| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K920794 |
08/10/1992 |
BRND SKIN PROTECTION PREP SERIES 33XX |
3M HEALTH CARE, LTD. |
SUZANNE M DANIELSON |
| K922991 |
08/27/1992 |
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE |
ABBOTT LABORATORIES |
CAROL M COOPER |
| K921697 |
08/25/1992 |
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER |
ABBOTT LABORATORIES |
DANIEL HAMILTON |
| K920884 |
08/19/1992 |
GUIDEWIRES, VARIOUS TYPES |
ACME-MONACO CORP. |
HERBERT CARTER |
| K921425 |
08/27/1992 |
SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R |
ACOMA MEDICAL IMAGING, INC. |
JAMES L LAMBRECHT |
| K920666 |
08/05/1992 |
INTRAMEDULARY FIXATION ROD |
ACUMED, INC. |
RANDALL HUEBNER |
| K921719 |
08/07/1992 |
ACS ANGIOTRAK(TM) SYSTEM |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
KEVIN CORRIGAN |
| K920204 |
08/05/1992 |
INSTASCAN |
ADVANCED NMR SYSTEMS, INC. |
JONATHAN S KAHAN |
| K922780 |
08/20/1992 |
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL |
ALAMAR BIOSCIENCES LABORATORY, INC. |
MICHAEL V LANCASTER |
| K922003 |
08/19/1992 |
ANTIMICROBIAL SUSCETIBILITY TEST PANEL |
ALAMAR BIOSCIENCES LABORATORY, INC. |
MICHAEL V LANCASTER |
| K920105 |
08/06/1992 |
SCALAMOBIL |
ALBER TECHNOLOGIES, INC. |
MINDY L KLASKY |
| K922322 |
08/05/1992 |
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW |
ALPHATEC MFG., INC. |
A HOGHAUG |
| K922167 |
08/06/1992 |
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES |
ALPHATEC MFG., INC. |
THOMAS A HOGHAUG |
| K922166 |
08/06/1992 |
ALPHATEC SMALL FRAGMENT SET |
ALPHATEC MFG., INC. |
THOMAS A HOGHAUG |
| K921496 |
08/14/1992 |
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED |
ALPINE SPECIALTIES, INC. |
ROBIN PASQUAROSA |
| K922143 |
08/10/1992 |
AMERICAN BURN SHEET |
AMERICAN SILK SUTURES, INC. |
EDWARD M GREENSPAN |
| K915530 |
08/17/1992 |
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE |
AMERICAN THRESHOLD INDUSTRIES, INC. |
ROBERT T BAYER |
| K920405 |
08/18/1992 |
STERILE SURGEON'S GOWN |
AMSCO STERILE RECOVERIES, INC. |
CAROLANN DOTULA-COOK |
| K920404 |
08/18/1992 |
SURGEON'S GOWN |
AMSCO STERILE RECOVERIES, INC. |
CAROLANN KOTULA-COOK |
| K921604 |
08/24/1992 |
TOUCH N' HEAT, MODIFICATION |
ANALYTIC TECHNOLOGY |
JOHAN MASRELIEZ |
| K921223 |
08/18/1992 |
ACS FREEZE-DRIED APTT REAGENT |
ANALYTICAL CONTROL SYSTEMS, INC. |
PAULINE BONDERMANN |
| K911575 |
08/10/1992 |
ANCHOR IMPLANT DENTAL ATTACHMENTS |
ANCHOR IMPLANT SYSTEMS, INC. |
ALAN DONALD |
| K922851 |
08/25/1992 |
CYTOLOGY BRUSH |
ANNEX MEDICAL, INC. |
STUART J LIND |
| K922678 |
08/25/1992 |
LOOP RETRIEVER |
ANNEX MEDICAL, INC. |
STUART J LIND |
| K920224 |
08/21/1992 |
DOSCOPE AND ACESSORIES |
APPLIED LAPAROSCOPY |
JO STEGWELL |
| K923159 |
08/06/1992 |
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS |
ARJO-CENTURY, INC. |
GREGORY D HOLMER |
| K921165 |
08/06/1992 |
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGSTINE |
| K920573 |
08/11/1992 |
CANNULA NASAL OXYGEN |
B & F MEDICAL PRODUCTS, INC. |
JIM SPILLIS |
| K923569 |
08/26/1992 |
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT |
BAXTER DIAGNOSTICS, INC. |
SCOTT BEGGINS |
| K922273 |
08/19/1992 |
ARRAY(R) 360 |
BECKMAN INSTRUMENTS, INC. |
WILLIAM T RYAN |
| K921759 |
08/10/1992 |
ACRYLASTIC |
BEIERSDORF, INC. |
KENNETH M NICOLL |
| K921760 |
08/10/1992 |
TRICOPLAST |
BEIERSDORF, INC. |
KENNETH M NICOLL |
