| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K852266 |
12/05/1985 |
ABBOTT STREP A P.S.D. |
ABBOTT LABORATORIES |
JEAN FRYDMAN |
| K853120 |
12/05/1985 |
ADDITIVE EXTENSION SYRINGE |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K853916 |
12/27/1985 |
P.M. HIP-FEMORAL PROSTHESIS |
ADVANCED BIOSEARCH ASSN. |
BARRY M CALVARESE |
| K854310 |
12/04/1985 |
ACS INDEFLATOR (MODIFICATION) |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
MARIANNA BRESCHINI |
| K854261 |
12/04/1985 |
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
JANE E BEGGS |
| K853142 |
12/17/1985 |
OVUTIME OVULATION PREDICTOR TEST |
ADVANCED CARE PRODUCTS |
JEAN GRIERE |
| K854225 |
12/27/1985 |
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS |
ADVANCED MEDICAL TECHNOLOGY, INC. |
THOMAS V KEELEY |
| K854213 |
12/19/1985 |
ARI STANDARD ANESTHESIA RECORD |
AGILENT TECHNOLOGIES, INC. |
EDWARD WEISGERBER |
| K854076 |
12/11/1985 |
MGA 2000 GAS ANALYSER |
AIRSPEC LTD. |
CRAWFORD |
| K853280 |
12/02/1985 |
FOUR CHANNEL PH PROBE |
AKRON CITY HOSPITAL |
VINCENT J GRECZANIK |
| K854172 |
12/05/1985 |
I.V. WATCH |
ALLTEK, INC. |
CLIFFORD A TYNER |
| K853633 |
12/03/1985 |
TENS CONDUCTIVE MEDIA PAD |
ALTERNATIVE DESIGN SYSTEMS, INC. |
JOHN L ESSMYER |
| K853950 |
12/11/1985 |
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL |
AMERICAN BENTLEY |
DONALD A RAIBLE |
| K854045 |
12/16/1985 |
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED |
AMERICAN BENTLEY |
DONALD A RAIBLE |
| K854314 |
12/16/1985 |
FANA 60 |
AMERICAN BIO-REAGENTS, INC. |
DAVID E KOLESAR |
| K854651 |
12/13/1985 |
PARAAMAX CHLORIDE DETERMINATION BY ISE |
AMERICAN DADE |
JAMES KELLER |
| K854759 |
12/17/1985 |
AMERICAN STERILE MAYO STAND TRAY |
AMERICAN HOSPITAL SUPPLY CORP. |
RICHARD B FARB. |
| K854739 |
12/27/1985 |
AMERICAN STERILE SURGICAL ABSORBENT TOWEL |
AMERICAN HOSPITAL SUPPLY CORP. |
RICHARD B FARB |
| K854490 |
12/27/1985 |
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES |
AMERICAN MICRO SCAN |
KRISTA UNDERWOOD |
| K852976 |
12/04/1985 |
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC |
AMERICAN MICRO SCAN |
ALICE J O'CONNELL |
| K852178 |
12/27/1985 |
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS |
AMERICAN OMNI MEDICAL, INC. |
GEORGE G SIPOSS |
| K854012 |
12/03/1985 |
AMERICAN PHARMASEAL HUMIDAIR CONDENSER |
AMERICAN PHARMASEAL DIV. AHSC |
ROBERT T MERRICK |
| K854232 |
12/10/1985 |
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES |
AMERICAN PHARMASEAL DIV. AHSC |
LAWRENCE GETLIN |
| K854714 |
12/17/1985 |
X-RAY DETECTABLE COTTON BALLS |
AMERICAN SILK SUTURES, INC. |
|
| K854568 |
12/02/1985 |
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP |
AMERICAN V. MUELLER |
MATTHEW NOWLAND |
| K842529 |
12/06/1985 |
AMIZYME-CMV KIT |
AMICO LAB, INC. |
|
| K842530 |
12/06/1985 |
AMIZYME-EBV TEST KIT |
AMICO LAB, INC. |
|
| K842531 |
12/06/1985 |
AMIZYME-HSV TYPES 1 & 2 TEST KITS |
AMICO LAB, INC. |
|
| K842661 |
12/06/1985 |
ANTI-CYTOMEGALOVIRUS KIT |
AMICO LAB, INC. |
|
| K842662 |
12/12/1985 |
ANTI-EPSTEIN-BARR VIRUS KIT |
AMICO LAB, INC. |
|
| K842663 |
12/06/1985 |
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 |
AMICO LAB, INC. |
|
| K853870 |
12/10/1985 |
EASY EYES TM LENS CARRYING CASE |
APPLIED LABORATORIES, INC. |
ANTHONY J MORAVEC |
| K854137 |
12/03/1985 |
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC |
ARROW INTL., INC. |
RONALD P CITRON |
| K854575 |
12/02/1985 |
MODIFIED AM-SERIES DIALYZERS |
ASAHI MEDICAL CO., LTD. |
RICHARD T NEY |
| K854281 |
12/02/1985 |
MAGNETIC RETRIEVER |
ASPEN LABORATORIES, INC. |
JOHNSON |
| K853725 |
12/09/1985 |
