| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K983788 |
11/25/1998 |
AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K983259 |
11/25/1998 |
SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE |
AB BIODISK |
ANNE BOLMSTROM |
| K983252 |
11/20/1998 |
SYSTEM U3 FOR GENTAMICIN |
AB BIODISK NORTH AMERICA, INC. |
ANNE BOLMSTROM |
| K983439 |
11/20/1998 |
ABBOTT ARCHITECT FREE T3 |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
| K983417 |
11/20/1998 |
ABBOTT ARCHITECT FREE T4 |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
| K983212 |
11/18/1998 |
ABBOTT ARCHITECT TESTOSTERONE |
ABBOTT LABORATORIES |
KAREN L GATES |
| K983434 |
11/20/1998 |
ABBOTT ARCHITECT TOTAL T3 |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
| K983440 |
11/25/1998 |
ABBOTT ARCHITECT TOTAL T4 |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
| K983442 |
11/20/1998 |
ABBOTT ARCHITECT TSH |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
| K983848 |
11/16/1998 |
ABBOTT AXSYM MYOGLOBIN |
ABBOTT LABORATORIES |
LAURA L GRANITZ |
| K983838 |
11/20/1998 |
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP |
ABBOTT LABORATORIES |
JERRY JENNINGS |
| K982362 |
11/18/1998 |
ABBOTT TESTPACK PLUS H. PYLORI |
ABBOTT LABORATORIES |
Irene Powers |
| K983441 |
11/04/1998 |
C3 |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983356 |
11/04/1998 |
C4 |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983359 |
11/04/1998 |
IGA |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983221 |
11/04/1998 |
IGG |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983132 |
11/04/1998 |
IGM |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983167 |
11/04/1998 |
TRF |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K983301 |
11/25/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K981526 |
11/06/1998 |
ACE ALVEOLAR DISTRACTOR |
ACE SURGICAL SUPPLY CO., INC. |
EDWARD J CARCHIDI |
| K983405 |
11/06/1998 |
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50 |
ACEME TECHNOLOGIES INTL. |
TONG ZHOU |
| K983407 |
11/06/1998 |
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F |
ACEME TECHNOLOGIES INTL. |
TONG ZHOU |
| K983090 |
11/18/1998 |
ACON MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
PATRICIA E BONNESS |
| K982911 |
11/16/1998 |
FORTE |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K983278 |
11/25/1998 |
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) |
ALDEN OPTICAL LABS., INC. |
MARTIN DALSING |
| K982315 |
11/18/1998 |
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY |
ALEXON - TREND, INC. |
KEN HOOD |
| K983150 |
11/25/1998 |
COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K983460 |
11/12/1998 |
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER |
AMERICAN BIOPRODUCTS CO. |
ANDREW LOC B LE |
| K983049 |
11/18/1998 |
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER |
AMERICAN ELECTROMEDICS CORP. |
FRANK FERGUSON |
| K983048 |
11/17/1998 |
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER |
AMERICAN ELECTROMEDICS CORP. |
FRANK FERGUSON |
| K983051 |
11/18/1998 |
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER |
AMERICAN ELECTROMEDICS CORP. |
FRANK FERGUSON |
| K983046 |
11/17/1998 |
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER |
AMERICAN ELECTROMEDICS CORP. |
FRANK FERGUSON |
| K982218 |
11/30/1998 |
NITRILE POWDER-FREE UNISEAL GLOVES |
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
TARANI DEVI |
| K981979 |
11/30/1998 |
UNISEAL GLOVES LOW PROTEIN POWDERED |
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
TARANI DEVI |
| K983191 |
11/18/1998 |
DBEST COCAINE TEST KIT |
AMERITEK, INC. |
K C YEE |
| K983189 |
11/18/1998 |
DBEST METHAMPHETAMINES TEST KIT |
AMERITEK, INC. |
K C YEE |
| K983190 |
11/18/1998 |
DBEST OPIATES TEST KIT |
AMERITEK, INC. |
K C YEE |
| K983188 |
11/18/1998 |
DBEST TETRAHYDROCANNABINOL TEST KIT |
AMERITEK, INC. |
K C YEE |
| K983428 |
11/16/1998 |
SAFETEX CERVICAL SCRAPER (PLASTIC) |
ANDWIN SCIENTIFIC |
NATALIE SARRAF |
| K982453 |
11/30/1998 |
NON-STERILE E.P. LATEX EXAMINATION GLOVE |
ANSELL PERRY |
JAMES R CHATTERTON |
| K983111 |
11/16/1998 |
XRAY VISION |
APTERYX, INC. |
KEVIN CRUES |
| K974738 |
11/19/1998 |
ASTRA TECH IMPLANT DENTAL SYSTEM |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
| K983218 |
11/06/1998 |
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K983108 |
11/27/1998 |
