| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K030909 |
04/10/2003 |
AAP ACROPLATE |
AAP IMPLANTATE AG |
DIPL.-LNG. CHRISTIAN ABEL |
| K031185 |
04/30/2003 |
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
| K023256 |
04/23/2003 |
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO |
ABBOTT LABORATORIES |
JANET CONNOLLY |
| K030799 |
04/08/2003 |
MICROS 60 |
ABX DIAGNOSTICS |
TIM LAWTON |
| K030261 |
04/24/2003 |
BATTERY, RECHARGEABLE |
ACCESS BATTERY, INC. |
ALEXANDER B HENDERSON |
| K024350 |
04/02/2003 |
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K023037 |
04/09/2003 |
MID STREAM PREGNANCY TEST |
ADVANCED DIAGNOSTICS, INC. |
D.M. CHOUHAN |
| K030092 |
04/04/2003 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ADVANCED MEDICAL OPTICS, INC. |
PAUL J NOWACKI |
| K030461 |
04/24/2003 |
A127 LEAD EXTENSION |
ADVANCED NEUROMODULATION SYSTEMS |
RASHMI MOZA |
| K023290 |
04/03/2003 |
STERRAD 50 & STERRAD 100S STERILIZERS |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| DEN030001 |
04/30/2003 |
NIOX ARTICLE NO: 02-1000 |
AEROCRINE AB |
SEAN M CURRY |
| K030556 |
04/22/2003 |
STEELEX ELECTRODE SET |
AESCULAP, INC. |
GEORG KELLER |
| K024285 |
04/16/2003 |
A/T X-RAY 70 |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K030459 |
04/04/2003 |
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K030430 |
04/18/2003 |
POLY STAT SERUM/URINE HCG TEST |
ALIDEX, INC. |
HELEN LANDICHO |
| K030906 |
04/23/2003 |
AXCEL SURGICAL LIGHT |
ALM |
FREDERICK R CATT |
| K023869 |
04/30/2003 |
'RAPIDTEC'-5M-MULTIPLE DIP TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K023547 |
04/15/2003 |
DIOLASE 980 D LASER SYSTEM |
AMERICAN DENTAL TECHNOLOGIES, INC. |
MARCIA VAN VALEN |
| K030059 |
04/07/2003 |
PORTABLE RO+ MODEL MROS09 |
AMERIWATER |
BRIAN R BOWMAN |
| K030594 |
04/10/2003 |
I-125 RAPID STRAND, MODEL 7000 |
AMERSHAM HEALTH |
SUBHASH PATEL |
| K030415 |
04/30/2003 |
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K021672 |
04/16/2003 |
PANCREATIC DRAINAGE TUBE |
AOMORI OLYMPUS CO., LTD. |
LAURA STORMS-TYLER |
| K030245 |
04/04/2003 |
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K030937 |
04/23/2003 |
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK |
ARROW INTERNATIONAL, INC. |
BRANDON EPTING |
| K030954 |
04/16/2003 |
ARTHROCARE PERCD SPINEWAND |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K023905 |
04/30/2003 |
ATHENA PELVIC MUSCLE TRAINER |
ATHENA FEMININE TECHNOLOGIES, INC. |
BARBARA SARKIS |
| K030881 |
04/10/2003 |
AVANTA CARPAL FUSION PLATING SYSTEM |
AVANTA ORTHOPAEDICS, INC. |
H. DOUG PLUNKETT |
| K030062 |
04/03/2003 |
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 |
AVANTEC VASCULAR CORP. |
JAMES M SHY |
| K030974 |
04/25/2003 |
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K030975 |
04/25/2003 |
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K030804 |
04/10/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K030801 |
04/09/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K030291 |
04/17/2003 |
COULTER ACT 5DIFF AUTOLOADER (AL) |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K030606 |
04/21/2003 |
COULTER LH 750 BODY FLUIDS APPLICATION |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K031002 |
04/29/2003 |
SYNCHRON SYSTEMS OPIATE REAGENT |
BECKMAN COULTER, INC. |
KIM WALKER |
| K030677 |
04/01/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K031009 |
04/28/2003 |
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K030555 |
04/11/2003 |
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A |
