FDA 510(k) Decisions During November, 1991  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K913054 11/27/1991 3M ANTI-CARDIOLIPIN FAST(TM) TEST 3M DIAGNOSTIC SYSTEMS, INC. SYLVIA ZORICH
K913653 11/07/1991 3M ANTI-DSDNA FAST TEST 3M DIAGNOSTIC SYSTEMS, INC. SYLVIA ZORICH
K913176 11/07/1991 DELPHIN II CENTRIFUGAL SYSTEM 3M HEALTH CARE, SARNS NANCY P ATWOOD
K913106 11/29/1991 ABBOTT IMX TOXO IGM POSITIVE CONTROL ABBOTT LABORATORIES JEAN FRYDMAN
K913150 11/29/1991 ABBOTT MATRIX AERO PLUS SYSTEM ABBOTT LABORATORIES CAROL M.COOPER
K913786 11/05/1991 FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP ABBOTT LABORATORIES DANIEL HAMILTON
K912598 11/27/1991 ACE CORTICAL BONE SCREW ACE MEDICAL CO. GLORIA TESKE
K914858 11/21/1991 ACE OPEN-BACK HALO RING ACE MEDICAL CO. CLAUDE O PERING
K911837 11/15/1991 SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE ACUFEX MICROSURGICAL, INC. RICHARD E FRANKO
K912909 11/05/1991 SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM AIR-SHIELDS VICKERS, INC. FRANCIS X CASEY
K913291 11/13/1991 MODEL C386 ISOLETTE(R) INFANT INCUBATOR AIR-SHIELDS, INC. FRANCIS X CASEY
K911587 11/01/1991 K-SOL(TM) ALCON LABORATORIES DENISE E MCEACHERN
K913950 11/01/1991 DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL MARIAN D HARDING
K913526 11/01/1991 SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL MARIAN D HARDING
K912289 11/22/1991 ULTIMA XS, MODIFICATION AMERICAN IMEX JOAN FONG
K913999 11/01/1991 NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE AMERICAN SURGICAL INSTRUMENTS CORP. JAMES H DORSEY
K913558 11/07/1991 RELIABLE CONE STYLE FACE MASK ANAGO, INC. JILL ALBRITTON
K913250 11/27/1991 ACS ULTRA-2 THROMBOPLASTIN ANALYTICAL CONTROL SYSTEMS, INC. PAULINE BONDERMAN
K913704 11/13/1991 ARGEBOND 80 ARGEN PRECIOUS METALS, INC. LAL MALHOTRA
K914100 11/07/1991 STETHOSCOPE ATLAS MEDICAL PRODUCTS, INC. JEROME MOORE
K912956 11/29/1991 ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT ATRIUM MEDICAL CORP. TED KARWOSKI
K912610 11/29/1991 MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955 ATRIUM MEDICAL CORP. TED KARWOSKI
K912609 11/29/1991 MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 ATRIUM MEDICAL CORP. TED KARWOSKI
K904236 11/27/1991 ENDOSSEOUS IMPLANTS ATTACHMENTS INTL., INC. PETER STAUBLI
K913015 11/20/1991 HEART NEBULIZER FLOWMETER ADAPTOR B & B MEDICAL TECHNOLOGIES, INC. STEPHEN W BRIGGS
K913875 11/27/1991 BARD(R) BIOPOTENTIAL AMPLIFIER II BARD ELECTROPHYSIOLOGY MATTHEW NOWLAND
K910257 11/07/1991 BAXA PCA INFUSOR BAXA CORP., SUB. OF COOK GROUP, INC. MARY STEGGALL
K914547 11/22/1991 LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM BAXTER HEALTHCARE CORP. CAROLE E MARCOT
K914048 11/27/1991 NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE BAXTER HEALTHCARE CORP. MARCIA MARCONI
K911400 11/19/1991 WALKAWAY TM 40 BAXTER HEALTHCARE CORP. KARLA TOMFOHRDE
K913772 11/19/1991 PRESSURE GUARD BEACON LABORATORIES, INC. RICHARD P FLEENOR
K914510 11/19/1991 CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY BECKMAN INSTRUMENTS, INC. WILLIAM T RYAN
K914940 11/22/1991 BELTONE CLEARVOICE BELTONE ELECTRONICS CORP. ROBERT A KRATOCHVIL
K914982 11/27/1991 BELTONE PROFILE IN-THE-EAR HEARING AID BELTONE ELECTRONICS CORP. ROBERT A KRATOCHVIL
K914981 11/27/1991 OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID BELTONE ELECTRONICS CORP. ROBERT KRATOCHVIL
K914939 11/22/1991 OTOSONIC ACS-ASP BELTONE ELECTRONICS CORP. ROBERT A KRATOCHVIL
K913692 11/15/1991 VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) BENTLEY LABORATORIES, INC. JILL SCHWEIGER
K914170 11/22/1991 LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) BIO-RAD SHARON K.SMTH,PH.D
K914906 11/27/1991 AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K912641 11/27/1991 BIOPRO ZIRALLOY MODULAR FEMORAL HEADS BIOPRO, INC. SERAFIN JR