ATRIUM PLASMA TFE SYNTHETIC ARTERY |
ATRIUM MEDICAL CORP. |
STEVE HERWECK |
| K854074 |
12/10/1985 |
MODEL 200 INFUSION PUMP |
AVI, INC. |
STANLEY J SUEDKAMP |
| K854073 |
12/10/1985 |
MODEL 210 INFUSION PUMP |
AVI, INC. |
STANLEY SUEDKAMP |
| K854147 |
12/27/1985 |
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL |
BATTLE CREEK EQUIPMENT CO. |
JOHN W DOTY |
| K854148 |
12/17/1985 |
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL |
BATTLE CREEK EQUIPMENT CO. |
JOHN W DOTY |
| K854634 |
12/27/1985 |
BARD PARKER THORACIC VENT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
RUSSELL ARNSBERGER |
| K854057 |
12/05/1985 |
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE |
BECKMAN INSTRUMENTS, INC. |
JACK E SOROKIN |
| K854001 |
12/31/1985 |
CERTI-FORM |
BELTONE ELECTRONICS CORP. |
JOHN J ZEI |
| K854579 |
12/17/1985 |
HYPODERMIC NEEDLE AND STYLET |
BERKLEY AND CO. |
STEVE CARWELL |
| K852533 |
12/12/1985 |
L.E.D. GOGGLES, MODEL 580-LEDGOG |
BIO-LOGIC SYSTEMS CORP. |
GIL RAVIV |
| K853760 |
12/03/1985 |
ADULT VENTILATOR TESTER VT-1 |
BIO-TEK INSTRUMENTS, INC. |
DAVID W KLYSZEIKO |
| K853697 |
12/16/1985 |
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT |
BIOSTAR MEDICAL PRODUCTS, INC. |
JERRY W BERKSTRESSE |
| K854864 |
12/24/1985 |
BI-POLAR FORCEPS |
BIRTCHER CORP. |
DONALD L EMMONS |
| K840569 |
12/30/1985 |
EKG 501 A |
BOSCH HEARING INSTRUMENTS, INC. |
|
| K840571 |
12/30/1985 |
EKG 503A |
BOSCH HEARING INSTRUMENTS, INC. |
|
| K853895 |
12/20/1985 |
AUDTEX 85 |
CAMI, INC. |
ROGER B MICHAUD |
| K853072 |
12/09/1985 |
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 |
CAMINO LABORATORIES, INC. |
DAN MCKAY |
| K854497 |
12/02/1985 |
VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON |
CANADIAN WHEELCHAIR |
STUART HODGINS |
| K853294 |
12/04/1985 |
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA |
CARDIAC CONTROL SYSTEMS, INC. |
ROBERT S SPRINGER |
| K853673 |
12/11/1985 |
CARDIORATER CR 51 |
CARDIAC RECORDERS, LTD. |
BEVIS |
| K854776 |
12/13/1985 |
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 |
CARROM HEALTHCARE, INC. |
PHILIP JONES |
| K853965 |
12/03/1985 |
NEOGUARD CHEST PERCUSSOR |
CAS MEDICAL SYSTEMS, INC. |
JOEL N HELFER |
| K854629 |
12/10/1985 |
CHURCHILL-H EXTENSION TUBE |
CHURCHILL CORP. |
DAVID W EVANS |
| K854435 |
12/05/1985 |
CHURCHILL-H NON-VENTED IV SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854436 |
12/05/1985 |
CHURCHILL-H SCALP VEIN SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854437 |
12/05/1985 |
CHURCHILL-H VENTED IV SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854636 |
12/10/1985 |
CHURCHILL-HE VENTED IV SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854630 |
12/10/1985 |
CHURCHILL-HS SUSPENDED NON-VENTED IV SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854627 |
12/10/1985 |
CHURCHILL-HS SUSPENDED VENTED IV SET |
CHURCHILL CORP. |
DAVID W EVANS |
| K854186 |
12/25/1985 |
IN VITRO TEST DETERMINATION OF SGPT(ALT) |
CLINICAL DATA, INC. |
ISRAEL M STEIN |
| K854183 |
12/19/1985 |
IN VITRO TEST DETERMINATION OF THEOPHYLLINE |
CLINICAL DATA, INC. |
ISRAEL M STEIN |
| K854184 |
12/04/1985 |
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN |
CLINICAL DATA, INC. |
ISRAEL M STEIN |
| K854580 |
12/13/1985 |
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH |
COLOPLAST A/S |
C/O R HAMMER/ASSOCI |
| K854270 |
12/09/1985 |
MURPHY ADJUSTABLE SPLINT |
COMFORTEX, INC. |
DONALD M SALYARDS |
| K853964 |
12/05/1985 |
COMPUTERIZED RADIATION TREATMENT PLANNING SYS |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
MELVIN MCCOLLUM |
| K854919 |
12/19/1985 |