SUTURE WELDING SYSTEM AND KIT (SWK) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K973322 |
11/10/1998 |
DIAPACT CRRT |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K983619 |
11/02/1998 |
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER |
BARCHENS CO. |
SUSAN D GOLDSTEIN-FALK |
| K983894 |
11/18/1998 |
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
DENNIS HAHN |
| K982775 |
11/03/1998 |
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K981909 |
11/24/1998 |
BAXTER HEMOSTASIS VALVE INTRODUCERS |
BAXTER EDWARDS |
SCOTT BEGGINS |
| K983294 |
11/03/1998 |
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 |
BAXTER HEALTHCARE CORP. |
LINDA COLEMAN |
| K983981 |
11/20/1998 |
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE |
BEAR MEDICAL SYSTEMS, INC. |
DARRYL SHELBY |
| K983895 |
11/25/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K983151 |
11/05/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K983209 |
11/04/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K983975 |
11/30/1998 |
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) |
BELMONT INSTRUMENT CORP. |
URAIWAN LABADINI |
| K981802 |
11/25/1998 |
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K983913 |
11/25/1998 |
MODIFICATION TO BIO-LOGIC SLEEPSCAN |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K984070 |
11/25/1998 |
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 |
BIO-RAD |
ELIZABETH PLATT |
| K983578 |
11/12/1998 |
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984073 |
11/25/1998 |
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984074 |
11/20/1998 |
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984072 |
11/24/1998 |
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 |
BIO-RAD |
ELIZABETH PLATT |
| K983602 |
11/12/1998 |
CV PERI-GUARD AND VASCU-GUARD |
BIO-VASCULAR, INC. |
DIANNA L GECK |
| K983581 |
11/06/1998 |
OCU-GUARD AND OCU-GUARD SUPPLE |
BIO-VASCULAR, INC. |
DIANNA L GECK |
| K981666 |
11/03/1998 |
2.5 MM LACTOSORB SCREWS |
BIOMET, INC. |
MARY VERSTYNEN |
| K983035 |
11/23/1998 |
CUSTOM FLANGED ACETABULAR COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K981651 |
11/25/1998 |
AB FLU OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K983185 |
11/12/1998 |
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K983469 |
11/25/1998 |
PRECISET SERUM PROTEINS CALIBRATOR |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K982840 |
11/09/1998 |
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING |
BOSTON SCIENTIFIC CORP. |
DONNA K TEMPLEMAN |
| K983480 |
11/23/1998 |
BPOS-IVAD STABILIZER |
BPOS, INC. |
TERRY SHAFFER |
| K983736 |
11/10/1998 |
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
SUSAN D GOLDSTEIN-FALK |
| K982043 |
11/09/1998 |
BRENEB |
BREMED ITALIA, S.R.L. |
MARK HEBENSTREIT |
| K982825 |
11/06/1998 |
BRENNEN MEDICAL BETA GLUCAN GEL |
BRENNEN MEDICAL, INC. |
KENNETH B HERLAND |
| K983101 |
11/03/1998 |
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
| K980895 |
11/06/1998 |
ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR |
CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI |
JEFF WHEATON |
| K982985 |
11/02/1998 |
CITREX HOSPITAL SPRAY DISINFECTANT |
CALTECH INDUSTRIES, INC. |
DONALD JOHNSON |
| K983869 |
11/30/1998 |
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH |
CALTECH INDUSTRIES, INC. |
DONALD A JOHNSON |
| K982243 |
11/19/1998 |
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 |
CANOGEN INTERNATIONAL LTD. |
MELISSA MAHALL |
| K981556 |
11/04/1998 |
CANON X-RAY DIGITAL CAMERA CXDI-11 |
CANON U.S.A., INC. |
GLENN IMPAL |
| K982803 |
11/13/1998 |
HEARTLINK, MODEL II |
CARDIAC TELECOM CORP. |
LEE G DENEAULT |
| K983135 |
11/13/1998 |
BLOWER/MISTER |
CARDIOTHORACIC SYSTEMS, INC. |
MIKE BILLIG |
| K982776 |
11/02/1998 |
9303 NEONATAL/ADULT VITAL SIGNS MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K983549 |
11/23/1998 |
QUADRANT ANTERIOR SHINE |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJIN |
| K983545 |
11/18/1998 |
QUADRANT UNIBOND |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJIN |
| K983751 |
11/30/1998 |
QUADRANT UNICHEM |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K983562 |
11/03/1998 |
MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 |
CDC TECHNOLOGIES, INC. |
GEORGE J WALLACE |
| K983585 |
11/06/1998 |
LOW PH PHENOLIC 256 |
CENTRAL SOLUTIONS, INC. |
PAUL J NOBREGA |
| K982829 |
11/06/1998 |