BIOMET, INC. |
LONNIE WITHAM |
| K030051 |
04/04/2003 |
VERSABOARD, MODEL 7040 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K030388 |
04/24/2003 |
IMPACT SUTURE ANCHOR. MODEL 433510 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K030806 |
04/08/2003 |
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
| K031028 |
04/28/2003 |
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
| K023205 |
04/24/2003 |
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K030585 |
04/28/2003 |
SCULPTING RESIN |
BISCO, INC. |
STEPHEN SMITH |
| K030595 |
04/24/2003 |
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K030862 |
04/17/2003 |
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K030855 |
04/17/2003 |
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K023288 |
04/02/2003 |
COBRA BIPOLAR CLAMP, MODEL 15902 |
BOSTON SCIENTIFIC EP TECHNOLOGIES |
APRIL MALMBORG |
| K030172 |
04/03/2003 |
SMALL HIGH SPEED MOTOR DRILL SYSTEM |
BRASSELER USA I, L.P. |
ANTHONY V ROSE |
| K030175 |
04/17/2003 |
2 BASIC |
CAPINTEC, INC. |
MARY ANNE DELL |
| K030451 |
04/30/2003 |
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K030216 |
04/02/2003 |
COLONCARE |
CARE PRODUCTS, INC. |
HUBERT POTOTSCHNIG |
| K022417 |
04/10/2003 |
CARE STIM |
CARE REHAB AND ORTHOPAEDIC |
CHRISTIAN E HUNT |
| K023614 |
04/07/2003 |
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM |
CASE MEDICAL, INC. |
MARCIA A FRIEZE |
| K030533 |
04/17/2003 |
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST |
CENOGENICS CORP. |
NITZ KATZ |
| K030259 |
04/24/2003 |
AMATOMICAL SHOULDER WITH REMOVABLE HEAD |
CENTERPLUS ORTHOPEDICS, INC |
AUDREY SWEARINGEN |
| K030167 |
04/02/2003 |
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER |
CLEARLAB PTE LTD. |
MARTIN DALSING |
| K030690 |
04/30/2003 |
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS |
CODONICS, INC. |
RICK DAYTON |
| K030850 |
04/08/2003 |
ENHANCE HUMAN SERUM ALBUMIN |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
| K021237 |
04/10/2003 |
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS |
COOPERSURGICAL, INC. |
HAIKO BELL |
| K030927 |
04/17/2003 |
POWDERED VINYL EXAM GLOVES, WHITE |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K030056 |
04/22/2003 |
WORRY-REMOVER IRRIGATOR |
CORISEN GROUP, LTD. |
WEI N ZUO |
| K030234 |
04/28/2003 |
COZART EIA COCAINE ORAL FLIUD KIT |
COZART BIOSCIENCE LTD. |
ROBERTO LIDDI |
| K024339 |
04/07/2003 |
COZART EIA OPIATES ORAL FLUID KIT |
COZART BIOSCIENCE LTD. |
ROBERTO LIDDI |
| K030613 |
04/17/2003 |
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K030303 |
04/29/2003 |
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE |
CRYOCATH TECHNOLOGIES, INC. |
JEAN-PIERRE DESMARAIS |
| K030340 |
04/11/2003 |
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) |
CYTOMEDIX |
CARELYN P FYLLING |
| K024342 |
04/23/2003 |
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 |
DAITO CO., LTD. |
EDWARD EPSTEIN |
| K023454 |
04/23/2003 |
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES |
DATEX-OHMEDA |
JOEL C KENT |
| K031213 |
04/30/2003 |
AQUASENS FLUID MONITORING SYSTEM |
DAVOL, INC. |
BRIAN A KANERVIKO |
| K030983 |
04/25/2003 |
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY |
DELTEC, INC. |
LISA STONE |
| K030133 |
04/29/2003 |
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE |
DENTALEZ GROUP |
WILLIAM GUSCOTT |
| K030833 |
04/10/2003 |
DEPUY ACROMED VBR SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K030979 |
04/24/2003 |
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
