FDA 510(k) Applications Received During October, 1985

FDA 510(k) Number Submission Date Device Name Applicant Contact
K854368 10/29/1985 CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER ABBOTT DIAGNOSTICS RUTH M BECKER
K854308 10/25/1985 POLYCATH-H CATHETER ABBOTT LABORATORIES FREDERICK GUSTAFSON
K854044 10/02/1985 TDX BARBITURATES ABBOTT LABORATORIES MARY E ZORC
K854163 10/15/1985 TDX COCAINE METABOLITE ABBOTT LABORATORIES MARY E ZORC
K854167 10/15/1985 TDX PHENCYCLIDINE ABBOTT LABORATORIES MARY E ZORC
K854154 10/11/1985 FOX BED MODEL 2001 ACE MFG. ERIC MADINGER
K854320 10/28/1985 ACKRAD ORAL SUCTION TUBE ACKRAD LABORATORIES BERNARD ACKERMAN
K854310 10/24/1985 ACS INDEFLATOR (MODIFICATION) ADVANCED CARDIOVASCULAR SYSTEMS, INC. MARIANNA BRESCHINI
K854261 10/23/1985 ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES ADVANCED CARDIOVASCULAR SYSTEMS, INC. JANE E BEGGS
K854225 10/18/1985 ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS ADVANCED MEDICAL TECHNOLOGY, INC. THOMAS V KEELEY
K854241 10/21/1985 AOT EXTERNAL COMPRESS DEVICE ADVANCED ORTHO-TECHNOLOGY, INC. ALLEN P SCHLEIN
K854344 10/29/1985 AQUACEL SURGICAL PREP PADS ADVANCED ORTHO-TECHNOLOGY, INC. ALLEN P SCHLEIN
K854259 10/23/1985 SEPACELL R-500 & SEPACELL R-500A ADVOCACY INTERNATIONAL, LTD. RICHARD T NEY
K854213 10/17/1985 ARI STANDARD ANESTHESIA RECORD AGILENT TECHNOLOGIES, INC. EDWARD WEISGERBER
K854076 10/07/1985 MGA 2000 GAS ANALYSER AIRSPEC LTD. CRAWFORD
K854159 10/11/1985 ELLIPTI-PUNCH ALCON LABORATORIES REBECCA G WALKER
K854172 10/15/1985 I.V. WATCH ALLTEK, INC. CLIFFORD A TYNER
K854030 10/01/1985 WRIST ACTIGRAPH AMBULATORY MONITORING, INC. WILLIAM GRUEN
K854113 10/08/1985 CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH AMERICAN BENTLEY DONALD A RAIBLE
K854045 10/02/1985 MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED AMERICAN BENTLEY DONALD A RAIBLE
K854314 10/28/1985 FANA 60 AMERICAN BIO-REAGENTS, INC. DAVID E KOLESAR
K854384 10/30/1985 ASSERACHROM FPA KIT AMERICAN BIOPRODUCTS CO. B LE
K854312 10/28/1985 ASSERACHROM IX:AG AMERICAN BIOPRODUCTS CO. B LE
K854278 10/24/1985 NEG COMBO BREAKPOINT PANEL POS COMBO AMERICAN MICRO SCAN KRISTA L UNDERWOOD
K854366 10/29/1985 ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD AMERICAN MONITOR CORP. LINDA M CHINN
K854232 10/21/1985 PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES AMERICAN PHARMASEAL DIV. AHSC LAWRENCE GETLIN
K854049 10/03/1985 HEYER-SCHULTE SYRINGO PERITONEAL SHUNT AMERICAN V. MUELLER MATTHEW NOWLAND
K854192 10/15/1985 ANADIAS NASAL SAW BLADES ANADIAS, INC. JOSEPH GIAMPAPA
K854161 10/11/1985 SUR-FIT FACE MASK ANESTHESIA RESPIRATORY TECHNOLOGY, INC. TIMOTHY D STRUTHERS
K854131 10/10/1985 PHASE V-MODEL 1500 RUVA APOLLO'S SUNTANNING SUPPLIES GRETCHEN M ENGEL
K854249 10/22/1985 COMPUTER ASSISTED DIABETIC INTRUCTION APPLIED BIOMEDICAL COMPUTATIONS, INC. JONATHAN S KAHAN
K854137 10/10/1985 ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC ARROW INTL., INC. RONALD P CITRON
K854281 10/24/1985 MAGNETIC RETRIEVER ASPEN LABORATORIES, INC. JOHNSON
K854577 10/23/1985 PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) AUSTIN BIOLOGICAL LABORATORIES DENNIS R SCHNEIDER
K854074 10/04/1985 MODEL 200 INFUSION PUMP AVI, INC. STANLEY J SUEDKAMP
K854073 10/04/1985 MODEL 210 INFUSION PUMP AVI, INC. STANLEY SUEDKAMP
K854173 10/15/1985 UCD URINE SPECIMEN COLLECTOR BAKER INSTRUCTIONS CORP. TOMALESKY
K854146 10/11/1985 SURGICAL & DENTAL INSTRUMENT BAORT, INC. BAYO OSHINNAIYE
K854147 10/11/1985 BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL BATTLE CREEK EQUIPMENT CO. JOHN W DOTY
