| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K031631 |
07/18/2003 |
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A |
3D LINE USA, INC. |
NADER SALEHI |
| K030899 |
07/02/2003 |
C-REACTIVE PROTEIN (CRP) |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K030960 |
07/16/2003 |
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE |
ACMI CORPORATION |
John DeLucia |
| K031784 |
07/14/2003 |
ACON STREP A RAPID TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K031905 |
07/07/2003 |
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 |
ACTHERM, INC. |
RICHARD HSIEH |
| K031438 |
07/17/2003 |
ACUMED SMALL BONE LOCKING ROD SYSTEM II |
ACUMED LLC |
ED BOEHMER |
| K030926 |
07/21/2003 |
FAST THROW STAINLESS STEEL SURGICAL SUTURE |
ADVANCED SURGICAL PRODUCTS, INC. |
JEFFERY S JONES |
| K031216 |
07/17/2003 |
MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE |
AESCULAP |
GEORG KELLER |
| K032059 |
07/25/2003 |
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM |
AESCULAP, INC. |
GEORG KELLER |
| K032147 |
07/25/2003 |
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES |
ALARIS MEDICAL SYSTEMS, INC. |
STACY L LEWIS |
| K031193 |
07/03/2003 |
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION |
ALCON, INC. |
KIM B KRACKE |
| K032058 |
07/30/2003 |
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K031394 |
07/25/2003 |
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE |
AMERICAN SYRINGE COMPANY |
DAVID M GARVIN |
| K031273 |
07/15/2003 |
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE |
AMERTEK MEDICAL, INC. |
GREG WIITA |
| K031978 |
07/21/2003 |
AMPLAID A756 SCREENING ADMITTANCE METER |
AMPLAID |
DANIEL KAMM |
| K030692 |
07/17/2003 |
POWER LASER 90 |
ANDI ELECTROMEDICAL APS |
JEFF WORRELL |
| K030754 |
07/11/2003 |
A/C ENZYMATIC HOMOCYSTEINE ASSAY |
ANTICANCER INC |
YUYING TAN |
| K023737 |
07/14/2003 |
INJECTOR |
ANTON MEYER & CO. LTD. |
THOMAS MEYER |
| K031913 |
07/09/2003 |
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K031716 |
07/10/2003 |
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE |
ASIA-MED GMBH AND CO KG |
Kevin Walls |
| K031319 |
07/17/2003 |
OSTEO-G BONE VOID FILLER SYSTEM |
ASPINE USA, INC. |
FLOYD G LARSON |
| K032082 |
07/30/2003 |
AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
JAMES R VEALE |
| K030638 |
07/09/2003 |
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML |
AVANTEC VASCULAR CORP. |
JAMES M SHY |
| K030830 |
07/15/2003 |
B. BRAUN NERVE BLOCK CATHETER |
B. BRAUN MEDICAL, INC. |
PATRICIA D WILSON |
| K030135 |
07/15/2003 |
SAFETY INTRODUCER NEEDLE |
B. BRAUN MEDICAL, INC. |
AMY K SMITH |
| K031950 |
07/17/2003 |
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K032013 |
07/24/2003 |
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K031870 |
07/15/2003 |
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K031530 |
07/10/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML |
BECTON DICKINSON & CO. |
MONICA EVELYN GIGUERE |
| K031912 |
07/21/2003 |
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K031699 |
07/30/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML |
BECTON, DICKINSON & CO. |
KATHRYN BABKA POWERS |
| K031589 |
07/11/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K031679 |
07/16/2003 |
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
BRADFORD SPRING |
| K031478 |
07/02/2003 |
MICROHEATER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K031352 |
07/16/2003 |
BIO-LOGIC INSERT EARPHONES |
BIO-LOGIC SYSTEMS CORP. |
ERIK C GUNDERSEN |
| K030076 |
07/07/2003 |
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM |
BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING |
SUSAN B FENTRESS |
| K031737 |
07/14/2003 |
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
