| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K964203 |
12/18/1996 |
PIPERACILLIN/TAZOBACTAM 4 |
AB BIODISK |
ANNE BOLMSTROM |
| K964007 |
12/16/1996 |
ACROMED CABLE/WIRE PEDICLE SCREW |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
| K964500 |
12/09/1996 |
ACUMED TENSION BAND PIN |
ACUMED, INC. |
SHARI L JEFFERS |
| K953269 |
12/20/1996 |
SAFECIRCUIT MANIFOLD/PULMONARY UNIT |
ADVANCED WARMING SYSTEMS, INC. |
RANDY HICKLE |
| K963204 |
12/09/1996 |
DMS-1000C DERMOABRADER |
AESTHETIC LASERS, INC. |
FRED DE JACMA |
| K961405 |
12/26/1996 |
ALBA HEALTH PAS WRAP SYSTEM |
ALBA-WALDENSIAN, INC. |
VICTOR H GARROU |
| K962864 |
12/18/1996 |
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS |
ALKO DIAGNOSTIC CORP. |
JANET A MCGRATH |
| K964125 |
12/23/1996 |
CONVERTORS DRAPE MATERIAL |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K964127 |
12/31/1996 |
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE |
ALLEGIANCE HEALTHCARE CORP. |
INGRID M HOOS |
| K962309 |
12/27/1996 |
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
MARY LANE |
| K964621 |
12/20/1996 |
A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON |
ALTO DEVELOPMENT CORP. |
MICHAEL T WOJCIECHOWICZ |
| K963328 |
12/04/1996 |
AMS AMBICOR PENILE PROSTHESIS |
AMERICAN MEDICAL SYSTEMS, INC. |
KRIS TEICH |
| K964554 |
12/17/1996 |
PERSONAL TELEMEDICINE MODULE |
AMERICAN TELECARE, INC. |
GERARD J PRUD`HOMME |
| K962424 |
12/20/1996 |
NPB-4000 |
ANALOGIC CORP. |
JAMES R LEVANI |
| K964775 |
12/10/1996 |
ARDENT FUTURA NON GAMMA-2 |
ARDENT PRODUCTION DEVELOPMENT |
CLYDE E INGERSOLL |
| K963669 |
12/12/1996 |
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM |
ASTRO-MED, INC. |
STEVE JOHNSON |
| K963877 |
12/06/1996 |
AHS OMEGA CONCEPT |
AUTHORIZED HEARING SYSTEMS, INC. |
HENRY SMITH |
| K963878 |
12/06/1996 |
AHS OMEGA HF |
AUTHORIZED HEARING SYSTEMS, INC. |
HENRY SMITH |
| K962230 |
12/16/1996 |
CELSITE PORT WITH PRECONNECTED CATHETER |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K964068 |
12/13/1996 |
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K964116 |
12/24/1996 |
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K964442 |
12/18/1996 |
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K952721 |
12/20/1996 |
RUBASCAN CARD TEST |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ROBERT E JAMES |
| K963062 |
12/13/1996 |
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 |
BECKMAN INSTRUMENTS, INC. |
MARGIE GEORGE |
| K963963 |
12/12/1996 |
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
CINDY MORROW |
| K964687 |
12/16/1996 |
N LATEX CRP MONO REAGENT |
BEHRING DIAGNOSTICS, INC. |
LAURA LEBARRON |
| K962968 |
12/13/1996 |
PROC APC ASSAY, PROC CONTROL PLASMA |
BEHRING DIAGNOSTICS, INC. |
PAUL L ROGERS JR. |
| K963699 |
12/23/1996 |
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY |
BELMONT EQUIPMENT CORP. |
JOHN E COLLINS |
| K963958 |
12/05/1996 |
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT |
BELTONE ELECTRONICS CORP. |
ROBERT A KRATOCHVIL |
| K963934 |
12/16/1996 |
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 |
BIO-RAD LABORATORIES, INC. |
JAN OLSEN |
| K963770 |
12/05/1996 |
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS |
BIOCIRCUITS CORP. |
SHEILA J RAMERMAN |
| K963951 |
12/31/1996 |
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
STEVEN R BOGGAN |
| K960643 |
12/16/1996 |
ADVANTAGE MAPF HIP FEMORAL COMPONENT |
BIOMET, INC. |
PATRICIA S BERES |
| K963709 |
12/04/1996 |
CEMENT-ON FEMORAL STEM |
BIOMET, INC. |
KARA L SCHWARTZ |
| K963806 |
12/12/1996 |
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) |
BMW MEDICAL, INC. |
PHI TRIOLO |
| K962734 |
12/10/1996 |
CEDIA DAU BENZODIAZEPINE ASSAY |
BOEHRINGER MANNHEIM CORP. |
BETSY SOARES-MADDOX |
| K964829 |
12/16/1996 |
ELECSYS CALCHECK FSH |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K964830 |
12/16/1996 |
ELECSYS CALCHECK LH |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K964693 |
12/16/1996 |
ELECSYS FSH ASSAY |