K854148 10/11/1985 BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL BATTLE CREEK EQUIPMENT CO. JOHN W DOTY
K854064 10/04/1985 BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854093 10/07/1985 LEUCO PREP BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854242 10/21/1985 QBC CENTRIFUGAL HEMATOLOGY SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854102 10/07/1985 SCEPTOR ENTERIC MIC PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854103 10/07/1985 SCEPTOR ENTERIC MIC/ID PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSEL ARNSBERGER
K854099 10/07/1985 SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854101 10/07/1985 SCEPTOR GRAM POSITIVE MIC PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854100 10/07/1985 SCEPTOR GRAM POSITIVE MIC/ID PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854098 10/07/1985 SCEPTOR PSEUDOMONAS PLUS MIC PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854097 10/07/1985 SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K854057 10/03/1985 PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE BECKMAN INSTRUMENTS, INC. JACK E SOROKIN
K854039 10/02/1985 LASER ASO KIT BEHRING DIAGNOSTICS, INC. JOHN E HUGHES
K854133 10/10/1985 BIO MEDICUS BIO CONSOLE 540 BIO MEDICUS, INC. JOHN R DALPEE
K854362 10/29/1985 MODIFIED BRAIN ATLAS III BIO-LOGIC SYSTEMS CORP. GABRIEL RAVIV
K854333 10/28/1985 BIOCHEM 515 RESPIRATION MONITOR BIOCHEM INTERNATIONAL, INC. KEITH R HARPER
K854059 10/03/1985 MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO BIOCLINICAL SYSTEMS, INC. BRUCE F WATKINS
K854379 10/30/1985 MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT BIOCLINICAL SYSTEMS, INC. BRUCE F WATKINS
K854208 10/17/1985 THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS BODYLOG, INC. STEVEN GOLDMAN
K854243 10/21/1985 ES 22 BOEHRINGER MANNHEIM CORP. SUE SMITHE
K854298 10/25/1985 IRON BOEHRINGER MANNHEIM CORP. SUE SMITH
K854081 10/07/1985 IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST BOOTS-CELLTECH DIAGNOSTICS, INC. JOHN G SIMPSON
K854283 10/24/1985 CAMBRIDGE MODEL XT1000 CAMBRIDGE MEDICAL INSTRUMENTS, INC. ANTHONY R LEWIS
K854282 10/24/1985 PREVIEW XT CAMBRIDGE MEDICAL INSTRUMENTS, INC. ANTHONY R LEWIS
K854109 10/08/1985 ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 CAMERON-MILLER, INC. JOHN W MARTIN
K854190 10/15/1985 CANTROL SPINAL FLUID CONTROL CANYON DIAGNOSTICS, INC. FALKOWSKI
K854041 10/02/1985 CD-100 CARDIAC MONITOR CARDIO DISPLAY CORP. MILAN KESLER
K854233 10/21/1985 CMI 3000 CARDIO MANAGEMENT, INC. DENNIS R TRAILER
K854383 10/30/1985 KERATOLUX CARL ZEISS, INC. MARIE PEDERSON
K854239 10/21/1985 OXYCOIL CHAD THERAPEUTICS, INC. CHARLES R ADAMS
K854251 10/22/1985 THE CSE FILM CHANGER SYSTEM CHANGER SERVICE & ENGINEERING, INC. LEIF JOHANSSON
K854197 10/15/1985 IOSERT LENS IMPLANT INSTRUMENT CHIRON VISION CORP. HELENIHI
K854348 10/29/1985 CHURCHILL 3-WAY STOPCOCK SET CHURCHILL CORP. DAVID W EVANS
K854188 10/15/1985 IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO CLINICAL DATA, INC. ISRAEL M STEIN
K854186 10/15/1985 IN VITRO TEST DETERMINATION OF SGPT(ALT) CLINICAL DATA, INC. ISRAEL M STEIN
K854183 10/15/1985 IN VITRO TEST DETERMINATION OF THEOPHYLLINE CLINICAL DATA, INC. ISRAEL M STEIN
K854181 10/15/1985 IN-VITRO TEST DETERMINATION OF ALBUMIN CLINICAL DATA, INC. ISRAEL M STEIN
K854187 10/15/1985 IN-VITRO TEST DETERMINATION OF SGOT (AST) CLINICAL DATA, INC. ISRAEL M STAIN
K854184 10/15/1985 IN-VITRO TEST DETERMINATION OF TOBRAMYCIN CLINICAL DATA, INC. ISRAEL M STEIN