| K031410 |
07/10/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K031734 |
07/01/2003 |
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS |
BIOMET, INC. |
GARY BAKER |
| K031881 |
07/28/2003 |
AIRBRUSH LIPOSCULPTOR SYSTEM |
BIOSCULPTURE TECHNOLOGY, INC. |
ROBERT CUCIN |
| K031161 |
07/22/2003 |
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WILLIAM WELCH |
| K024337 |
07/03/2003 |
GENERAL SEMEN ANALYSIS (GSA) KIT |
BIOSHAF LTD. |
TOM TSAKERIS |
| K031118 |
07/08/2003 |
INTRAOS 70 |
BLUE X IMAGING SRL |
AL SOSA |
| K030769 |
07/14/2003 |
ULTRAFLEX PRECISION COLONIC STENT |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K031844 |
07/15/2003 |
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K032008 |
07/14/2003 |
VAXCEL WITH PASV PORT, MODEL 45-213 |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K030113 |
07/02/2003 |
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K032133 |
07/21/2003 |
BRODA MODEL 587 MANUAL WHEELCHAIR |
BRODA ENT., INC. |
PHILLIP MCTAGGART |
| K030442 |
07/21/2003 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
RAMON RICART |
| K030268 |
07/30/2003 |
NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS |
C.R. BARD, INC. |
GLENN NORTON |
| K031328 |
07/25/2003 |
RECOVERY FILTER SYSTEM, MODEL RF-048F |
C.R. BARD, INC. |
Mary J Edwards |
| K032044 |
07/10/2003 |
X-PROT DUO PORT |
C.R. BARD, INC. |
JOHN C KNORPP |
| K031987 |
07/30/2003 |
POWERHEART AED G3, MODEL 9300 |
CARDIAC SCIENCE |
KENNETH OLSON |
| K031207 |
07/15/2003 |
SAFETY RELEASE ARCH BAR KIT |
CASEY SURGICAL, LLC |
JAMES E STANLEY |
| K030403 |
07/17/2003 |
CEFAR REHAB 2 AND REHAB 2 PRO |
CEFAR MEDICAL AB |
CONSTANCE G BUNDY |
| K031183 |
07/14/2003 |
TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE |
CENTERPULSE ORTHOPEDICS, INC. |
ROBERT M WOLFARTH |
| K031416 |
07/15/2003 |
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF |
CLEAR MEDICAL, INC. |
LANE ABENROTH |
| K031044 |
07/15/2003 |
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K031536 |
07/18/2003 |
BRAIN COIL, MODEL 9900GE-64 |
CLINICAL MR SOLUTIONS, LLC |
RALPH S HASHOIAN |
| K031575 |
07/23/2003 |
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K031623 |
07/03/2003 |
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K031956 |
07/17/2003 |
MODIFICATION TO HERMES O.R. CONTROL CENTER |
COMPUTER MOTION, INC. |
KEITH LOWREY |
| K031720 |
07/11/2003 |
MODIFICATION TO HERMES O.R. CONTROL CENTER |
COMPUTER MOTION, INC. |
KEITH LOWREY |
| K031979 |
07/25/2003 |
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
| K031704 |
07/31/2003 |
FILMLESS CLINIC |
CONNECT IMAGING, INC. |
PHILIP J MANLY |
| K030841 |
07/11/2003 |
COOK GASTRIC SIZING BALLOON CATHETER |
COOK, INC. |
CAROL ZWISSLER |
| K031821 |
07/18/2003 |
MODIFICATION TO COOK ZILVER BILIARY STENT |
COOK, INC. |
CAROL ZWISSLER |
| K031802 |
07/21/2003 |
CORIX 70 PLUS-USV |
CORAMEX, S.A. |
AL SOSA |
| K031777 |
07/07/2003 |
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K031208 |
07/07/2003 |
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 |
CORGENIX, INC. |
NANCI DEXTER |
| K031482 |
07/10/2003 |
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE |
CRYOMEDICAL INSTRUEMTS LTD. |
GARETH COPPING |
| K031258 |
07/08/2003 |
CYNOSURE PHOTOLIGHT PL |
CYNOSURE, INC. |
GEORGE CHO |
| K031690 |
07/08/2003 |
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) |
CYNOSURE, INC. |
GEORGE CHO |
| K031512 |
07/23/2003 |
EMIT II PLUS COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K031602 |
07/31/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K031910 |
07/25/2003 |
STAINLESS STEEL AQUATIC WHEELCHAIR |
DB PERKS & ASSOCIATES LTD. |
ED OLIVER |
| K031615 |
07/21/2003 |
SLED CURING LIGHT SYSTEM |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K031145 |