BOEHRINGER MANNHEIM CORP. |
BETSY SOARES-MADDOX |
| K963127 |
12/16/1996 |
ELECSYS FT3 |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS, RAC |
| K963691 |
12/12/1996 |
COURIER BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K963988 |
12/12/1996 |
INTRAVASCULAR INFUSION DEVICE |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K964121 |
12/04/1996 |
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
CATHY YOHNK |
| K963596 |
12/04/1996 |
POLAR CARE 300 |
BREG, INC. |
KATHLEEN BARBER |
| K964241 |
12/12/1996 |
BRENNEN MEDICAL GLUCAN II WOUND DRESSING |
BRENNEN MEDICAL, INC. |
MITCHELL C MUHICH |
| K963128 |
12/05/1996 |
NOVAGEL SILICONE GEL SHEETING |
BRENNEN MEDICAL, INC. |
MITCHELL C MUHICH |
| K962538 |
12/17/1996 |
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) |
C.R. BARD, INC. |
EVANS YI-WEN WUU |
| K950550 |
12/04/1996 |
XH-1 NEUROMUSCULAR STIMULATOR |
CALIFORNIA MEDICAL RESEARCH INSTITUTE |
LAIYIN YAN |
| K962928 |
12/20/1996 |
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) |
CAMINO NEUROCARE, INC. |
DONNA L FREE |
| K960839 |
12/18/1996 |
FILM SCANNER 300 |
CANNON U.S.A., INC. |
GLEN IMPAL |
| K964640 |
12/13/1996 |
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 |
CANYON DIAGNOSTICS, INC. |
ANTHONY FALKOWSKI |
| K963811 |
12/04/1996 |
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
BOAZ VINOGRADOV |
| K964469 |
12/11/1996 |
700-F SERIES STIMULATION ELECTRODES |
CARDIOTRONICS SYSTEMS, INC. |
TIM J WAY |
| K963728 |
12/12/1996 |
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS |
CHINA CHONGQING BASHAN INSTRUMENT FACTORY |
LU RAO |
| K963111 |
12/23/1996 |
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S |
CHROMOGENIX AB |
RONALD G LEONARDI |
| K960915 |
12/24/1996 |
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX |
CLARUS MEDICAL SYSTEMS, INC. |
JOHN VADEN HOEK |
| K962591 |
12/04/1996 |
FOOT WEIGHT ALARM |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
| K963159 |
12/11/1996 |
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES |
CMC SENSE-IT, INC. |
CLARK VIER |
| K964243 |
12/05/1996 |
HUMERUS WIRES |
COMPAGNIE FINANCIERE & MEDICALE (CF&M) |
FRANK FERGUSON |
| K963558 |
12/04/1996 |
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR |
CONTEMPORARY PRODUCTS, INC. |
BARRY A SCHWARTZ |
| K964749 |
12/13/1996 |
COVERAGE HBV |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
MICHAEL G SARLI |
| K964835 |
12/16/1996 |
COVERAGE SPRAY HBV |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
MIKE EBERS |
| K961992 |
12/27/1996 |
NEEDLE'S EYE SNARE |
COOK PACEMAKER CORP. |
NEAL E FEARNOT |
| K962185 |
12/17/1996 |
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS |
COOPERVISION, INC. |
BERNARD HALLATT |
| K960999 |
12/30/1996 |
ISOLATION GOWN |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K961342 |
12/30/1996 |
SHOE COVER, NON-STERILE |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K955265 |
12/20/1996 |
CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER |
CORDIS CORP. |
STEPHEN M ENOS |
| K963839 |
12/12/1996 |
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 |
CORDIS CORP. |
STEPHEN M ENOS |
| K964618 |
12/23/1996 |
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 |
COULTER CORP. |
MARION S GAIDE |
| K961223 |
12/10/1996 |
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K964145 |
12/31/1996 |
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 |
CRYSTAL MARK, INC. |
DONNA L FREE |
| K963094 |
12/16/1996 |
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K963493 |
12/03/1996 |
FERRITIN CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
CATHY P CRAFT |
| K963641 |
12/18/1996 |
STREPTOCOCCUS MIC PANEL |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K962037 |
12/26/1996 |
IMAGEN RESPIRATORY SCREEN |
DAKO DIAGNOSTICS LTD. |
ELISABETH JOHNSON-PROCTOR |
| K955425 |
12/30/1996 |
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM |
DASH MEDICAL GLOVES SDN BHD |
KHOO SEANG HOE |
| K964211 |
12/02/1996 |