FORTE, MODEL CPS ULTRASOUND |
CHATTANOOGA GROUP, INC. |
JOE ELROD |
| K982830 |
11/06/1998 |
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO |
CHATTANOOGA GROUP, INC. |
JOE ELROD |
| K982828 |
11/06/1998 |
FORTE, MODELS CPS 400 STIM, CPS 200 STIM |
CHATTANOOGA GROUP, INC. |
JOE ELROD |
| K983291 |
11/25/1998 |
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K982168 |
11/17/1998 |
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K980492 |
11/17/1998 |
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) |
CIRCON ACMI |
RONALD J EHMSEN |
| K981412 |
11/23/1998 |
M1145 (UPS1-1.25K-1G-MP) UPS |
CLARY CORP. |
SUSAN D GOLDSTEIN-FALK |
| K983042 |
11/25/1998 |
SWEEN WOUN'DRES |
COLOPLAST CORP. |
HARVEY M ARBIT |
| K982350 |
11/25/1998 |
EA-D IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K982348 |
11/25/1998 |
EBNA-1 IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983390 |
11/18/1998 |
IS-ANTI-MPO IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983740 |
11/18/1998 |
IS-ANTI-PR3 IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K982352 |
11/25/1998 |
VCA IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983771 |
11/12/1998 |
STRATEGY CORONARY WIRE GUIDE |
COOK, INC. |
APRIL LAVENDER |
| K981886 |
11/03/1998 |
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K982280 |
11/25/1998 |
CRYOPRO MAXI AND CRYOPRO MINI |
CORTEX TECHNOLOGY APS |
MARSHA WERTZBERGER |
| K980800 |
11/09/1998 |
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K983020 |
11/25/1998 |
COMPACT KTP LASER |
COSMOS MEDICAL TECHNOLOGY |
JOHN P CLARK |
| K982167 |
11/09/1998 |
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
COULTER CORP. |
MARION S GAIDE |
| K982166 |
11/05/1998 |
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
COULTER CORP. |
MARION S GAIDE |
| K983087 |
11/18/1998 |
BREATHTIQUE TONGUE SCRAPER |
CUSTOM MEDICAL ARTS, INC. |
BARRY GOLDBERG |
| K983181 |
11/16/1998 |
CYTOPREP |
CYTOPREP INC. EST. |
K G PAGANIS |
| K983850 |
11/18/1998 |
DIMENSION AHDL CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983693 |
11/04/1998 |
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983722 |
11/04/1998 |
STRATUS CS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K981199 |
11/18/1998 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K971616 |
11/04/1998 |
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) |
DATA SCIENCES INTL., INC. |
JIM HUHN |
| K981378 |
11/03/1998 |
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
| K983684 |
11/06/1998 |
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS |
DATEX-OHMEDA, INC. |
TOM KROENKE |
| K982975 |
11/10/1998 |
DIGITAL ECG HOLTER RECORDER, MODEL DR512 |
DATRIX |
JON BARRON |
| K983136 |
11/25/1998 |
DEPUY LUSTER STEM |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983750 |
11/30/1998 |
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER |
DEROYAL INDUSTRIES, INC. |
CAMILLE MATLOCK |
| K983172 |
11/30/1998 |
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT |
DIABETES TECHNOLOGIES, INC. (DTI) |
ARTHUR G WILLIAMS |
| K983971 |
11/18/1998 |
CARDIAC MARKER CONTROL MODULE, MODEL CCCM |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983970 |
11/25/1998 |
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983323 |
11/12/1998 |
DIGOXIN IMMUNOASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K983159 |
11/05/1998 |
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K983268 |
11/18/1998 |
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K983812 |
11/16/1998 |
NAPA EIA ASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K983280 |
11/06/1998 |
VANCOMYCIN EIA ASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K981871 |
11/09/1998 |
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K983617 |
11/16/1998 |
25-HYDROXYVITAMIN D 125I RIA KIT |
DIASORIN, INC. |
JUDITH J SMITH |
| K982027 |
11/25/1998 |
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K982855 |
11/04/1998 |
DIGIRAD 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
R. SCOTT HUENNEKENS |
| K983963 |
11/25/1998 |
DORNIER MEDILA H |
DORNIER MEDTECH AMERICA, INC. |
CAROL WERNECKE |
| K981911 |
11/12/1998 |
PROFA |
DUNCAN HYND ASSOCIATES, LTD. |
DIANA UPTON |
| K982241 |
11/30/1998 |
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX |
DUXBURY SCIENTIFIC INC. |
ROBERT M ENGLER |
| K982713 |
11/02/1998 |
RT DESKTOP |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