| K923150 |
08/27/1992 |
SILON TRANSPARENT WOUND DRESSINGS |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K920352 |
08/14/1992 |
BIO-DETEK EEG ELECTRODE |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K921617 |
08/05/1992 |
CYLINDER OF GAS, CAN OF GAS (CC12F2) |
BIO-RAD |
RICHARD W TEASDALE |
| K922823 |
08/05/1992 |
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS |
BIO-RAD LABORATORIES, INC. |
JAN OLSEN |
| K914473 |
08/05/1992 |
SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES |
BIOMEDICAL OPTICS CO. OF AMERICA, INC. |
ALAN J MITTELMAN |
| K922285 |
08/13/1992 |
AGC AND MAXIM KNEE COMPONENTS WITH NTS |
BIOMET, INC. |
PATRICIA S BERES |
| K922765 |
08/20/1992 |
BIOSTARS STREP A OIA -- MODIFICATION |
BIOSEARCH MEDICAL PRODUCTS, INC. |
DAN W CHILDERS |
| K920525 |
08/05/1992 |
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL |
BIOTRACK, INC. |
JILL FINDLAY |
| K921855 |
08/03/1992 |
BIOTROL BICARBONATE STANDARDS |
BIOTROL, USA, INC. |
ALLAN C MURPHY |
| K920528 |
08/12/1992 |
CATHETER INTRODUCER |
BOSTON SCIENTIFIC CORP. |
PAMELA CADORETTE |
| K922349 |
08/14/1992 |
DOWD(TM) II |
BOSTON SCIENTIFIC CORP. |
LORRAINE M HANLEY |
| K923217 |
08/03/1992 |
DANNIFLEX CPM 2000 |
BUCKMAN CO., INC. |
DAVID W SCHLERF |
| K923216 |
08/03/1992 |
DANNINFLEX CPM 800 |
BUCKMAN CO., INC. |
DAVID W SCHLERF |
| K922916 |
08/24/1992 |
BARD MARLEX MESH DART |
C.R. BARD, INC. |
CRAIG M AUDET |
| K921994 |
08/03/1992 |
BARD PCA II PUMP WITH PROGRAM CARTRIDGES |
C.R. BARD, INC. |
ERIC P ANKERUD |
| K920342 |
08/26/1992 |
BARD STONE REMOVAL BALLOON CATHETER |
C.R. BARD, INC. |
JEANETTE SCHIER |
| K920980 |
08/24/1992 |
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT |
C.R. BARD, INC. |
CHRISTINE ERICKSON |
| K922647 |
08/11/1992 |
COLOR DISKSTORE |
CAMTRONICS, LTD. |
SCOTT PEASE |
| K913303 |
08/06/1992 |
LAP SPONGES, MODIFIED |
CARWILD CORP. |
JOEL S WILDSTEIN |
| K922638 |
08/10/1992 |
TEMPIT-E |
CENTRIX, INC. |
JOHN DISCKO |
| K921468 |
08/21/1992 |
PERMAMESH HYDROXYLAPATITE MATRIX |
CERAMED CORP. |
BARBARA A WATSON |
| K922595 |
08/31/1992 |
MODIFIED SITE MACROBORE PHACO NEEDLE |
CHIRON VISION CORP. |
BRUNT MILLER |
| K922800 |
08/26/1992 |
PLATELET AGGREGATION REAGENTS |
CHRONO-LOG CORP. |
AURTHUR FREILICH |
| K914959 |
08/20/1992 |
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM |
CIBA CORNING DIAGNOSTICS CORP. |
WILLIAM J.PIGNATO |
| K922144 |
08/05/1992 |
CITSCOPE (MODEL EXTENSIONS) |
CITATION MEDICAL CORP. |
EDWARD F WADDELL |
| K921573 |
08/27/1992 |
RUBELLA IGM |
CLARK LABORATORIES, INC. |
GARY LEHNUS |
| K922936 |
08/26/1992 |
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE |
CLINICAL NEURO SYSTEMS LLC. |
STEPHEN W LAGUETTE |
| K922941 |
08/26/1992 |
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA |
CLINICAL NEURO SYSTEMS LLC. |
STEPHEN W LAGUETTE |
| K921077 |
08/25/1992 |
DISPOSABLE INTUBATION KITS |
COAST MEDICAL CORP. |
DOUGLAS R MONGEON |
| K922461 |
08/17/1992 |
COMFEEL WOUND DRESSING ORD |
COLOPLAST A/S |
RICHARD A HAMER |
| K922466 |
08/17/1992 |
COMFEEL WOUND DRESSING SD |
COLOPLAST A/S |
RICHARD A HAMER |
| K922615 |
08/03/1992 |
COLTENE A.R.T. BOND |
COLTENE/WHALEDENT INC. |
VOGELSTEIN |
| K922445 |
08/12/1992 |
VACU-PRO |
CONCORD/PORTEX |
ROBERT WHEELER |
| K921896 |
08/03/1992 |
TILTING MAG |
CONTINENTAL X-RAY CORP. |
OSCAR KHUTORYANSKY |
| K920675 |
08/18/1992 |
