10/07/2002 |
TRILUX, Z-TONE, ACRY ROCK |
RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO |
Kevin Walls |
| K022754 |
10/16/2002 |
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP |
S & T AG |
BERNHARD TEITZ |
| K023270 |
10/17/2002 |
SAS STREPALERT |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K020054 |
10/16/2002 |
SANARUS INDICA MARKER SYSTEM |
SANARUS MEDICAL, INC. |
VINCENT CUTARELLI |
| K022314 |
10/15/2002 |
SANARUS VISICA TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
SETH STABINSKY |
| K022953 |
10/02/2002 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
DANIEL MICHAELI |
| K022381 |
10/18/2002 |
PROFILE 1320 LASER SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K023058 |
10/24/2002 |
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM |
SERADYN |
LISA BROWN |
| K023235 |
10/18/2002 |
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE |
SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K023145 |
10/11/2002 |
VINYL EXAMINATION GLOVES, PRE-POWDERED |
SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K023428 |
10/25/2002 |
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE |
SHANGHAI JIAWANG INDUSTRIAL CO. LTD. |
JANNA P TUCKER |
| K023343 |
10/28/2002 |
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K023190 |
10/24/2002 |
E.CAM COMPUTER / E.SOFT WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
RICHARD S DEMKE |
| K022382 |
10/04/2002 |
RHS ACETABULAR COMPONENT |
SIGNAL MEDICAL CORP. |
LOUIS SERAFIN |
| K023053 |
10/03/2002 |
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM |
SMITH & NEPHEW, INC. |
STEVEN JACKSON |
| K023302 |
10/25/2002 |
ECHELON POROUS PLUS HA HIP STEMS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K023134 |
10/09/2002 |
JET-X TIN COATED HALF PINS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K023021 |
10/04/2002 |
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T |
SMITH & NEPHEW, INC. |
WILLIAM MCCALLUM |
| K022902 |
10/02/2002 |
SMITH & NEPHEW HIP SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K021815 |
10/17/2002 |
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS |
SMITH & NEPHEW, INC. |
GINO J ROUSS |
| K020948 |
10/09/2002 |
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II |
SMITH & NEPHEW, INC. |
JASON BILOBRAM |
| K022958 |
10/02/2002 |
TOTAL HIP FEMORAL HEADS AND LINERS |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K021564 |
10/25/2002 |
INCOMPASS SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K022620 |
10/11/2002 |
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT |
SPIRE BIOMEDICAL, INC. |
DONALD FICKETT |
| K022706 |
10/25/2002 |
SPSMEDICAL SPORVIEW STEAM BI TEST PACK |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K022380 |
10/01/2002 |
LIVESIRE ELECTROPHYSIOLOGY CATHETER |
ST. JUDE MEDICAL |
JIM M TAUFEN |
| K023447 |
10/31/2002 |
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) |
ST. JUDE MEDICAL |
GLENN JACQUES |
| K022565 |
10/08/2002 |
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 |
STEREOTAXIS, INC. |
PETER A TAKES |
| K012537 |
10/11/2002 |
REPROCESSED IMAGING CATHETERS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K022280 |
10/11/2002 |
STOCKERT CORONARY PERFUSION CANNULAE |
STOCKERT INSTRUMENTE GMBH |
LYNNE LEONARD |
| K022321 |
10/09/2002 |
STOCKERT V172-28 VENOUS FEMORAL CANNULA |
STOCKERT INSTRUMENTE GMBH |
SHAWN RIEDEL |
| K022489 |
10/09/2002 |
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 |
SUMMIT MEDICAL LTD. |
NEIL R ARMSTRONG |
| K022477 |
10/25/2002 |
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET |
SUMMIT MEDICAL LTD. |
NEIL R ARMSTRONG |
| K022604 |
10/25/2002 |
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES |
SUN FLOWER GLOVES CO., LTD. |
W. J. HU |
| K021889 |
10/16/2002 |
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
CAMERON J FORDYCE |
| K022264 |
10/02/2002 |
CLEAN 'N' OIL |