PAUL L SUMNER |
| K983206 |
11/03/1998 |
SMALL VAGINAL/RECTAL ELECTRODE |
EMPI |
CAROLYN M STEELE HUSTEN |
| K982059 |
11/30/1998 |
ROTECNO 2000 SURGICAL GOWN |
ENCOMPASS GROUP, LLC. |
TIM CUMMINS |
| K983285 |
11/04/1998 |
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS |
ENGLE DENTAL SYSTEMS |
MARVIN FOX |
| K981343 |
11/24/1998 |
ERCO-RIBBON |
ERCONS, INC. |
YAKOV ALTSHULER |
| K981357 |
11/24/1998 |
ERCO-VAC |
ERCONS, INC. |
YAKOV ALTSHULER |
| K983009 |
11/25/1998 |
BSM- BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
MICHAEL SCHTTENBERG |
| K983249 |
11/25/1998 |
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN |
EUROMED, INC. |
MARY MCNAMARA-CULLINANE |
| K983112 |
11/10/1998 |
RESPIRATORY HUMIDIFIER, MODEL # MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
CHRIS MANDER |
| K982170 |
11/30/1998 |
FLUIDSENSE FLUID DELIVERY SYSTEM |
FLUIDSENSE CORP. |
ERIC BRENNAN |
| K983859 |
11/25/1998 |
SPECTRUM SMALL FRY |
FREEDOM DESIGNS, INC. |
GINNY S MALOCO |
| K983763 |
11/23/1998 |
SPECTRUM SPIRIT |
FREEDOM DESIGNS, INC. |
GINNY S MALOCO |
| K982760 |
11/04/1998 |
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET |
GAMBRO HEALTHCARE |
WILLIAM M TOWNSEND |
| K982972 |
11/16/1998 |
SIGNA PROFILE SMALL HEAD COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K982955 |
11/04/1998 |
SILHOUETTE VR |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K980756 |
11/05/1998 |
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RICHARD CEHOVSKY |
| K982933 |
11/06/1998 |
VINYL EXAMINATION GLOVES, POWDER FREE |
GENERAL GLOVES CORP. |
DAVID HU |
| K983726 |
11/25/1998 |
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL |
GENZYME CORP. |
BARBARA PIZZA |
| K983494 |
11/05/1998 |
VINYL EXAM GLOVES, POWDER FREE |
GLORMED INTL., INC. |
JANNA P TUCKER |
| K983287 |
11/05/1998 |
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE |
GRAPHIC CONTROLS CORP. |
KATHLEEN SELOVER |
| K981964 |
11/13/1998 |
MEDI-TRACE 4103 NEONATAL ELECTRODE |
GRAPHIC CONTROLS CORP. |
SUSAN KRASNY |
| K983033 |
11/10/1998 |
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE |
GUIDANT CORP. |
JENNIFER PAE RIGGS |
| K982876 |
11/10/1998 |
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 |
GUIDANT CORP. |
SUSAN SILAVIN |
| K983367 |
11/06/1998 |
QLICKSMART |
HANDREN ASSOC. |
ROBERT T HANDREN JR |
| K981691 |
11/03/1998 |
SILICONE SOFT RELINE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K983004 |
11/25/1998 |
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI |
HAYES MEDICAL, INC. |
JOHN B STASSI |
| K983916 |
11/23/1998 |
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) |
HDC CORP. |
JAMES S ABILLA |
| K982857 |
11/04/1998 |
HELAX-IMCON, VERSION 1.0 |
HELAX AB |
JAN TORNQVIST |
| K982639 |
11/04/1998 |
SPIFE URINE IFE |
HELENA LABORATORIES |
PAT FRANKS |
| K983028 |
11/13/1998 |
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
HOLOGIC, INC. |
NANDINI MURPHY |
| K983419 |
11/25/1998 |
HOFFMANN II MIAMI POST |
HOWMEDICA CORP. |
JOSEPH VOLPE |
| K982958 |
11/20/1998 |
ZETA MULTIZONE LOCKING NAIL SYSTEM |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K983358 |
11/18/1998 |
G/K SFN AND STN LOCKING NAILS |
HOWMEDICA, INC. |
VIVIAN KELLY |
| K982946 |
11/18/1998 |
PAINBUSTER INFUSION KIT |
I-FLOW CORP. |
ROBERT J BARD |
| K982898 |
11/30/1998 |
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
| K983681 |
11/27/1998 |
DOMINATOR |
IMPACT WHEELCHAIR MANUFACTURE, INC. |
ZAVE ABERMAN |
| K983861 |
11/24/1998 |
DISTAFLO BYPASS GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K983064 |
11/19/1998 |
IMPRA HIGH POROSITY GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K982843 |
11/10/1998 |
CMS-2000 |
INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE |
MING-CHENG CHANG |
| K983325 |
11/24/1998 |
IN-PROBE II URODYNAMIC SYSTEM |
INFLUENCE, INC. |
PETER A BICK |
| K982790 |
11/04/1998 |
QUANTA LITE H. PYLORI IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K983084 |
11/04/1998 |
QUANTA LITE RF IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K983083 |
11/04/1998 |
QUANTA LITE RF IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K980999 |
11/06/1998 |
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT |
INSTRUMENT MAKAR, INC. |
LANNY J JOHNSON |
| K981249 |
11/23/1998 |
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
| K983178 |
11/03/1998 |
