| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K021445 |
06/06/2002 |
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE |
AB BIODISK |
ANNE BOLMSTROM |
| K020866 |
06/11/2002 |
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
DONNA K TEMPLEMAN |
| K012701 |
06/12/2002 |
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) |
ACCUMETRICS, INC. |
RHONDA MOE |
| K021669 |
06/05/2002 |
PHYSICIAN'S DESKTOP REVIEW |
ADAC LABORATORIES |
COLEEN COLEMAN |
| K021518 |
06/06/2002 |
PAINDOC |
ADVANCED NEUROMODULATION SYSTEMS |
RASHMI MOZA |
| K021008 |
06/20/2002 |
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K021423 |
06/17/2002 |
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K012645 |
06/24/2002 |
REPROCESSED EBI EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012623 |
06/24/2002 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012648 |
06/24/2002 |
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012634 |
06/24/2002 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
| K014040 |
06/03/2002 |
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS |
ALTUS MEDICAL, INC. |
KATHY MAYNOR |
| K021072 |
06/06/2002 |
FILMSAVER, NT VERSION 5.03 |
AMERICAN MEDICAL RESOURCES, LTD. (AMR) |
ELIZABETH N FAULSTICH |
| K011592 |
06/19/2002 |
OXYGEN TREATMENT HOOD |
AMRON INTERNATIONAL DIVING SUPPLY, INC. |
NORMA F OCKWIG |
| K021700 |
06/04/2002 |
ANIMUS EZSERTER INFUSION SET INSERTER |
ANIMAS CORP. |
RICHARD MICHELIN |
| K021754 |
06/28/2002 |
APEX MEDICAL DIGITAL EMS TS1311, TS1312 |
APEX MEDICAL CORP. |
ALAN CHANG |
| K021755 |
06/12/2002 |
APEX MEDICAL DIGITAL TENS TS1211, TS1212 |
APEX MEDICAL CORP. |
ALAN CHANG |
| K020296 |
06/25/2002 |
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 |
APOTHECARY PRODUCTS, INC. |
GREG LARSON |
| K021412 |
06/07/2002 |
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K021462 |
06/06/2002 |
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K021567 |
06/19/2002 |
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 |
ARROW INTL., INC. |
WILLIAM G MCLAIN |
| K021519 |
06/06/2002 |
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K021640 |
06/19/2002 |
HANSATOME EXCELLUS MICROKERATOME |
BAUSCH & LOMB, INC. |
DENNIS POZZO |
| K020666 |
06/24/2002 |
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML |
BAXTER HEALTHCARE CORP. |
ARLENE VIDOR |
| K014088 |
06/07/2002 |
DUPLOREACH |
BAXTER HEALTHCARE CORP. |
ARLENE VIDOR |
| K021535 |
06/27/2002 |
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K021532 |
06/27/2002 |
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
| K020739 |
06/03/2002 |
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR |
BCI, INC. |
DONALD J ALEXANDER |
| K021150 |
06/11/2002 |
COULTER CELLPREP |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K021229 |
06/28/2002 |
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 |
BECKMAN COULTER, INC. |
BRUCE BACKLUND |
| K020834 |
06/12/2002 |
BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LASLIE WOOD |
| K021801 |
06/27/2002 |
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K020835 |
06/12/2002 |
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K013790 |
06/11/2002 |
CALCIGEN-S BONE VOID FILER |
BIOMET ORTHOPEDICS, INC. |
PATRICIA S BERES |
| K021799 |
06/26/2002 |
CEMENTED FEMORAL HEAD RESURFING DEVICE |
BIOMET ORTHOPEDICS, INC. |
PATRICIA SANDBORN BERES |
| K021832 |
06/26/2002 |
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER |
BIOMET, INC. |
SARA B SHULTZ |
| K021559 |
06/05/2002 |
ASCENT ALL-POLY PS TIBIAL BEARINGS |
BIOMET, INC. |
DALENE T BINKLEY |