SVENSKA DENTAL INSTRUMENTS AB |
EMMA BERGQUIST |
| K022265 |
10/02/2002 |
LIGHT TIP |
SVENSKA DENTAL INSTRUMENTS AB |
EMMA BERGQUIST |
| K022266 |
10/03/2002 |
AURORA SR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K022710 |
10/11/2002 |
SMARTPACS |
TAIWAN ELECTRONIC DATA PROCESSING CORPORATION |
CARL ALLETTO |
| K022336 |
10/11/2002 |
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD |
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. |
DAVID HU |
| K022907 |
10/21/2002 |
ANSPACH POWERED KERRISON SYSTEM (PKS) |
THE ANSPACH EFFORT, INC. |
WILLIAM G CONETY |
| K010401 |
10/30/2002 |
TRI-PLEX ADAPTER |
THE MEDICAL DEVICE GROUP, INC. |
E.J. Smith |
| K022503 |
10/25/2002 |
UTERINE INJECTOR |
THOMAS MEDICAL, INC. |
THOMAS J ZINNANTI |
| K021056 |
10/31/2002 |
PERMACOL |
TISSUE SCIENCE LABORATORIES, PLC |
HOWARD M HOLSTEIN |
| K022641 |
10/02/2002 |
TOKUYAMA REBASE II |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K022824 |
10/17/2002 |
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
| K022016 |
10/15/2002 |
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE |
TOP GLOVE MEDICAL (THAILAND) CO., LTD. |
AUDIE SEOW |
| K023207 |
10/09/2002 |
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K022656 |
10/08/2002 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K021937 |
10/11/2002 |
TGDC-01 PRA |
TRUEVISION INSTRUMENTS |
RALF THOMAIER |
| K023042 |
10/28/2002 |
PQ1 |
ULTRADENT PRODUCTS, INC. |
MARKUS GEE |
| K023227 |
10/22/2002 |
USG 2000SA |
ULTRAGUIDE LTD. |
GEORGE MYERS |
| K021333 |
10/08/2002 |
ARTEMIS |
ULTRALINK, LLC. |
GEORGE D WISEMAN |
| K022582 |
10/22/2002 |
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K022316 |
10/10/2002 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012344 |
10/04/2002 |
VANGUARD REPROCESSED PULSE OXIMETER SENSORS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K023220 |
10/25/2002 |
VARISOURCE BREAST TEMPLATE SYSTEM |
VARIAN MEDICAL SYSTEMS |
LINDA S NASH |
| K023052 |
10/11/2002 |
ACUITY RADIATION THERAPY SIMULATOR |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K022996 |
10/09/2002 |
VITA IN-CERAM YZ CUBES FOR CEREC |
VIDENT |
BARBARA LEWANDOWSKI |
| K021976 |
10/25/2002 |
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON |
VITAL SCIENTIFIC N.V. |
ISRAEL M STEIN |
| K022286 |
10/11/2002 |
ENCIRCLE LOCALIZATION DEVICE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K022797 |
10/10/2002 |
TWINKY STAR |
VOCO GMBH |
GERALD W SHIPPS |
| K023221 |
10/11/2002 |
CONTACT LASER & DIAGNOSTIC LENSES |
VOLK OPTICAL, INC. |
RICHARD E LIPPMAN |
| K022938 |
10/25/2002 |
VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 |
VOLUME INTERACTIONS PTE LTD |
JOHN BABY |
| K022257 |
10/04/2002 |
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX |
VOMED VOLZER MEDIZINTECHNIK GMBH & CO. |
DAGMAR MASER |
| K023055 |
10/22/2002 |
BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 |
VSM MEDTECH LTD. |
DARYL WISDAHL |
| K022415 |
10/11/2002 |
BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST |
WAISMED LTD. |
DORIT WINITZ |
| K023495 |
10/31/2002 |
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
| K022663 |
10/31/2002 |
KERADEC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K022595 |
10/17/2002 |
WILSON-COOK CYSTOTOME |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
| K020641 |
10/29/2002 |
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
JONATHAN LEE |
| K023088 |
10/02/2002 |
BONE GRAFT SYRINGE, MODEL 8600-00X0 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROGER D BROWN |
| K022904 |
10/03/2002 |
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K022808 |
10/03/2002 |
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
V. NADARAJAN |
| K022653 |
10/28/2002 |
ELITE MONOPHASE |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K023211 |
10/17/2002 |
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