DAVOL PLUME FILTER (5541420) |
DAVOL, INC., SUB. C.R. BARD, INC. |
CHRISTINE NICHOLS |
| K964603 |
12/06/1996 |
ARTICULAR HEARING AIDS |
DECIBEL INSTRUMENTS, INC. |
LISA S JONES |
| K963861 |
12/18/1996 |
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE |
DEJARNETTE RESEARCH SYSTEMS |
WAYNE T DEJARNETTE |
| K964070 |
12/31/1996 |
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG |
DEKNATEL, INC. |
DIANE E MINEAR |
| K961937 |
12/09/1996 |
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM |
DELPHI CONSULTING GROUP |
J. HARVEY KNAUSS |
| K964659 |
12/23/1996 |
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM |
DENTSPLY INTL. |
DANIEL P MURPHY |
| K964040 |
12/06/1996 |
TRUBYTE SOFT RELINE SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K963973 |
12/16/1996 |
DEPUY CANNULATED CROSS PIN SCREW SYSTEM |
DEPUY, INC. |
ARLENE SAULL |
| K962486 |
12/27/1996 |
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM |
DEPUY, INC. |
CHERYL HASTINGS |
| K963465 |
12/19/1996 |
PELVIC HOLDER |
DEROYAL INDUSTRIES, INC. |
CAMILLE MATLOCK |
| K963835 |
12/10/1996 |
DIGOXIN ENZYME IMMUNOASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K964212 |
12/18/1996 |
QUINIDINE ENZYME IMMUNOASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K950259 |
12/06/1996 |
COUPLING DEVICE FOR DENTAL PROSTHESIS |
DR. JOSEPH E. GRASSO, D.D.S. |
JOSEPH E GRASSO |
| K961687 |
12/13/1996 |
EVITA 4 |
DRAGER, INC. |
HARALD KNEUER |
| K963733 |
12/13/1996 |
NICCHECK I |
DYNAGEN, INC. |
PETER J MIONE |
| K963762 |
12/23/1996 |
CORNEAL TOPOGRAPHER 200 |
ECLIPSE VENTURES |
RICHARD G HUNTER |
| K962840 |
12/23/1996 |
ECOLOTION TRANSMISSION AND MASSAGE LOTION |
ECO-MED PHARMACEUTICALS, INC. |
PAUL L HOOEY |
| K963692 |
12/10/1996 |
VERDICT PCP |
EDITEK, INC. |
CAROLE GOLDEN |
| K964111 |
12/16/1996 |
LITHOVAC SUCTION/ASPIRATION PROBE |
ELECTRO MEDICAL SYSTEMS SA |
MARY MCNAMARA-CULLINANE |
| K952315 |
12/04/1996 |
SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE |
EMG SCIENTIFIC |
SHMUEL EINSTEIN |
| K964008 |
12/27/1996 |
FOUNDATION KNEE SYSTEM |
ENCORE ORTHOPEDICS, INC. |
ASHLEY M BOCK |
| K963826 |
12/18/1996 |
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM |
ENDOCARE, INC. |
VIN CUTARELLI |
| K963938 |
12/26/1996 |
MODEL 5500 CEAS |
ESA, INC. |
JAMES MAYOL |
| K963417 |
12/20/1996 |
VITLITE (TR7700) |
ESCALON TREK MEDICAL |
RONALD L HUENEKE |
| K964345 |
12/16/1996 |
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED |
ETHICON, INC. |
JOHN D PAULSON, PH.D. |
| K964072 |
12/18/1996 |
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED |
ETHICON, INC. |
JOHN D PAULSON |
| K964262 |
12/27/1996 |
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD |
EXACTECH, INC. |
MARTHA MILLER |
| K963231 |
12/04/1996 |
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
| K964289 |
12/17/1996 |
EYE FIXATION SPECULUM |
EYEFIX, INC. |
RICHARD E LIPPMAN |
| K964774 |
12/20/1996 |
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS |
FCI OPHTHALMICS, INC. |
ANNE BOHSACK |
| K964323 |
12/16/1996 |
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL |
FEN DENTAL MFG., INC. |
ROBERT W BAUER, PH.D. |
| K963689 |
12/12/1996 |
RECOVER ADULT VEIN WARMER |
FLORIDA MEDICAL INDUSTRIES, INC. |
PATRICK J LAMB |
| K962256 |
12/06/1996 |
GALILEO HYSTEROSCOPES AND LAPAROSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
MARY MCNAMARA-CULLINANE |
| K964476 |
12/04/1996 |
DE ORO 77 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964788 |
12/20/1996 |
EL DORADO 55 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964569 |
12/06/1996 |
EL DORADO 58 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964567 |
12/06/1996 |
EL DORADO 75 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964789 |
12/20/1996 |
LA PLATA 39 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964792 |
12/20/1996 |
LA PLATA 40 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964566 |
12/06/1996 |
OZARK 20 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964477 |