K911378 11/22/1991 TOWNLEY GREAT TOE JOINT BIOPRO, INC. MICHAEL G GORMAN
K911336 11/29/1991 BIRD NEBULIZATION SYNCHRONIZER BIRD PRODUCTS CORP. W. C BENTINCK
K913871 11/25/1991 FLOSWITCH(R) HP BOSTON SCIENTIFIC CORP. PAMELA L CADORETTE
K913391 11/05/1991 TEGWIRE (TM) BOSTON SCIENTIFIC CORP. STEPHEN M PAGE
K911795 11/19/1991 KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) BREG, INC. NANCY A WILLCOX
K913463 11/29/1991 MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN BRUKER MEDICAL IMAGING, INC. KENNETH R PASTOTNIK
K914212 11/27/1991 BARD SINGULAR BIOPSY FORCEPS C.R. BARD, INC. JOSEPH KICEINA
K911871 11/07/1991 CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS CARDIODYNE, INC. PATRICK PHILLIPS
K914725 11/05/1991 COORDINATOR, CABLE INPUT CARDIOTRONICS, INC. TIM J WAY
K914200 11/07/1991 VASCUMAP MEDICAL AIR PLETHYSMOGRAPH CAROLINA MEDICAL ELECTRONICS JAMES S CAMPBELL
K914619 11/22/1991 CVM CIBA CORNING DIAGNOSTICS CORP. ARMIDA B NUUTINEN
K914101 11/22/1991 CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR CIRCON VIDEO ERVIN F TAYLOR
K914833 11/22/1991 IMMULITE DIGOXIN CIRRUS DIAGNOSTICS, INC. M.DI TULLIO
K913674 11/22/1991 RECORD AND VERIFY MEVATRON ADAPTER COMPUTERIZED MEDICAL SYSTEMS, INC. KIM ORT
K912516 11/19/1991 CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 CONTINENTAL X-RAY CORP. OSCAR KHUTORYANSKY
K913577 11/05/1991 MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR CONTROL-X, INC. ZSIGMOND KOVACS
K913578 11/01/1991 MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR CONTROL-X, INC. ZSIGMOND KOVACS
K914352 11/22/1991 CORDIS OBTURATOR CORDIS CORP. MIRJAM BARBOZA,M.D.
K914426 11/27/1991 ENTREE NEEDLE CORE DYNAMICS, INC. TIM REIS
K914486 11/27/1991 COULTER CARBON DIOXIDE REAGENT COULTER CORP. JIM HOSKINSON
K911118 11/20/1991 DTF-1000LL,DTF-1000 CP MEDICAL CARL GRODACH
K913427 11/19/1991 SICKLE HEMOGLOBIN (HBA/S) CONTROL SET CREATIVE LABORATORY PRODUCTS, INC. GARY J PROKSCH
K913371 11/08/1991 TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL CREATIVE LABORATORY PRODUCTS, INC. GARY J PROKSCH
K913637 11/27/1991 ECAT SCANNER (MODEL 921) CTI PET SYSTEMS, INC. DONALD A PERRINE
K913735 11/18/1991 SONGER(TM) CABLE SYSTEM DANEK MEDICAL, INC. RICHARD W TREHARNE
K910997 11/05/1991 DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON DATASCOPE CORP. BILL CORRIGAN
K914526 11/22/1991 DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) DAVOL, INC. ROBIN M DRAGO
K913684 11/15/1991 DAVOL POST-OP AUTOTRANSFUSION SYSTEM DAVOL, INC. ROBIN M DRAGO
K914339 11/07/1991 DENTOMAT 3 AMALGAMATORS DEGUSSA AG JOE RICHTER
K914340 11/13/1991 DUOMAT 3 AMALGAMATOR DEGUSSA AG JOE RICHTER
K914341 11/13/1991 MIXOMAT AMALGAMATOR DEGUSSA AG JOE RICHTER
K914368 11/13/1991 PART 872 DEGUFILL H & DEGUFILL M DA DEGUSSA AG JOE RICHTER
K913860 11/13/1991 ULTRACROWN(TM) PD ALLOY POST-SOLDER DENTSPLY INTL. JEFFERY LEHN
K913027 11/27/1991 VESSEL DILATOR DESERET MEDICAL, INC. BECTON DICKINSON
K911883 11/29/1991 DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER DIAG CORP. J FLEISCHHACKER
K912294 11/22/1991 ALLERGY INFORMATION MANAGER DIAGNOSTIC PRODUCTS CORP. KENNETH B ASARCH
K896378 11/05/1991 LYME-CHECK(TM) TEST KIT DIAGNOSTIC TECHNOLOGY, INC. IMRE PINTER
K913098 11/05/1991 APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 DLP, INC. ROGER W BRINK
K913874 11/27/1991 INFINITY(TM) MICROTAPER HIP SYSTEM DOW CORNING WRIGHT MICKI ROY
K913394 11/22/1991 INCUBATOR 8000 IC DRAGERWERK AG STEFAN FREMBGEN
K914226 11/19/1991 ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK E.I. DUPONT DE NEMOURS & CO., INC. CHRISTOPHER BENTSEN
K914225 11/22/1991 ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC. CHRISTOPHER BENTSEN
K914508 11/27/1991 DIMENSION(R) LACTIC ACID METHOD E.I. DUPONT DE NEMOURS & CO., INC. ROBERT B TAYLOR