07/15/2003 |
ESTYLUS ELECTRIC MOTOR SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K031203 |
07/14/2003 |
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST |
DEPUY ORTHOPAEDICS, INC. |
DINA L WEISSMAN |
| K031803 |
07/01/2003 |
DEPUY CERAMIC FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
KARLA A HAM |
| K031969 |
07/28/2003 |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY ORTHOPAEDICS, INC. |
KATHY K TRIER |
| K030477 |
07/18/2003 |
DIADEXUS PLAC TEST |
DIADEXUS, INC. |
ROBERT L WOLFERT |
| K032040 |
07/09/2003 |
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K031400 |
07/15/2003 |
FABIUS TIRO ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
| K032135 |
07/21/2003 |
SITE-RITE IV ULTRASOUND SYSTEM |
DYMAX CORP. |
CHARLES MORREALE |
| K030058 |
07/30/2003 |
EARLYDETECT MENOPAUSE TEST FOR FSH |
EARLY DETECT, INC. |
PETER GEORGE |
| K031355 |
07/22/2003 |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K031424 |
07/22/2003 |
EBI SPINELINK SPINAL FIXATION SYSTEM |
EBI, L.P. |
BARRY SANDS |
| K031093 |
07/10/2003 |
EBI XFIX OPTIROM KNEE FIXATOR |
EBI, L.P. |
JON CAPAROTTA |
| K031045 |
07/10/2003 |
AEROLET TOILET LIFT, MODEL AER-01 |
ECONOMIC HOLLAND B.V. |
STEPHANIE WOLFKAMP |
| K024303 |
07/03/2003 |
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KAVIN DRISKO |
| K030637 |
07/22/2003 |
EKOS PERIPHERAL INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K031638 |
07/21/2003 |
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION |
ELECTROMED IMAGING INC. |
WARREN BAKER |
| K020478 |
07/17/2003 |
ELECTROMEDICARIN 900 |
ELECTROMEDICARIN, S.A. |
JAY MANSOUR |
| K031999 |
07/25/2003 |
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K031980 |
07/25/2003 |
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K031846 |
07/21/2003 |
CARDIOVATIONS OPTICAL BIPOLAR DEVICE |
ETHICON, INC. |
PETER CECCHINI |
| K031847 |
07/21/2003 |
CARDIOVATIONS RETRACTOR |
ETHICON, INC. |
PETER CECCHINI |
| K031227 |
07/17/2003 |
LORDEX POWER TRACTION EQUIPMENT |
EVER PROSPEROUS INSTRUMENT INC |
JOHN BOREN |
| K031500 |
07/25/2003 |
EXCEL PRIMARY SOLUTION SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K031067 |
07/14/2003 |
FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS |
FIRST QUALITY HYGIENIC, INC. |
ROBERT J STAAB |
| K020332 |
07/07/2003 |
RESPIRATORY HUMIDIFIER, MODEL MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
BRETT WHISTON |
| K031828 |
07/17/2003 |
NATURALASE LP ND:YAG LASER |
FOCUS MEDICAL, LLC. |
JOHN LEE, JR |
| K024204 |
07/07/2003 |
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM |
FOTONA D.D. |
MOJCA VALJAVEC |
| K031916 |
07/17/2003 |
GALT MEDICAL GUIDEWIRE |
GALT MEDICAL CORP. |
DAVID CATLIN |
| K030962 |
07/25/2003 |
DPX SERIES BRAVO DUO BONE DENSITOMETER |
GE LUNAR CORP. |
JAMES P RASKOB |
| K032045 |
07/30/2003 |
8 CHANNEL CARDIAC PHASED ARRAY COIL |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K031927 |
07/02/2003 |
GE DELTA SOFTWARE OPTION FOR MRI |
GE MEDICAL SYSTEMS |
LARRY KREGER |
| K031376 |
07/16/2003 |
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K031036 |
07/10/2003 |
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 |
GEBAUER CO. |
AMY J PAUKOVITS |
| K030788 |
07/12/2003 |
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS |
GEISTER MEDIZINTECHNIK GMBH |
DAGMAR MASER |
| K032182 |
07/25/2003 |
GE LOGIQ 7, MODEL 2354858 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K031554 |
07/25/2003 |
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
GENZYME BIOSURGERY |
DENISE LIMA |
| K031647 |
07/29/2003 |
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
GETINGE USA, INC |
KARLA BYRNE |
| K031033 |
07/01/2003 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K031581 |