12/02/1996 |
OZARK 40 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964568 |
12/06/1996 |
OZARK 46 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964837 |
12/20/1996 |
PACIFIC 56 (CB-40) |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964572 |
12/06/1996 |
PALLADIA 76 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964838 |
12/20/1996 |
PALLADIA 85 (PM-13) |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964573 |
12/06/1996 |
PIEDMONT 70 (CH-35) |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964707 |
12/16/1996 |
SOLDER 585 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964708 |
12/16/1996 |
SOLDER 615 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964706 |
12/16/1996 |
SOLDER 650 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964713 |
12/16/1996 |
SOLDER GPW |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K964705 |
12/16/1996 |
SOLDER GPY |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K963952 |
12/23/1996 |
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K963896 |
12/18/1996 |
MOBILE CT PROSPEED FAMILY |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K961530 |
12/05/1996 |
GISH RELIANCE OXYGENATOR (MODEL HFO) |
GISH BIOMEDICAL, INC. |
JACK W BROWN |
| K955661 |
12/30/1996 |
ACU-HALT |
GLEDERER & CO., INC. |
GABE LEDERER |
| K960734 |
12/10/1996 |
HAEMOCELL SYSTEM 350 OR S350 |
HAEMOCELL PLC |
R C HALL |
| K964059 |
12/19/1996 |
MICADENT |
HAMPTON RESEARCH |
WILLIAM H HARRIS, DDS |
| K964453 |
12/23/1996 |
REP 3 FLUR SPE-60 KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K964471 |
12/23/1996 |
REP FLUR CHOLESTEROL-60 KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K961908 |
12/10/1996 |
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 |
HELENA LABORATORIES |
PAT FRANKS |
| K962276 |
12/05/1996 |
HEMAGEN ENA DSDNA KIT (EIA METHOD) |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K964006 |
12/31/1996 |
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K964057 |
12/31/1996 |
INCARE HOT/ICE SYSTEM SHOULDER BLANKET |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K963824 |
12/12/1996 |
LI'S ITCH STOPPER |
HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY |
HUAN-CHEN LI |
| K963796 |
12/09/1996 |
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K960492 |
12/23/1996 |
SI CONTROLLER MODEL SI 500 |
I.C. MEDICAL, INC. |
KURT HASPER |
| K963953 |
12/18/1996 |
IMIG-MRI |
IMIG-MRI SYSTEMS, LLC. |
GREGORY C HURST |
| K963296 |
12/16/1996 |
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) |
INCSTAR CORP. |
MARY FRICK |
| K963297 |
12/16/1996 |
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) |
INCSTAR CORP. |
MARY FRICK |
| K961859 |
12/16/1996 |
NOVUS STANDARD AND PEDIATRIC VALVES |
INTEGRA NEUROCARE LLC. |
TERRY N LAYTON |
| K963802 |
12/12/1996 |
SHUNT TAP |
INTEGRA NEUROCARE LLC. |
TERRY N LAYTON |
| K954610 |
12/16/1996 |
MODEL 430-07 ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
ALAN D TOTAH |
| K961318 |
12/17/1996 |
1ST RESPONSE DISPOSABLE MANOMETER |
INTERTECH RESOURCES, INC. |
AVIA TONEY, RAC |
| K945410 |
12/19/1996 |
IRT LOCKING SYRINGE |
INTERVENTIONAL RESEARCH TECHNOLOGIES |
LAURENCE SHANLEY |
| K962583 |
12/18/1996 |
CAT SCOOTER WITH DS60 VONYTOLLRT |
INVACARE RESPIRATORY CORP. |
EDWARD A KROLL |
| K960101 |
12/16/1996 |
ISLAND BIOSURGICAL BOLSTER |
ISLAND BIOSURGICAL, INC. |
HUNTER A MCKAY |
| K963985 |
12/27/1996 |
UM-D3000/UM-D4000 |
J.J. CONSULTING SERVICES, INC. |
ANNIE VELEZ |
| K964158 |
12/13/1996 |
JEL-40 (CODE NAME RD-0430) |
JELENKO CO. |
TRIDIB DASGUPTA |
| K964578 |
12/03/1996 |
FIBREKOR |
JENERIC/PENTRON, INC. |
MURRAY G GAMBERG |
| K964721 |
12/18/1996 |
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
| K964558 |
12/16/1996 |
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
| K962226 |
12/23/1996 |
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM |
JOHNSON & JOHNSON MEDICAL, INC. |
PHYLLIS ELSON |
| K964016 |
12/31/1996 |
TIELLE HYDROPOLYMER FOAM DRESSING |