K914470 11/29/1991 PNEUMO-SEAL(TM) EDWARD WECK, INC. GLENN M MATTEI
K904619 11/05/1991 INFU.DISK ELECTROCHEMICAL DRUG DELIVERY, INC. CONI ROSATI
K913921 11/22/1991 ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 EM DIAGNOSTIC SYSTEMS, INC. ANNA G BENTLEY
K913764 11/05/1991 ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 EM DIAGNOSTIC SYSTEMS, INC. ANNA G BENTLEY
K914464 11/22/1991 ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 EM DIAGNOSTIC SYSTEMS, INC. ANNA G BENTLEY
K914018 11/22/1991 ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 EM DIAGNOSTIC SYSTEMS, INC. ANNA G BENTLEY
K912015 11/15/1991 TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 EMPI STACY MATTSON
K912203 11/13/1991 EMS SINGLE USE MANUAL RESUSCITATORS ENGINEERED MEDICAL SYSTEMS JEFF QUINN
K912281 11/19/1991 ES1600 PARAMEDIC TELEPHONE EPIC SYSTEMS, INC. JAY M ESTUS
K914610 11/29/1991 SWEDE CROSS MANUAL WHEELCHAIR ETAC US, INC. MELODY B DILL
K914091 11/19/1991 POWER RECLINER WHEELCHAIR EVEREST & JENNINGS, INC. JACKIE WILKINS
K911503 11/19/1991 EXMOOR SILICONE RUBBER SHEET EXMOOR PLASTICS LTD. BRIAN EAST
K911844 11/21/1991 HYSTEROFLATOR 1500 F.M. WIEST USA, INC. GEORGE R BATCHELOR
K913366 11/05/1991 IN-THE-EAR HEARING AIDS FENWICK HEARING INSTRUMENTS JAMES A FENWICK
K912848 11/29/1991 I.V. FILTER EXTENSION SET FILTERTEK, INC. LARRY LARKIN
K905694 11/27/1991 FVP-1000 FAMILY AND FVP-1000D FAMILY FISCHER IMAGING CORP. RICHARD S LUCAS
K914266 11/27/1991 MICRO-X 30 HF FISCHER IMAGING CORP. THOMAS H GALLINGER
K914236 11/27/1991 MICRO-X 50 HF FISCHER IMAGING CORP. THOMAS H GALLINGER
K913269 11/22/1991 OSTEO BONE SCREWS FRED C. BRYSON FRED C BRYSON
K912969 11/05/1991 TORQUE FITTING FREEDOM MACHINE, INC. PHYLLIS L.ELLETT
K914851 11/13/1991 CLA-1400 SYSTEM GAYMAR INDUSTRIES, INC. PETER SCOTT
K914527 11/22/1991 CEQUAL(TM) GENERAL ELECTRIC CO. LARRY A KROGER
K913532 11/22/1991 TX 3 TENS MODIFIED GLOBALCARE/BAY MEDICAL CORP. JOHN DUNN
K914674 11/22/1991 MICROAIR 3500 GSI DEVELOPMENT CO. OLIVER H BODINE
K913697 11/05/1991 AUTOMATIC CORNEAL SHAPER HANSA RESEARCH & DEVELOPMENT, INC. BRIGITTA HELLENKAMP
K913608 11/29/1991 SNAPPER HEALTHTEK, INC. HILARY R HEDMAN
K913807 11/27/1991 REP(R) SPE TEMPLATE 30, 16, & 8 HELENA LABORATORIES PAT FRANKS
K913041 11/05/1991 ANTI-DSDNA ANTIBODY TEST HELIX DIAGNOSTICS, INC. VIRGINIA L CAPPEL
K904377 11/15/1991 ELECTROCONDUCTIVE MEDIA HENLEY INTL. ERNEST HENLEY
K913827 11/19/1991 MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG HEWLETT-PACKARD CO. CHARLES R BURR
K913533 11/07/1991 MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) HEWLETT-PACKARD CO. DAVID OSBORN
K912404 11/07/1991 TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY HEWLETT-PACKARD CO. LESLIE FULLERTON
K914211 11/22/1991 CATH CONTROL HIGHPOINT MEDICAL CORP. ROGER LIEBELT
K911993 11/22/1991 MRH-500 HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT H MCCARTHY
K914263 11/22/1991 MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS HITACHI MEDICAL SYSTEMS AMERICA, INC. JOCHEN ROGERS
K914019 11/01/1991 MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) HITACHI MEDICAL SYSTEMS AMERICA, INC. JOCHEN ROGERS
K914358 11/19/1991 ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP HOBBS MEDICAL, INC. ROBERT G WHALEN
K913321 11/01/1991 HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER HOLOGIC, INC. VON STETTEN
K914082 11/27/1991 SUAN FLAT DISSECTOR SPONGES ICN PHARMACEUTICALS, INC. STEPHEN J GOLDNER
K913755 11/19/1991 STATVIEW IMAGE SYSTEMS, INC. GARY J ALLSEBROOK
K913352 11/29/1991 C-150 ULTRAFAST CT SCANNER IMATRON, INC. CODUTO
K913616 11/07/1991 LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP IMPLANT TECHNOLOGY, INC. JAMES ABRAHAM
K912244 11/22/1991 UROTEST GPH IN WHA PHARMACEUTICAL CO., LTD.