DUODERM SUSTAINED COMPRESSION BANDAGE |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
STEVEN PELTIER |
| K921120 |
08/04/1992 |
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K922192 |
08/07/1992 |
VAS DILATOR |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K922181 |
08/17/1992 |
COULTER MH009 |
COULTER ELECTRONICS, INC. |
RICHARDSON-JONES |
| K922995 |
08/12/1992 |
LIPID CONTROLS |
CREATIVE LABORATORY PRODUCTS, INC. |
GARY J PROKSCH |
| K921843 |
08/14/1992 |
CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K921841 |
08/04/1992 |
CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K922327 |
08/12/1992 |
DENLEY WELLPREP 2 SAMPLE PROCESSOR |
DENLEY INSTRUMENTS, INC. |
JOYCE T DAVIS |
| K922183 |
08/11/1992 |
WELLPREP 2000 SAMPLE PROCESSOR |
DENLEY INSTRUMENTS, INC. |
JOYCE T DAVIS |
| K910992 |
08/10/1992 |
AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE |
DEPUY, INC. |
STEPHEN J PEOPLES |
| K921350 |
08/04/1992 |
QUALTEX TUBE/CORD ORGANIZER |
DEROYAL INDUSTRIES, INC. |
DBRA MANNING |
| K921825 |
08/18/1992 |
QUICK-CHECK II REAGENT STRIP |
DIAGNOSTIC SOLUTIONS, INC. |
CHEN, PH.D. |
| K915566 |
08/07/1992 |
DISETRONIC PANOMAT PUMP |
DISETRONIC MEDICAL SYSTEMS |
LEE LEICHTER |
| K922318 |
08/10/1992 |
DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET |
DOUGLAS MEDICAL PRODUCTS CORP. |
DOUGLAS JOHNSON |
| K920593 |
08/31/1992 |
CERAMIC FEMORAL HEAD |
DOW CORNING WRIGHT |
MICKI ROY |
| K922234 |
08/11/1992 |
DYNASTY ISOLATION GOWN |
DYNATECH MEDICAL PRODUCTS |
MITCHELL DAVIS |
| K922633 |
08/06/1992 |
CAVI-ZYME |
E&D DENTAL PRODUCTS, INC. |
ED SPEHAR |
| K922697 |
08/10/1992 |
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD |
E.I. DUPONT DE NEMOURS & CO., INC. |
CHRISTOPHER BENTSEN |
| K922680 |
08/20/1992 |
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT |
E.I. DUPONT DE NEMOURS & CO., INC. |
CHRISTOPHER BENTSEN |
| K922700 |
08/20/1992 |
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. |
E.I. DUPONT DE NEMOURS & CO., INC. |
CHRISTOPHER BENTSEN |
| K922696 |
08/12/1992 |
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO |
E.I. DUPONT DE NEMOURS & CO., INC. |
CHRISTOPHER BENTSEN |
| K923165 |
08/10/1992 |
AMERLITE FREE THYROID CONTROL SERA LAN.4002 |
EASTMAN KODAK COMPANY |
BRADFORD M SPRING |
| K922411 |
08/24/1992 |
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 |
EASTMAN KODAK COMPANY |
NORMAN H GEIL |
| K921826 |
08/26/1992 |
KODAK INSIGHT PORTABLE IMAGING SYSTEM |
EASTMAN KODAK COMPANY |
NORMAN H GEIL |
| K921882 |
08/25/1992 |
THE CLEANER ACCESSORY |
EATON MEDICAL CORP. |
BRON EATON |
| K922082 |
08/03/1992 |
LAPAROSCOPIC INTRODUCER |
ENDOMEDIX |
WAYNE R HOHMAN |
| K920752 |
08/06/1992 |
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER |
ETHICON, INC. |
MELISSA WALKER |
| K921484 |
08/07/1992 |
MEDVISION |
EVERGREEN TECHNOLOGIES, INC. |
KAREN SIEGEL |
| K921954 |
08/26/1992 |
ISOTRON III |
EXCEL TECH. LTD. |
JOHN MUMFORD |
| K921953 |
08/26/1992 |
MULTI III |
EXCEL TECH. LTD. |
JOHN MUMFORD |
| K920298 |
08/11/1992 |
DISPOSABLE HEMOSTATS |
FALCON INSTRUMENTS, INC. |
NEAL DUNNING |
| K921393 |
08/20/1992 |
IMAGICA MICRO-ENDOSCOPE |
FIBEROPTIC MEDICAL PRODUCTS, INC. |
JOHN REISS |
| K922967 |
08/03/1992 |
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER |
FORTRESS SCIENTIFIC LTD. |
KNABLE GOTTS |
| K922966 |
08/03/1992 |
FORTRESS 1704FS FOUR WHEEL SCOOTER |
FORTRESS SCIENTIFIC LTD. |