07/24/2003 |
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG |
GREEN PROSPECT SDN BHD |
JANNA P TUCKER |
| K031580 |
07/25/2003 |
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE |
GREEN PROSPECT SDN BHD |
JANNA P TUCKER |
| K030547 |
07/11/2003 |
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE |
GUARDIAN ANGEL PRODUCTS, INC. |
ERNEST H PESCATORE |
| K031459 |
07/23/2003 |
RAPIDO CUT-AWAY CUTTER |
GUIDANT CORP. |
SHAH HILALI |
| K031688 |
07/02/2003 |
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE |
GUIDANT CORPORATION |
STEPHANIE ISGRIGG ROBINSON |
| K031085 |
07/21/2003 |
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K031695 |
07/01/2003 |
HL168R |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K031835 |
07/01/2003 |
HL888RA |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K022967 |
07/08/2003 |
SUILE WOUND DRESSING |
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
ERIC LUO |
| K014074 |
07/23/2003 |
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION |
HOFFRICHTER GMBH |
STEPHEN H GORSKI |
| K030703 |
07/11/2003 |
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K031718 |
07/02/2003 |
LIFEVALVE CENTRAL VENOUS CATHTER |
HORIZON MEDICAL PRODUCTS, INC. |
SCOTT MOELLER |
| K031480 |
07/31/2003 |
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K031941 |
07/24/2003 |
HOFFMANN II COMPACT BALTIMORE COUPLING |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K031959 |
07/25/2003 |
STRYKER PLATING SYSTEM PERIARTICULAR PLATES |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K031893 |
07/17/2003 |
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K031383 |
07/07/2003 |
MODEL 780 |
HUDSON RESPIRATORY CARE, INC. |
CHARLES MIERKIEWICZ |
| K031986 |
07/24/2003 |
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS |
ICS MEDICAL |
DELMAR F BLOEM |
| K031991 |
07/30/2003 |
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS |
IMAGE ANALYSIS, INC. |
BEN ARNOLD |
| K031490 |
07/16/2003 |
RUBELLACOL |
IMMUNOSTICS, INC. |
JEFFREY FLEISHMAN |
| K031475 |
07/28/2003 |
OSSEOTITE NT CERTAIN IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUELYN A HUGHES |
| K031823 |
07/11/2003 |
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 |
IMPLEX CORP. |
MARCI HALEVI |
| K031829 |
07/31/2003 |
HEMOSIL FACTOR IX DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K030600 |
07/11/2003 |
AUTION JET AJ-4270 URINE ANALYZER |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
CYNTHIA J.M. NOLTE |
| K031417 |
07/11/2003 |
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K031783 |
07/01/2003 |
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 |
INTRAVASCULAR INCORPORATED |
STEVE APERAVICH |
| K031115 |
07/10/2003 |
RH-900 |
IOMED, INC. |
CURTIS JENSEN |
| K031059 |
07/10/2003 |
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 |
IVD RESEARCH, INC. |
DAVE LAMBILLOTTE |
| K031342 |
07/10/2003 |
JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II |
JASON MARINE ENTERPRISES, INC. |
BRIAN GAGNON |
| K023668 |
07/01/2003 |
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR |
JMS NORTH AMERICA CORP. |
SWEE CHEAU CHONG |
| K024377 |
07/21/2003 |
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 |
KALACO SCIENTIFIC, INC. |
GRACE BARTOO |
| K032081 |
07/24/2003 |
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 |
KAVO AMERICA |
DANIEL KAMM |
| K031868 |
07/09/2003 |
PROPHYPEARLS |
KAVO AMERICA |
DANIEL KAMM |
| K031484 |
07/03/2003 |
STAND OUT |
KERR CORP. |
COLLEEN BOSWELL |
| K031444 |
07/02/2003 |
OPTIBOND FL |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K031504 |
07/18/2003 |
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K031309 |
07/31/2003 |
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 |