K910448 11/21/1991 SNAP-LOCK MICRO PORT, MODIFICATION INFUSAID CORP. NANCY C HALL
K911680 11/19/1991 QUANTA LITE(TM) ACA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K912021 11/22/1991 MAKAR MINI CANNULATED CANCELLOUS SCREWS INSTRUMENT MAKAR, INC. KEITH M MCGRATH
K912893 11/05/1991 ORTHOPANTOMOGRAPH 100 INSTRUMENTARIUM CORP. PEKKA MARTTINEN
K914151 11/29/1991 IL TEST(TM DIGOXIN INSTRUMENTATION LABORATORY CO. GEORGE A LYNA
K913738 11/07/1991 IL TEST(TM) AMPHETAMINE INSTRUMENTATION LABORATORY CO. GEORGE A LYNA
K913742 11/07/1991 IL TEST(TM) OPIATE INSTRUMENTATION LABORATORY CO. GEORGE A LYNA
K913743 11/07/1991 IL TEST(TM) PHENCYCLIDINE INSTRUMENTATION LABORATORY CO. GEORGE A LYNA
K913633 11/22/1991 TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS INTERMEDICS ORTHOPEDICS WEBB
K911114 11/19/1991 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM INTERSON CORP. GARY J ALLSEBROOK
K913763 11/20/1991 INTERPRET(TM) CATHETER LINEAR TRANSLATOR INTERTHERAPY, INC. THOMAS P SCHROEDER
K912600 11/19/1991 INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER INTERTHERAPY, INC. THOMAS P SCHROEDER
K912477 11/05/1991 ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION INTERVENTIONAL THERAPEUTICS CORP. LUANNE TERMEER
K913052 11/22/1991 ITC GUIDING CATHETER INTERVENTIONAL THERAPEUTICS CORP. LUANNE TERMEER
K913932 11/22/1991 PERCUTANEOUS DILATOR WITH SHEATH INTERVENTIONAL THERAPEUTICS CORP. COLIN J NICHOLS
K913430 11/15/1991 IRIS OCULIGHT(R) SLX IRIDERM DIV. A BOUTACOFF
K911103 11/08/1991 DANBY D.S.P. SYRINGE PUMP ISYS MEDICAL LTD. TOM HORNE
K913629 11/13/1991 JOHNSON AND JOHNSON POWER SYSTEM JOHNSON & JOHNSON ORTHOPAEDICS, INC. MARSHA J STONE
K913632 11/13/1991 BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM KIRSCHNER MEDICAL CORP. SAM SON
K913514 11/05/1991 ELECTROSURGICAL UNIT CABLE KIRWAN SURGICAL PRODUCTS, INC. FRED TERRY
K905276 11/07/1991 THERMA-H KURE SWISS MEDICAL AG CORP. EDGAR HOFFMAN
K913517 11/05/1991 ISOLATE INFUSION CATHETR SYSTEM LAKE REGION MFG., INC. PAUL KOHL
K914066 11/07/1991 ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS LAPAROMED CORP. PAUL LUBOCK
K912247 11/13/1991 UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY LASER ENGINEERING, INC. ROBERT I RUDKO
K913758 11/20/1991 KTP/532 AND KTP/YAG LASERSCOPE DONNA PAGE
K913357 11/07/1991 ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST LIFESCAN, INC. ROSEMARY D SELF
K913264 11/01/1991 HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE MALLINCKRODT GROUP, INC. MARK L FRIEDMAN
K914872 11/19/1991 MARLOW SUCTION/IRRIGATION PROBES MARLO SURGICAL TECHNOLOGY SCOTT C MARLOW
K901704 11/19/1991 RELIEF BAND (T.E.N.S. DEVICE) MAVEN LABS, INC. GAROLD G BREIT
K914076 11/13/1991 MDT/CASTLE 2000 SURGICAL LIGHTS MDT CORP., INC. MARK N SMITH
K914697 11/13/1991 MDT/CASTLE PURUS DENTAL UNIT MDT CORP., INC. MARK N SMITH
K912775 11/08/1991 SAPPHIRE 4ME EMG/EP SYSTEM MEDELEC INTL. CORP. J. B HOLLOWAY
K913498 11/27/1991 MX927 BLOOD TRANSFER DEVICE MEDEX, INC. CATHY CHENETSKI
K914268 11/22/1991 I-125 SEEDS IN CARRIER, CODE: 6720 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING FRANK J LYMAN
K914281 11/22/1991 I-125 SEEDS, CODE: 6711 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING FRANK J LYMAN
K914535 11/27/1991 MODEL 311GE-64: WHOLE VOLUME NECK COIL MEDICAL ADVANCES, INC. THOMAS TYNES
K914536 11/27/1991 MODELS 190GE-64/191GE-64/192GE-64/193GE-64 MEDICAL ADVANCES, INC. THOMAS TYNES