KARLA A HAM |
| K030365 |
04/29/2003 |
DEROYAL DRAPES, STERILE, NON-STERILE |
DEROYAL INDUSTRIES, INC. |
AUDREY DANIELS |
| K030364 |
04/28/2003 |
DEROYAL GOWNS, STERILE, NON-STERILE |
DEROYAL INDUSTRIES, INC. |
AUDREY DANIELS |
| K030136 |
04/07/2003 |
DRIP ALERT |
DRIP ALERT, INC. |
POLLY D HESEMAN |
| K030854 |
04/16/2003 |
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 |
E-Z-EM, INC. |
JUDY HAUSER |
| K030353 |
04/25/2003 |
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS |
EAGLE VISION, INC. |
BILLY HANNAFORD |
| K031087 |
04/24/2003 |
EDWARDS INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
Daun Putnam |
| K030395 |
04/08/2003 |
EMPI ACTION PATCH IONTOPHORESIS SYSTEM |
EMPI |
SUSAN ONEL |
| K023794 |
04/01/2003 |
CONSTRAINED LINER |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
| K020925 |
04/29/2003 |
CARBODISSECTING ENDOSCOPE |
ENDO SURGICAL DEVICES, INC. |
DEBBIE IAMPIETRO |
| K030129 |
04/22/2003 |
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
KAREN J MCKELVEY |
| K030297 |
04/28/2003 |
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 |
ENRAF-NONIUS B.V. |
RICK COELET |
| K030656 |
04/08/2003 |
ENVAN HEART RATE MONITOR |
ENVAN, LLC |
MARIE MARLOW |
| K030562 |
04/03/2003 |
TUOHY EPIDURAL NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER B LAKE |
| K030686 |
04/02/2003 |
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT |
EXACTECH, INC. |
GARY MILLER |
| K022112 |
04/03/2003 |
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 |
FORTUNE MEDICAL INSTRUMENT CORP. |
JESSICA CHAN |
| K022124 |
04/03/2003 |
GALEMED PEAK FLOW METER, MODELS 3751/3752 |
GALEMED CORP. |
BRUCE KUO |
| K030953 |
04/10/2003 |
GE 3.0T GENERAL PURPOSE FLEX COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K030934 |
04/17/2003 |
GE LOGIQ 9 MODEL 2375600 |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K030027 |
04/01/2003 |
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% |
GELFLEX LABORATORIES |
PETER G BRYANT |
| K030673 |
04/04/2003 |
FLEXIBLE TIP THERMOMETER, MODEL 011206 |
GLOBAL TREASURE INDUSTRIES LTD. |
FRAN WHITE |
| K021154 |
04/11/2003 |
GOLDWAY PATIENT MONITOR, MODEL # UT4000F |
GOLDWAY US, INC. |
Y. JUSTIN CHEN |
| K030292 |
04/15/2003 |
GROMAN PREPMASTER |
GROMAN INC. |
BARRY B GROMAN |
| K030198 |
04/01/2003 |
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM |
HAND INNOVATIONS, INC. |
RICHARD D BLISS, JR. |
| K030808 |
04/21/2003 |
HANSON MEDICAL CALF IMPLANT |
HANSON MEDICAL, INC. |
JOHN HARRISON |
| K030809 |
04/21/2003 |
HANSON MEDICAL GLUTEAL IMPLANT |
HANSON MEDICAL, INC. |
JOHN HARRISON |
| K030151 |
04/10/2003 |
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM |
HAYES MEDICAL, INC. |
WILLIAM J GRIFFIN |
| K030205 |
04/01/2003 |
CONSENSUS UNIPOLAR HEAD, COCR |
HAYES MEDICAL, INC. |
WILLIAM J GRIFFIN |
| K030498 |
04/11/2003 |
HL888HA |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K030499 |
04/17/2003 |
HL888HM |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K030541 |
04/24/2003 |
HL888JF |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K024207 |
04/14/2003 |
VINCO BRAND ACUPUNCTURE NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
| K030572 |
04/01/2003 |
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
| K020421 |
04/29/2003 |
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
HENNIG ENTERPRISES EUROPE S.R.L. |
GEORGE O'NEIL |
| K030318 |
04/03/2003 |
P2 POLYETHER |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K021622 |
04/01/2003 |
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 |