KUANN DAH INDUSTRY CO., LTD. |
Ke-Min Jen |
| K031250 |
07/15/2003 |
DBC PRESS ACUPUNCTURE NEEDLES |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K031060 |
07/11/2003 |
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K031981 |
07/25/2003 |
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 |
LINVATEC BIOMATERIALS, LTD. |
LAURA KREJCI |
| K030033 |
07/21/2003 |
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES |
LUMENIS, LTD. |
ANNE WORDEN |
| K030342 |
07/17/2003 |
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS |
LUMENIS, LTD. |
ANDREA L RUTH |
| K024169 |
07/01/2003 |
MACROPORE OS RECONSTRUCTION |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K031445 |
07/01/2003 |
MAINLINE MAXIE HCG URINE PREGNANCY TEST |
MAINLINE TECHNOLOGY, INC. |
MARTHA MAZUREK |
| K031339 |
07/11/2003 |
OPTIBOLUS |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
ELLIS ROGERS |
| K031372 |
07/02/2003 |
PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION |
MAXXVISION, LLC |
JAMES K WALKER |
| K031119 |
07/15/2003 |
MAYO CLINIC BC-10 1.5T |
MAYO MEDICAL VENTURES |
JADE SADOSTY |
| K031890 |
07/16/2003 |
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K031392 |
07/01/2003 |
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K031441 |
07/01/2003 |
URICHEMTRAK LIQUID ASSAYED URINE CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K022558 |
07/08/2003 |
NGT |
MEDICAL INNOVATIVE PRODUCTS |
DEBBIE IAMPIETRO |
| K031861 |
07/29/2003 |
MIX2VIAL TRANSFER DEVICE |
MEDIMOP MEDICAL PROJECTS, LTD. |
BENNY ARAZY |
| K030919 |
07/03/2003 |
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES |
MEDISISS |
MRRY ANN BARKER |
| K031843 |
07/03/2003 |
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
| K031808 |
07/11/2003 |
MEDRAD SWABBABLE VALVE TRANSFER SET |
MEDRAD, INC. |
ANDREW P ZELTWANGER |
| K031032 |
07/14/2003 |
VERDICT II, PROFILE II |
MEDTOX DIAGNOSTICS, INC. |
ALAN MORRIS |
| K031776 |
07/25/2003 |
MC2X MULTI-STAGE VENOUS CANNULA |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K031827 |
07/02/2003 |
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K031780 |
07/30/2003 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K031211 |
07/17/2003 |
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH |
MEDTRONIC VASCULAR |
LYNN JENSEN |
| K031247 |
07/17/2003 |
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM |
MEDTRONIC VASCULAR |
SCOTT CUNDY |
| K030671 |
07/31/2003 |
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K030239 |
07/24/2003 |
MEGATECH SCIENTIFIC FACE MASK |
MEGATECH SCIENTIFIC PTE LTD |
CHIAM KIA CHEE |
| K031767 |
07/17/2003 |
MENTOR OBTAPE TRANS-OBTURATOR TAPE |
MENTOR CORP. |
DONNA CRAWFORD |
| K031411 |
07/30/2003 |
MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 |
MERCURY MEDICAL |
WAYNE GLOVER |
| K030392 |
07/21/2003 |
SAPPHIRE DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| K031050 |
07/14/2003 |
PCW PERCUTANEOUS COMPRESSION WIRE |
MILLENNIUM MEDICAL TECHNOLOGIES, INC. |
DAVID W SCHLERF |
| K031390 |
07/23/2003 |
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 |
MINIMED, INC. |
MIRIELLE MENGOTTO |
| K030852 |
07/10/2003 |
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
| K031182 |
07/25/2003 |
ELI 200+ AUDICOR |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K031998 |
07/24/2003 |
MODEL J-5 MVO-MONITOR |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
| K030221 |
07/25/2003 |
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR |
MYTECH TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| K031173 |
07/23/2003 |
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 |
NEEDLETECH PRODUCTS, INC. |
RICK TRIPP |
| K032188 |
07/31/2003 |
NICHOLS ADVANTAGE ALDOSTERONE ASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K031070 |