K913881 11/01/1991 ENDOSTAT ELECTROSURGICAL UNIT MEDICAL AND SCIENTIFIC ENTERPRISES, INC. LLYNNE ARONSON
K914384 11/13/1991 MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE MEDICAL DESIGN & MANUFACTURING CORP. MICHAEL SOUTHWORTH
K913136 11/01/1991 LASER ENDOSCOPE DISC DECOMPRESSION KITS MEDICAL LASER, INC. GREGORY J.MATHISON
K914628 11/07/1991 PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF MEDICAL RESOURCES, LTD. RICHARD H GHENN
K914696 11/13/1991 MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 MEDIX BIOTECH, INC. JOHN CHEN
K914498 11/27/1991 POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES MEDMARK, INC. MARJORIE SKINNER
K913442 11/22/1991 MEDTRONIC 3625 SCREENER SYSTEM MEDTRONIC VASCULAR DARYLE PETERSEN
K912764 11/22/1991 MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT MEDTRONIC VASCULAR DAVID MUELLER
K914460 11/22/1991 MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES MEDTRONIC VASCULAR JOHN M OTTO
K914116 11/27/1991 PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION MEDTRONIC VASCULAR DAVID H MUELLER
K913682 11/15/1991 MERIT CUSTOM KIT MERIT MEDICAL SYSTEMS, INC. DENNIS REIGLE
K914627 11/13/1991 PLATINUM FOIL PLATINUM MILING WAFER METALOR DENTAL USA CORP. BRIAN F SCHILLER
K913589 11/05/1991 EARSCAN DSP-1 PURE TONE AUDIOMETER MICRO AUDIOMETRICS CORP. LARRY DEDERNARDO
K914346 11/27/1991 DRILL MODULES MODELS 2116/2117 MICRO SURGICAL INSTRUMENTS CORP. MOE KHOSRAVI
K913369 11/01/1991 MICRO-AIRE MODEL 2060 MICRO SURGICAL INSTRUMENTS CORP. MOE KHROSRAVI
K914490 11/29/1991 MICRO EIA FOR MARIJUANA METABOLITES MICRODIAGNOSTICS, INC. ROY CHUNG
K914046 11/08/1991 THE BIG EASY Y-ADAPTER MICROVENA CORP. RUDY MAZZOCCHI
K914134 11/22/1991 INCUBATOR 8000 SC NATIONAL DRAEGER, INC. STEFAN FREMBGEN
K913856 11/29/1991 INFRARED HEAT LAMP MODEL NH-201 NATIONAL HEALTH-CARE EQUIPMENT, INC. PETER WINOCUR
K913880 11/29/1991 INFRARED HEAT LAMP MODEL NH-202 NATIONAL HEALTH-CARE EQUIPMENT, INC. PETER WINOCUR
K913973 11/29/1991 INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 NATIONAL HEALTH-CARE EQUIPMENT, INC. PETER WINOCUR
K913695 11/13/1991 NELLCOR(R) N-180 PULSE OXIMETER NELLCOR, INC. KENNETH R MICHAEL
K911865 11/01/1991 NORTEC CONNECTING TUBE SET NORTH AMERICAN STERILIZATION & PACKAGING CO. HARRY A SCHLAKMAN
K911974 11/05/1991 PGK STEREOTACTIC DEVICE NORTHERN VIRGINIA RADIOLOGY AND NUCLEAR MEDICINE PANOS KOUTROUVELIS
K913955 11/29/1991 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION NORTHGATE TECHNOLOGIES, INC. SCOTT K GILCHRIST
K914403 11/27/1991 GENERAL USE KIT #7-510-20 NORTHGATE TECHNOLOGIES, INC. PETER A MANZIE
K914402 11/27/1991 RECIRCULATION KIT #7-510-18 NORTHGATE TECHNOLOGIES, INC. PETER A MANZIE
K914401 11/27/1991 UNIVERSAL GENERAL USE KIT #7-510-16 NORTHGATE TECHNOLOGIES, INC. PETER A MANZIE
K911179 11/13/1991 VERRES NEEDLES 5 & 6 INCHES NORTHGATE TECHNOLOGIES, INC. SAMUELLA D EMRICH
K911734 11/07/1991 TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM NORTHLAND CATARACT & EYE CARE CLINIC JERRY W COOK
K913516 11/04/1991 MODEL 520A NOVAMETRIX PULSE OXIMETER NOVAMETRIX MEDICAL SYSTEMS, INC. ROBERT SCHIFFMAN
K914296 11/27/1991 CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC NUCCARDIAC SOFTWARE, INC. VAN TRAIN
K914529 11/13/1991 SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS OASIS MEDICAL, INC. JAMES CHRISTENSEN