| K021621 |
06/05/2002 |
FIXED BEARING UNI COMPONENT |
BIOMET, INC. |
DALENE T BINKLY |
| K021260 |
06/05/2002 |
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM |
BIOMET, INC. |
SARA B SHULTZ |
| K021930 |
06/25/2002 |
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL |
BIONOSTICS, INC. |
KATHY STORRO |
| K021924 |
06/24/2002 |
MEDICA EASYQC HEMATOCRIT CONTROL |
BIONOSTICS, INC. |
KATHY STORRO |
| K020056 |
06/26/2002 |
DUET SUTURE ANCHOR |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K021684 |
06/26/2002 |
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
CAROL E JONES |
| K014247 |
06/03/2002 |
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K020821 |
06/03/2002 |
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K021833 |
06/10/2002 |
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM |
BLUE SKY BIO |
ALBERT ZICKMANN |
| K021721 |
06/20/2002 |
EQUALIZER BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K021494 |
06/06/2002 |
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K020860 |
06/06/2002 |
M3 (MICRO-MULTILEAF COLLIMATOR) |
BRAINLAB AG |
STEFAN VILSMEIER |
| K013032 |
06/04/2002 |
PHYSIOLOG, SERIES 95000 |
CAMTRONICS, LTD. |
SCOTT J PEASE |
| K020958 |
06/21/2002 |
CANDELA CBEAM PULSED DYE LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
| K021484 |
06/14/2002 |
HEMOGLOBIN A1C CONTROL |
CANTERBURY SCIENTIFIC LTD. |
MAURICE OWEN |
| K021160 |
06/12/2002 |
DERMMATRIX SURGICAL MESH |
CARBON MEDICAL TECHNOLOGIES, INC. |
KAREN E PETERSON |
| K013593 |
06/24/2002 |
CARDEON AEGIS CATHETER |
CARDEON CORP. |
JANE BEGGS |
| K020487 |
06/04/2002 |
CARESIDE ALT |
CARESIDE, INC. |
KENNETH B ASARCH |
| K021787 |
06/21/2002 |
VISUCAM |
CARL ZEISS OPHTHALMIC SYSTEMS, INC. |
DIONNE N LABATORE |
| K021704 |
06/06/2002 |
VAXCEL PICC WITH PASV VALVE TECHNOLOGY |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K020803 |
06/10/2002 |
CEFAR MEDICAL AB CEFAR PRIMO |
CEFAR MEDICAL AB |
CONSTANCE G BUNDY |
| K021129 |
06/03/2002 |
CHARE CARIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
DAVE HERNON |
| K013733 |
06/03/2002 |
SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET |
CHF SOLUTIONS, INC. |
DIANNA THOMSEN |
| K021480 |
06/27/2002 |
EXTENSION SET LIGHT-SAFE, MODEL BC565 |
CODAN US CORP. |
MARILYN R POURAZAR |
| K020211 |
06/28/2002 |
BODY FORCE, MODEL BT 6000 |
COMPOSITES SOLUTIONS, INC. |
RANDY SISK |
| K021299 |
06/26/2002 |
CONMED HEATWAVE HAND-CONTROLLED ELETRODE |
CONMED CORP. |
IRA D DUESLER |
| K013814 |
06/21/2002 |
ABSORBENT ANTIMICROBIAL WOUND DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
DEMETRIOS KYDONIEUS |
| K010952 |
06/10/2002 |
SURGISIS GUIDED TISSUE REGENERATION MATRIX |
COOK BIOTECH, INC. |
MARK BLEYER |
| K021743 |
06/10/2002 |
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K021345 |
06/28/2002 |
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM |
CORDIS CORP. |
KAREN WILK |
| K021593 |
06/13/2002 |
MODIFICATION TO ENVOY AND VISTA BRITE TIP |
CORDIS CORP. |
STEPHEN M ENOS |
| K020776 |
06/03/2002 |
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS |
CORONET GROUP NORTH AMERICA, LLC. |
THOMAS E FERARI |
| K020980 |
06/21/2002 |
DIMENSION TPSA CALIBRATOR, MODEL #RC459 |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K020410 |
06/11/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K021381 |
06/10/2002 |
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 |
DADE BEHRING, INC. |
DONNA A WOLF |
| K020979 |
06/27/2002 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K021018 |
06/11/2002 |
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021181 |