07/03/2003 |
CARBON FIBER BRIDGE, MODEL 28757 |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K031719 |
07/02/2003 |
ESTHETIC ZIRCONIA ABUTMENT |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K031345 |
07/24/2003 |
NOBEL DIRECT, MODELS 30937, 30938 |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K023044 |
07/23/2003 |
MODEL 9600, AVANT PULSE OXIMETER |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K030669 |
07/18/2003 |
PROVIDENCE MOLDING HELMET |
NORTHEAST ORTHOTICS AND PROTHETICS, INC. |
D. BARRY MCCOY |
| K030470 |
07/07/2003 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K031477 |
07/18/2003 |
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS |
OCULAR SCIENCES, INC. |
RICHARD E LIPPMAN |
| K032092 |
07/16/2003 |
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE |
OLYMPUS OPTICAL CO., LTD. |
MASAO WADA |
| K031648 |
07/24/2003 |
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V |
OLYMPUS OPTICAL CO., LTD. |
TINA STEFFANIE-OAK |
| K031256 |
07/23/2003 |
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TINA STEFFANIE-OAK |
| K030170 |
07/28/2003 |
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 |
OPUS MEDICAL, INC. |
JAMES W HART |
| K021362 |
07/31/2003 |
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) |
ORGAN RECOVERY SYSTEMS, INC. |
STANLEY J HARRIS |
| K031201 |
07/15/2003 |
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM |
ORTHO DEVELOPMENT CORP. |
NADEEM AHMED |
| K030288 |
07/17/2003 |
POLYGRAFT BONE GRAFT SUBSTITUTE |
OSTEOBIOLOGICS, INC. |
GABRIELE G NEIDERAUER |
| DEN030004 |
07/08/2003 |
WEST NILE VIRUS IGM CAPTURE ELISA |
PANBIO LIMITED |
HELEN JENNINGS |
| K031212 |
07/11/2003 |
TEMPORARY RESIN CEMENT |
PARKELL, INC. |
NELSON J GENDUSA |
| K031727 |
07/30/2003 |
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K032123 |
07/31/2003 |
SHOCKWAVE SUSPENSION WHEELCHAIR |
PER4MAX MEDICAL, LLC |
TIM CRISWELL |
| K024080 |
07/02/2003 |
SECQUIRE CELL SEPARATOR |
PERFUSION PARTNERS & ASSOC. INC. |
E.J. Smith |
| K030939 |
07/15/2003 |
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE |
PHILIPS MEDICAL SYSTEMS |
JUDITH K PHILLIPS |
| K031422 |
07/03/2003 |
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K032103 |
07/22/2003 |
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K032096 |
07/18/2003 |
PHILIPS VIEWFORUM 2003 |
PHILIPS MEDICAL SYSTEMS |
LYNN T HARMER |
| K030973 |
07/23/2003 |
PICOSAT II SPO2 PULSE OXIMETRY MODULE |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K031597 |
07/21/2003 |
DUNLEE FORMAT COLLIMATOR FAMILY |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K032046 |
07/17/2003 |
PHILLIPS OMNIDIAGNOST ELEVA |
PHILIPS MEDICAL SYSTEMS, INC. |
LYNN HARMER |
| K032036 |
07/11/2003 |
GEMINI 16 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
CHRISTOF LITTWITZ |
| K030426 |
07/17/2003 |
OMNILUX RED |
PHOTO THERAPEUTICS LIMITED |
MAUREEN O'CONNELL |
| K032052 |
07/25/2003 |
UC-PLUS SOLUTION UNICONDYLAR KNEE |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K021841 |
07/17/2003 |
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER |
PNEU PAC, LTD. |
DONALD ALEXANDER |
| K031057 |
07/18/2003 |
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT |
PORTEX, INC. |
TIMOTHY J TALCOTT |
| K032007 |
07/28/2003 |
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K030329 |
07/03/2003 |
FASTPACK FREE T4 IMMUNOASSAY |
Qualigen, Inc. |
DOROTHY DEINZER |
| K032129 |
07/17/2003 |
RADIUS 018 COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
| K031565 |
07/17/2003 |
XPECT INFLUENZA A/B |
REMEL INC |
MARY ANN SILVIUS |
| K024191 |
07/02/2003 |
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK |
RESMED LTD. |
ROGER KOTTER |
| K031656 |
07/30/2003 |