K854182 10/15/1985 IN-VITRO TEST DETERMINATION OF TRIALYCERIDE CLINICAL DATA, INC. ISRAEL M STEIN
K854185 10/15/1985 IN-VITRO TEST DETERMINATION OF URIC ACID CLINICAL DATA, INC. ISRAEL M STEIN
K854180 10/15/1985 IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN CLINICAL DATA, INC. ISRAEL M STEIN
K854179 10/15/1985 IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL CLINICAL DATA, INC. ISRAEL M STEIN
K854178 10/15/1985 IN-VITRO TEST FOR THE DETERMINATION OF CREATININE CLINICAL DATA, INC. ISRAEL M STEIN
K854177 10/15/1985 IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE CLINICAL DATA, INC. ISRAEL M STEIN
K854231 10/21/1985 ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES CLINICAL TECHNOLOGY CORP. JOHN SCOVILLE
K854160 10/11/1985 CNS-16 & LTM 1.0 SOFTWARE CNS, INC. DANIEL E COHEN
K854119 10/09/1985 ACCURACY COLUMBIA DIAGNOSTICS, INC. JOHN INNOCENTI
K854270 10/23/1985 MURPHY ADJUSTABLE SPLINT COMFORTEX, INC. DONALD M SALYARDS
K854327 10/28/1985 SUBCUTANEOUS TUNNELING NEEDLES & HANDLES CONCORD LABORATORIES, INC. ROBERT WHEELER
K854040 10/02/1985 I.V. DRESSING CONSOLIDATED MEDICAL EQUIPMENT, INC. WILLIAM ABRAHAM
K854132 10/10/1985 COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS COOK PACEMAKER CORP. RICHARD E SHIREY
K854130 10/09/1985 DEMAND ETHYL ALCOHOL COOPER BIOMEDICAL, INC. CARL DEATON
K854375 10/30/1985 COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR COOPERVISION, INC. DAVID W KRAPF
K854214 10/17/1985 MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE CORDIS CORP. DEAN E CIPORKIN
K854114 10/08/1985 COULTER COUNTER MODEL T-660 COULTER ELECTRONICS, INC. RICHARDSON
K854305 10/25/1985 DART IRON & IRON BINDING CAPACITY REAGENT COULTER ELECTRONICS, INC. RICHARD-JONES
K854339 10/28/1985 CUI CHIN SIZER COX-UPHUFF INTL. DAVID J SCHUESSLER
K854125 10/09/1985 CRAIGWELL AID FITTING SYSTEM AFS CRAIGWELL ELECTRONICS, LTD. WELLBURN
K854124 10/09/1985 CRAIGWELL AID HA300 CRAIGWELL ELECTRONICS, LTD. WELLBURN
K854126 10/09/1985 CRAIGWELL MASTER HEARING AID MHA CRAIGWELL ELECTRONICS, LTD. WELLBURN
K854054 10/03/1985 PLACIDO DISC CUTLER MEDICAL INSTRUMENTS DAVID P CUTLER
K854106 10/08/1985 BAYSILEX CUTTER LABORATORIES, INC. STEVEN J OJALA
K854265 10/23/1985 SIMULATOR CYGNUS OF SOUTH FLORIDA, INC. DAVID FRIEDMAN
K854118 10/09/1985 DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS DACOMED CORP. MICHAEL W WALSH
K854391 10/31/1985 HEMODIALYSIS CONCENTRATE DANA LABORATORIES RONALD GOODMAN
K854092 10/07/1985 DMA CALIBRATORS DATA MEDICAL ASSOCIATES, INC. JERRY A GRAHAM
K854134 10/10/1985 FIBEROPTIC COLLIMATING HANDPIECE DAWN LASER TECHNOLOGY, INC. NYLE G UTTERBACK
K854301 10/25/1985 PLEUR-EVAC II AUTOTRANSFUSION SYSTEM DEKNATEL, INC. RICHARD J LARKIN
K854268 10/23/1985 DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER DEL MAR AVIONICS DAVID JOHNSON
K854269 10/23/1985 MODEL 509A PHYSIOCORDER AMBULATORY RECORDER DEL MAR AVIONICS DAVID R JOHNSON
K854042 10/02/1985 RESIN TRAY IMPRESSION MATERIAL DENTSPLY INTL. JOHN SEMMELMAN
K854253 10/22/1985 ROOT CANAL FILLING RESIN DENTSPLY INTL. JOHN SEMMELMAN
K854285 10/25/1985 GDC 1453 CASTING ALLOY DERINGER-NEY INC. DONALD LANDMANN
K854176 10/15/1985 POLYCHROME IV STAIN DEVETEC, INC. DONALD L PRICE
K854072 10/04/1985 JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR- DEXIDE, INC. MARY K BRUCH
K854066 10/04/1985 DOUBLE ANTIBODY C-PEPTIDE RIA KIT DIAGNOSTIC PRODUCTS CORP. SIDNEY A AROESTY
K854240 10/21/1985 CALCITONIN RIA KIT DIAGNOSTIC SYSTEMS LABORATORIES, INC. GOPAL SAVJANI