06/17/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021111 |
06/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021110 |
06/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021188 |
06/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021184 |
06/20/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021078 |
06/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K020938 |
06/03/2002 |
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K021169 |
06/06/2002 |
MICROSTREP PLUS PANEL, AZITHROMYCIN |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K013896 |
06/19/2002 |
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA |
DEFIBTECH, LLC |
GINTARAS VAISNYS |
| K021378 |
06/07/2002 |
PORTABLE HDX INTRAORAL X-RAY |
DENTALEZ GROUP |
DEON BECK |
| K021879 |
06/26/2002 |
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) |
DEPUY ACROMED |
LISA GILMAN |
| K021880 |
06/26/2002 |
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) |
DEPUY ACROMED |
LISA GILMAN |
| K020753 |
06/13/2002 |
DEROYAL SURGICAL, UMBILICUP |
DEROYAL |
AUDREY DANIELS |
| K021257 |
06/03/2002 |
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K021695 |
06/20/2002 |
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
| K021598 |
06/10/2002 |
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE |
ECI MEDICAL TECHNOLOGIES, INC. |
SHIRANTHA SAMARAPPULI |
| K021100 |
06/18/2002 |
300 PV COMPLETE ELECTROTHERAPY SYSTEM |
EMPI |
SHEILA HEMEON-HEYER |
| K020741 |
06/04/2002 |
UNICONDYLAR KNEE |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K021748 |
06/26/2002 |
ENDIUS ATAVI SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K021010 |
06/06/2002 |
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE |
ENDOCARE, INC. |
EBEN GORDON |
| K020974 |
06/26/2002 |
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER |
ENVIRONMENTAL TECTONICS CORP. |
MICHAEL W ALLEN |
| K020588 |
06/13/2002 |
X-IMAGE DIGITAL X-RAY SYSTEM |
ESCAPE TECHNOLOGY, INC. |
JAY CHOI |
| K020779 |
06/05/2002 |
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
| K021715 |
06/12/2002 |
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL |
EXACTECH, INC. |
GARY J MILLER |
| K021113 |
06/13/2002 |
MAMMOPATH |
FISCHER IMAGING CORP. |
SAMIR B PALIWAL |
| K013977 |
06/14/2002 |
ECHO-SCREEN T, TA, TD, TDA, TC |
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
MICHAEL SOERENSEN |
| K020279 |
06/20/2002 |
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM |
FOREX CORP. |
ROBERT MALONE |
| K021140 |
06/28/2002 |
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT |
FOSSA INDUSTRIES, INC. |
GLORIA KOLB |
| K021109 |
06/12/2002 |
ESOP CO-CR FEMORAL HEADS |
FOURNITURES HOSPITALIERES |
ANDRE WEITH |
| K021030 |
06/25/2002 |
TITANIUM CANNULATED INTERFERENCE SCREW |
FUTURE MEDICAL SYSTEMS, INC. |
PATRICK JANIN |
| K021016 |
06/17/2002 |
AMX-4 PLUS MOBILE X-RAY SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K020560 |
06/19/2002 |
WORKBENCH BY |
GENX INTL., INC. |
MICHAEL D CECCHI |
| K021019 |
06/18/2002 |
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE |
GENZYME CORP. |
MARY GRAY |
| K020205 |
06/24/2002 |
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT |
GETINGE/CASTLE, INC. |
MARK N SMITH |
| K021353 |
06/06/2002 |
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE |
GLORMED INTL., INC. |
JANNA P TUCKER |
| K020603 |
06/13/2002 |
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
| K021043 |
06/21/2002 |
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
| K020891 |
06/17/2002 |
NAKAO SNARE II AND NAKAO SNARE III |