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K031926 |
07/17/2003 |
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) |
RITA MEDICAL SYSTEMS INC |
ERIN MAZZONE |
| K031755 |
07/03/2003 |
ACCU-CHEK COMPACT TEST STRIP |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K031880 |
07/16/2003 |
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K031879 |
07/17/2003 |
COBAS INTEGRA CARBON DIOXIDE ASSAY |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K031824 |
07/09/2003 |
COBAS INTEGRA CHOLESTEROL GEN. 2 |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K031650 |
07/17/2003 |
FERRITIN GENERATION 2 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K032089 |
07/30/2003 |
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K031731 |
07/30/2003 |
MR FIBER OPTIC ECG GATING SYSTEM |
SA INSTRUMENTS, INC. |
G. RONALD MORRIS |
| K030278 |
07/30/2003 |
SAUFLON MULTIPURPOSE SOLUTION - NO RUB |
SAUFLON PHARMACEUTICALS, LTD. |
LIGIA DELACRUZ |
| K031534 |
07/30/2003 |
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
| K031381 |
07/30/2003 |
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS |
SEASPINE |
DIANA SMITH |
| K031163 |
07/08/2003 |
SEZ SAFETY SYRINGE |
SEZ CORPORATION |
DANIEL KAMM |
| K031854 |
07/25/2003 |
VINYL EXAM GLOVES, POWDER-FREE, YELLOW |
SHANGHAI JIAWANG INDUSTRIAL CO. LTD. |
JANNA P TUCKER |
| K031467 |
07/17/2003 |
GLASIONOMER FX-II |
SHOFU DENTAL CORP. |
ROBERT NOBLE |
| K032111 |
07/18/2003 |
ACUSON CV70 CARDIOVASCULAR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CAREY CHAVEZ |
| K032114 |
07/21/2003 |
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JERRY W TSUTSUMI |
| K031757 |
07/30/2003 |
PEEK TETRIS SPINAL IMPLANT |
SIGNUS MEDICAL LLC. |
AL ALEXANDER |
| K024367 |
07/28/2003 |
SINCLAIR WOUND AND SKIN EMULSION |
SINCLAIR PHARMACEUTICALS, LTD. |
MICHAEL KILLEEN |
| K031181 |
07/14/2003 |
EXTERNAL FIXATION SYSTEMS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K030766 |
07/25/2003 |
OXINIUM FEMORAL HEADS |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K031685 |
07/01/2003 |
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 |
SMITH & NEPHEW, INC. |
JASON BILOBRAM |
| K031222 |
07/23/2003 |
SCANLUBE |
SONOTECH, INC. |
MARGARET J LARSON |
| K031894 |
07/18/2003 |
SCANTEC PAD |
SONOTECH, INC. |
MARGARET J LARSON |
| K031658 |
07/29/2003 |
BENCO SPHERICAL |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K031837 |
07/24/2003 |
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K030087 |
07/17/2003 |
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K031914 |
07/12/2003 |
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE |
SPINAL CONCEPTS, INC. |
LISA PETERSON |
| K030177 |
07/21/2003 |
ORLON NONABSORABLE SURGICAL SUTURE USP |
SRI ORION PHARMACEUTICALS & SUTURES |
NORMAN F ESTRIN |
| K031906 |
07/18/2003 |
APEEL CS CATHETER DELIVERY SYSTEM |
ST. JUDE MEDICAL |
MIKE BURNSIDE |
| K032062 |
07/29/2003 |
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K031055 |
07/07/2003 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
| K023836 |
07/08/2003 |
THE SUAD DEVICE |
STRONG DENTAL INC. |
CLYDE A TAKEGUCHI |
| K031249 |
07/21/2003 |
MODIFICATION TO STRYKER PAINPUMP |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K024007 |
07/14/2003 |
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J |
SUNDER BIOMEDICAL TECH. CO., LTD. |
TONY HUNG |
| K031576 |
07/31/2003 |
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 |
SURGITECH, INC. |
CHRISTOPHER CROWELL |
| K031133 |
07/03/2003 |
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS |
SURGRX INC |
LINDA OLESON |
| K024307 |
07/02/2003 |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
SYBARITIC, INC. |
RANDALL E BERGLUND |
| K031476 |
07/02/2003 |