K854357 10/29/1985 GEM-6, WITH COMPONENTS DIAMOND ELECTRO-TECH, INC. STEVEN ENZER
K854089 10/07/1985 DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT DIATECH, INC. BETTY L WHITE
K854090 10/07/1985 DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT DIATECH, INC. BETTY L WHITE
K854196 10/15/1985 DCI MODEL EP-2 CLINICAL STIMULATOR DIGITAL CARDIOVASCULAR INSTRUMENTS, INC. HAAKON T MAGNUSSEN
K854386 10/31/1985 MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM DIRECTED ENERGY, INC. EDWARD JOHANSEN
K854399 10/31/1985 MODEL 20-B CO2 LASER SYSTEM DIRECTED ENERGY, INC. EDWARD JOHANSEN
K854387 10/31/1985 MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM DIRECTED ENERGY, INC. EDWARD JOHANSEN
K854398 10/31/1985 MODEL CO2 LASER SYSTEM 8B DIRECTED ENERGY, INC. EDWARD JOHANSEN
K854158 10/11/1985 RESNICK EMITTER, ARTIFICIAL LARYNX DYNAMED AUDIO, INC. JOSEPH A RESNICK
K854303 10/25/1985 MR 700 MICROPLATE READER 012-700-1000 DYNATECH LABORATORIES, INC. HEIDI E CHANDONNET
K854122 10/09/1985 PRECIOUS LITE MODEL 4224 E & B TECHNOLOGIES, INC. ED BURLESON
K854396 10/31/1985 RUB E-Z E-Z INSTRUMENTS CO. KENNETH R HARTMAN
K854248 10/21/1985 GOODLEY POLYAXIAL CERVICAL TRACTION UNIT E-Z-EM, INC. JACK T BERGER
K854206 10/16/1985 ULTRACLONE 05-100 GUINEA PIG RBC EARL-CLAY LABORATORIES, INC. ROBERT E LOVINS
K854139 10/10/1985 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB EASTMAN KODAK COMPANY PHILIP J HARTER
K854219 10/17/1985 KODAK M35 X-OMAT PROCESSOR EASTMAN KODAK COMPANY PHILIP J HARTER
K854138 10/10/1985 KODAKEKTACHEM DTR MODULE EASTMAN KODAK COMPANY PHILIP J HARTER
K854359 10/29/1985 LM2000A SURGICAL SUCTION MONITOR ENGINEERING, INC. GREGORY A HATFIELD
K854153 10/11/1985 MARATHON POWER DRIVE-WHEELCHAIR EVEREST & JENNINGS, INC. WILLIAM B CALHOUN
K854051 10/03/1985 MODULAR POWER BASE EVEREST & JENNINGS, INC. WILLIAM B CALHOUN
K854169 10/15/1985 PUPILSCAN FAIRVILLE MEDICAL OPTICS, INC. ANTHONY G SCOTT
K854356 10/29/1985 STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE FONTAINE INDUSTRIES, INC. HARRY NISHIGUCHI
K854309 10/25/1985 GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 GAMBRO, INC. JEFFREY SHIDEMAN
K854224 10/18/1985 GOLDEN RULE SUN TANNING BEDS GOLDEN RULE TANNING CO., INC. DOUGLAS BEDWELL
K854403 10/31/1985 MODEL 2120 SPIROSCREEN GOULD, INC. PAUL L KITTINGER
K854082 10/07/1985 PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD GRAY WAVE CORP. MYRON NORENBERT
K854355 10/29/1985 GREENLEAF SMART POLYGRAPH PROGRAM GREENLEAF SCIENCE CORP. WALTER GREENLEAF
K854374 10/30/1985 OXYGEN CONCENTRATOR, MODEL BX-5000 HEALTHDYNE, INC. RICHARD SHEFFIELD
K854162 10/15/1985 SUPPORT ARM HEALTHMATE, INC. KEN WIESELMAN
K854315 10/28/1985 HEARTECH MODEL IN TECH HEARING TECH, INC. THOMAS P HUBER
K854376 10/30/1985 HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS HEMOTEC, INC. WILLIAM A MORTON
K854377 10/30/1985 HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS HEMOTEC, INC. WILLIAM A MORTON
K854135 10/10/1985 HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A HEWLETT-PACKARD CO. DAVID M PEROZEK
K854112 10/08/1985 FLEXIBLE GRASPING FORCEPS HOOD LABORATORIES BRUCE BARBER
K854267 10/23/1985 HUNTLEIGH DOPCORD, D140 HUNTLEIGH TECHNOLOGY, INC. JAMES BRITTON
K854155 10/11/1985 STERILE SALINE SOLUTION I M, INC. AMIR PORAT
K854094 10/07/1985 IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS IMMUCHEM CORP. BARRY J BURNS
K854104 10/08/1985 IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) IMMUNCHEM CORP. BOB HUDAK
K854207 10/16/1985 EBV(EPSTEIN-BARR VIRUS) TEST KIT IMMUNO-DIAGNOSTIC PRODUCTS, INC. NADEEM M MUNA