KNABLE GOTTS |
| K920850 |
08/24/1992 |
GAC THUMB-SUCKING CONTROL APPLIANCE |
GAC INTL., INC. |
ERNEST BOHN |
| K921777 |
08/12/1992 |
CARDIAC FIRST PASS ANALYSIS |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K920400 |
08/20/1992 |
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST |
GENERAL BIOMETRICS, INC. |
BRYAN L KIEHL |
| K920401 |
08/20/1992 |
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST |
GENERAL BIOMETRICS, INC. |
BRYAN L KIEHL |
| K923124 |
08/27/1992 |
GLENROE GOLDEN ORTHODONTIC BRACKET |
GLENROE |
JOHN F BOZMAN |
| K915270 |
08/24/1992 |
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 |
GRASEBY MEDICAL LTD. |
|
| K912866 |
08/13/1992 |
PEAK EXPIRATORY FLOW METER |
HEALTH PRODUCTS, INC. |
LAUREN R ZIEGLER |
| K922175 |
08/06/1992 |
HEALTHPAK CHAIR SOX BARRIERS |
HEALTHPAK, INC. |
DENNIS M GRONEK |
| K923306 |
08/05/1992 |
HEALTHPAK UTILITY SOX BARRIERS |
HEALTHPAK, INC. |
DENNIS M GRONEK |
| K923317 |
08/25/1992 |
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL |
HELENA LABORATORIES |
PAT FRANKS |
| K923318 |
08/25/1992 |
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL |
HELENA LABORATORIES |
PAT FRANKS |
| K920820 |
08/17/1992 |
MODIFICATION COLUMNMATE |
HELENA LABORATORIES |
PAT FRANKS |
| K922053 |
08/18/1992 |
REP SPE PLUS (PONCEAU S) SYSTEM |
HELENA LABORATORIES |
PAT FRANKS |
| K923038 |
08/24/1992 |
MILES POTASSIUM METHOD |
HERAEUS KULZER, INC. |
ROBERT L HABIG |
| K923039 |
08/24/1992 |
MILES URINE CREATININE METHOD |
HERAEUS KULZER, INC. |
ROBERT L HABIG |
| K912364 |
08/26/1992 |
ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED |
HITACHI MEDICAL CORP. OF AMERICA |
TAKIGUCHI |
| K923010 |
08/25/1992 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JOCHEN ROGERS |
| K922739 |
08/06/1992 |
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K920371 |
08/12/1992 |
HPM REPLACEMENT ULPA FILTER MODEL UF001 |
HPM ENT. |
HENRY P MULLER |
| K921574 |
08/03/1992 |
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC |
HYCOR BIOMEDICAL, INC. |
ANNE JEPSON |
| K921616 |
08/11/1992 |
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT |
INCSTAR CORP. |
MARY FRICK |
| K920954 |
08/03/1992 |
AIR STAR |
INFRASONICS CORP. |
JIM HITCHIN |
| K922477 |
08/24/1992 |
MODEL 105 VENTILATOR, MODIFICATION |
INFRASONICS CORP. |
JIM HITCHIN |
| K922391 |
08/18/1992 |
ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS |
INSTRATEK, INC. |
PERRY FORRESTER |
| K920012 |
08/12/1992 |
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM |
INSTRUMENTATION LABORATORY CO. |
MURACA, JR |
| K912664 |
08/24/1992 |
TEC ROTATING DUAL HEMOVALVE |
INTENSIVE TECHNOLOGY, INC. |
MICHAEL E KLICPERA |
| K923618 |
08/03/1992 |
PEEP VALVE |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
SHEEHAN III |
| K922114 |
08/03/1992 |
ENDOSCOPIC RETRIEVAL BASKET |
INTRAMED LABORATORIES, INC. |
STEPHEN A SOSNOWSKI |
| K922663 |
08/11/1992 |
IRIS OCULIGHT SL |
IRIDERM DIV. |
THEODORE BOUTACOFF |
| K922446 |
08/05/1992 |
ACCU-STAR |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922450 |
08/05/1992 |
BENCHMARK C |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922448 |
08/05/1992 |
BENCHMARK I |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922447 |
08/05/1992 |
BENCHMARK III |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922451 |
08/05/1992 |
LEGACY-XT |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922449 |