FILL-IN |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K031555 |
07/08/2003 |
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K031276 |
07/02/2003 |
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM |
SYNTHES (USA) |
JON GILBERT |
| K031807 |
07/02/2003 |
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS |
SYNTHES (USA) |
BONNIE J SMITH |
| K031724 |
07/14/2003 |
SYNTHES SMALL COBINATION CLAMP-MR SAFE |
SYNTHES (USA) |
BONNIE SMITH |
| K031179 |
07/17/2003 |
TAGA VELOCITY HUMIDIFIER |
TAGA MEDICAL TECHNOLOGIES, INC. |
GARY AUSTIN |
| K030991 |
07/11/2003 |
C. DIFF CHEK - 30 |
TECHLAB, INC. |
DAVID M LYERLY |
| K030992 |
07/11/2003 |
C. DIFF CHEK - 60 |
TECHLAB, INC. |
DAVID M LYERLY |
| K024155 |
07/17/2003 |
MX 300 OXYGEN MONITOR |
TELEDYNE ANALYTICAL INSTRUMENTS |
RAY KHAJAVI |
| K024228 |
07/17/2003 |
RX300 OXYGEN ANALYZER |
TELEDYNE ANALYTICAL INSTRUMENTS |
RAY KHAJAVI |
| K031229 |
07/09/2003 |
TELZUIT CARDIAC MONITORING SYSTEM |
TELZUIT TECHNOLOGIES, INC. |
CYNTHIA J.M. NOLET |
| K031891 |
07/29/2003 |
VIRTUOSAPH |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
KIM AVES |
| K031453 |
07/08/2003 |
TERUMO SURGUARD 2 SAFETY NEEDLE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K031016 |
07/15/2003 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K031040 |
07/24/2003 |
THERIFIL BONE FILLER |
THERICS, INC. |
UMBERTO V PARROTTA, JR |
| K031747 |
07/02/2003 |
SPI DENTAL IMPLANT ABUTMENTS |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K030912 |
07/25/2003 |
THYRO TEST |
THRYOTEC |
FRAN WHITE |
| K031624 |
07/24/2003 |
TINNITUS RX |
TINNITUS CONTROL, INC. |
RUSS PAGANO |
| K031920 |
07/23/2003 |
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 |
TRANS VASCULAR INCORPORATED |
RICHARD E ANDERSON |
| K031545 |
07/16/2003 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K031874 |
07/18/2003 |
MODIFICATION TO WBR, MODEL HR |
U.C.G. TECHNOLOGIES LTD. |
DAN LAOR |
| K031366 |
07/11/2003 |
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031365 |
07/18/2003 |
PRIMA III TOTALSENSE TORSO COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K024343 |
07/11/2003 |
BUTLER GUM PROPHY PASTE WITH NOVAMIN |
USBIOMATERIALS CORP. |
DAVID C GREENSPAN |
| K030456 |
07/11/2003 |
VASC-ALERT |
VASC-ALERT L.L.C. |
JOHN KENNEDY |
| K030271 |
07/07/2003 |
VENTLAB BACTERIAL FILTER, MODEL BF100 |
VENTLAB CORP. |
ROBERT M KELLY |
| K031194 |
07/30/2003 |
SPIROSOFT |
VIASYS HEALTHCARE GMBH |
EARL DRAPER |
| K030634 |
07/21/2003 |
ENDOS DC |
VILLA SISTEMI MEDICALI S.P.A. |
ANDREW HRYNDZA |
| K031448 |
07/31/2003 |
RSV (RADIOLOGY SYSTEM VISIODENT |
VISIODENT SA |
CLAUDE D BERTHOIN |
| K031790 |
07/02/2003 |
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K031550 |
07/29/2003 |
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE |
VIVOMETRICS, INC. |
HOWARD M HOLSTEIN |
| K030158 |
07/17/2003 |
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED |
WALSH MEDICAL DEVICES, INC. |
DAVID STILES |
| K031174 |
07/10/2003 |
BODY SIGNAL ECG ELECTRODE |
WANDY RUBBER INDUSTRIAL CO., LTD |
JANIS YANG |
| K030758 |
07/31/2003 |
COACH 888 |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K030760 |
07/10/2003 |
COACH 888W |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K031929 |
07/08/2003 |
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION |
WIDE CORPORATION |
CARL ALLETTO |
| K032174 |
07/24/2003 |
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A |
WIDE CORPORATION |
CARL ALLETTO |
| K023179 |
07/02/2003 |
READI-STRAND, MODEL PSSTRAND |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
| K031817 |
07/17/2003 |
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K031199 |
07/09/2003 |
ENTERALITE INFINITY ENTERAL FEEDING PUMP |
ZEVEX INTL., INC. |
SEAN M CURRY |