K854194 10/15/1985 IMT ULTRASONIC STRIDE MONITOR INNOVATIVE MEDICAL TECHNOLOGIES, INC. JOHN L TRIMBLE
K854055 10/03/1985 I.C.L.S. COMPULYZER INTEGRATED COMPUTERIZED LABORATORY SYSTEMS, INC. STEVEN J HOLT
K854069 10/04/1985 POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD INTERMEDICS, INC. DAVID MAKANANI
K854071 10/04/1985 POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD INTERMEDICS, INC. DAVID MAKANANI
K854166 10/15/1985 HEMATOLOGY CALIBRATOR CONTROL INTERSCIENCE DIAGNOSTICS, INC. WILLIAM WHELPLEY
K854065 10/04/1985 INFANT LIFE SUPPORT MODULE-20 INTL. BIOMEDICS, INC. LADDIE L DAVIS
K854258 10/22/1985 PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA INTL. PLAYTEX, INC. IRWIN BUTENSKY
K854171 10/15/1985 I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC INTL. SOLARIUM MANUFACTURER, INC. ERNEST B KNAPP
K854170 10/15/1985 I.S.M. PRODUCT FAMILY MODEL R3600C INTL. SOLARIUM MANUFACTURER, INC. ERNEST B KNAPP
K854164 10/15/1985 CRUISER INVACARE CORP. JAMES R THALER
K854120 10/09/1985 MURRAY CHAIR LIFT J.B. MURRAY ENTERPRISES, INC. CHARLES WILSON
K854029 10/01/1985 RESPIRATORY RESUSCITATION DEVICE JOHN H. HARRISON JOHN H HARRISON
K854341 10/28/1985 DELTA-LITE CASTING RESIN JOHNSON & JOHNSON PROFESSIONALS, INC. MARSHA J STONE
K854050 10/03/1985 EXCEL BRACKET ADHESIVE JOHNSON & JOHNSON PROFESSIONALS, INC. CAROL LANDSMAN
K854256 10/22/1985 KEELER AMOILS SURGICAL ASTIGOMETER KEELER INSTRUMENTS, INC. VAN ARSDAL
K854244 10/21/1985 THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE KEELER INSTRUMENTS, INC. VAN ARSDALE
K854110 10/08/1985 KEITHLEY MODEL 75100 & 75200 KEITHLEY INSTRUMENTS, INC. JERRY L NICKOL
K854304 10/25/1985 KEYMED OFFICE COUCH KEYMED, INC. ROGER GRAY
K854257 10/22/1985 COMBO 36 KG ENGINEERING, INC. RALPH E LEADER
K854378 10/30/1985 DEPEND FITTED BRIEF KIMBERLY-CLARK CORP. DER WAL
K854046 10/02/1985 CONICAL COLLAR HIP PROSTHESIS KIRSCHNER MEDICAL CORP. SAM SON
K854107 10/08/1985 DIMENSION TOTAL HIP PROSTHESIS POROUS COATED KIRSCHNER MEDICAL CORP. SAN SON
K854205 10/16/1985 KIRSCHNER COMPRESSION HIP SCREW SYSTEM KIRSCHNER MEDICAL CORP. SANM SON
K854338 10/28/1985 KIRSCHNER INTRAMEDULLARY NAIL SYSTEM KIRSCHNER MEDICAL CORP. SAN SON
K854307 10/25/1985 KONTRON DEFIBRILLATOR 7501 KONTRON INSTRUMENTS, INC. GEORGE CHO
K854204 10/16/1985 DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS LA JOLLA TECHNOLOGY, INC. THEODORE B HILL
K854140 10/10/1985 MODIFIED MYDRIATIC SPECTACLE LA RUE OPTICAL LA PRAIRIE
K854266 10/23/1985 STERILE LASER RESISTANT SURGICAL FIELD DRAPE LASERSAFE, INC. EDWARD TEEPLE
K854027 10/01/1985 LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM LASERSCOPE ROSS ERICKSON
K854083 10/07/1985 XYLENE SUBSTITUTE MONTANT LERNER LABORATORIES, INC. SUSAN E SEGAL
K854230 10/21/1985 MEBIASIS AGAR GEL DIFFUSION KIT LMD LABORATORIES DAVID LAMBILLOTTE
K854247 10/21/1985 JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS M/S SEOHUNG INDUSTRIAL CO., LTD. MICHAEL D KIM
K854058 10/03/1985 PK-AC POWERED PATIENT MANUPULATING DEVICE MANNESMANN DEMAG CORP. DAVID R MARSHALL
K854136 10/10/1985 ARRHYTHMIA REVIEW STATION MARQUETTE ELECTRONICS, INC. THOMAS MASSOPUST
K854221 10/18/1985 DIESSE CRP TEST KIT MARVIC INTERPHARMA, INC. MOTAFRAM
K854222 10/18/1985 DIESSE RF TEST KIT MARVIC INTERPHARMA, INC. MOTAFRAM
K854223 10/18/1985 VES-TEC/VES-MATIC MARVIC INTERPHARMA, INC. MOTAFRAM
K854262 10/23/1985 MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY MEADOX SURGIMED, INC. SCOTT MINDREBO
K854390 10/31/1985 WIRE CUTTING PLIERS OR LINEMAN'S PLIERS MED-TOOL, INC. JOHN M MAYERIK