K914117 11/13/1991 LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET OCULAR INSTRUMENTS, INC. TAMSIN J ERICKSON
K912612 11/01/1991 SMOKE/ODOR EVACUATOR #757 OLSEN ELECTROSURGICAL, INC. MARIA MURSELL
K913829 11/22/1991 OLYMPUS FLEXIBLE TIP THORACOSCOPE OLYMPUS CORP. DANIEL J DILLON
K904798 11/22/1991 SUPRAPUBIC FLOW CONTROLLER OLYMPUS CORP. DANIEL DILLON
K913523 11/06/1991 AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR OMRON HEALTHCARE, INC. LEE COBOT
K913929 11/27/1991 DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM OPHTHALMIC IMAGING SYSTEMS STEVEN R VERDOONER
K913816 11/08/1991 ORIGINEEDLE, MODIFICATION ORIGIN MEDSYSTEMS, INC. FREDERIC H MOLL
K914616 11/20/1991 KLEER(TM) ORTHODONTIC BRACKET ORMCO CORP. FRANCES ZEE
K913519 11/19/1991 SUMO GLASS IONOMER CEMENT ORTHO SOURCE ANDREA G MUSTACHIO
K913913 11/27/1991 REFURBISHED ORTHODONTIC APPLIANCES ORTHO-CYCLE CO. CLAUDE G MATASA
K913559 11/07/1991 OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR OSTEO AG BRYSON, JR.
K913812 11/22/1991 OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES OSTEONICS CORP. ROBERT A KOCH
K911939 11/15/1991 SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES OVERSEAS IMPORT & EXPORT DIST. WAYNE FUNG
K913776 11/07/1991 PATIENT EXAMINATION GLOVES P.T. IRAMA DINAMIKA LATEX VENKATESAN
K913805 11/19/1991 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER PACE MEDICAL ROBERT C MACE
K912880 11/14/1991 VITALMAX 510/520 PACE TECH, INC. MARY J BILGUTAY
K913938 11/07/1991 OPUS(R) LH TEST SYSTEM PB DIAGNOSTIC SYSTEMS, INC. LORI BARANAUSKAS
K913536 11/22/1991 PRC AUTOPSY DEVICE PENNSTATE THOMAS MONAHAN
K913747 11/05/1991 STAYFREE(TM) MAXI-PAD PERSONAL PRODUCTS CO. RUBER
K911926 11/07/1991 POLARIS, OPHTHALMOLOGY PFIZER LASER SYSTEMS COLETTE COZEAN
K914800 11/05/1991 P54 BTE HEARING AID PHILIPS HEARING INSTRUMENTS CO. ROBERT MARTIN
K911872 11/22/1991 PHILIPS RIGID VOLUME COILS PHILIPS MEDICAL SYSTEMS, INC. WILLIAM G MCMAHON
K913568 11/01/1991 SURGI-SPRAY O.R. IRRIGATION SYSTEM PHOENIX SURGICAL PRODUCTS, INC. WILLIAM RESSE
K914015 11/21/1991 CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP PILLING CO. RICHARD G JONES
K914560 11/29/1991 STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL PPG INDUSTRIES, INC. VINCENT CUTARELLI
K914184 11/27/1991 P2020-8-0 BEAM-LIMITING DEVICE PRECISE OPTICS JOHN D MARCO
K913306 11/01/1991 BONE-TEMNO/STERNUM-TEMNO PROACT, LTD. JOSEPH M LOONEY
K914128 11/27/1991 CONNECTING SET PROCEDURE PRODUCTS, INC. ROBERT B EVERETT
K914394 11/13/1991 BACK MASTER PROGRESSIVE ELECTRICAL THERAPEUTICS GARY HUDDLESTON
K911143 11/29/1991 PB100 DIAGNOSTIC SPIROMETER PURITAN BENNETT CORP. TIMOTHY D SAMSEL
K912463 11/13/1991 MICRO-Q QUANTITATIVE MEDICINE, INC. YORK MCGAVIN
K912460 11/13/1991 Q-TENS QUANTITATIVE MEDICINE, INC. YORK MCGAVIN
K910017 11/05/1991 Q4500 STREE TEST MONITOR QUINTON, INC. RON DUCK
K913879 11/27/1991 CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE R & D SYSTEMS, INC. KAREN VISKOCHIL
K910481 11/29/1991 EPO-RIA RAMCO LABORATORIES, INC. CANDICE GORIN
K912623 11/27/1991 MEDICAL TAPE RENFREW TAPE, LTD. ROBERT SARGENT
K913325 11/01/1991 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE RESONEX, INC. BRUCE FLOYD
K913981 11/13/1991 RICH-MAR MODEL II ULTRASOUND RICH-MAR CORP. DAVID RICHARDS