GRANIT MEDICAL INNOVATIONS |
NAOMI L NAKAO |
| K020987 |
06/25/2002 |
BMN I TYPE MARROW ASPIRATION NEEDLE |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
| K021605 |
06/14/2002 |
MEDGEM |
HEALTHETECH, INC. |
GLENN M THIBAULT |
| K021706 |
06/21/2002 |
HORIZONS HOT BIOPSY FORCEPS |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K020772 |
06/05/2002 |
OMEGA II SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K020830 |
06/06/2002 |
SCORPIO INSET PATELLAR COMPONENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K021744 |
06/26/2002 |
T2 FEMORAL NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K011866 |
06/06/2002 |
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES |
HYPERBARIC TECHNOLOGIES, INC. |
DAVE HEANEY |
| K013213 |
06/04/2002 |
HYPERION VISIQUANT ANA TEST KIT |
HYPERION, INC. |
RADHA GOOLABSINGH |
| K020729 |
06/04/2002 |
NLITE SYSTEM,MODEL A00-1051 |
ICN PHOTONICS LTD. |
IAN MORTIMER |
| K021252 |
06/17/2002 |
BLOOD-PRESSURE METER |
IDT TECHNOLOGY LIMITED |
LILY LI |
| K020855 |
06/04/2002 |
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT |
IGEL VISION CARE PTE LTD. |
DEBBIE MCINTIRE |
| K014018 |
06/24/2002 |
CHOLESTEROL 1, 2, 3 |
IMI |
THOMAS M TSAKERIS |
| K021586 |
06/14/2002 |
SECURE RELINE/PICKUP MATERIAL |
IMTEC CORP. |
BRAD VANCE |
| K021036 |
06/26/2002 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 |
INTUITIVE SURGICAL, INC. |
DAVID CASAL |
| K021680 |
06/18/2002 |
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 |
INVACARE CORP. |
RAE ANN FARROW |
| K010156 |
06/19/2002 |
SLEEP PAT 200 DEVICE |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
GEORGE H MYERS |
| K021017 |
06/19/2002 |
LEESPEC DISPOSABLE VAGINAL SPECULUM |
ITL CORPORATION, PTY LTD. |
WILLIAM L MOBBS |
| K021372 |
06/07/2002 |
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K014183 |
06/12/2002 |
AFB (ABSORBABLE FOAM BUTTRESS) |
J&J CORPORATE BIOMATERIALS CENTER |
DAVID A DALESSANDRO |
| K021050 |
06/26/2002 |
KSEA NEUROENDOSCOPES AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K012308 |
06/26/2002 |
KAVO QUATTROCARE |
KAVO AMERICA |
JOHN WESTERMEIER |
| K020764 |
06/03/2002 |
NAVIPRO |
KINAMED, INC. |
VINEET K SARIN |
| K021427 |
06/07/2002 |
CLEARFIL SA PRIMER |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
| K021943 |
06/28/2002 |
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
JOHN E HUGHES |
| K003720 |
06/27/2002 |
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM |
LIFESTREAM PURFICATION SYSTEMS, LLC. |
RICHARD A HAMER |
| K020395 |
06/04/2002 |
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K021449 |
06/18/2002 |
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHIN CHIN CHANG |
| K020368 |
06/04/2002 |
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K013131 |
06/11/2002 |
BIOSCREW XTRALOK |
LINVATEC CORP. |
LAURA D SENEFF |
| K020880 |
06/10/2002 |
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES |
MARKNEW PRODUCTS |
GREG HOLLAND |
| K020971 |
06/06/2002 |
DCM 2.0 |
MDS NORDION AB |
E. S MARTELL |
| K021004 |
06/06/2002 |
VALVED PEELABLE INTRODUCER |
MEDAMICUS, INC. |
KARYL HASKELL |
| K020996 |
06/24/2002 |
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K020999 |
06/20/2002 |
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K021433 |
06/13/2002 |
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL |
MEDICAL ADVANCES, INC. |
JERRY FROHLICH |
| K021168 |
06/26/2002 |
JUMP START, MODEL 970300 |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K020382 |
06/28/2002 |
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA |
MEDICOTEST A/S |
EMALEE G MURPHY |
| K020907 |
06/14/2002 |
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES |
MEDICOTEST A/S |
EMALEE G MURPHY |
| K012969 |
06/12/2002 |
DOUBLE SPRINGERS NONOXNOL 9 CONDOM |
MEDTECH PRODUCTS LTD. |
A. V. K. REDDY |
| K013962 |
06/20/2002 |
EQUATION FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K021066 |
06/18/2002 |
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K021305 |
06/28/2002 |
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K013297 |
06/14/2002 |
AIRCAST, MODEL #3011 |
MILLENIUM REPROCESSING SERVICES, INC. |
GARY J SFEIR |
| K020791 |
06/06/2002 |
HBS HEADLESS BONE SCREW |
MILLENNIUM MEDICAL TECHNOLOGIES, INC. |
DAVID W SCHLERF |
| K021373 |
06/27/2002 |
H12+HOLTER RECORDER |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K020850 |
06/06/2002 |
GPF-29 GENERAL PURPOSE COIL SET |
MRI DEVICES CORP. |
DAVID A MOLYNEAUX |
| K021570 |
06/12/2002 |
HNC-127-TRIO NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K021575 |
06/12/2002 |
OBC-127 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K021811 |
06/19/2002 |
UNIDRIVE II PLUS DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
JAMES A LEE |
| K014282 |
06/26/2002 |
BACSTOP FILTER,BACSTOP FILTER/HME |
MUNKTELL FILTER AB |
PAUL DRYDEN |
| K014281 |
06/26/2002 |
GARD FILTER, COMBIGARD FILTE / HME |
MUNKTELL FILTER AB |
PAUL DRYDEN |
| K021089 |
06/19/2002 |
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K021144 |
06/24/2002 |
SUBDURAL STRIP ELECTRODE |
NICOLET BIOMEDICAL, INC. |
Gary Syring |
| K013309 |
06/24/2002 |
GLUCOPRO EVO INFUSION PUMP |
NIPRO DIABETES SYSTEMS, INC. |
KAELYN B HADLEY |
| K014114 |
06/26/2002 |
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX |
NIPRO DIABETES SYSTEMS, INC. |
KAELYN B HADLEY |
| K021584 |
06/05/2002 |
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM |
NOBEL BIOCARE UAS INC |
RICHARD T ROSS |
| K020297 |
06/10/2002 |
STAT PROFILE CRITICAL CARE XPRESS ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K021823 |
06/17/2002 |
CARDIOSPECT D90/CARDIO CAM |
NUCLEAR CARDIOLOGY SYSTEMS, INC. |
CHARLIE H ROSE |
| K021656 |
06/13/2002 |
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 |
NUCLEAR DIAGNOSTICS |
JAN BERTLING |
| K020853 |
06/13/2002 |
NUVASIVE MESH |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K021288 |
06/27/2002 |
ORS-1000LD |
O.R. SOLUTIONS, INC. |
STEVE HANNES |
| K021289 |
06/26/2002 |
WARMER 2000LD |
O.R. SOLUTIONS, INC. |
STEVE HANNES |
| K013613 |
06/27/2002 |
SOFT PLUG ABSORBABLE PLUG-SA |
OASIS MEDICAL, INC. |
JAMES CHRISTENSEN |
| K020389 |
06/04/2002 |
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES |
RICHARD E LIPPMAN |
| K020335 |
06/18/2002 |
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 |
OLYMPIC MEDICAL CORP. |
EDWARD B (TED) WEILER |
| K021886 |
06/19/2002 |
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K014166 |
06/25/2002 |
UHI-3 HIGH FLOW INSUFFLATION UNIT |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K020800 |
06/10/2002 |
OPTAX SYSTEM |
OPTAX SYSTEMS, INC. |
DEBBIE IAMPIETRO |
| K021502 |
06/06/2002 |
OSCAR, MODEL OE3000 |
ORTHOSONICS, LTD. |
T. WHIT ATHEY |
| K020896 |
06/14/2002 |
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE |
OSYPKA MEDICAL, INC. |
MARKUS J OSYPKA |
| K013041 |
06/11/2002 |
PLEXOLONG SETS |
PAJUNK GMBH |
BURK A BRANDT |
| K020941 |
06/19/2002 |
PALOMAR LUXG HANDPIECE |
PALOMAR |
Marcy Moore |
| K020717 |
06/13/2002 |
EBV V VCA IGM ELISA KIT MODEL# EBM-200 |
PAN BIO PTY. LTD. |
HELEN JERNNINGS |
| K020707 |
06/13/2002 |
EBV-EBNA IGG ELISA KIT, MODEL EBG-100 |