K854035 10/01/1985 MICRO THERM MT-500 & MT-600 MEDEQUI, DIVISION OF KING YIP CO., INC. ALICE YAN
K854116 10/08/1985 PHACO PACKS, 1A PACKS & PACK COMPONENTS MEDICAL CORP. OF AMERICA THOMAS V KEELEY
K854234 10/21/1985 ESCORT ECG MONITOR SIEMENS SIRECUST 466 MEDICAL DATA ELECTRONICS CHIP HARLOW
K854316 10/28/1985 FASTENS(TM) MEDICAL DEVICES, INC. BRUCE MACFARLANE
K854317 10/28/1985 MINIPAC (TM) MEDICAL DEVICES, INC. BRUCE A MACFARLANE
K854108 10/08/1985 POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. DAVID A WALL
K854354 10/29/1985 THE BLEDSOE PASSIVE MOTION EXERCISER MEDICAL TECHNOLOGY AND INNOVATIONS, INC. GARY R BLEDSOE
K854346 10/29/1985 MEDIFLEX DISPOSABLE TUBING CLAMP MEDIFLEX INTL. EDGAR UDINE
K854215 10/17/1985 DYNAFEED MEDLINE INDUSTRIES, INC. ROBERT FASANA
K854254 10/22/1985 TENSION-ISOMETER MEDMETRIC CORP. WATKINS
K854291 10/25/1985 MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854290 10/25/1985 MEDSURG AMNIOCENTESIS TRAY MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854292 10/25/1985 MEDSURG ARTHROGRAM TRAY MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854297 10/25/1985 MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854293 10/25/1985 MEDSURG POTT-COURNAND NEEDLE MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854294 10/25/1985 MEDSURG SELDINGER NEEDLE MEDSURG INDUSTRIES, INC. DONNA COLLIER
K854289 10/25/1985 MEDSURG ULTRASOUND BIOPSY TRAY MEDSURG INDUSTRIES, INC. DONNA DOLLIER
K854331 10/28/1985 MICRO-AIRE OTO/NEURO DRILL SYSTEM MICRO-AIRE SURGICAL INSTRUMENTS, INC. GERALD BROOKS
K854332 10/28/1985 MICRO-AIRE STAPES DRILL SYSTEM MICRO-AIRE SURGICAL INSTRUMENTS, INC. GERALD BROOKS
K854402 10/31/1985 THE NEW MCINTYRE I.A. HANDPIECE MICROSURGICAL TECHNOLOGY, INC. NILSSON
K854401 10/31/1985 THE NEW MOBILE TIP MCINTYRE CANNULA MICROSURGICAL TECHNOLOGY, INC. NILSSON
K854063 10/04/1985 MICROVASIVE SILICONE SPRAY MICROVASIVE SAMUEL D WADE
K854238 10/21/1985 NEEDLE W/STYLET FOR IMPLANTATION MICROVASIVE SAMUEL D WADE
K854123 10/09/1985 MIDAS REX OPERATING ROOM VISE MIDAS REX PNEUMATIC TOOLS, INC. FOREST BARBER
K854365 10/29/1985 IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS MIGADA, LTD. DAVID THALER
K854288 10/25/1985 OPHALMIC LASER PHOTOCOAGULATOR MIRA, INC. MARK W FURLONG
K854151 10/11/1985 HOMECARE CLINICS INFRAHEAT #230 NELKIN/PIPER INTL. MARC BERNSTEIN
K854389 10/31/1985 NIDEK US-1600 A-SCAN NIDEK, INC. JOHN BRATKOWSKY
K854370 10/29/1985 MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR NIHON KOHDEN AMERICA, INC. DENNIS JAVENS
K854371 10/29/1985 MTC 6210A CARDIAC OUTPUT COMPUTER NIHON KOHDEN AMERICA, INC. DENNIS JAVENS
K854372 10/29/1985 VM 781 SLAVE SCOPE NIHON KOHDEN AMERICA, INC. DENNIS JAVENS
K854369 10/29/1985 WEP 7604 TELEMETRY MONITOR NIHON KOHDEN AMERICA, INC. DENNIS JAVENS
K854236 10/21/1985 HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS NMS PHARMACEUTICALS, INC. PERRY C RUCKER
K854095 10/07/1985 BIOPSY TRAY I & II NORTH COAST MEDI-TEK THERESA SOLOLOSKI
K854052 10/03/1985 CSM MEDIUM NORTHERN SCIENTIFIC, INC. ROBERT W CASE
K854175 10/15/1985 DEFIGARD 2000 ODAM CANSELL
K854306 10/25/1985 OHMEDA CPU AIR COMPRESSOR MODEL 3350 OHMEDA MEDICAL RIDDLE
K854201 10/15/1985 OMRON DIGITAL BP MONITOR HEM-700CP OMRON TATEISI ELECTRONICS CO. HISA
K854218 10/17/1985 THE ULTRA-MATE LENS OPTICAL SYSTEMS INTL., INC. DE ROJAS
K854271 10/23/1985 ASA BLOOD TUBING LINES ORGANON TEKNIKA CORP. MARING ROBERTS
K854367 10/29/1985 HD-SECURA HEMADIALYSIS MACHINE ORGANON TEKNIKA CORP. MARTIN ROBERTS