HILL-ROM AIR-SHIELDS |
MONICA FERRANTE |
| K023001 |
04/08/2003 |
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L |
HOME CARE TECHNOLOGY CO., LTD. |
SHU-CHEN CHENG |
| K031090 |
04/24/2003 |
MODIFICATION TO XIA STAINLESS STEEL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K031127 |
04/28/2003 |
ORTHOPEDIC WIRE |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K023412 |
04/09/2003 |
THERMO BUDDY, MODELS TB-100, TB-110, TB-120 |
HUBDIC CO., LTD |
GUENTER GINSBERG |
| K022294 |
04/25/2003 |
APNEACHECK |
IM SYSTEMS |
DAVID T KRAUSMAN |
| K021174 |
04/29/2003 |
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR |
IMAGYN SURGICAL |
JULIE POWELL |
| K030427 |
04/18/2003 |
HP-3 HD ELECTRIC WHEELCHAIR |
IMC-HEARTWAY, LLC |
JUAN CARLOS RIVERA |
| K023073 |
04/07/2003 |
SEED LINK |
IMPLANT SCIENCES CORP. |
JOHN J MUNRO |
| K030243 |
04/23/2003 |
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 |
IMTEC CORP. |
J.BRAD VANCE |
| K024117 |
04/22/2003 |
INSORB ABSORBABLE STAPLES, MODEL SP-B20 |
INCISIVE SURGICAL, INC. |
JIM PETERSON |
| K022614 |
04/08/2003 |
INVIGRA |
INDUS MEDICARE LTD. |
P. JANARDHAN REDDY |
| K031013 |
04/17/2003 |
INFINTT CO., LTD. STARPACS SYSTEM |
INFINITT COMPANY |
CARL ALLETTO |
| K030681 |
04/24/2003 |
QUANTA PLEX ENA PROFILE 5 |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K030723 |
04/03/2003 |
IVS INTRODUCER SET, MODEL 1003 |
INTEGRATED VASCULAR SYSTEMS, INC. |
SUSAN TURNER |
| K030181 |
04/17/2003 |
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM |
INTERNATIONAL BIOPHYSICS CORP. |
LEN HICKEY |
| K030818 |
04/02/2003 |
HEMOCHRON RESPONSE/SYSTEM |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
| K030984 |
04/24/2003 |
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K030436 |
04/15/2003 |
BIO UNIVERSAL |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
| K030435 |
04/15/2003 |
BIOUNIVERSAL PKF |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
| K023365 |
04/18/2003 |
LEFORTE SYSTEM BONE SCREW |
JEIL MEDICAL CORPORATION |
DANIEL KAMM |
| K024325 |
04/04/2003 |
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 |
JI-EE INDUSTRY CO., LTD. |
Ke-Min Jen |
| K030540 |
04/16/2003 |
HTS ARRAY COIL |
JOCKEY CLUB MRI ENGINEERING CENTER |
FRANCIS LEE |
| K030009 |
04/02/2003 |
KSEA POWERSHAVER SYSTEM S2 |
KARL STORZ ENDOSCOPY |
RENATE A MACLAREN |
| K030385 |
04/15/2003 |
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR |
KAWASUMI LABORATORIES AMERICA, INC. |
JACK PAVLO |
| K030959 |
04/25/2003 |
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 |
LASER PERIPHERALS LLC. |
JEFFREY M STEIN |
| K030362 |
04/14/2003 |
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K030893 |
04/02/2003 |
LEVO COMBI |
LEVO AG |
THOMAS RAEBER |
| K030422 |
04/14/2003 |
LINA-BAG, MODELS LB-60, LB-100 |
LINA MEDICAL CML APS |
NIELS KORNERUP |
| K030203 |
04/21/2003 |
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER |
LONG WELL ELECTRONICS CORP. |
JENNIFER REICH |
| K030147 |
04/15/2003 |
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS |
LUMENIS, LTD. |
ANNA WORDEN |
| K030323 |
04/02/2003 |
MRI-CADDY |
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH |
ROBERT N CLARK |
| K021876 |
04/08/2003 |
MAS WITH OR WITHOUT SYRINGE |
MARINA MEDICAL INSTRUMENTS, INC. |
JAY MANSOUR |
| K030905 |
04/09/2003 |
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER |
MEDAMICUS, INC. |
KARYL HASKELL |
| K030270 |
04/11/2003 |
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON |
MEDCOMP |
MEGHAN J TINTLE |
| K030942 |
04/28/2003 |