K914509 11/01/1991 ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K914806 11/19/1991 ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K913911 11/01/1991 ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K914750 11/22/1991 ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K914195 11/08/1991 RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED RONDEX PRODUCTS, INC. GENE R BALDWIN
K914196 11/08/1991 RONDEX MASKS MODELS 9015/9011/901102 MODIFIED RONDEX PRODUCTS, INC. GENE R BALDWIN
K912630 11/04/1991 XKNIFE RADIOSURGERY SYSTEM RSA, INC. ROBERT J LEDOUX
K912575 11/21/1991 EXTERNAL GASTROSTOMY TUBE RETAINER SANDOZ NUTRITION ROBERT J LANG
K914277 11/29/1991 WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY SCHNEIDER U.S. STENT DIV. RUSSELL W OLSON
K914312 11/22/1991 SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS SCIMED LIFE SYSTEMS, INC. MERCEDES P BAYANI
K913830 11/22/1991 SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS SCIMED LIFE SYSTEMS, INC. MERCEDES P BAYANI
K912937 11/19/1991 SR1 FREE T4 ENZYME IMMUNOASSAY SERONO-BAKER DIAGNOSTICS, INC. DAVID B THOMAS
K914967 11/22/1991 SHARP ENDOKNOT PUSHER SHARPE ENDOSURGICAL CORP. ELAINE DUNCAN
K913413 11/29/1991 KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE SHERWOOD MEDICAL CO. DENNIS POZZO
K910991 11/27/1991 SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM SHILEY, INC. ALLAN ABATI
K914348 11/01/1991 ER-1000 CATHERIZATION C-ARM SYSTEMS SHIMADZU MEDICAL SYSTEMS DE MINT
K914313 11/27/1991 HICOR SIEMENS GAMMASONICS, INC. IRENA KRUTULIS
K914350 11/22/1991 ICON COMPUTER SYSTEM SIEMENS GAMMASONICS, INC. IRENA KRUTULIS
K913996 11/22/1991 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. LINDA J JALBERT
K914525 11/19/1991 FLUROSPOT H VERSION 2 SIEMENS MEDICAL SOLUTIONS USA, INC. STEPHEN K DEOL
K913869 11/25/1991 RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. LINDA J JALBERT
K914165 11/05/1991 X-RAY TABLE SIEMENS MEDICAL SOLUTIONS USA, INC. STEPHAN K.DEOL
K913794 11/20/1991 SIMPEX INC. SURGICAL DRESSING SIMPEX, INC. XI MEI
K913654 11/22/1991 SMITH AND DAVIS PRESSURE THERAPY SYSTEM SMITH & DAVIS MFG. CO. DARRELL MCENTIRE
K913979 11/27/1991 ENDO I/A "Y" SET SNOWDEN-PENCER NORMAN M BLACK
K913835 11/07/1991 SNOWDEN-PENCER INSUFFLATOR TUBING SET SNOWDEN-PENCER NORMAN M BLACK
K913573 11/07/1991 SAFETY PLUS DENTAL INJECTION NEEDLE SPECIALITES SEPTODONT PETER S REICHERTZ
K914177 11/29/1991 HYDRODISECTOR SPIESS DESIGN, INC. JOACHIM SPIESS
K905608 11/07/1991 INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 STELLAR BIO SYSTEMS, INC. JOHN M BREWER
K914609 11/07/1991 TRIGLYCERIDES REAGENT SET STERLING DIAGNOSTICS, INC. DAVID L CALLENDER
K911206 11/29/1991 MAXIMA-10 STIRN INDUSTRIES ROBERT HARRINGTON
K911782 11/22/1991 PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM STRATO MEDICAL CORP. NANCY C HALL
K914677 11/08/1991 MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG SUNRISE TECHNOLOGIES, INC. CHARLES L ROSE
K914568 11/07/1991 MODEL DLASER 1000 ND;YAG LASER SYSTEM SUNRISE TECHNOLOGIES, INC. CHARLES L ROSE
K913928 11/19/1991 SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT SURGITEK MEDICAL ENGINEERING CORP. WILLIAM H DUFFELL
K914546 11/29/1991 ANGLED BLADE PLATE SYNTHES (USA) DIANE COCHET-WYNANT
K914472 11/07/1991 SPIKED WASHER SYNTHES (USA) DIANE COCHET-WYNANT
K915003 11/29/1991 EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) SYVA CO. PAUL L ROGERS
K914973 11/29/1991 SYVA EMIT D.A.U. COCAINE METABOLITE SYVA CO. PAUL L ROGERS
K911779 11/08/1991 HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED TARGET THERAPEUTICS HIRAM CHEE