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY |
COOK PACEMAKER CORP. |
RICHARD W SHIRLEY |
| K854132 |
12/03/1985 |
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS |
COOK PACEMAKER CORP. |
RICHARD E SHIREY |
| K854375 |
12/27/1985 |
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR |
COOPERVISION, INC. |
DAVID W KRAPF |
| K854657 |
12/27/1985 |
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS |
CORDIS CORP. |
DAVID KORNHAUSER |
| K854214 |
12/03/1985 |
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE |
CORDIS CORP. |
DEAN E CIPORKIN |
| K854708 |
12/30/1985 |
DART CK-MB REAGENT SYSTEM |
COULTER ELECTRONICS, INC. |
RICHARDSON-JONES |
| K851864 |
12/16/1985 |
SPINAL STABILIZING UNIT |
COUNTERSTRESS PRODUCTS, INC. |
GREGORY MELVIN |
| K852654 |
12/04/1985 |
CARDIAC COMMUNICATOR 2000 |
CREATIVE MEDICAL, INC. |
ALAN P SCHWARTZ |
| K854054 |
12/27/1985 |
PLACIDO DISC |
CUTLER MEDICAL INSTRUMENTS |
DAVID P CUTLER |
| K854005 |
12/06/1985 |
DEDO SUCTION CANNULA |
DEDO MANUFACTURER, INC. |
DOUGLAS D DEDO |
| K852630 |
12/18/1985 |
DEN-MAT PAINT-ON RUBBER DAM |
DEN-MAT CORP. |
ROBERT L IBSEN |
| K854253 |
12/16/1985 |
ROOT CANAL FILLING RESIN |
DENTSPLY INTL. |
JOHN SEMMELMAN |
| K854285 |
12/27/1985 |
GDC 1453 CASTING ALLOY |
DERINGER-NEY INC. |
DONALD LANDMANN |
| K854784 |
12/19/1985 |
ABSORBANCE (ABS) TEST PAK |
DIAGNOSTIC SYSTEMS |
RAYMOND L MILLER |
| K854650 |
12/13/1985 |
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
GOPAL SAVJANI |
| K854671 |
12/19/1985 |
DSL ACTIVE TESTOSTERONE RIA (DSL #4000) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
GOPAL SAVJANI |
| K854674 |
12/19/1985 |
DSL ANDROSTENDIONE RIA (DSL #4200) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
GOPAL SAVJANI |
| K854649 |
12/13/1985 |
DSL PROGESTERONE RIA (DSL #3400) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
GOPAL SAVJANI |
| K851972 |
12/31/1985 |
DIASONICS ADA400 ADVANCED DIGITAL ARRAY |
DIASONICS, INC. |
FLOR FERNANDEZ |
| K853943 |
12/23/1985 |
CRITIC C LEVEL I & II |
DIMENSION DIAGNOSTICS |
CLYDE E HAM |
| K853588 |
12/18/1985 |
FIBRELIGHT NASAL SPECULA |
DOWNS SURGICAL LTD. |
JARVIS CRIBB |
| K853589 |
12/23/1985 |
SHAH SELF-CLEARING MASTOID SUCTION TUBE |
DOWNS SURGICAL LTD. |
JARVIS CRIBB |
| K854158 |
12/13/1985 |
RESNICK EMITTER, ARTIFICIAL LARYNX |
DYNAMED AUDIO, INC. |
JOSEPH A RESNICK |
| K854604 |
12/06/1985 |
AUTO MASH |
DYNATECH CORP. |
BARRY S LAZAR |
| K854602 |
12/06/1985 |
MINI MASH 2000 |
DYNATECH CORP. |
BARRY S LAZAR |
| K854603 |
12/06/1985 |
MULTI MASH 2000 |
DYNATECH CORP. |
BARRY S LAZAR |
| K853667 |
12/18/1985 |
BRONCHIAL CYTOLOGY BRUSH |
E-Z-EM, INC. |
JACK T BERGER |
| K853136 |
12/03/1985 |
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) |
E.A. FISCHIONE INSTRUMENT MFG. |
PAUL E FISCHIONE |
| K854764 |
12/30/1985 |
LECTROSTILL DISTILLED WATER U.S.P. |
ELECTRIFIED COMPANIES, INC. |
ALAN P SCHHWARTZ |
| K853719 |
12/04/1985 |
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 |
ELECTRO THERAPEUTIC DEVICES, INC. |
CHOONG |
| K853718 |
12/04/1985 |
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 |
ELECTRO THERAPEUTIC DEVICES, INC. |
CHOONG |
| K854585 |
12/05/1985 |
ULTRAZYME PLUS & SYSTEMATE LDH |
EM DIAGNOSTIC SYSTEMS, INC. |
RAYMOND L MILLER |
| K844853 |
12/12/1985 |
NIFA NON INVASIVE FLUTTER ASSEMBLY |
EMERGENCY MANAGEMENT PRODUCTS, INC. |
KENNETH A ZSELTVAY |
| K854513 |
12/06/1985 |
EMPI, NMS/SUE CUTANEOUS ELECTRODE |
EMPI |
GEORGE E MATHIESEN |
| K854900 |
12/24/1985 |
EPISIOTOMY SCISSORS |
EURO-MED INTL. |
DONALD HOLSTEN |
| K854893 |
12/24/1985 |
KEYES SKIN PUNCH |
EURO-MED INTL. |
DONALD HOLSTEN |
| K854899 |
12/24/1985 |