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K023231 |
04/04/2003 |
ELFCARE DEVICE, MODELS 314A THROUGH 314G |
MEDISEB LTD. |
AHAVA STEIN |
| K023621 |
04/10/2003 |
BIOFLEX PROFESSIONAL THERAPY SYSTEM |
MEDITECH INTERNATIONAL, INC. |
RICHARD KEEN |
| K030696 |
04/11/2003 |
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K030735 |
04/18/2003 |
MODIFIED VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K030736 |
04/02/2003 |
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K023553 |
04/22/2003 |
MASTERGRAFT MATRIX |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K030779 |
04/24/2003 |
5F MEDTRONIC LAUNCHER GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K031003 |
04/11/2003 |
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
| K030888 |
04/02/2003 |
EVA EMPTY SOLUTION CONTAINER |
METRIX CO. |
JAMES J OLDHAM |
| K030880 |
04/18/2003 |
VECTORSONIC, MODEL VU-270 |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVE TOMAN |
| K030110 |
04/03/2003 |
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K030940 |
04/09/2003 |
NOMAD ND1000M AUGMENTED VISION SYSTEM |
MICROVISION INCORPORATED |
KARL BYLUND |
| K030416 |
04/14/2003 |
CERACAST-V |
MOUNTAIN MEDICO, INC. |
PAUL C CHANG |
| K030823 |
04/09/2003 |
ALGO 3I NEWBORN HEARING SCREENER |
NATUS MEDICAL, INC. |
RON KOHLHARDT |
| K023234 |
04/17/2003 |
ENDOSCOPIC PLICATION SYSTEM |
NDO SURGICAL, INC. |
ERIC BANNON |
| K030715 |
04/24/2003 |
SAFFRON NM GUIDING CATHETER |
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED |
RAYMOND LIN |
| K030918 |
04/01/2003 |
SUPEROPEN 0.35T, MODEL NSM-P035 |
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. |
WANG ZHIQIANG |
| K020754 |
04/21/2003 |
NICOLET PIONEER TC8080 |
NICOLET BIOMEDICAL |
Gary Syring |
| K021978 |
04/08/2003 |
PETIT SOPHIA |
NISHITOMO CO., INC. |
LLOYD DUPLANTIS |
| K023623 |
04/22/2003 |
NOVAVISION, MODEL 2.0 |
NOVAVISION, INC. |
SANDRA J.P. DENNIS |
| K030471 |
04/17/2003 |
OPHTEC ENCLAVATION NEEDLE |
OPHTEC USA |
RICK MCCARLEY |
| K023676 |
04/24/2003 |
APPLANATION TONOMETER |
OPTILASA S.L. |
JOSE M BOBES |
| K030235 |
04/23/2003 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
RENE VAN DE ZANDE |
| K023308 |
04/14/2003 |
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
| K024300 |
04/03/2003 |
MICROCAP PLUS/NPB-75 |
ORIDION MEDICAL 1987 LTD. |
SANDY BROWN |
| K030619 |
04/01/2003 |
ODI 7.0MM CANNULATED SCREW SYSTEM |
ORTHOPEDIC DESIGNS, INC. |
PATRICK J COSGROVE |
| K030208 |
04/16/2003 |
IMBIBE II SYRINGE |
ORTHOVITA, INC. |
ANDREINA IDE |
| K022277 |
04/01/2003 |
OSTEOMED CRANIAL FLAP FIXATION SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K020418 |
04/29/2003 |
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES |
P.T. GREENLEAF |
GEORGE O'NEIL |
| K030603 |
04/14/2003 |
PROANGLE DISPOSABLE PROPHY ANGLE |
PAC-DENT INTERNATIONAL (SUZHOU), LTD. |
XU WANG |
| K030620 |
04/14/2003 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K024170 |
04/14/2003 |
L1 SYSTEM |
PELIKAN TECHNOLOGIES, INC |
JACK GREEN |
| K023818 |
04/03/2003 |
FIBERFILL AGP |
PENTRON CLINICAL TECHNOLOGIES |
ANNMARIE TENERO |
| K030447 |
04/14/2003 |
AT HOME DRUG CUP, MODEL 9150X |
PHAMATECH |
CARL MONGIOVI |
| K022950 |
04/18/2003 |
MINIPHYSIONIZER 2.0 AND ELECTRODES |
PHYSION, INC. |
ERIC J NEMETH |
| K030971 |
04/24/2003 |
MODIFICATION TO MODULAR PLUS REVISION STEM |
PLUS ORTHOPEDICS |
J.D. WEBB |
| K030457 |
04/08/2003 |
REX, VERSION 3.0 |
POINTDX, INC |
FRANCIS BONK |
| K023860 |
04/28/2003 |
MICROALBUMIN REAGENT SET AND CALIBRATORS |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K030061 |