08/05/1992 |
PA-400 |
J.F. JELENKO & CO., INC. |
COSTANTINO VOLPE |
| K922508 |
08/26/1992 |
RUBBER FRAME SUNGLASSES |
JEDDA DIST., INC. |
SY ROSENFELD |
| K923202 |
08/27/1992 |
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL |
JENERIC/PENTRON, INC. |
ARUN PRASAD |
| K922681 |
08/31/1992 |
CUTINOVA FOAM |
JOBST INSTITUTE, INC. |
ANGELO R PEREIRA |
| K920308 |
08/24/1992 |
COWBOY II |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
| K922835 |
08/04/1992 |
CALCIUM (AZ III) REAGENT |
KING DIAGNOSTICS, INC. |
FRANCES LOH |
| K922964 |
08/18/1992 |
KING DIAGNOSTIC TRIGLYCERIDES REAGENT |
KING DIAGNOSTICS, INC. |
FRANCES LOH |
| K921672 |
08/07/1992 |
INTER-"HA" HIP PROSTHESIS |
KIRSCHNER MEDICAL CORP. |
SAM SON |
| K920396 |
08/07/1992 |
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM |
KIRSCHNER MEDICAL CORP. |
SAM SON |
| K912837 |
08/26/1992 |
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS |
KIRSCHNER MEDICAL CORP. |
SAM SON |
| K922544 |
08/07/1992 |
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE |
KIRSCHNER MEDICAL CORP. |
PATRICIA CARPENTER |
| K914675 |
08/07/1992 |
MODULAR FEMORAL HEAD WITH OFFSET TRUNION |
KIRSCHNER MEDICAL CORP. |
SAM SON |
| K921921 |
08/17/1992 |
CATHETER CHOLANGIOGRAPHY |
LAPAROMED CORP. |
PAUL LUBOCK |
| K921053 |
08/06/1992 |
LAPAROMED LIGATING LOOP |
LAPAROMED CORP. |
PAUL LUBOCK |
| K923050 |
08/03/1992 |
ND:YAG LASER-12 |
LASER ENDO TECHNIC |
FRANCOIS D LEVY |
| K922770 |
08/18/1992 |
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 |
LEICA, INC. |
JOHN CROCKER |
| K922540 |
08/24/1992 |
WOUND DRESSING |
LES LABORATORIRES BROTHIER, S.A. |
EVAN DICK |
| K922186 |
08/06/1992 |
HEM-O-LOK -- MODIFICATION |
LINVATEC CORP. |
GLENN M MATTEI |
| K921348 |
08/05/1992 |
OIC MODEL J4 TMJ CPM |
LM PRODUCT DESIGN, INC. |
LOREN M MATTHEW |
| K920227 |
08/24/1992 |
QUADRATURE SHOULDER CONTOUR COIL |
MAGNETIC RESEARCH, INC. |
WENDELL A GIBBY |
| K923027 |
08/28/1992 |
NEURAY SURGICAL PATTIES AND STRIPS |
MARTLAND HEALTHCARE, INC. |
JON C MARTINSEN |
| K922212 |
08/10/1992 |
MDT CASTLE BIOSIGN TEST PACK |
MDT CORP., INC. |
MARK N SMITH |
| K920397 |
08/04/1992 |
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT |
MEDICAL ANALYSIS SYSTEMS, INC. |
DONNA L ANDERSON |
| K921178 |
08/26/1992 |
PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS |
MEDICAL ASSOCIATED SERVICES, INC. |
MARK S ALSBERGE |
| K920360 |
08/03/1992 |
TIMOX OXYGEN TIMER |
MEDICAL FITTINGS, INC. |
JOHN R SELADY |
| K921564 |
08/10/1992 |
POLYCLEAN |
MEDICAL POLYMERS, INC. |
ANNE CROSSWAY |
| K922047 |
08/05/1992 |
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 |
MEDIX BIOTECH, INC. |
JOHN CHEN |
| K921612 |
08/18/1992 |
INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2 |
MEDSTAR, INC. |
CRAIG SEYL |
| K920828 |
08/14/1992 |
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT |
MENLO CARE, INC. |
JOCK WALKER |
| K922346 |
08/14/1992 |
FEMALE URINE SAMPLING DEVICE |
MENTOR CORP. |
BYRON H WICKETT |
| K922353 |
08/24/1992 |
DIGOXIN COATED TUBE RIA |
MONOBIND |
FREDERICK R JEROME |
| K915416 |
08/03/1992 |
FYMCO FLYER |
MOTION DYNAMICS |
BLAINE HOBSON |
| K923291 |
08/06/1992 |
NAICO WHEEL CHAIRS |
NAICO CORP. |
TONA L HWANG |
| K911970 |
08/14/1992 |
NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE |
NASORCAP ENT., INC. |
STEVEN J DERRICK |
| K921058 |
08/11/1992 |