JOHNSON & JOHNSON MEDICAL, INC. |
RALPH H LARSEN |
| K963885 |
12/09/1996 |
ULTIMA FX FEMORAL HIP STEMS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN FERROS |
| K964418 |
12/13/1996 |
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET |
KAMIYA TECHNOLOGY SERVICES |
MARY REES |
| K964415 |
12/13/1996 |
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT |
KAMIYA TECHNOLOGY SERVICES |
MARY REES |
| K962212 |
12/13/1996 |
KARL STORZ FRIMBERGER VARIOGUIDE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIKA ANDERSON |
| K963852 |
12/10/1996 |
KSEA THERMOCOAGULATOR (MODEL 265100 20) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
BETTY M JOHNSON |
| K955073 |
12/06/1996 |
KSEA THERMOFLATOR (MODEL 26 4320 20) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
BETTY M JOHNSON |
| K963949 |
12/19/1996 |
KSEA UNIMAT PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K963960 |
12/20/1996 |
KSEA UNIMAT PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K964519 |
12/20/1996 |
CURITY THORACENTESIS TRAY |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K962528 |
12/12/1996 |
OLYMPUS MOBILE CHAIR/COUCH |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
ROGER GRAY |
| K963972 |
12/24/1996 |
NEO-CARE DUAL LUMEN UMBILICAL CATHETER |
KLEIN-BAKER MEDICAL, INC. |
CLYDE N BAKER |
| K953111 |
12/27/1996 |
CORAIL |
LANDOS, INC. |
NORMAN F ESTRIN |
| K962917 |
12/16/1996 |
MULTIDEX HYDROPHILIC WOUND DRESSING GEL |
LANGE MEDICAL PRODUCTS, INC. |
LEON FERN |
| K964411 |
12/31/1996 |
TAKI ACUPUNCTURE NEEDLES |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K954505 |
12/10/1996 |
EZ STIM |
LIFE-TECH INTL., INC. |
ANDREW C KYLE |
| K955031 |
12/10/1996 |
MAXISTIM |
LIFE-TECH INTL., INC. |
ALFRED C COATS |
| K964458 |
12/09/1996 |
ELLIS EXTERNAL MINI-FIXATOR SYSTEM |
LINK AMERICA, INC. |
DOUGLAS W STUART |
| K963679 |
12/12/1996 |
LOVING SMARTER - SAFER SEX |
LOVING SMARTER, INC. |
PATRICIA A EVERETT |
| K964515 |
12/31/1996 |
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 |
M.C. HEALTHCARE PRODUCTS, INC. |
RALPH N THOMPSON |
| K963849 |
12/13/1996 |
MANAN D BAG |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K963743 |
12/06/1996 |
MANAN PROSTATE UNI-LOCK |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K965256 |
12/09/1996 |
DMS-1000C DERMOABRADER |
MATTIOLI ENGINEERING, SRL |
GIAN FRANCO BERNABEI |
| K963749 |
12/17/1996 |
HIGH PRESSURE INJECTION LINES |
MAXXIM MEDICAL |
RICHARD A HAMER |
| K962661 |
12/09/1996 |
ML MICROKERATOME BLADE |
MED-LOGICS, INC. |
GLENN A DUNKIN-JACOBS |
| K962612 |
12/12/1996 |
BILIBED PHOTOTHERAPY LAMP |
MEDELA, INC. |
STEPHEN D SMITH |
| K961013 |
12/20/1996 |
DISPOSABLE NEEDLE ELECTRODE |
MEDELEC INTL. CORP. |
JEFF HALL |
| K961138 |
12/10/1996 |
ESORT II + 400 SERIES MONITOR |
MEDICAL DATA ELECTRONICS |
DAVID M TRUBLOOD |
| K962969 |
12/06/1996 |
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K964637 |
12/24/1996 |
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA |
MEDICAL PACKAGING CORP. |
PATRICIA V WILLIS |
| K964316 |
12/17/1996 |
PLASTIC SUNGLASSES |
MEDICAL REPORTS EXCHANGE, INC. |
E.J. Smith |
| K961643 |
12/09/1996 |
MEDICOTEST ECG ELECTRODES |
MEDICOTEST, INC. |
RANDY R MARIANI |
| K962641 |
12/16/1996 |
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER |
MEDTRONIC VASCULAR |
DEBRA KRIDNER |
| K961601 |
12/23/1996 |
H.A.M. APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX W MICK |
| K954642 |
12/17/1996 |
HYDRO-SELECT GUIDEWIRE |
MICROVENA CORP. |
JODI LOCHER |
| K964794 |
12/23/1996 |
DAHLBERG K-AMP BTE |
MIRACLE-EAR, INC. |
MELANIE RASKA |
| K964669 |
12/26/1996 |
MIRACLE-EAR OR AUDIOTONE |
MIRACLE-EAR, INC. |
MELANIE RASKA |
| K964376 |
12/23/1996 |
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A |
MP SCIENTIFIC, INC. |
RICHARD GABRIEL |
| K963707 |
12/13/1996 |
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) |
NELLCOR PURITAN BENNETT, INC. |
DONNA PAGE |
| K962601 |
12/24/1996 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K962598 |