COAMATIC HEPARIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K983819 |
11/24/1998 |
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN |
INTERVASCULAR, INC. |
JAMES S MILLER |
| K980045 |
11/16/1998 |
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM |
INVIVO RESEARCH, INC. |
FRANCIX X CASEY |
| K983855 |
11/17/1998 |
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F |
JAWON MEDICAL CO., LTD. |
|
| K983266 |
11/09/1998 |
FIBREKOR POST SYSTEM |
JENERIC/PENTRON, INC. |
MURRAY G GAMBERG |
| K983394 |
11/03/1998 |
MODIFICATION TO TIELLE HYDROPOLMER DRESSING |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
TERRY J DAGNON |
| K983240 |
11/30/1998 |
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
MARGARET MARSH |
| K983234 |
11/25/1998 |
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
TERRY J DAGNON |
| K983141 |
11/06/1998 |
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
DEANA BOUSHELL |
| K982837 |
11/06/1998 |
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K983384 |
11/25/1998 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K982813 |
11/06/1998 |
NATURALYTE, MODEL # 08-4004-1 |
KAYBATH, INC. |
BONNIE NAKAYAMA |
| K983515 |
11/30/1998 |
KLS INTRAORAL VERTICAL DISTRACTOR |
KLS-MARTIN L.P. |
ED RANSOM |
| K982986 |
11/24/1998 |
TUBING BLOOD FLOW METER MODEL NUMBER HD-800 |
KOVEN TECHNOLOGY, INC. |
PAUL G KOVEN |
| K983361 |
11/13/1998 |
PANAVIA F |
KURARAY AMERICA, INC. |
KOJI FUJITA |
| K983380 |
11/16/1998 |
DUREX LUBRAGEL LATEX CONDOM |
LONDON INTL. LLC. |
NEIL ANDERSON |
| K982924 |
11/16/1998 |
DUREX SENSIDOM LATEX CONDOM |
LONDON INTL. LLC. |
NEIL ANDERSON |
| K983271 |
11/18/1998 |
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS |
LUNAR CORP. |
KENNETH D BUROKER |
| K983269 |
11/18/1998 |
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER |
LUNAR CORP. |
KENNETH D BUROKER |
| K983262 |
11/18/1998 |
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS |
LUNAR CORP. |
KENNETH D BUROKER |
| K982797 |
11/30/1998 |
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB |
LUTHER MEDICAL PRODUCTS, INC. |
KATHLEEN ROBERTS |
| K982877 |
11/30/1998 |
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE |
MATANG MFG. SDN. BHD. |
RONALD LEONG |
| K981772 |
11/03/1998 |
HALOLITE AAD SYSTEM |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K982978 |
11/23/1998 |
MODEL 340GE-21C QUADRATURE BRAIN COIL |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K982104 |
11/25/1998 |
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
| K981845 |
11/03/1998 |
HAWK ANAESTHESIA INDUCTION UNIT |
MEDICAL INDUSTRIAL EQUIPMENT |
HENRY MARSHALL |
| K983307 |
11/20/1998 |
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K973171 |
11/13/1998 |
NIR BILIARY STENT |
MEDINOL LTD. |
TAMI ABUDI |
| K983253 |
11/20/1998 |
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT |
MEDISENSE, INC. |
DENISE HALEY |
| K983076 |
11/25/1998 |
MEDISYSTEMS TRANSDUCER PROTECTOR |
MEDISYSTEMS CORP. |
LARRY R PILOT |
| K983092 |
11/06/1998 |
TRITON HUDSON CHUCK ATTACHMENT |
MEDNEXT, INC. |
STEWART WILLASON |
| K982921 |
11/03/1998 |
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA |
MEDRAD, INC. |
JIM FERGUSON, JR. |
| K982932 |
11/02/1998 |
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC |
MEDRAD, INC. |
JIM FERGUSON |
| K982959 |
11/03/1998 |
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC |
MEDRAD, INC. |
JIM FERGUSON JR |
| K982919 |
11/02/1998 |
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC |
MEDRAD, INC. |
JIM FERGUSON, JR. |
| K982902 |
11/10/1998 |
PERIPHERAL NERVE STIMULATION |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K982826 |
11/06/1998 |
MEGA 2000 |
MEGADYNE MEDICAL PRODUCTS, INC. |
JOHN W SMITH |
| K983582 |
11/13/1998 |
CARDIOBEEPER CB250 |
MERDIAN MEDICAL TECHNOLOGIES LTD. |
GERARD LYNN |
| K982711 |
11/25/1998 |
PREMIER GIARDIA |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K983021 |
11/13/1998 |
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC |
METROSOFT, INC. |
JIM WEBB |
| K982878 |
11/03/1998 |
EARSCAN 3 |
MICRO AUDIOMETRICS CORP. |
JASON R KELLER |
| K981976 |
11/25/1998 |
ACUTRON MENTOR MODEL 961 |
MICROCURRENT RESEARCH, INC. |
PAUL DAVIS |
| K982667 |
11/24/1998 |
MICROMEDICS NASAL SEPTAL BUTTON |
MICROMEDICS, INC. |
CHARLES GROTE |
| K982657 |
11/18/1998 |
AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 |
MICROVENA CORP. |
TONYA WEIGEL |
| K973765 |
11/04/1998 |