04/07/2003 |
PS 3000 DIGATAL PHOTOSPOT SYSTEM |
PRECISE OPTICS |
RICHARD KEEN |
| K023991 |
04/28/2003 |
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 |
PRECISION BIOLOGIC |
STEPHEN L DUFF |
| K030283 |
04/22/2003 |
BABY POD |
PRISM ENTERPRISES, INC. |
ELAINE DUNCAN |
| K030826 |
04/03/2003 |
PRECISET DAT AMPHETAMINE |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
| K030882 |
04/04/2003 |
RABBIT MOBILE STANDING FRAME |
R82 A/S |
KIRK L MACKENZIE |
| K030697 |
04/04/2003 |
RADIONICS SINGLE USE GROUND PAD (DGP-HP) |
RADIONICS, INC. |
KEVIN J O'CONNELL |
| K030772 |
04/11/2003 |
RDI EXTENDED RANGE CRP CALIBRATOR SET |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K030798 |
04/09/2003 |
MIRAGE ACTIVA MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K023847 |
04/30/2003 |
HEMO-STREAM HEMODIALYSIS CATHETER SET |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K030967 |
04/21/2003 |
RITA STARBURST SDE ELECTROSURGICAL DEVICE |
RITA MEDICAL SYSTEMS |
ERIN MAZZONE |
| K030936 |
04/01/2003 |
RITA CLIPS FOR INFUSION PUMPS |
RITA MEDICAL SYSTEMS INC |
VICKI HACKER |
| K030740 |
04/01/2003 |
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K030213 |
04/11/2003 |
ONLINE DAT II CANNABINOIDS II |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K030428 |
04/28/2003 |
ROCHE ONLINE TDM PHENYTOIN |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K031022 |
04/14/2003 |
PROTEC-TOP, STERIDENT, BENTO |
RONPAK, INC. |
THOMAS A AUGURT |
| K030437 |
04/10/2003 |
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM |
SALTON, INC. |
GEORGIA C RAVITZ |
| K024237 |
04/14/2003 |
URINE MONOVETTE BORIC ACID |
SARSTEDT, INC. |
PETER RUMSWINKEL |
| K030382 |
04/01/2003 |
SELITHERM, MODEL C100 |
SELICOR, INC. |
JAMES B BINGHAM |
| K030943 |
04/22/2003 |
MODIFICATION TO HIOX |
SENSOR MEDICS CORP. |
EARL W DRAPER |
| K030405 |
04/28/2003 |
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 |
SERADYN |
LES PADILLA |
| K030094 |
04/01/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
GLORIA CHANG |
| K030982 |
04/08/2003 |
SYNGO COLONOGRAPHY SOFTWARE PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K022793 |
04/08/2003 |
TETRIS SPINAL IMPLANT |
SIGNUS MEDICAL LLC. |
ANN QUINLAN-SMITH |
| K030233 |
04/25/2003 |
TRAVELSOME STANDARD |
SIM ITALIA S.R.L. |
SUSAN D GOLDSTEIN-FALK |
| K022864 |
04/11/2003 |
SK MED M201 MIXER |
SK MED |
DIPAK GHOSH |
| K030890 |
04/04/2003 |
SWITCHBLADE |
SNOWDEN PENCER, INC. |
DAVID J BOOTH |
| K030949 |
04/07/2003 |
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL HOFFMAN |
| K030568 |
04/24/2003 |
RADII |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K030516 |
04/17/2003 |
RIVA-SELF CURE |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K030548 |
04/04/2003 |
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
ST. SHINE OPTICAL CO., LTD. |
GAROLD L EDWARDS |
| K023096 |
04/10/2003 |
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM |
STD MFG., INC. |
STEVE EK |
| K021802 |
04/08/2003 |
STEREOTAXIS CATHETER ADVANCER SYSTEM |
STEREOTAXIS, INC. |
GARY M RAUVOLA |
| K030072 |
04/10/2003 |
EVERSTICK PERIO |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K030885 |
04/18/2003 |
MODIFICATION TO STRYKER PAINPUMP2 |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K030414 |
04/09/2003 |
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K030176 |
04/17/2003 |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT |
SURETEX, LTD. |
CYNTHIA A INGRAM |
| K030186 |
04/14/2003 |