12/10/1996 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K963860 |
12/23/1996 |
THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM |
NOMOS CORP. |
MARVIN L SUSSMAN |
| K964177 |
12/30/1996 |
KROMALGIN IMPRESSION MATERIAL |
NORTH AMERICAN ORTHODONTIC LABORATORIES, INC. |
MARGARET H CHRISTOPHERSON |
| K964196 |
12/23/1996 |
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K950719 |
12/11/1996 |
OES UROLOGY |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K963170 |
12/02/1996 |
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K962474 |
12/20/1996 |
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K963184 |
12/31/1996 |
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K964563 |
12/30/1996 |
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE |
OMNI SALES CORP. |
WILLIAM E PATTON |
| K962435 |
12/26/1996 |
STC AUTO-LYTE URINARY GLUCOSE ASSAY |
ORASURE TECHNOLOGIES, INC. |
LISA VAIL |
| K964071 |
12/12/1996 |
ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR |
ORATEC INTERVENTIONS, INC. |
HUGH SHARKEY |
| K963228 |
12/18/1996 |
REPLIDERM WOUND DRESSING |
ORPHAN MEDICAL, INC. |
DAYTON T REARDAN |
| K962314 |
12/09/1996 |
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM |
OSTEONICS CORP. |
CHARLES RYAN |
| K963959 |
12/19/1996 |
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) |
OSTEONICS CORP. |
TERRY SHERIDAN |
| K964683 |
12/12/1996 |
DIGIFOCUS ITE |
OTICON, INC. |
PREBEN BRUNVED |
| K964475 |
12/06/1996 |
CLINICAL BLOOD GAS MIXTURES |
OXARC, INC. |
TRAVIS AUGER |
| K953990 |
12/09/1996 |
TRANSFLOW TEST |
P.K. MORGAN LTD. |
R. H. KERNAGHAN |
| K960854 |
12/23/1996 |
SIEMENS SERVO ULTRA NEBULIZER 345 |
PACESETTER, INC. |
STEVEN CLARKE |
| K964222 |
12/20/1996 |
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING |
PALADIN MEDICAL, INC. |
ELAINE DUNCAN |
| K963924 |
12/10/1996 |
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 |
PARI HOLDING CO. |
MIGUEL A ARRIZON |
| K962855 |
12/11/1996 |
ULE-2, MULE-2, HAND ACCESSORY KIT |
PENNY AND GILES BIOMETRICS LTD. |
IAN THOMAS |
| K962976 |
12/23/1996 |
PHARMACIA CAP SYSTEM RAST FEIA |
PHARMACIA & UPJOHN CO. |
JOYCE DAVIS |
| K963980 |
12/23/1996 |
PHILIPS EASYVISION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K964124 |
12/18/1996 |
PHILIPS COMPUTED RADIOGRAPHY |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
| K963624 |
12/06/1996 |
PHILIPS SLI SERIES LINEAR ACCELERATOR |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K964035 |
12/04/1996 |
PHONAK MICROLINK, PERSONAL FM RECEIVER |
PHONAK, INC. |
HELMUT ERMANN |
| K962447 |
12/12/1996 |
EQUINOX DIGITAL EEG SYSTEM |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K964123 |
12/12/1996 |
REUSABLE TROCAR WITH SLEEVE (COMMON) |
PILLING WECK GROUP |
KARENANN J BROZOWSKI |
| K962049 |
12/18/1996 |
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT |
POLYMEDCO, INC. |
JOHN H OLSEN |
| K960970 |
12/03/1996 |
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P |
POSSIS MEDICAL, INC. |
JAMES D GUSTAFSON |
| K963771 |
12/19/1996 |
CHLOROPRENE EXAM GLOVES |
PT. IRAMA DINAMIKA LATEX |
ANIL TANELJA |
| K962518 |
12/19/1996 |
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES |
PT. IRAMA DINAMIKA LATEX |
ANIL TANEJA |
| K963633 |
12/16/1996 |
VENTNET; CENTRAL MONITORING STATION |
PURITAN BENNETT CORP. |
RAY PIZINGER |
| K964421 |
12/06/1996 |
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK |
REMEL, L.P. |
MARY A SILVIUS |
| K955324 |
12/20/1996 |
BIPAP S/T-D 30 SYSTEM |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K962203 |
12/05/1996 |
WHISPER SWIVEL II EXHALATION PORT |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K964173 |
12/13/1996 |
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K962172 |
12/02/1996 |
FLEXIBLE MINI-FIBERSCOPES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT CASARSA |
| K964120 |
12/30/1996 |
INJECTO FLUSH |
ROBERT J. JYNCH, JR. |
ROBERT J JYNCH, JR. |
| K964355 |
12/13/1996 |
ONTRAK TESTCUP 5 (MODIFICATION) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K963993 |