PAN BIO PTY. LTD. |
HELEN JENNINGS |
| K020706 |
06/13/2002 |
EBV-VCA IGG ELISA TEST, MODEL EBG-100 |
PAN BIO PTY. LTD. |
HELEN JENNINGS |
| K021420 |
06/04/2002 |
PARACON II/FECAL CONCENTRATOR II |
PARA SCIENTIFIC CO. |
ERIC CARLSON |
| K020827 |
06/12/2002 |
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT |
PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. |
MARYLOU PANICO |
| K021912 |
06/24/2002 |
M2376 DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
DENISE HADLEY |
| K020364 |
06/04/2002 |
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS |
PHOENIX DIAGNOSTICS, INC. |
RAN NUNNA |
| K021714 |
06/21/2002 |
RT-PLUS PE INSERT CLAMP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K021099 |
06/27/2002 |
REX, VERSION 1.0 |
POINTDX, INC |
ROBERT ANDERSON |
| K021701 |
06/21/2002 |
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K020718 |
06/03/2002 |
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE |
PRECISION DYNAMICS CORP. |
KALYNA SNYLYK |
| K013654 |
06/05/2002 |
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER |
PRECISION SYSTEMS, INC. |
BILL HADEN |
| K014069 |
06/10/2002 |
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014067 |
06/10/2002 |
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014066 |
06/10/2002 |
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K021012 |
06/25/2002 |
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM |
QUALITY MEDICAL SOLUSIONS LLC |
JAY MANSOUR |
| K021683 |
06/21/2002 |
CINESCAN S |
QUANTEL MEDICAL |
GEORGE MYERS |
| K021393 |
06/13/2002 |
PRECISET DAT PLUS |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
| K020856 |
06/13/2002 |
SPATOUCH PHOTOEPILATION SYSTEM |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K012512 |
06/11/2002 |
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM |
RADIANT MEDICAL |
ANDREW CLEELAND |
| K021441 |
06/14/2002 |
RADIUS SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
MAUREEN FINLAYSON |
| K021607 |
06/27/2002 |
RDI HS CRP CALIBRATOR SET |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K021609 |
06/27/2002 |
RDI HS CRP KIT |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K020966 |
06/13/2002 |
RPI REPLACEMENT HEATING ELEMENTS |
REPLACEMENT PARTS INDUSTRIES, INC. |
IRA LAPIDES |
| K021861 |
06/19/2002 |
REMSTAR PRO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K021513 |
06/11/2002 |
ACCU-CHEK ADVANTAGE MODULE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K021448 |
06/03/2002 |
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K020884 |
06/12/2002 |
EXCELLITE LIGHT CURE UNIT |
ROLENCE ENT. INC. |
STERLING CHENG |
| K020877 |
06/12/2002 |
EXCELLITE TURBO LIGHT CURE UNIT |
ROLENCE ENT. INC. |
STERLING CHENG |
| K020874 |
06/12/2002 |
ULTRA-LITE 5 TURBO LIGHT CURE UNIT |
ROLENCE ENT. INC. |
STERLING CHENG |
| K021763 |
06/13/2002 |
RS2MI MUSCLE STIMULATOR FAMILY |
RS MEDICAL |
MICHAEL B MCGRAW |
| K014273 |
06/12/2002 |
ACUSTIM |
S.H.P. INTL. PTY., LTD. |
E.D. RICHARDS |
| K013980 |
06/06/2002 |
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES |
SAFE SHIELD CO. LTD |
SUSAN D GOLDSTEIN-FALK |
| K021667 |
06/11/2002 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE |
SAFEHEALTH MEDICAL SUPPLY CORP. |
P. M YEH |
| K002159 |
06/28/2002 |
SNORE SAT RECORDER, MODEL SS41 |
SAGATECH ELECTRONICS, INC. |
HEATHER PLATT-MELAX |
| K021211 |
06/26/2002 |
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
VINCENT CUTARELLI |
| K021137 |
06/26/2002 |
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM |
SANARUS MEDICAL, INC. |
VICENT CUTARELLI |
| K012232 |