NOVAK CURETTE |
EURO-MED INTL. |
DONALD HOLSTEN |
| K854888 |
12/24/1985 |
RANDALL CURETTE |
EURO-MED INTL. |
DONALD HOLSTED |
| K854892 |
12/24/1985 |
RULER |
EURO-MED INTL. |
DONALD HOLSTEN |
| K854153 |
12/27/1985 |
MARATHON POWER DRIVE-WHEELCHAIR |
EVEREST & JENNINGS, INC. |
WILLIAM B CALHOUN |
| K854051 |
12/27/1985 |
MODULAR POWER BASE |
EVEREST & JENNINGS, INC. |
WILLIAM B CALHOUN |
| K853307 |
12/23/1985 |
DIRECT ELISA FOR HERPES SIMPLEX VIRUS |
FAIRLEIGH DICKINSON LABORATORIES, INC. |
TERRY L FOSTER |
| K854169 |
12/16/1985 |
PUPILSCAN |
FAIRVILLE MEDICAL OPTICS, INC. |
ANTHONY G SCOTT |
| K852826 |
12/03/1985 |
AN PRESSURE MONITOR |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K852824 |
12/03/1985 |
PMA PRESSURE MONITOR |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K852825 |
12/03/1985 |
TMA TEMPERATURE MONITOR |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K852962 |
12/09/1985 |
PERIPHERAL NERVE STIMULATOR MODEL A400 |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
DAVE MILBURN |
| K854309 |
12/13/1985 |
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 |
GAMBRO, INC. |
JEFFREY SHIDEMAN |
| K853711 |
12/18/1985 |
5.0 MHZ INTRACAVITARY SECTOR PROBE |
GENERAL ELECTRIC CO. |
JAMES M HOWARD |
| K853249 |
12/09/1985 |
RT3600(115V) RT3600(220/240V) |
GENERAL ELECTRIC CO. |
JAMES M HOWARD |
| K853635 |
12/20/1985 |
SUBDERM TM |
GENERAL MEDICAL CO. |
LARRY R PILOT |
| K842066 |
12/30/1985 |
PERI-GUARD PERICARDIAL PATCH |
GENETIC LABORATORIES, INC. |
|
| K853869 |
12/09/1985 |
TITANIUIM BONE SCREW |
GEORGE TIEMANN & CO. |
RICHARD MORIARTY |
| K854521 |
12/23/1985 |
BIOGRAM |
GILES SCIENTIFIC, INC. |
DAVID L GIBBS |
| K853758 |
12/03/1985 |
PY-RITE |
GOLDEN DENTAL PRODUCTS, INC. |
DON WHITE |
| K854494 |
12/23/1985 |
CERAM-ETCH |
GRESCO PRODUCTS, INC. |
CLINTON D VAUPEL |
| K854495 |
12/27/1985 |
GRESCO N.P. DENTAL ALLOY |
GRESCO PRODUCTS, INC. |
CLINTON D VAUPEL |
| K852645 |
12/09/1985 |
FLUID MANAGEMENT SYSTEM |
HAEMONETICS CORP. |
PAUL H PATRONE |
| K853043 |
12/13/1985 |
700-123 EYE SHADE |
HEALTH SAVER PRODUCTS |
MALONEY |
| K854162 |
12/09/1985 |
SUPPORT ARM |
HEALTHMATE, INC. |
KEN WIESELMAN |
| K852653 |
12/30/1985 |
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 |
HEALTHTEAM |
JOHN CHAMBERS |
| K852458 |
12/30/1985 |
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145 |
HEALTHTEAM |
JOHN CHAMBERS |
| K852457 |
12/30/1985 |
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165 |
HEALTHTEAM |
JOHN CHAMBERS |
| K852459 |
12/30/1985 |
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175 |
HEALTHTEAM |
JOHN CHAMBERS |
| K854376 |
12/04/1985 |
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS |
HEMOTEC, INC. |
WILLIAM A MORTON |
| K854377 |
12/04/1985 |
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS |
HEMOTEC, INC. |
WILLIAM A MORTON |
| K854135 |
12/23/1985 |
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A |
HEWLETT-PACKARD CO. |
DAVID M PEROZEK |
| K853967 |
12/27/1985 |
HI-TECH LAB MODEL CONCHA ALL IN EAR |
HI-TECH LABORATORIES, INC. |
HOWARD E SANDER |
| K854715 |
12/23/1985 |
TRANSPORT CULTURE MEDIA |
HILLCREST BIOLOGICALS |
LOUIS C CULLMAN |
| K853419 |
12/06/1985 |
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE |
HOOD LABORATORIES |
PAUL VAYO |
| K853940 |
12/13/1985 |
THE GRONINGEN VOICE PROSTHESIS |
HOOD LABORATORIES |
BRUCE BARBER |
| K853511 |
12/19/1985 |
THE HOOD LIFE SAVER |
HOOD LABORATORIES |
BRUCE BARBAR |
| K853405 |
12/04/1985 |
ELECTROLYTE ANALYZER SERA-252 |
HORIBA INSTRUMENTS, INC. |
TIM SCOTT |
| K854155 |
12/10/1985 |
STERILE SALINE SOLUTION |
I M, INC. |
AMIR PORAT |