K854087 10/07/1985 NML TSH IRMA ORGANON TEKNIKA CORP. ROBERT WURZEL
K854084 10/07/1985 PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT ORGANON TEKNIKA CORP. MARTIN ROBERTS
K854129 10/09/1985 ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS ORION DIAGNOSTICA, INC. DE MARCO
K854313 10/28/1985 SONGER TITANIUM SPINE-L-ROD ORTHO-ENGINEERING PRODUCTS CO. ROBERT J SONGER
K854336 10/28/1985 MONOFIXATEUR ORTOPEDIA GMBH LOTHAR GRIESSBACH
K854128 10/09/1985 OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE OSCOR MEDICAL CORP. DE GRAAD
K854220 10/18/1985 PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD PACESETTER SYSTEMS NESTOR KUSNIERZ
K854195 10/15/1985 PROGRAMALITH III MODELS 238 & 239 PACESETTER SYSTEMS ANITA POWE
K854079 10/07/1985 THROMBO SCREEN SICKLE CELL ASSAY SET PACIFIC HEMOSTASIS MICHAEL D BICK
K854062 10/04/1985 PALL PULMONARY FUNCTION FILTER PALL BIOMEDICAL PRODUCTS CO. SIDNEY KRAKAUER
K854324 10/28/1985 PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT PANTEX, DIV. BIO-ANALYSIS, INC. NEIL Y CHIAMORI
K854330 10/28/1985 IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM PAR TECHNOLOGY PARK JAMES CAMBIER
K854150 10/11/1985 PHADIRECT STREP A TEST PHARMACIA, INC. BRIAN D BOLLWAGE
K854149 10/11/1985 TSK STERIJECT STERILE EPIDURAL NEEDLE PHARMACIA, INC. BRIAN D BOLLWAGE
K854328 10/28/1985 MEDEX X-RAY TABLE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. WILLIAM J GERBER
K854279 10/24/1985 NORELCO ELECTRONIC DIGITAL BP METER HC3030 PHILIPS PARK TED FLOWERS
K854117 10/09/1985 AMENDMENT LIFEPAK 8, NPN 052 PHYSIO-CONTROL CORP. MICHAEL B GROPP
K854067 10/04/1985 SELECT FLOWMETER PRECISION MEDICAL, INC. CLYDE W SHUMAN
K854121 10/09/1985 MICRO-MAT SYSTEM PREVO MICRO-MAT SYSTEM ROBERT K MCEWEN
K854157 10/11/1985 PMT ACCUPRESSURE INFUSION SYSTEM 3601 PROGRESS MANKIND TECHNOLOGY ALFRED A IVERSEN
K854300 10/25/1985 7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY PURITAN BENNETT CORP. HARTLEY C ERICSON
K854070 10/04/1985 MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM PURITAN BENNETT CORP. HARTLEY ERICSON
K854198 10/15/1985 PE-3000 PULSE RATE MONITOR QUANTUM LIFE SYSTEMS, INC. LINDA D BAKER
K854353 10/28/1985 PLATELET-TROL II R & D SYSTEMS, INC. DALE CHRISTENSEN
K854228 10/18/1985 COLUMBIA 5% BLOOD AGAR R. KENT RICHARDS, INC. KENT RICHARDS
K854275 10/18/1985 THAYER-MARTIN MEDIUM (MOD) R. KENT RICHARDS, INC. KENT RICHARDS
K854212 10/17/1985 ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR RESPIRATORY SUPPORT PRODUCTS, INC. STEVE GEORGEVICH
K854326 10/28/1985 NO FLOSS FLOSSER RGM ASSOC. RENATO G MARTINEZ
K854047 10/03/1985 IN-HOME VISION MONITORING KIT RICH-LARKY COMPANY, INC. EUGENE M PFEIFER
K854361 10/29/1985 CO2 LASER LAPAROSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP. CHARLES P GILL
K854325 10/28/1985 TRICON UNICOMPARTMENTAL KNEE SYSTEM RICHARDS MEDICAL CO., INC. ROBERT F GAMES
K854202 10/15/1985 ANESTHESIA VENTILATOR MODEL 100 RUSZ INSTRUMENTS, INC. TIBOR RUSZ
K854363 10/29/1985 SARATOGA SCT HEATED HUMIDIFICATION SYSTEM SARATOGA MEDICAL INSTRUMENTATION, INC. JOHN KURAS
K854358 10/29/1985 EZ DETECH-URINE BLOOD TEST STICKS SELF CARE SYSTEMS, INC. CONNEALY
K854260 10/23/1985 CHEMPRO 1000 SEN TECH MEDICAL CORP. WALTER SEMBROWICH
K854263 10/23/1985 SETMA FHT, MODEL ST 8130 SETMA, INC. RICHARD B DARDAS
K854329 10/28/1985 DIAGEM 300 BG REAGENT STRIPS SETON PRODUCTS, INC. DONALD A BORIG
K854319 10/28/1985 SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER SHILEY, INC. DAVID B THOMAS
K854337 10/28/1985 SDL-300 SHIMADZU CORP. TAKAO SOMEYAMA