POLRIS LV |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K030879 |
04/24/2003 |
VERITAS COLLAGEN MATRIX |
SYNOVIS SURGICAL INNOVATIONS |
ANGELA MALLERY |
| K030858 |
04/04/2003 |
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS |
SYNTHES (USA) |
LISA M BOYLE |
| K030866 |
04/18/2003 |
SYNTHES ANTERIOR CSLP SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K030390 |
04/01/2003 |
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE |
SYNTHES (USA) |
BONNIE SMITH |
| K030069 |
04/08/2003 |
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
| K030310 |
04/22/2003 |
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K030334 |
04/21/2003 |
T-SCIENTIFIC T-PAD |
T-SCIENTIFIC, INC. |
DENNIS METCALF |
| K030404 |
04/24/2003 |
C. DIFFICILE TOX A/B II |
TECHLAB, INC. |
DAVID A WALL |
| K030704 |
04/21/2003 |
IBD-QUIK CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K030165 |
04/16/2003 |
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM |
THERMATREK |
DAVID R BALZER |
| K023947 |
04/17/2003 |
GC OIA |
THERMO BIOSTAR, INC. |
JOHN G ADAMS |
| K030791 |
04/17/2003 |
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) |
TINNITECH LTD |
LACHLAN JAMES |
| K030272 |
04/25/2003 |
FLAT PANEL DISPLAY, ME183L |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K030276 |
04/25/2003 |
FLAT PANEL DISPLAYS, CDL SERIES |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K030274 |
04/25/2003 |
MEDICAL FLAT PANEL DISPLAY, ME315L |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K021421 |
04/18/2003 |
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE |
TZ MEDICAL, INC. |
MADALYN DUNCAN |
| K030870 |
04/09/2003 |
WBR, MODEL HR |
U.C.G. TECHNOLOGIES LTD. |
DAN LAOR |
| K030650 |
04/14/2003 |
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS |
URIDYNAMICS, INC. |
MYRON RAPKIN |
| K031091 |
04/23/2003 |
VTI 20 MHZ GATED DOPPLER |
VASCULAR TECHNOLOGY INCORPORATED |
DAVID L REGAN |
| K030999 |
04/09/2003 |
EPTFE VASCULAR PROSTHESIS; SEALPTFE |
VASCUTEK LTD. |
STEVEN ARICK |
| K030783 |
04/04/2003 |
FRONTIER MODEL X5 |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
| K023939 |
04/17/2003 |
VELOCITY ADVANTAGE |
VISION CARE DEVICES, INC. |
CHET CRACCHIOLO |
| K021939 |
04/22/2003 |
VITALCARE FOLEY CATHETER |
VITALCARE, INC. |
MICHAEL MCAVENIA |
| K021938 |
04/22/2003 |
VITALCARE URETHRAL CATHETER |
VITALCARE, INC. |
MICHAEL MCAVENIA |
| K023872 |
04/10/2003 |
VITALCARE URETHRAL CATHETER RED RUBBER |
VITALCARE, INC. |
MICHAEL MCAVENIA |
| K030231 |
04/18/2003 |
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON |
VITALCOR, INC. |
WILLIAM HUCK |
| K023311 |
04/09/2003 |
LOOP MICROWAVE ABLATION PROBE |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K030782 |
04/21/2003 |
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W. L. GORE & ASSOCIATES, INC. |
MIKE JOHNSON |
| K030402 |
04/17/2003 |
ARTHROSCOPY PUMP, MODEL A107 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K022449 |
04/10/2003 |
HYSTEREOSCOPY PUMP HM4 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K030320 |
04/11/2003 |
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K030707 |
04/04/2003 |
WU'S POWERED WHEELCHAIR, MAMBO 3 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K030709 |
04/04/2003 |
WU'S POWERED WHEELCHAIR, MAMBO 5 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K023672 |
04/29/2003 |
X O ODONTOSURGE 4 |
XO CARE A/S |
JAMES DIEROFF |
| K030764 |
04/24/2003 |
Z-BOX |
Z-KAT, INC. |
CHRISTINA VANCE |
| K030153 |
04/01/2003 |
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 |
ZIMMER, INC. |
KAREN CAIN |