BIO-2000 |
MICRYLIUM LABORATORIES |
THAD J OVERMYER, DMD |
| K983085 |
11/13/1998 |
HEMOCOR HPH 700 HEMOCONCENTRATOR |
MINNTECH CORP. |
MARK MURPHY |
| K983818 |
11/23/1998 |
MITEK FASTIN RC ANCHOR |
MITEK PRODUCTS |
EDWARD F KENT |
| K982769 |
11/03/1998 |
MITRA IMAGING INC. EXHIBIT |
MITRA IMAGING, INC. |
GARY J ALLSEBROOK |
| K983554 |
11/10/1998 |
ALLDRESS, ABSORBENT FILM DRESSING |
MOLNLYCKE HEALTH CARE, INC. |
MIGUEL A NEGRON |
| K982821 |
11/05/1998 |
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 |
MULTIMEDIA MEDICAL SYSTEMS, INC. |
ALEXANDER CROSBY |
| K982748 |
11/03/1998 |
BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
| K982431 |
11/18/1998 |
NMT SAFETY SYRINGE |
NEW MEDICAL TECHNOLOGY LTD. |
JOHN CAMPBELL |
| K980551 |
11/17/1998 |
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
NIDEK MEDICAL PRODUCTS, INC. |
GREGG GASKINS |
| K983453 |
11/18/1998 |
PROCERA ALLCERAM FUSING MATERIAL |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
| K983247 |
11/03/1998 |
SUPER PORCELAIN ADDMATE |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
| K983857 |
11/04/1998 |
AUTOVENT 1500 |
O-TWO SYSTEMS INTL., INC. |
KEVIN BOWDEN |
| K983282 |
11/19/1998 |
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 |
OHIO MEDICAL INSTRUMENT CO., INC. |
KENNETH B MILLER |
| K982610 |
11/16/1998 |
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) |
OLYMPUS OPTICAL, CO. |
LAURA STORMS-TYLER |
| K982716 |
11/30/1998 |
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K982110 |
11/06/1998 |
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR |
OPTECH, INC. |
JAMES A BROOKS |
| K983168 |
11/18/1998 |
AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 |
ORA INNOVATIONS, INC. |
GERALD L COGAN |
| K982745 |
11/18/1998 |
AUTO-LYTE BARBITURATES EIA |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K982831 |
11/12/1998 |
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K982759 |
11/20/1998 |
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K982801 |
11/04/1998 |
AUTO-LYTE PCP EIA, MODEL #1254U |
ORASURE TECHNOLOGIES, INC. |
R.SAM NIEDBALA |
| K982971 |
11/23/1998 |
ORATEC TAC-C, MONOPOLAR CAUTERY PROBE |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K983478 |
11/09/1998 |
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON |
ORGANIC ESSENTIALS |
LA RHEA PEPPER |
| K983513 |
11/03/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K983507 |
11/04/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K982963 |
11/20/1998 |
POLYMER THREADED ANCHOR / SUTURE COMBINATION |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
JEFFRY B SKIBA |
| K983045 |
11/25/1998 |
AMIELLE |
Owen Mumford USA, Inc. |
ROBERT E SHAW |
| K983008 |
11/25/1998 |
PERIPHERAL AVE STENT SYSTEM |
PERIPHERAL AVE |
PAUL MEYER |
| K983140 |
11/04/1998 |
CT BIOPSYVIEW |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K983069 |
11/02/1998 |
PHILIPS DUO DIAGNOST |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K982795 |
11/24/1998 |
PHILIPS BUCKY VISION |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K982010 |
11/19/1998 |
FACTS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K983659 |
11/16/1998 |
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC |
PLANMED OY |
LARS MORING |
| K982447 |
11/25/1998 |
PLUS BIPOLAR PROSTHESIS COCRMO |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K970811 |
11/13/1998 |
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN |
PNEUMOCARE, INC. |
JOSEPH H BALES |
| K983245 |
11/02/1998 |
POS-T-VAC (AVP-1000) |
POS-T-VAC, INC. |
ED STEWART JR |
| K983246 |
11/02/1998 |
POS-T-VAC (IVP-600) |
POS-T-VAC, INC. |
ED STEWART JR |
| K981379 |
11/23/1998 |
AURORA |
PREMIER LASER SYSTEMS, INC. |
BETH A SOPER |
| K983386 |
11/25/1998 |
BIOSTREP A-DIRECT STREP A ANTIGEN TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K973585 |
11/06/1998 |
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR |
PROPPER MFG. CO., INC. |
FRANK E PLATKO |
| K981064 |
11/05/1998 |
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES |
PT. IRAMA DINAMIKA LATEX |
ANIL TANEJA |
| K981820 |
11/20/1998 |
NEUROMAP |
RADIONICS, INC. |
JEFFREY R MANNION |
| K983669 |
11/18/1998 |
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS |
RADIONICS, INC. |
DAVID CROMWICK |
| K983603 |
11/10/1998 |
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME |
RADIONICS, INC. |
KEVIN O'CONNELL |
| K982854 |