DISPOSABLE ISOLATION GOWN |
NAT'L SURTEX CORP. |
DICKSON HEE |
| K905434 |
08/27/1992 |
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 |
NOBELPHARMA USA, INC. |
THOMAS MALDOON |
| K923266 |
08/12/1992 |
NOVA TOTAL PROTEIN MODULE |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K922671 |
08/11/1992 |
CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS |
NUCCARDIAC SOFTWARE, INC. |
VAN TRAIN |
| K913039 |
08/25/1992 |
FLLYNN(R) GENESIS AC |
O-TWO SYSTEMS INTL., INC. |
JOE LASSALINE |
| K922405 |
08/14/1992 |
O.R.C. ADAPTER |
O.R. CONCEPTS, INC. |
JOHN MAYALL |
| K922355 |
08/18/1992 |
POLLY'S VITREOUS SCISSORS J-225-S |
O.R. SPECIALTIES, INC. |
JACK W HOWARD |
| K920590 |
08/31/1992 |
OHMEDA MODEL 5250 RGM MONITOR |
OHMEDA MEDICAL |
KEVIN MORNINGSTAR |
| K923608 |
08/18/1992 |
OLYMPUS DIRECT BILIRUBIN REAGENT |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K923564 |
08/18/1992 |
OLYMPUS INORGANIC PHOSPHORUS REAGENT |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K923411 |
08/18/1992 |
OLYMPUS MAGNESIUM REAGENT |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K922687 |
08/31/1992 |
OPTHALMIC FRAMES |
OPTIQUE FORTE LTD. |
GEORGE KUX |
| K915698 |
08/05/1992 |
FIBRINOSTIKA TDP MICROELISA SYSTEM |
ORGANON TEKNIKA CORP. |
RON SANYAL |
| K914188 |
08/26/1992 |
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
PATRICK A ROCHE |
| K921321 |
08/11/1992 |
ORTHO CHLAMYDIA ANTIGEN ELISA TEST |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
KIM W GRAY |
| K913853 |
08/27/1992 |
FISSURE SEALER |
ORTHO SOURCE |
ANDREA G MUSTACHIO |
| K920698 |
08/03/1992 |
FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS |
ORTHOMET, INC. |
DENNIS H CRANE |
| K920426 |
08/03/1992 |
PSK FEMORAL AND TIBIAL INSERT COMPONENT |
ORTHOMET, INC. |
DENNIS H CRANE |
| K920256 |
08/10/1992 |
SPINE MOTION ANALYZER WITH EMG |
ORTHOPEDIC SYSTEMS, INC. |
ROBERT R MOORE |
| K922104 |
08/11/1992 |
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA |
OSTEONICS CORP. |
ROBERT A KOCH |
| K922146 |
08/11/1992 |
OSTRONCS HEMI-HIP STEM SERIES |
OSTEONICS CORP. |
ROBERT A KOCH |
| K923388 |
08/06/1992 |
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER |
OTICON CORP. |
PREBEN BRUNVED |
| K923490 |
08/06/1992 |
BTE HEARING AID PERSONIC 410 |
OTICON CORP. |
PREBEN BRUNVED |
| K923491 |
08/06/1992 |
BTE HEARING AID PERSONIC 425 |
OTICON CORP. |
PREBEN BRUNVED |
| K920295 |
08/18/1992 |
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) |
OXFORD MEDILOG, INC. |
CHARLES HOLZ |
| K920673 |
08/13/1992 |
PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT |
PERCUDISC, INC. |
CHARLES L ROSE |
| K923924 |
08/24/1992 |
VOICEWAVE |
PERSONAL SOUND TECHNOLOGIES, INC. |
PAUL W O'BRIEN |
| K915512 |
08/18/1992 |
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
MARGARET CROWE |
| K921725 |
08/11/1992 |
PHILIP XP SERIES, IN-THE CANAL HEARING AID |
PHILIPS HEARING INSTRUMENTS CO. |
ROBERT MARTIN |
| K920714 |
08/20/1992 |
VISTA HPQ SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K922622 |
08/11/1992 |
PHILIPS CARDIAC WORKSTATION |
PHILIPS MEDICAL SYSTEMS, INC. |
WILLIAM G MCMAHON |
| K922720 |
08/24/1992 |
GROUP AUDITORY TRAINING SYSTEM |
PHONIC EAR, INC. |
ROBERT L REINKE |
| K913101 |
08/12/1992 |
PETERS CARDIOFLON(TM) SUTURE |
PROMEDICA PRODUCTS, INC. |
LEE HAND |
| K913102 |
08/03/1992 |
PETERS CARDIONYL(TM) SUTURE |
PROMEDICA PRODUCTS, INC. |