06/07/2002 |
INSIGHT, MODEL S980000 |
SANDHILL SCIENTIFIC, INC. |
LEWIS WARD |
| K021223 |
06/26/2002 |
BELIMED STEAM STERILIZER, MODEL TOP 5000 |
SAUTER AG |
HANS STADLER |
| K021032 |
06/03/2002 |
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
| K021388 |
06/10/2002 |
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM |
SEAL POLYMER INDUSTRIES BHD. |
CHUN CHOOI FONG |
| K021527 |
06/07/2002 |
SECTRA OSTEOPOROSIS PACKAGE |
SECTRA-IMTEC AB |
CARL ALLETTO |
| K020943 |
06/06/2002 |
STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K021506 |
06/06/2002 |
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| K021613 |
06/20/2002 |
NIVEOUS LIQUID DAM |
SHOFU DENTAL CORP. |
ROBERT NOBLE |
| K021220 |
06/06/2002 |
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
SIAM SEMPERMED CORP. LTD. |
JOHN V CALHOUN |
| K014113 |
06/14/2002 |
ENDOMAP |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SANDRA ROBINSON |
| K021021 |
06/06/2002 |
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SANDRA ROBINSON |
| K020991 |
06/13/2002 |
SYNGO MR 2002B |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K020836 |
06/11/2002 |
RABEA CEMENT RESTRICTOR |
SIGNUS MEDICAL LLC. |
ANN QUINLAN-SMITH |
| K021673 |
06/11/2002 |
TOTAL HIP FEMORAL HEAD - 12/14 TAPER |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K010132 |
06/04/2002 |
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 |
SOADCO, S.L. |
MERCEDES ROLDAN |
| K020959 |
06/19/2002 |
GLO-SPEC I, II AND III |
SOL WEISS MD INC |
SOL WEISS |
| K020915 |
06/14/2002 |
SOPRO LIGHT SOURCES AND ACCESSORIES |
SOPRO |
PIERRE MONTILLOT |
| K014211 |
06/11/2002 |
OXYARM CO2 |
SOUTHMEDIC, INC. |
PAUL E DRYDEN |
| K021097 |
06/28/2002 |
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 |
SPACELABS MEDICAL, INC. |
EDWARD M BASILE |
| K021009 |
06/18/2002 |
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K021295 |
06/04/2002 |
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
ST. SHINE OPTICAL CO., LTD. |
Kevin Walls |
| K020378 |
06/21/2002 |
QUPID PLUS E.R. |
STANBIO LABORATORY |
KIRK JOHNSON |
| K021006 |
06/10/2002 |
STARTOX DRUG OF ABUSE SCREENING TEST |
STARPLEX SCIENTIFIC, INC. |
FRAN WHITE |
| K021741 |
06/26/2002 |
CRITERTION, MODEL #1067511 |
STERNGOLD |
MARIA RAO |
| K021045 |
06/26/2002 |
ERA IMPLANT |
STERNGOLD |
MARIA RAO |
| K021922 |
06/25/2002 |
MODIFICATION TO PARA 5X |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K013022 |
06/13/2002 |
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS |
SULZER CARBOMEDICS, INC. |
LISA PETERSON |
| K021729 |
06/21/2002 |
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K021463 |
06/06/2002 |
MODEL 1133 IVD PC VERSION |
SUN NUCLEAR CORP. |
JIM MIXON |
| K020932 |
06/28/2002 |
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR |
SUNRISE MEDICAL |
RAY HOFFMAN |
| K020900 |
06/03/2002 |
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM |
SUNRISE MEDICAL HHG, INC. |
JOE MITCHELL |
| K020329 |
06/19/2002 |
DEVILBISS PD1000 |
SUNRISE MEDICAL HHG, INC. |
BRIAN HERSHEY |
| K012667 |
06/03/2002 |
REPROCESSED ARTHROSCOPIC SHAPERS |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
ROBERT S MCQUATE |
| K012669 |
06/27/2002 |
REPROCESSED ELECTROSURGICAL ELECTRODES |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
ROBERT S MCQUATE |
| K021797 |
06/27/2002 |
L.E.DEMETRON |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K021298 |
06/19/2002 |
ELEMENTS DIAGNOSTIC UNIT |
SYBRON ENDO/ANALYTIC |
COLLEEN BOSWELL |
| K021850 |
06/10/2002 |
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS |
SYNTHES (USA) |
MATTHEW M HULL |
| K020872 |
06/12/2002 |
SYNTHES 3.5 MM BROAD LC-DCP PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
| K021241 |
06/25/2002 |
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I |
SYSMEX CORPORATION OF AMERICA |
NINA M GAMPERLING' |
| K014009 |
06/24/2002 |
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE |
TANITA CORP. OF AMERICA |
CAROL ALLOIAN (BENSON) |
| K013321 |
06/04/2002 |
SILICONE TRACHEAL T-TUBES |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
| K020783 |
06/07/2002 |
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB |
TELESIS TECHNOLOGIES INC. |
Ke-Min Jen |
| K021020 |
06/10/2002 |
TERUMO GAS FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K020967 |
06/20/2002 |
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
STEVE ARICK |
| K020985 |
06/25/2002 |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
TFX MEDICAL, INC. |
RICK LYKINS |
| K021034 |
06/26/2002 |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
TFX MEDICAL, INC. |
RICK LYKINS |
| K021081 |
06/17/2002 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K020539 |
06/20/2002 |
TIPOWER POWERDRIVE AND RIMPOWER X & SX |
TISPORT |
SANDRA GLADSTONE |
| K020639 |
06/20/2002 |
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER |
TISPORT |
SANDRA GLADSTONE |
| K020736 |
06/03/2002 |
TRAATEK COTTONOID PATTIES |
TRAATEK, INC. |
TERRY JOHNSTON |
| K021627 |
06/20/2002 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K013902 |
06/05/2002 |
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
| K020630 |
06/13/2002 |
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
KEN SETO |
| K021632 |
06/13/2002 |
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C |
URESIL, L.P. |
CHARLES P GILL |
| K021141 |
06/27/2002 |
MILLENNIUM 5000 MEUROVASCULAR COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K020969 |
06/05/2002 |
VACURECT VACUUM CONSTRICTION DEVICE |
VACURECT MANUFACTURING (PTY) LTD. |
MARY MCNAMARA-CULLINANE |
| K020857 |
06/14/2002 |
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER |
VASOMEDICAL, INC. |
THOMAS R VARRICCHIONE |
| K021866 |
06/14/2002 |
KARMA 800 SERIES MANUAL WHEELCHAIR |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
| K020957 |
06/13/2002 |
ORACAM |
VIDEO DENTAL CONCEPTS, INC. |
CLAUDE D BERTHOIN |
| K021290 |
06/28/2002 |
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 |
VISTA MEDICAL TECHNOLOGIES, INC. |
GRAHAM BAILLIE |
| K011676 |
06/18/2002 |
VIVAWAVE MICROWAVE SYSTEM |
VIVANT MEDICAL, INC. |
STEVEN KIM |
| K020711 |
06/03/2002 |
WALLACH LOOP ELECTRODE |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
| K021756 |
06/27/2002 |
WELCH ALLYN ABPM 6100 |
WELCH ALLYN, INC. |
DAVID KLEMENTOWSKI |
| K021733 |
06/26/2002 |
AUTOPAL 50 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
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06/05/2002 |
ENDOSCOPIC LIGHT SOURCE XL202/L3 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K020869 |
06/11/2002 |
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) |
WORLDWIDE MEDICAL CORP. |
FRANCISCO J ROJAS |
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06/10/2002 |
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR |
WRP SPECIALTY PRODUCTS SDN. BHD. |
V. NADARAJAN |
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06/11/2002 |
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O |
WRP SPECIALTY PRODUCTS SDN. BHD. |
V. NADARAJAN |
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06/26/2002 |
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM |
ZAP LASERS, LLC |
JAY GOBLE |