K913312 11/08/1991 HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED TARGET THERAPEUTICS LLOYD H GRIESE
K914001 11/22/1991 TARGET THERAPEUTICS RADIOPAQUE STYLET TARGET THERAPEUTICS WENDY J ZENZEN
K914511 11/27/1991 TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL TECHNICON INSTRUMENTS CORP. THOMAS C BREWSTER
K914025 11/22/1991 TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) TECHNICON INSTRUMENTS CORP. THOMAS C BREWSTER
K914888 11/27/1991 TECHNICON CHEM 1(TM) SYST (GEN2 SYST) TECHNICON INSTRUMENTS CORP. THOMAS C BREWSTER
K913494 11/01/1991 TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC TELEX COMMUNICATIONS, INC. THOMAS J LAKE
K913495 11/01/1991 TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC TELEX COMMUNICATIONS, INC. THOMAS J LAKE
K913074 11/05/1991 0.016" GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE TERUMO MEDICAL CORP. ALAN B HERSHMAN
K913131 11/07/1991 HUMAN BETA-2 MICROGLOBIN EN-RID KIT THE BINDING SITE, LTD.
K914602 11/22/1991 DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG AMY PETERSON
K912250 11/05/1991 ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES THETA SYSTEMS, INC. KEVIN RUSSELL
K914012 11/27/1991 MRT-150A TOSHIBA AMERICA MRI, INC. BEN KHOSRAVI
K914731 11/19/1991 TRACE GAMMA GT-SS REAGENT TRACE SCIENTIFIC LTD. PETER MURPHY
K913464 11/13/1991 STOMAVISION (STV) TROPHY RADIOLOGIE JY SEVESTRE
K910978 11/07/1991 ACCU-BEAM LAPAROSCOPIC SYSTEM TTI MEDICAL LOWELL CROW
K913305 11/22/1991 CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER UNIPATH LTD. SHERB EDMONDSON
K914688 11/05/1991 HEARING AID, UNITRON MODEL VISTA 3000 UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K914689 11/05/1991 HEARING AID, UNITRON MODEL VISTA 4000 UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K913119 11/07/1991 VARIAN C-SERIES CLINACS (CLINAC 2300C/D) VARIAN ASSOC., INC. CHARLES H WILL
K913174 11/05/1991 VARIAN CLINAC 600SR VARIAN ASSOC., INC. CHARLES H WILL
K911111 11/19/1991 MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS VERMONT DIAMOND INSTRUMENTS PETER A KUYKENDALL
K913837 11/05/1991 MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM VISION MEDICAL, INC. THOMAS LO
K914085 11/19/1991 HMS-5000 VITALOG MONITORING,INC. LAUGHTON E MILES
K914448 11/05/1991 GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE W.L. GORE & ASSOCIATES,INC DAWN LOPEZ
K914450 11/05/1991 GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE W.L. GORE & ASSOCIATES,INC DAWN LOPEZ
K914447 11/05/1991 GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE W.L. GORE & ASSOCIATES,INC DAWN LOPEZ
K912730 11/07/1991 ROCKET SURGICAL SKIN MARKING PEN WEST TEXAS LIGHTHOUSE FOR THE BLIND RONALD J BEARD
K914785 11/22/1991 WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR WHEELCHARIOTS, INC. KELLY BURKE
K913212 11/22/1991 3M IGE SINGLE POINT FAST TEST WHITTAKER BIOPRODUCTS, INC. SYLVIA ZORICH
K913583 11/13/1991 CONVERSIL FL AND CONVERSIL P WILDE-USA, INC. ROGERT BAUER
K912992 11/13/1991 KERALLOY NON-GAMMA 2 AMALGAM WILDE-USA, INC. ROBERT W BAUER
K911893 11/22/1991 EASY ACCESS BED WILLIS THERAPEUTIC INNOVATIONS, INC. WILLIAM WILLIS
K913685 11/07/1991 UNICATH EP. XRE CORP. THOMAS F FLYNN
K913620 11/01/1991 ENEMA KIT YORK COUNTY BLIND CENTER WILLLIAM RHINESMITH
K913649 11/13/1991 MODULAR CALCAR REPLACEMENT ZIMMER, INC. CAROL VIERLING


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