LEE HAND |
| K921253 |
08/06/1992 |
INSTRUMENT IRRIGATION PUMP |
PSI MEDICAL PRODUCTS, INC. |
JOHN J SOKOLOWSKI |
| K922755 |
08/20/1992 |
PULPDENT HARD CORE |
PULPDENT CORP. |
KENNETH J BERK |
| K920338 |
08/27/1992 |
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR |
PURITAN BENNETT CORP. |
MARSHALL SMITH |
| K923013 |
08/14/1992 |
ACOUSTIC APPRAISE CD-3 |
QUALITONE |
BRUCE A BROWN |
| K922922 |
08/28/1992 |
ABL50 BLOOD GAS SYSTEM |
RADIOMETER AMERICA, INC. |
DONALD L BAKER |
| K923723 |
08/12/1992 |
SILICONE BRAIN SPATULA SET |
REDMOND NEUROSURGICAL, INC. |
JOHN A REDMOND |
| K922570 |
08/06/1992 |
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 |
RESOUND CORP. |
JEANNETTE S JOHNSON |
| K923340 |
08/04/1992 |
ROCHE ABUSCREEN ONLINNE CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K914097 |
08/14/1992 |
SAFEMED LATEX SURGICAL GLOVES |
SAFETYTECH SDN. BHD. |
WONG |
| K921538 |
08/10/1992 |
AMALGAPHASE |
SASKAN AMALGAM ALLOYS, INC. |
AN-SHIH CHENG |
| K915054 |
08/04/1992 |
STATIM CASSETT AUTOCLAVE, MODIFICATION |
SCICAN |
DUNCAN NEWMAN |
| K915347 |
08/17/1992 |
SCIMED VIPER CATHETER |
SCIMED |
DARLENE THOMETZ |
| K923398 |
08/14/1992 |
CPI MODEL 2215 |
SEAMED CORP. |
MARCIA A PAGE |
| K923314 |
08/24/1992 |
AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY |
SEREX, INC. |
VICTOR LEE-OWN |
| K920470 |
08/26/1992 |
MEYER FOREIGN BODY LOCATOR |
SEYMOUR W. MEYER |
SEYMOUR W MEYER |
| K920212 |
08/20/1992 |
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM |
SHARED SYSTEMS, INC. |
ROBERT C HICKS |
| K921265 |
08/03/1992 |
DIASTAT ANTI-CARDIOLIPIN KIT |
SHIELD DIAGNOSTICS, LTD. |
GEORGE ZAJICEK |
| K922373 |
08/17/1992 |
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM |
SIEMENS GAMMASONICS, INC. |
IRENA KRUTULIS |
| K922372 |
08/17/1992 |
MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM |
SIEMENS GAMMASONICS, INC. |
IRENA KRUTULIS |
| K923379 |
08/18/1992 |
SIEMENS MODEL INFINITI 1001 B |
SIEMENS HEARING INSTRUMENTS, INC. |
LAURA S LIDDLE |
| K923380 |
08/18/1992 |
SIEMENS MODEL TRITON 3004 B |
SIEMENS HEARING INSTRUMENTS, INC. |
LAURA S LIDDLE |
| K922804 |
08/28/1992 |
AWOS ANGIOGRAPHIC WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K921318 |
08/03/1992 |
ADAPTING SLEEVE KIT MODEL 4023 |
SIEMENS-PACESETTER, INC. |
GLENN THOMPSON |
| K921328 |
08/20/1992 |
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA |
SOLARCARE TECHNOLOGIES CORP,INC. |
SAM NIEDBALA |
| K921140 |
08/20/1992 |
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA |
SOLARCARE TECHNOLOGIES CORP,INC. |
SAM NIEDBALA |
| K915867 |
08/14/1992 |
SOLCOVAC WOUND DRAINAGE SYSTEM |
SOLCO BASLE, INC. |
ROBERT W CUNNINGHAM |
| K922492 |
08/24/1992 |
SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER |
SPECIALTY PACKAGING PRODUCS, INC. |
EDWARD F VALDEZ |
| K922554 |
08/24/1992 |
STANDARD IMAGING HDR 1000 ION CHAMBER |
STANDARD IMAGING, INC. |
RAYMOND T RIDDLE |
| K921668 |
08/03/1992 |
STAODYN TUWAVE |
STAODYNE, INC. |
THOMAS W ROBIRDS |
| K921110 |
08/14/1992 |
TENS |
STAODYNE, INC. |
THOMAS W ROBIRDS |
| K923784 |
08/26/1992 |
STARKEY SM SERIES BTE HEARING AIDS |
STARKEY LABORATORIES, INC. |
JERROLD LANG |
| K920958 |
08/07/1992 |
SUMMIT NUCLEAR VISION NEUROSPECT |
SUMMIT NUCLEAR |
JOCHEN ROGERS |
| K922205 |
08/11/1992 |
BIO THERAPY PLUS |
SUNRISE MEDICAL, INC. |
GREG GODFREY |
| K923041 |
08/10/1992 |
INTESTINAL SPONGES |
SURGIC AID, INC. |
PAUL W O'REILLY |
| K922542 |
08/19/1992 |
GRASPING FORCEPS |
SURGITEK |
BRIAN KUNST |
| K922813 |
08/11/1992 |
GEN-X 800-400 -- MODIFICATION |
SWISSRAY MEDICAL SYSTEMS |
MICHAEL W SCOTT |
| K921539 |
08/11/1992 |
GEN-X 800/6/50 |
SWISSRAY MEDICAL SYSTEMS |
MICHAEL W SCCOTT |
| K920762 |
08/26/1992 |
BIOSPSY FORCEPS |
SYMBIOSIS CORP. |
KEVIN W SMITH |
| K922571 |
08/11/1992 |
INSTRUMENT, MANUAL, GENERAL SURGICAL |
SYMBIOSIS CORP. |
KEVIN W SMITH |
| K923028 |
08/04/1992 |
TURKEL PNEUMOTHORAX KIT |
SYMBIOSIS CORP. |
W SMITH |
| K922915 |
08/24/1992 |
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT |
SYVA CO. |
ROGERS, JR. |
| K922914 |
08/24/1992 |
EMIT 2000 PROCAINAMIDE CALIBRATORS |
SYVA CO. |
ROGERS, JR. |
| K922913 |
08/24/1992 |
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS |
SYVA CO. |
ROGERS, JR. |
| K922055 |
08/10/1992 |
STERILE AND NON-STERILE GAUZE SPONGES |
TEAM MFG., INC. |
NORRIS R HAROD |
| K922054 |
08/10/1992 |
STERILE GAUZE SPONGES X-RAY DETECTABLE |
TEAM MFG., INC. |
NORRIS R HAROD |
| K914489 |
08/17/1992 |
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING |
TELECTRONICS PACING SYSTEMS, INC. |
DUANE A SCHULTZ |
| K915365 |
08/27/1992 |
AP-6CR CINERADIOGRAPHIC FILM PROCESSOR |
THE ALLEN PRODUCTS CO. |
RONALD L BAILER |
| K922417 |
08/20/1992 |
AL-ACID GLYCOPROTEIN RID KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K920948 |
08/11/1992 |
TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER |
TOPOX THERAPEUUTIC RENTALS, INC. |
LYNNE ARONSON |
| K922240 |
08/07/1992 |
ELECTRONIC PHOTOSPOT 20 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
TIMOTHY W CAPEHART |
| K921413 |
08/14/1992 |
MRT-50 |
TOSHIBA AMERICA MRI, INC. |
BEN KHOSRAVI |
| K921204 |
08/13/1992 |
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K921394 |
08/13/1992 |
DRESSING CHANGE TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K920518 |
08/17/1992 |
E.R. SUTURE TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K921203 |
08/13/1992 |
INCISSION & DRAINAGE TRAY |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K921281 |
08/27/1992 |
TRACHEOSTOMY CARE KIT |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K920281 |
08/27/1992 |
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K923044 |
08/27/1992 |
MONAD NUCLEAR IMAGING SYSTEM |
TRIONIX RESEARCH LABORATORY, INC. |
KEVIN M MURROCK |
| K920354 |
08/05/1992 |
OPHTHALMIC SPONGES |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K920355 |
08/06/1992 |
SPECIALTY SPONGES |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K920356 |
08/06/1992 |
SURGICAL SPONGES |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K922090 |
08/04/1992 |
FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION |
VALLEYLAB, INC. |
PEGGY WALLINE |
| K922853 |
08/10/1992 |
AQUA IONOFIL |
VOCO GMBH |
GAIL E GILLENWATER |
| K922854 |
08/05/1992 |
AQUA MERON |
VOCO GMBH |
GAIL E GILLENWATER |
| K923070 |
08/20/1992 |
WAKO IGG-HA |
WAKO CHEMICALS, USA, INC. |
EDWARD ZIOR |
| K922513 |
08/20/1992 |
COMFIT STERILE LATEX EXAMINATION GLOVE |
WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
KUEI CHOO |
| K922719 |
08/07/1992 |
WILLIAMS ADVANTAGE ELEVATION TABLE |
WILLIAMS MANUFACTURING CO. |
WAYNE L PETERSON |
| K912270 |
08/05/1992 |
POLYCATH #WMC-900 |
WORLDWIDE MEDICAL |
TODD JOHNSON |
| K921189 |
08/31/1992 |
THERMA-H |
ZEWA AG |
BURK A BRANDT |