| K854104 |
12/05/1985 |
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) |
IMMUNCHEM CORP. |
BOB HUDAK |
| K853942 |
12/18/1985 |
INT'L MODEL XE BEHIND-THE-EAR HEARING AID |
INT'L HEARING AIDS, INC. |
PATRICIA J BING |
| K853941 |
12/18/1985 |
INT'L MODEL XG BEHIND-THE-EAR HEARING AID |
INT'L HEARING AIDS, INC. |
PATRICIA J BING |
| K853517 |
12/04/1985 |
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 |
INTERMEDICS, INC. |
LISA S JONES |
| K854069 |
12/09/1985 |
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD |
INTERMEDICS, INC. |
DAVID MAKANANI |
| K854071 |
12/04/1985 |
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD |
INTERMEDICS, INC. |
DAVID MAKANANI |
| K853521 |
12/04/1985 |
POLYFLEX IMPLANTABLE PACING LEAD-476-07 |
INTERMEDICS, INC. |
LISA S JONES |
| K853981 |
12/18/1985 |
INFUSAID INFUSE-A-PORT (MODIFIED) |
INTERMEDICS/INFUSAID, INC. |
VINCENT A BUCCI |
| K854752 |
12/17/1985 |
THE CALIFORNIA SPLINT |
INTL. MEDICATION SYSTEMS, LTD. |
DIANE GILLETT |
| K854799 |
12/11/1985 |
EMERSON MODEL 3MV-OAA ALARM MODULE |
J. H. EMERSON CO. |
GEORGE P EMERSON |
| K854554 |
12/11/1985 |
DELTA-LITE CASTING RESIN |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
MARSHA J STONE |
| K844050 |
12/06/1985 |
ARTHOPOR-ACETABULAR COMPONENT |
JOINT MEDICAL PRODUCTS CORP. |
DOUGLAS G NOILES |
| K854483 |
12/11/1985 |
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT |
KALLESTAD LABORATORIES, INC. |
QUINLAN SMITH |
| K854256 |
12/13/1985 |
KEELER AMOILS SURGICAL ASTIGOMETER |
KEELER INSTRUMENTS, INC. |
VAN ARSDAL |
| K854411 |
12/30/1985 |
KEELER-COMPACT CRYO SYSTEM |
KEELER INSTRUMENTS, INC. |
VAN ARSDALE |
| K854440 |
12/16/1985 |
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 |
KEELER INSTRUMENTS, INC. |
VAN ARSDALE |
| K854422 |
12/30/1985 |
SERIES 25 SLIMLINE CRYO PROBES |
KEELER INSTRUMENTS, INC. |
VAN ARSDALE |
| K854541 |
12/17/1985 |
TIP OFF FORCEPS |
KELLER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K854378 |
12/02/1985 |
DEPEND FITTED BRIEF |
KIMBERLY-CLARK CORP. |
DER WAL |
| K854338 |
12/09/1985 |
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM |
KIRSCHNER MEDICAL CORP. |
SAN SON |
| K854524 |
12/09/1985 |
KIRSCHNER SPINAL PRODUCT SYSTEM |
KIRSCHNER MEDICAL CORP. |
SAM SON |
| K854307 |
12/04/1985 |
KONTRON DEFIBRILLATOR 7501 |
KONTRON INSTRUMENTS, INC. |
GEORGE CHO |
| K853099 |
12/03/1985 |
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION |
L.O.N. RESEARCH, INC. |
DE PEDRO |
| K854140 |
12/17/1985 |
MODIFIED MYDRIATIC SPECTACLE |
LA RUE OPTICAL |
LA PRAIRIE |
| K854027 |
12/02/1985 |
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM |
LASERSCOPE |
ROSS ERICKSON |
| K854537 |
12/03/1985 |
HEADSTRAP |
LIFE DESIGN SYSTEMS, INC. |
GILBERT M KIRK |
| K854022 |
12/24/1985 |
LPA-1 PRESSURE MONITOR |
LIFE PRODUCTS, INC. |
DOUGLAS BARNES |
| K853936 |
12/02/1985 |
1351 UROFLOW AUTO START |
LIFE-TECH INTL., INC. |
ALFRED C COATS |
| K854724 |
12/13/1985 |
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE |
LIFETRAC, INC. |
WILL & |
| K854826 |
12/27/1985 |
LINK CANCELLOUS SCREWS |
LINK AMERICA, INC. |
EDWARD B SCHUSSLER |
| K854827 |
12/27/1985 |
LINK CORTICAL SCREWS |
LINK AMERICA, INC. |
EDWARD B SCHUSSLER |
| K852365 |
12/16/1985 |
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM |
LINK AMERICA, INC. |
ED SCHUSSLER |
| K852760 |
12/05/1985 |
LBK 1244 DELFIA HCG KIT |
LKB INSTRUMENTS, INC. |
ED ZIOR |
| K850754 |
12/10/1985 |
MEDAJET XL - JET INJECTOR |
MADA MEDICAL PRODUCTS, INC. |
ADAM |
| K852656 |
12/27/1985 |
MODEL "M" HEARING AID |
MAGNATONE HEARING AID CORP. |
J CAMPBELL |
| K853919 |
12/18/1985 |