11/10/1998 |
MR COMPATIBLE LEVEEN NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K983517 |
11/12/1998 |
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM |
RAM SCIENTIFIC |
GEOFFREY LEVITT |
| K982410 |
11/06/1998 |
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE |
REHABILICARE, INC. |
EDWARD F VALDEZ |
| K983621 |
11/03/1998 |
NEEDLE GUIDE |
REMINGTON MEDICAL, INC. |
STEVE WOODY |
| K982454 |
11/03/1998 |
BIPAP VISION VENTILATORY SUPPORT |
RESPIRONICS, INC. |
DOUG MECHLENBURG |
| K981072 |
11/12/1998 |
ESPRIT VENTILATOR |
RESPIRONICS, INC. |
PAUL WOODRING |
| K982544 |
11/19/1998 |
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES |
RICH-MAR CORP. |
DAVID RICHARDS |
| K982965 |
11/23/1998 |
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K980129 |
11/05/1998 |
INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983388 |
11/18/1998 |
ONTRAK TESTCUP-ER |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983174 |
11/18/1998 |
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983357 |
11/13/1998 |
MUCOPREN SOFT RELINING SYSTEM |
ROYDENT DENTAL PRODUCTS, INC. |
DON LEROY |
| K983125 |
11/17/1998 |
EPIDURAL CATHETER MODELS 1210/1200 |
RUSCH INTL. |
JAMES R WHITNEY |
| K974241 |
11/12/1998 |
SCIMED INFORMER PRESSURE WIRE SYSTEM |
SCIMED LIFE SYSTEMS, INC. |
JILL TOWNSEND |
| K983532 |
11/30/1998 |
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K983531 |
11/30/1998 |
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K983612 |
11/05/1998 |
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES |
SHANGHAI JIATAI PLASTIC PRODUCTS CO., LTD. |
DON MORRIS |
| K981365 |
11/25/1998 |
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS |
SHERWOOD MEDICAL CO. |
ROSEMARY HARRY |
| K982720 |
11/05/1998 |
H-RAY |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
LIN CHIN YU |
| K982416 |
11/24/1998 |
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE |
SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. |
WILLIAM C LOWENKAMP |
| K981975 |
11/20/1998 |
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED |
SIAM SEMPERMED CORP. LTD. |
DON MORRIS |
| K982536 |
11/24/1998 |
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE |
SIEMENS CORP. |
MALGORZATA STANEK |
| K983980 |
11/16/1998 |
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K983632 |
11/06/1998 |
SIEMENS SC 8000 BEDSIDE MONITOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K983283 |
11/06/1998 |
SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM |
SIGNET RADIOLOGY, INC. |
ALEX CETATEANU |
| K982838 |
11/04/1998 |
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K982839 |
11/02/1998 |
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K982836 |
11/02/1998 |
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K983706 |
11/12/1998 |
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K983538 |
11/06/1998 |
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY |
SOLOS ENDOSCOPY, INC. |
PAUL DIAS |
| K982717 |
11/02/1998 |
SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
| K981530 |
11/20/1998 |
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM |
SPACELABS MEDICAL, INC. |
RUSS GARRISON |
| K982354 |
11/23/1998 |
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M |
SPECIAL DEVICES, INC. |
JOSEPH J SPRANZA |
| K982773 |
11/03/1998 |
QUICKSET LIQUID AND POWDER |
SPECIALITES SEPTODONT |
PETER S REICHERTZ |
| K982956 |
11/24/1998 |
FLOWMATE II PLUS, MODEL #4000 |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
DONALD HENTON |
| K982188 |
11/20/1998 |
STERI-PAK BOWIE DICK TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
LON BRUSO |
| K983786 |
11/13/1998 |
STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION |
STERNGOLD/IMPLAMED |
CHAD PATTERSON |
| K983006 |
11/23/1998 |
OSTEO 5.0MM CANNULATED SCREW SYSTEM |
STRYKER OSTEONICS |
ELIZABETH A STAUB |
| K982435 |
11/06/1998 |
IRRIGATION SYRINGE KIT |
SUB-Q, INC. |
VAUGHAN P WHALEN |
| K983520 |
11/06/1998 |
BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K983677 |
11/06/1998 |
QUICKIE G SERIES, MODEL G-424 |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSON |
| K981462 |
11/06/1998 |
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K981885 |
11/12/1998 |
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K983050 |
11/25/1998 |
PNEUMATIC CUTTER SYSTEM |
SURGICAL LASER TECHNOLOGIES, INC. |
MONICA FERRANTE |
| K981768 |
11/23/1998 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K983755 |
11/20/1998 |
NASAL DORSAL SERIES |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
RICHARD T NOCK |
| K983754 |
11/20/1998 |
STANDARD CHIN |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
RICHARD T NOCK |
| K983756 |
11/20/1998 |
SURGIFORM ANATOMICAL MALAR |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
RICHARD T NOCK |
| K983370 |
11/18/1998 |
PRODIGY- 3 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K983304 |
11/04/1998 |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED INTL., INC. |
MARCIA J ARENTZ |
| K982322 |
11/25/1998 |
SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM |
SYNTHES (USA) |
JONATHAN M GILBERT |
| K983113 |
11/18/1998 |
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT |
SYNTRON BIORESEARCH, INC. |
CHARLES YU |
| K981950 |
11/03/1998 |
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 |
SYSMEX CORP. |
CATHERINE M TRESTER |
| K983450 |
11/12/1998 |
STARRYSHINE GAUZE SPONGE |
T.C. DENTAL PRODUCTS, INC. |
JEN WANG |
| K982815 |
11/06/1998 |
ALPHATRAC, MODEL A200 |
TEFTEC CORP. |
THOMAS E FINCH, III |
| K983066 |
11/27/1998 |
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 |
TEFTEC CORP. |
THOMAS E FINCH, III |
| K983490 |
11/30/1998 |
TERUMO VENOJECT,LUER ADAPTER |
TERUMO CORP. |
KRISTINE WAGNER |
| K982976 |
11/24/1998 |
ULTRASOUND WORKSTATION, UIWS-300A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K983244 |
11/30/1998 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K980182 |
11/16/1998 |
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
U.S. FILTER/IONPURE, INC. |
CHERYL ARDIZZONI |
| K983668 |
11/30/1998 |
MODIFICATION OF PQ1 |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K982611 |
11/02/1998 |
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) |
UNIJECT GLOVES PCL |
SARA JOHNSON |
| K982575 |
11/06/1998 |
MESH, SURGICAL, POLYMERIC |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JAMIE YIEH |
| K980278 |
11/20/1998 |
URESIL VASCU-FLO INFUSION CATHETER |
URESIL CORP. |
MATTHEW CURTIS |
| K983143 |
11/16/1998 |
MARK 5000 PHASED ARRAY SHOULDER COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K980576 |
11/02/1998 |
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA NASH |
| K981277 |
11/20/1998 |
PERIFORM |
VERIMED HOLDINGS, INC. |
KISHORE PUPPALA |
| K982937 |
11/19/1998 |
MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER |
VICTOREEN, INC. |
EDWARD W SIUREK, III |
| K982994 |
11/16/1998 |
SKULL BASE INSTATRAK SYSTEM |
VISUALIZATION TECHNOLOGY, INC. |
MARY MCNAMARA-CULLINANE |
| K982016 |
11/03/1998 |
PIPER IPPB MODEL 2055 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
| K983910 |
11/25/1998 |
ARTHRO-SURGIMAT-1500 |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
| K981853 |
11/17/1998 |
BONE INJECTION GUN (B.I.G.) DEVICE |
WAISMED LTD. |
AHAVA STEIN |
| K982906 |
11/12/1998 |
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K982944 |
11/19/1998 |
HEM-O-LOCK, MODEL 523935 |
WECK CLOSURE SYSTEMS |
BRIAN J YOUNG |
| K982941 |
11/19/1998 |
HEM-O-LOK MODEL NUMBERS 523900, 523970 |
WECK CLOSURE SYSTEMS |
JAMES L LUCKY |
| K982870 |
11/03/1998 |
EPIFILM OTOLOGIC LAMINA |
XOMED, INC. |
ROY BERENS |
| K983025 |
11/06/1998 |
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT |
XOMED, INC. |
DEBRA N CORTNER |
| K981600 |
11/02/1998 |
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED |
YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
JOHN A TAPOCIK |
| K983608 |
11/05/1998 |
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
E.J. Smith |
| K983378 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984034 |
11/30/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983464 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983423 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983465 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983426 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983422 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983376 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983425 |
11/18/1998 |
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983418 |
11/18/1998 |
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983420 |
11/18/1998 |
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K980711 |
11/12/1998 |
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
ZIMMER, INC. |
RUTH ANN WOOD |