K854347 10/29/1985 HYBRID POINTS SHOFU DENTAL CORP. MARTY DYMEK
K854245 10/21/1985 SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV SIGMA DIAGNOSTICS, INC. QUINCY E CRIDER
K854311 10/25/1985 EARLENS SOUND ACOUSTIC SYSTEMS, LTD. LEONARD H COHEN
K854343 10/29/1985 SIOM SOUTH WEST INTL., INC. ELIZABETH BURNES
K854255 10/22/1985 SPAN / AID SYRINGE SPAN-AMERICA MEDICAL SYSTEMS, INC. CHARLES B MITCHELL
K854335 10/28/1985 GLUCOSE REAGENT SET (GOD/TRINDER) STERLING DIAGNOSTICS, INC. DAVID L CALLENDER
K854318 10/28/1985 LIFEPORT AMBULATORY INFUSION PUMP STRATO MEDICAL CORP. ROBERT L MILLER
K854077 10/07/1985 MIX EVAC II STRYKER CORP. HARMON H WOODWORTH
K854111 10/08/1985 EXPRESS TAN SUN CANOPY SUNMAKER TANNING SYSTEMS, LTD. LINDA A LIBERTY
K854061 10/04/1985 SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM SYVA CO. ELEANOR CHIV
K854397 10/31/1985 HEMOSTATIC SIDEARM TARGET THERAPEUTICS MARIE DANIELS
K854340 10/28/1985 TECHNICARE 720 HPS CT SCANNER TECHNICARE CORP. RAYMOND E URSICK
K854152 10/11/1985 TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN TECHNICON INSTRUMENTS CORP. LEAONARD A DWARICA
K854345 10/28/1985 TECHNICON RA-500 SYSTEM TECHNICON INSTRUMENTS CORP. LEONARD DWARICA
K854203 10/16/1985 TEC 2720 MAMEX DC MAG TECNOMED, INC. JEAN GRISWOLD
K854143 10/11/1985 BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS TELECTRONICS, INC. WILLIAM C NEALON
K854142 10/11/1985 STYLET INTRODUCER FUNNEL TELECTRONICS, INC. WILLIAM C NEALON
K854043 10/02/1985 AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B TELEDYNE AVIONICS DIV. OF TELEDYNE JACK COWARDIN
K854280 10/23/1985 CLIRANS TAF HOLLOW FIBER DIALYZER TERUMO MEDICAL CORP. HAROLD JACOBY
K854210 10/16/1985 TERUMO SENSIBEAD EIA COLORIMETER TERUMO MEDICAL CORP. HARALD JACOBY
K854227 10/18/1985 FASCILULATED NAIL THE DECA CO. WILLIAM HALLORAN
K854277 10/23/1985 NEUROPATH 4000 THERAPEUTIC TECHNOLOGIES, INC. RICHARD T NEY
K854349 10/29/1985 TIGER'S DIGITAL THERMOMETER TIGER ELECTRONICS, INC. ARNOLD R RISSMAN
K854252 10/22/1985 TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER TRANSTRACHEAL SYSTEMS PETER L DURANTE
K854168 10/15/1985 TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES TRAVENOL LABORATORIES, S.A. BRIAN STEMBAL
K854088 10/07/1985 UNITEK LIFT-OFF DEBRACKETING INSTRUMENT UNITEX CORP. LAWRENCE STEVENS
K854028 10/01/1985 AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER VERIFIED MEDICAL RESEARCH, INC. GARY W SHIRES
K854193 10/15/1985 ELECTRO-MYOGRAPHIC PERINEOMETER VERIMED HOLDINGS, INC. WILLIAM HASSEL
K854115 10/08/1985 CUSTO PORT 24-H ECG AMBULATORY RECORDER VERSACOR, INC. SPERO M ALEX
K854299 10/25/1985 GORE-TEX PERIODONTAL MATERIAL W.L. GORE & ASSOCIATES,INC MARY EDWARDS
K854334 10/28/1985 PAINBLOCKER WA5000 WALLACH SURGICAL DEVICES, INC. VINCENT FRAZZETTA
K854068 10/04/1985 EXTERNAL MECHANICAL FASTENER WELLS JOHNSON CO. JOHN JOHNSON
K854264 10/23/1985 SUNGLASSES/OPTICAL FRAMES WHA CHUN INDUSTRIES, CO., LTD. INHO PARK
K854032 10/01/1985 SNAP-LOCK ADDITIVE CAP #SL 200 WILLIAMS MEDICAL CO. DANIEL J WILLIAMS
K854034 10/01/1985 SNAP-LOCK ADDITIVE CAP #SL 300 WILLIAMS MEDICAL CO. DANIEL J WILLIAMS
K854031 10/01/1985 SNAP-LOCK ADDITIVE CAP #SL100 WILLIAMS MEDICAL CO. DANIEL J WILLIAMS
K854033 10/01/1985 SNAP-LOCK ADDITIVE CAP #SL400 WILLIAMS MEDICAL CO. DANIEL J WILLIAMS
K854392 10/31/1985 TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU WINDSOR LABORATORIES, INC. GUY W RUCKER
K854085 10/07/1985 OMNI PLANE SYSTEM XRE CORP. DONNA GLENCROSS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact