FDA 510(k) Decisions During September, 1996  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K955770 09/09/1996 GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM ABAXIS, INC. DANIEL WONG
K963158 09/10/1996 ABBOTT AXSYM DIGITOXIN (MODIFY) ABBOTT LABORATORIES GRACE LEMIEUX
K953943 09/20/1996 AXSYM CMV IGG ANTIBODY ASSAY ABBOTT LABORATORIES JOANNE RUPPRECHT
K954045 09/24/1996 AXSYM RUBELLA IGG ANTIBODY ASSAY ABBOTT LABORATORIES JOANNE RUPPRECHT
K962467 09/17/1996 RV PACING LEAD ABBOTT LABORATORIES DAVE GUZEK
K961023 09/09/1996 AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) ACCUIMAGE, INC. GARY J ALLSEBROOK
K962851 09/06/1996 ACRYNOODLES ABSORBENT WOUND DRESSING ACRYMED, INC. BRUCE GIBBINS
K962698 09/09/1996 ACUTEK'S CLEARPASAGE ACUTEK ADHESIVE SPECIALTIES, INC. MARCIA FAJARDO
K962495 09/12/1996 INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115" ROTATING HEMOSTATIC VALVE) ADVANCED CARDIOVASCULAR SYSTEMS, INC. MARGARET ANDERSON
K960337 09/24/1996 AMD HOME HEALTH MONITORING SYSTEM ADVANCED MEDICAL DEVICES, INC. BRIAN W PETERSEN
K962493 09/11/1996 ENDOSCOPIC CLIP APPLIER AESCULAP, INC. MARY ELLEN HOLDEN
K962592 09/23/1996 OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS ALCON LABORATORIES MARTIN A KAUFMAN
K962402 09/19/1996 AMO PRESTIGE DAY PACK (ALLERGAN, INC.) ALLERGAN, INC. MONIQUE M HEYNINCK
K962671 09/13/1996 STA-VWF CALIBRATOR KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC B. LE
K962469 09/09/1996 ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962330 09/11/1996 AMO ARTHOSCOPES AMERICAN MICROPTIKS, INC. GEORGE HALLACK
K952882 09/09/1996 PERSONAL TELEMEDICINE SYSTEM AMERICAN TELECARE, INC. CHARLES R ABBRUSCATO
K962400 09/09/1996 AIR MAX EXTERNAL NASAL DILATOR STRIP AMERICAN WHITE CROSS, INC. PAUL B CALLAHAN
K963197 09/19/1996 ON.SITE ALCOHOL ANSYS, INC. LORNA GAMBOA
K963359 09/24/1996 INSUFFLATION NEEDLE APPLIED MEDICAL RESOURCES HOWARD V ROWE
K961345 09/17/1996 DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE APPLIED MEDICAL TECHNOLOGIES KATHY FELTRIN
K963088 09/13/1996 SHEATH, ELECTROSURGICAL PENCIL ASPEN LABORATORIES, INC. CHARLES M HART
K962888 09/23/1996 AFFIRM ONE-STEP HOME PREGNANCY TEST ATHENA MEDICAL CORP. ROBERT BUCK
K962589 09/20/1996 AURORA DIAGNOSTIC WORKSTATION AURORA TECHNOLOGY, INC. C. PAUL PESEK
K963154 09/05/1996 RIONET HB-54AS AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963152 09/05/1996 RIONET HB-55AS AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963153 09/05/1996 RIONET HB-55S AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K952660 09/17/1996 BRAUN HEMODIALYSIS CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K961745 09/17/1996 BRAUN PERCUTANEOUS INTRODUCER SET B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K960674 09/19/1996 CONTRAST INJECTION LINES B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K962499 09/05/1996 ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER BARTELS, INC. REBECCA D FULLER
K963142 09/27/1996 DCA 2000 + MICROALBUMIN/CREATININE ASSAY BAYER CORP. ROSANNE M SAVOL, R.A.C.
K963080 09/27/1996 TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP. GABRIEL J MURACA, JR.
K962519 09/04/1996 EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS BEHRING DIAGNOSTICS, INC. PAUL L ROGERS
K962275 09/05/1996 MAICO MA25 SERIES II WITH SPEECH BERNAFON-MAICO, INC. SCOTT SAVRE
K961376 09/12/1996 SMART-TENS, MODEL 456 BIO-MEDICAL RESEARCH, LTD. TOM BOONE
K961941 09/16/1996 LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 BIO-RAD ELIZABETH PLATT
K962266 09/10/1996 0.014 INCH EXTRA LONG FLOPPY AND 0.014" EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING BIOCOMPATIBLES CARDIOVASCULAR, INC. NANCY F TEAGUE
K962552 09/25/1996 EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K961928 09/16/1996 BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 BIOMEDIX, INC. KEITH E HOFFMAN
K962216 09/19/1996 TSH (MICROWELL) ELISA BIOMERICA, INC. JAY SINGH
K960984 09/17/1996 SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS BIOMET, INC. PATRICIA SANDBORN BERES
K961359 09/13/1996 LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 BIOPROCESSING, INC. GARY GOODRICH
K953044 09/27/1996 UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION BIOTRONIK, INC. JOSEPH J SCHOWEBEL
K961980 09/12/1996 BIPORE BALLOON DILATATION CATHETER BIPORE, INC. DURMUS KOCH
K962946 09/03/1996 ORTHO-ONE BISCO, INC. JAMES L SANDRIK
K961832 09/06/1996 BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER BLUE RIDGE MEDICAL, INC. MARK J RICE
K962300 09/05/1996 CLAMPLESS VALVED CATHETER BMW MEDICAL, INC. PHIL TRIOLO, PH.D.
K963191 09/10/1996 CEDIA ANTIBIOTIC TDM MULTI-CALS BOEHRINGER MANNHEIM CORP. BETSY SOARES-MADDOX
K963181 09/10/1996 ELECSYS CALCHECK T UPDATE BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K962375 09/04/1996 MICROVASIVE BALLOON GASTROSTOMY TUBE KIT BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K963252 09/20/1996 TBAN BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K962177 09/04/1996 BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT C.R. BARD, INC. SANDRA L PERREAND
K954350 09/10/1996 CARD GUARD MODEL CG-6500 CARD GUARD SCIENTIFIC SURVIVAL, LTD. BOAZ VINOGRADOV
K954426 09/16/1996 CPR LIFE MASK COMPACT BARRIER CAREFREE TRADING, INC. RICK STOCKETT
K962218 09/12/1996 CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG CARRINGTON LABORATORIES, INC. DENNIS R SPARKMAN, PH.D.
K962629 09/13/1996 DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR CASCO STANDARDS CHRISTINE V BEACH
K961594 09/05/1996 "BETTER-VENTER" CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K962255 09/11/1996 CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) CLARUS MEDICAL SYSTEMS, INC. JOHN VANDEN HOEK
K962242 09/03/1996 SURESCAN CLINICON CORP. ALAN BUNTING
K961140 09/20/1996 FLUOROPLUS CARDIAC TV CMT MEDICAL TECHNOLOGIES, LTD. IMRE FARKASH
K960965 09/12/1996 FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 COEUR LABORATORIES, INC. JAMES M CLINTON
K961815 09/27/1996 QUALITROL ANA CONTROL SERUM SET CONSOLIDATED TECHNOLOGIES, INC. WILLIAM CONE
K961544 09/24/1996 QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 CONSOLIDATED TECHNOLOGIES, INC. WILLIAM CONE
K961550 09/24/1996 QUALITROL MONO CONTROL SERUM SET CONSOLIDATED TECHNOLOGIES, INC. WILLIAM CONE
K961545 09/24/1996 QUALITROL RF CONTROLS CONSOLIDATED TECHNOLOGIES, INC. WILLIAM CONE
K963346 09/09/1996 STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 CONSOLIDATED TECHNOLOGIES, INC. WILLIAM CONE
K954728 09/23/1996 PROD NO. 01-1694 - 4X4 FOAM DRESSING CONTINENTAL MEDICAL LABORATORIES, INC. JOSEPH DUNN
K961006 09/11/1996 MEDLITE/755 ALEXANDRITE LASER SYSTEM CONTINUUM BIOMEDICAL, INC. LAURIE A RIDENER
K962590 09/20/1996 SIGNALDRESS CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K953663 09/18/1996 CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER CORDIS WEBSTER, INC. MARY ADAMS
K963044 09/20/1996 ENDOBEAM CORIN U.S.A. JACK THOMAS
K963043 09/20/1996 ENDOSPOT CORIN U.S.A. JACK THOMAS
K962596 09/27/1996 CUSTOMED BLOOD EXTRACTION KIT CUSTOMED, INC. CAROLANN KOTULA
K963244 09/23/1996 ACETAMINOPHEN FLEX REAGENT CARTRIDGE DADE INTL., INC. CAROLYN K GEORGE
K962820 09/13/1996 CARBAMAZEPINE FLEX REAGENT CARTRIDGE DADE INTL., INC. CAROLYN K GEORGE
K962817 09/16/1996 DRUG CALIBRATOR II DADE INTL., INC. CAROLYN K GEORGE
K962819 09/13/1996 GENTAMICIN FLEX REAGENT CARTRIDGE DADE INTL., INC. CAROLYN K GEORGE
K962818 09/13/1996 TOBRAMYCIN FLEX REAGENT CARTRIDGE DADE INTL., INC. CAROLYN K GEORGE
K963267 09/13/1996 VANCOMYCIN FLEX REAGENT CARTRIDGE DADE INTL., INC. CAROLYN K GEORGE
K960503 09/16/1996 DANTEC DUET DANTEC MEDICAL, INC. ALAN J SCHAEFER
K950025 09/03/1996 SELF PROPELLED ROBOTIC WHEEL (SPRW) DATATRAN, INC. SAL ALBRACCIO