MA25 PORTABLE AUDIOMETER |
MAICO HEARING INSTRUMENTS, INC. |
PAUL M D'AMICO |
| K853850 |
12/04/1985 |
EXPLORER |
MANSFIELD SCIENTIFIC, INC. |
BRUCE BEAUCHEMIN |
| K854136 |
12/04/1985 |
ARRHYTHMIA REVIEW STATION |
MARQUETTE ELECTRONICS, INC. |
THOMAS MASSOPUST |
| K853807 |
12/16/1985 |
ALL-IN-ONE HARD CONTACT LENS SOLUTION |
MAURRY BIOLOGICAL CO. |
DES ROCHERS |
| K853811 |
12/16/1985 |
HARD CONTACT LENS SOAKING SOLUTION |
MAURRY BIOLOGICAL CO. |
DES ROCHERS |
| K853810 |
12/16/1985 |
WETTING SOLUTION FOR HARD CONTACT LENSES |
MAURRY BIOLOGICAL CO. |
DES ROCHERS |
| K854794 |
12/24/1985 |
MCGHAN INTEGRAL VALVE TISSUE EXPANDER |
MCGHAN MEDICAL CORP. |
LAURENS LICHTY |
| K854262 |
12/24/1985 |
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY |
MEADOX SURGIMED, INC. |
SCOTT MINDREBO |
| K854404 |
12/02/1985 |
ROTEX SCREW BIOPSY NEEDLE |
MEADOX SURGIMED, INC. |
SCOTT MINDREBO |
| K853785 |
12/03/1985 |
SERIES 2000 MEDS MASK |
MED SYSTEMS |
DAVIS |
| K853767 |
12/02/1985 |
FLOSPIK |
MEDELCO LTD. |
WILLIAM J SEIDEL |
| K854561 |
12/02/1985 |
BLADE, SCALPEL |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854860 |
12/24/1985 |
BLADES, SCALPEL CARBON STEET |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854859 |
12/24/1985 |
BLADES, SCALPEL STAINLESS STEEL |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854563 |
12/09/1985 |
DISPOSABLE SYRINGES & NEEDLES |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854858 |
12/24/1985 |
SCALPEL HANDLE |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854857 |
12/24/1985 |
SCALPEL, ONE-PIECE, DISPOSABLE |
MEDELEC INTL. CORP. |
OSCAR D DOCAL |
| K854567 |
12/06/1985 |
PENICILLIN/STREPTOMYCIN SOLUTION |
MEDIATECH, INC. |
ROBERT R TASCHNER |
| K854116 |
12/27/1985 |
PHACO PACKS, 1A PACKS & PACK COMPONENTS |
MEDICAL CORP. OF AMERICA |
THOMAS V KEELEY |
| K853848 |
12/05/1985 |
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR |
MEDICAL GRAPHICS CORP. |
RONALD BERGESON |
| K854551 |
12/19/1985 |
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S |
MEDIPART JERRY ALEXANDER |
JERRY ALEXANDER |
| K854550 |
12/19/1985 |
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA |
MEDIPART JERRY ALEXANDER |
JERRY ALEXANDER |
| K854215 |
12/02/1985 |
DYNAFEED |
MEDLINE INDUSTRIES, INC. |
ROBERT FASANA |
| K853398 |
12/04/1985 |
MEDTRONIC MODEL 5062 |
MEDTRONIC VASCULAR |
EDWARD NUMAINVILLE |
| K854559 |
12/24/1985 |
MEDTRONIC PERMANENT LEAD INTRODUCER |
MEDTRONIC VASCULAR |
ALAN MARQUARDT |
| K854402 |
12/30/1985 |
THE NEW MCINTYRE I.A. HANDPIECE |
MICROSURGICAL TECHNOLOGY, INC. |
NILSSON |
| K854401 |
12/30/1985 |
THE NEW MOBILE TIP MCINTYRE CANNULA |
MICROSURGICAL TECHNOLOGY, INC. |
NILSSON |
| K854611 |
12/30/1985 |
RAMP URINE HCG ASSAY |
MONOCLONAL ANTIBODIES, INC. |
MICHAEL C MALONEY |
| K852680 |
12/23/1985 |
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG |
MULTIGON INDUSTRIES, INC. |
WILLIAM STERN |
| K853836 |
12/09/1985 |
NEURO PULSE II |
NAGATA ENGINEERING CO. |
TAKAO NAGATA |
| K854479 |
12/16/1985 |
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH |
NIPRO COMPANY, LTD. |
INUI |
| K854620 |
12/17/1985 |
SURGICAL BLADES |
NIRAJ INDUSTRIES |
HAVEL'S INC. |
| K853925 |
12/02/1985 |
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA |
NMS PHARMACEUTICALS, INC. |
PERRY G RUCKER |
| K854718 |
12/19/1985 |
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 |
NOBEL SCIENTIFIC INDUSTRIES, INC. |
DONALD F DWYER |
| K854052 |
12/31/1985 |
CSM MEDIUM |
NORTHERN SCIENTIFIC, INC. |
ROBERT W CASE |
| K853791 |
12/09/1985 |
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 |
NORTON PERFORMANCE PLASTICS CORP. |
CHRISTINE D ENGER |
| K854608 |
12/05/1985 |
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K854518 |
12/23/1985 |
EPIDURAL ANESTHESIA TRAY |
OMNIS SURGICAL, INC. |
THOMAS D NICKEL |
| K844373 |
12/19/1985 |
O.M.S. ULTRA-PHACO |
OPTICAL MICRO SYSTEMS, INC. |
GERALD A CLAY |
| K854367 |
12/16/1985 |
HD-SECURA HEMADIALYSIS MACHINE |
ORGANON TEKNIKA CORP. |
MARTIN ROBERTS |
| K853442 |
12/09/1985 |
MODEL 804 (TENS) |
ORIENTAL MEDICAL SUPPLIES, INC. |
THOMAS RIIHIMAKI |
| K853738 |
12/06/1985 |
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
LARRY D MCCLAIN |
| K852892 |
12/09/1985 |
MEDILOG M6 |
OXFORD MEDILOG, INC. |
JOHN K LAURIE |
| K853804 |
12/27/1985 |
VICON (MODIFICATION) |
OXFORD METRICS, INC. |
CRAIG SMITH |
| K853914 |
12/03/1985 |
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI |
PACESETTER SYSTEMS |
RITA BROWN |
| K854220 |
12/04/1985 |
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD |
PACESETTER SYSTEMS |
NESTOR KUSNIERZ |
| K854405 |
12/04/1985 |
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD |
PACESETTER SYSTEMS |
NESTOR KUSHIERZ |
| K853987 |
12/11/1985 |
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE |
PALL BIOMEDICAL PRODUCTS CO. |
SIDNEY KRAKAUER |
| K854324 |
12/05/1985 |
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT |
PANTEX, DIV. BIO-ANALYSIS, INC. |
NEIL Y CHIAMORI |
| K854330 |
12/13/1985 |
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM |
PAR TECHNOLOGY PARK |
JAMES CAMBIER |
| K853732 |
12/09/1985 |
LIFEPAK 8 MODIFICATION |
PHYSIO-CONTROL CORP. |
MICHAEL B GROPP |
| K854735 |
12/10/1985 |
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. |
PORTABLE MEDICAL LABORATORIES, INC. |
WARREN R SANBORN |
| K853930 |
12/10/1985 |
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT |
QUANTIMETRIX CORP. |
LYNETTE SCHNEIDER |
| K853932 |
12/19/1985 |
QUANTTEST TOTAL PROTEIN ASSAY |
QUANTIMETRIX CORP. |
LYNETTE SCHNEIDER |
| K853217 |
12/30/1985 |
QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES |
QUANTUM MEDICAL SYSTEMS, INC. |
FRANCIS G SMITH |
| K853990 |
12/30/1985 |
OSM3 HEMOXIMETER |
RADIOMETER AMERICA, INC. |
GERALD L VEDAA |
| K854512 |
12/02/1985 |
TUBING CLAMP CAT#1000-A |
RAO MEDICAL DEVICES, INC. |
ROLF A OSCARSSON |
| K854544 |
12/13/1985 |
RAICHEM CO2 REAGENT |
REAGENTS APPLICATIONS, INC. |
ALFRED E PEACOCK |
| K854816 |
12/19/1985 |
EPIDURAL ANESTHESIA NEEDLES |
REGANES, INC. |
JOSEPH E HARMS |
| K854934 |
12/24/1985 |
VENTILATOR PRESSURE ALARM MODEL VPA-100 |
RESPIRATORY SUPPORT PRODUCTS, INC. |
ANTHONY V BERAN |
| K854047 |
12/13/1985 |
IN-HOME VISION MONITORING KIT |
RICH-LARKY COMPANY, INC. |
EUGENE M PFEIFER |
| K854325 |
12/09/1985 |
TRICON UNICOMPARTMENTAL KNEE SYSTEM |
RICHARDS MEDICAL CO., INC. |
ROBERT F GAMES |
| K851560 |
12/13/1985 |
PORTASPIR II |
ROSEBURG SA |
CHAMBORD |
| K853728 |
12/13/1985 |
KESTREL CONTACT LENS STORAGE CASE(NORYL) |
RYDER INTL. CORP. |
ANTHONY J MORAVEC |
| K853729 |
12/13/1985 |
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) |
RYDER INTL. CORP. |
ANTHONY J MORAVEC |
| K854363 |
12/31/1985 |
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM |
SARATOGA MEDICAL INSTRUMENTATION, INC. |
JOHN KURAS |
| K853621 |
12/05/1985 |
REPLACEMENT PUMP TUBING |
SHABAN MFG. CO. |
BARBARA H SNEADE |
| K854347 |
12/27/1985 |
HYBRID POINTS |
SHOFU DENTAL CORP. |
MARTY DYMEK |
| K854501 |
12/04/1985 |
CK(OPTIMIZED) REAGENT |
SIGMA DIAGNOSTICS, INC. |
MATHEW MADAPPALLY |
| K840367 |
12/11/1985 |
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT |
SMEC, INC. |
|
| K851365 |
12/03/1985 |
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM |
SORIN BIOMEDICA, FIAT, USA, INC. |
JEANNE-MARIE VARGA |
| K853806 |
12/10/1985 |
MA-400 EMB FEEDBACK DEVICE |
SPECTRAL DATA SYSTEMS |
LARRY WOODARD |
| K852522 |
12/27/1985 |
SATALEC SERVOTOME |
SPELNA, INC. |
ROBERT E MECDONNELL |
| K853971 |
12/09/1985 |
REGULATOR-INHALATOR SYSTEM |
STEPHENSON INDUSTRIES, INC. |
LASLEY |
| K853430 |
12/16/1985 |
STORZ IAS DISPOSABLE PACK |
STORZ INSTRUMENT CO. |
DAN REGAN |
| K852710 |
12/04/1985 |
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A |
TELECTRONICS, INC. |
WILLIAM C NEALON |
| K854043 |
12/31/1985 |
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B |
TELEDYNE AVIONICS DIV. OF TELEDYNE |
JACK COWARDIN |
| K854280 |
12/13/1985 |
CLIRANS TAF HOLLOW FIBER DIALYZER |
TERUMO MEDICAL CORP. |
HAROLD JACOBY |
| K854210 |
12/05/1985 |
TERUMO SENSIBEAD EIA COLORIMETER |
TERUMO MEDICAL CORP. |
HARALD JACOBY |
| K854520 |
12/09/1985 |
PULMO-AIDE MODEL 5610D |
THE DEVILBISS CO. |
JAMES C STANGE |
| K853840 |
12/09/1985 |
LIFE WATCH RESPIRATORY MONITOR |
THE PERKIN-ELMER CORP. |
HAERR |
| K854614 |
12/19/1985 |
LONG TERM PERITONEAL CATHETER |
THERMADICS, INC. |
ROBERT R MURFITT |
| K852159 |
12/02/1985 |
NEW OPTIONAL PROBES FOR SSA-90A |
TOSHIBA MEDICAL SYSTEMS |
WYATT CANNADY |
| K852090 |
12/02/1985 |
SONOLAYER-L, SAL-77A |
TOSHIBA MEDICAL SYSTEMS |
WYATT CANNADY |
| K854586 |
12/13/1985 |
HOLLOW FIBER DIALYZER |
TRAVENOL LABORATORIES, S.A. |
JULIA A MEYER |
| K854517 |
12/02/1985 |
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET |
TRAVENOL LABORATORIES, S.A. |
BRIAN STEMBAL |
| K853881 |
12/02/1985 |
THE TRAVENOL 5 ML/HR INFUSOR |
TRAVENOL LABORATORIES, S.A. |
PATRICIA S BARSANTI |
| K853257 |
12/27/1985 |
SPECULITE DISPOSABLE VAGINAL LIGHT |
TRYLON ASSOCIATES, LTD. |
MARTIN L LONLY |
| K854962 |
12/23/1985 |
MICRO-MAT SYSTEM |
ULSTER SCIENTIFIC, INC. |
ROBERT K MCEWEN |
| K854413 |
12/02/1985 |
MALIS IRRIGATION SYSTEM |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K854592 |
12/17/1985 |
MALIS MICRO BIPOLAR COAGULATOR |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K854028 |
12/02/1985 |
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER |
VERIFIED MEDICAL RESEARCH, INC. |
GARY W SHIRES |
| K843717 |
12/30/1985 |
VIRATEK SMALL PARTICLE AEROSOL GENERAT |
VIRATEK, INC. |
|
| K853695 |
12/04/1985 |
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT |
VIROMED LABORATORIES, INC. |
BONITA BASKIN |
| K853863 |
12/18/1985 |
MODEL 310 IMPEDANCE SYSTEM |
VIRTUAL CORP. |
JONATHAN D BIRCK |
| K853035 |
12/13/1985 |
HESSBURG LIGHT GUARD |
VISITEC CO. |
THOMAS B GIVENS |
| K853961 |
12/13/1985 |
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 |
VISITEC CO. |
THOMAS B GIVENS |
| K853892 |
12/02/1985 |
VISTA MED-URISTAT |
VISTA MED |
JAY F SCHAEFER |
| K854526 |
12/24/1985 |
VITALOGRAPH COMPACT |
VITALOGRAPH LTD. |
LOVINA G FREEMAN |
| K853383 |
12/03/1985 |
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN |
WEBSTER LABORATORIES, INC. |
WILTON W WEBSTER |
| K853793 |
12/02/1985 |
WIDEX MODEL M1 |
WIDEX HEARING AID CO., INC. |
HENRY MELTSNER |
| K851954 |
12/17/1985 |
PVL-4.8-200 BALLOON STONE EXTRACTOR |
WILSON-COOK MEDICAL, INC. |
JON WILSON |
| K851962 |
12/17/1985 |
ZIMMON BILIARY STENT SET |
WILSON-COOK MEDICAL, INC. |
JON WILSON |
| K854392 |
12/05/1985 |
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU |
WINDSOR LABORATORIES, INC. |
GUY W RUCKER |
| K854746 |
12/17/1985 |
SURGICAL INSTRUMENT TRAY |
ZBI, INC. |
MATTHEW H BROWN |
| K850006 |
12/20/1985 |
TENS |
ZIMMER ELEKTROMEDIZIN GMBH |
DETLEF GANSERA |
| K853661 |
12/09/1985 |
MILLAR/GALANTE PRECOATED TOTAL KNEE |
ZIMMER, INC. |
MAX SHERMAN |