12/17/1996 |
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET |
RUSCH, INC. |
NEIL R ARMSTRONG |
| K960771 |
12/10/1996 |
SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM |
RYMED TECHNOLOGIES, INC. |
DANA W RYAN |
| K964610 |
12/13/1996 |
TRIAD II DISINFECTANT CLEANER AND DEODORANT |
S.C. JOHNSON & SON, INC. |
ROBERT B O'BRIEN |
| K964828 |
12/19/1996 |
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT |
S.C. JOHNSON & SON, INC. |
ROBERT B O'BRIEN |
| K964613 |
12/13/1996 |
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT |
S.C. JOHNSON & SON, INC. |
ROBERT B O'BRIEN |
| K964535 |
12/13/1996 |
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT |
S.C. JOHNSON & SON, INC. |
ROBERT B O'BRIEN |
| K963547 |
12/02/1996 |
THE WRAP IMMOBILIZATION SYSTEM |
SAFE RESTRAINTS, INC. |
MARK RYCHLIK |
| K962139 |
12/19/1996 |
SAFESKIN |
SAFESKIN CORP. |
MICHELLE MOLLOY |
| K963276 |
12/06/1996 |
THE SAFETY 1ST DIGITAL PACIFIER |
SAFETY 1ST, INC. |
PAUL A WARE |
| K963906 |
12/02/1996 |
PATIENT RESTRAINTS |
SAFETY INTL., INC. |
GEORGE BOLUKBAS |
| K963859 |
12/18/1996 |
QLVA PLUS |
SANDERS DATA SYSTEMS, LLC. |
WILLIAM SANDERS |
| K962572 |
12/17/1996 |
SCIMED CHOICE PT VISION PTCA GUIDE WIRE |
SCIMED LIFE SYSTEMS, INC. |
CONNIE J DEL TORO |
| K961209 |
12/24/1996 |
BRIO AUTOMATIC SAMPLINC UNIT |
SEAC S.R.L. |
JOSEPH RESS |
| K964545 |
12/30/1996 |
POWDER FREE VINYL EXAMINATION GLOVE |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
ANTHONY L GIACCIO |
| K960982 |
12/23/1996 |
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA |
SHERWOOD MEDICAL CO. |
CHERLY WINTERS-HEARD |
| K962880 |
12/09/1996 |
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM |
SHERWOOD MEDICAL CO. |
DENNIS POZZO |
| K963888 |
12/18/1996 |
C-ARM TABLE IVS-100 |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K964334 |
12/09/1996 |
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH MAXWELL LAKE |
| K963539 |
12/16/1996 |
SIGMA DIAGNOSTICS WASH CONCENTRATE |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K964031 |
12/23/1996 |
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM |
SLT-J LTD. |
MICHAEL D JOHNSON |
| K964215 |
12/20/1996 |
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM |
SMITH & NEPHEW ENDOSCOPY, INC. |
TEDD GOSIAN |
| K962557 |
12/05/1996 |
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L CRAIG |
| K964163 |
12/27/1996 |
TRIMAX NAIL SYSTEM |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L CRAIG |
| K961633 |
12/05/1996 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE, PH.D. |
| K963884 |
12/16/1996 |
SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
T WEHMAN |
| K962093 |
12/23/1996 |
ULTRAMIX |
SONOTECH, INC. |
MARGARET J LARSON |
| K963956 |
12/09/1996 |
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT |
SOUTHERN RESEARCH, INC. |
SUSAN D GOLDSTEIN-FALK |
| K963517 |
12/02/1996 |
SPECTRA SCIENCE BIOPSY FORCEPS |
SPECTRASCIENCE, INC. |
BRIAN MCMAHON |
| K962418 |
12/26/1996 |
UREA NITROGEN (BUN) LIQUI-UV |
STANBIO LABORATORY |
KIRK JOHNSON |
| K964216 |
12/06/1996 |
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER |
STARKEY LABORATORIES, INC. |
SHARI L SWIDEN |
| K964250 |
12/18/1996 |
LINX NETWORKING SYSTEM |
STERLING DIAGNOSTIC IMAGING, INC. |
JEAN E BARTLETT |
| K964443 |
12/20/1996 |
SURGIFORM ANATOMICAL MALAR |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
RICHARD T NOCK |
| K963736 |
12/04/1996 |
SOFT DENTURE REBASING RESIN |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K963862 |
12/02/1996 |
TOUCH N' HEAT |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K963939 |
12/18/1996 |
SYNERMED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
MARCIA J ARENTZ |
| K962608 |
12/09/1996 |
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR |
SYNTHES (USA) |
DIANE T BROWN |
| K964328 |
12/13/1996 |
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K962894 |
12/17/1996 |
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K963341 |
12/02/1996 |
MIDSTREAM ONESTEP PREGNANCY HOME TEST |
SYNTRON BIORESEARCH, INC. |
CHARLES YU |
| K960389 |
12/05/1996 |
HYPERBARIC CHAMBER |
TAMPA HYPERBARIC ENT. |
MICHAEL CAPRIA |
| K963307 |
12/17/1996 |
GDC PATIENT RETURN ELECTTRODE MODEL 45021 |
TARGET THERAPEUTICS |
LARAINE PANGELINA |
| K962283 |
12/16/1996 |
EEG ELECTRODES |
TECA, INC. |
WILLIAM H BROWN |
| K964102 |
12/05/1996 |
TENET TIBIAL FRACTURE SUPPORT |
TENET MEDICAL ENGINEERING |
KEN MOORE |
| K963320 |
12/03/1996 |
TFX MEDICAL GUIDEWIRE |
TFX MEDICAL GROUP |
NEIL R ARMSTRONG |
| K963621 |
12/04/1996 |
STETHOS |
THERATECHNOLOGIES, INC. |
MICHEL GUERETTE |
| K962050 |
12/16/1996 |
THERATEST EL-RFSCR |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU, MD., PH.D. |
| K954523 |
12/10/1996 |
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 |
THERMOSCAN, INC. |
BARBARA STEVENS |
| K961780 |
12/24/1996 |
HEMODIALYSIS INTRODUCER SET |
THOMAS MEDICAL PRODUCTS, INC. |
THOMAS J CHAPMAN |
| K963807 |
12/18/1996 |
TOMTEC ECHO-SCAN |
TOMTEC IMAGING SYSTEMS, INC. |
KEVIN MORNINGSTAR |
| K963705 |
12/02/1996 |
COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
STEVEN M KAY |
| K962138 |
12/23/1996 |
FLEXART V3.1 SOFTWARE |
TOSHIBA AMERICA MRI, INC. |
JAVAD SEYEDZADEH |
| K960948 |
12/23/1996 |
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A |
TOSHIBA MEDICAL SYSTEMS |
JAVAD SEYEDZADEH |
| K961984 |
12/10/1996 |
PORPHOBILINOGEN (PBG) |
TRACE AMERICA, INC. |
David Johnston |
| K964429 |
12/12/1996 |
SUNGLASSES OR MULTIPLE |
TRADE RESOURCES LTD. |
LAURA SPINGOLA |
| K964060 |
12/24/1996 |
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE |
TRAVENOL LABORATORIES (ISRAEL) LTD. |
HARRY LEINWAND |
| K964134 |
12/31/1996 |
TRUSLIFT PORCH LIFT |
TRUS T LIFT |
RICHARD MEUNIER |
| K963979 |
12/12/1996 |
ULTRADENT UNIVERSAL DENTIN SEALANT |
ULTRADENT PRODUCTS, INC. |
DAN E FISCHER |
| K962296 |
12/16/1996 |
STREPTOLEX-STAT |
UNIPATH LTD. |
FRAN WHITE |
| K963825 |
12/20/1996 |
AUTO SUTURE* ABBI* SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CURTIS RAYMOND |
| K964270 |
12/18/1996 |
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
| K964459 |
12/18/1996 |
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
| K964175 |
12/05/1996 |
VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES |
VALLEYLAB, INC. |
PEGY WALLINE |
| K940242 |
12/23/1996 |
VENTANA CEA PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
KATHLEEN WINDALL |
| K962148 |
12/20/1996 |
VERGE VIDEOMETER |
VERG, INC. |
VERNON C TAYLOR |
| K935778 |
12/05/1996 |
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM |
VIA MEDICAL CORP. |
DAN MCKAY |
| K961607 |
12/06/1996 |
VIRAPUMP II (MODELS AND MODEL M) |
VIATRO, CORP. |
JAN J LEWANDOWSKI |
| K963795 |
12/23/1996 |
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH |
VISION-SCIENCES, INC. |
PAMELA L PAPINEAU |
| K964100 |
12/16/1996 |
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K962625 |
12/10/1996 |
VITAJET |
VITAJET CORP. |
SERGIO LANDAU |
| K962915 |
12/10/1996 |
ACTIS (VENOUS FLOW CONTROLLER) |
VIVUS, INC. |
NEIL GESUNDHEIT, M.D. |
| K963910 |
12/16/1996 |
HEART NEBULIZER #100609 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
| K955791 |
12/17/1996 |
SURGIFLATOR-20 PIM |
W.O.M. WORLD OF MEDICINE, GMBH |
ROBERT P REZNICK |
| K963847 |
12/24/1996 |
WAKO DIRECT HDL-C |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K963922 |
12/06/1996 |
ALPHA-DENT ROOT CANAL SEALER & FILLER |
WALLACE A. ERICKSON & CO. |
ABNER T DE LA CRUZ |
| K963837 |
12/20/1996 |
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN |
WESTCON CONTACT LENS CO., INC. |
BERNICE BARNARD |
| K963747 |
12/16/1996 |
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. |
WHITEHILL MANUFACTURING, INC. |
PETER P WALTERS |
| K963746 |
12/12/1996 |
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID |
WHITEHILL ORAL TECHNOLOGIES, INC. |
PETER P WALTERS |
| K964150 |
12/27/1996 |
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