K962971 09/16/1996 POLYPROPYLENE MESH (VARIOUS SIZES) DAVIS & GECK, INC. STEPHEN J TAMSETT
K961039 09/12/1996 BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL DAYSPRING MEDICAL, INC. NEIL RASMUSSEN
K960301 09/30/1996 ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR DEL MEDICAL SYSTEMS CORP. KARL WEYDIG
K962651 09/30/1996 S-52 ELECTRONIC VIDEO LAPAROSCOPE DEL MEDICAL SYSTEMS CORP. KARL J WEYDIG
K962979 09/25/1996 S-53 INTRORAL DENTAL SYSTEM DEL MEDICAL SYSTEMS CORP. KARL J WEYDIG
K961186 09/17/1996 DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM DEPUY, INC. SALLY FOUST
K961239 09/17/1996 DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL DEPUY, INC. CHERYL HASTINGS
K962644 09/06/1996 VIGOR COMPRESSION HIP SCREW SYSTEM DEUTSCHLAND SURGICAL, INC. THOMAS WOLTER
K960578 09/05/1996 ELVIS HSV GOLD DIAGNOSTIC HYBRIDS, INC. J.L. BROWN
K962118 09/09/1996 DSL ACTIVE FSH IRMA DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K962895 09/10/1996 DSL DHEA-S-7 DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K963508 09/26/1996 DISPENS-O-DISC MEROPENEM DIFCO LABORATORIES, INC. DAVID GATES
K962260 09/09/1996 REAL-TIME VIDEO CONTRAST ENHANCER DIGIVISION, INC. CHARLES A BRASS
K953238 09/16/1996 DRAGER MICRO VENT DRAGER, INC. HARALD KNEUER
K962544 09/20/1996 MICRO DIAMOND-POINT DISSECTION NEEDLES DSP WORLDWIDE ROSINA ROBINSON
K961261 09/05/1996 DYNATRON 525 DYNATRONICS CORP. JOHN S RAMEY
K962896 09/20/1996 KODAK DIGITAL SCIENCE REMOTE CASSETTE EASTMAN KODAK COMPANY JOHN LE CLAIR
K963261 09/27/1996 EBI THERMAL THERAPY SYSTEM ELECTRO-BIOLOGY, INC. SHARON A STAROWICZ
K963291 09/30/1996 VARELISA ANA (4) PROFILE ELIAS USA, INC. GOTTFRIED KELLERMANN, PH.D.
K962677 09/20/1996 ESTEEM 1.5T MRI SYSTEM ELSCINT MR, INC. ELIZABETH F LOWDER
K962618 09/04/1996 GYREX V-EP ELSCINT, INC. THOMAS J SPACKMAN
K961526 09/17/1996 PRESS-FIT POROUS SHELL ENCORE ORTHOPEDICS, INC. ASHLEY M BOCK
K962560 09/19/1996 VITALITY HIP STEM ENCORE ORTHOPEDICS, INC. ASHLEY M BOCK
K962293 09/16/1996 ENDOSONICS AUTOMATIC PULL BACK DEVICE ENDOSONICS CORP. ADAM D SAVAKUS
K954168 09/12/1996 E100A PULSE OXIMETER FINGER SENSOR/PROBE EPIC MEDICAL EQUIPMENT SERVICES, INC. KENNETH F PERDUE
K960078 09/20/1996 ASTHMA MONITOR ERICH JAEGER, INC. D GROTHEER
K960772 09/11/1996 PHOTODERM PL. ESC MEDICAL SYSTEMS LTD. HILLIEL BACHRACH
K962428 09/12/1996 EBS (ESPE BONDING SYSTEM) ESPE GMBH & CO. KG. BARBARA WAGNER
K962442 09/11/1996 HYTAC APLITIP/HYTAC OSB ESPE GMBH & CO. KG. BARBARA WAGNER
K962440 09/11/1996 PERTAC II/PERTAC II APLITIP ESPE GMBH & CO. KG. BARBARA WAGNER
K962258 09/11/1996 ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP ETHICON ENDO-SURGERY, INC. MELISSA WALKER, M.S., R.A.C.
K960902 09/26/1996 EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 EUREDUC PHILIPPE P JOUBERT
K963039 09/23/1996 SURESKIN STANDARD, BORDER, AND THIN EUROMED A/S DIANE E MINEAR
K963047 09/10/1996 AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) FENWICK HEARING INSTRUMENTS JAMES A FENWICK III
K962307 09/17/1996 RHYDER DIAGNOSTIC CATHETER FIDUS MEDICAL TECHNOLOGY CORP. TED ORMSBY
K962427 09/20/1996 COBE CENTRYSYSTEM 700 HG HEMODIALYZER GAMBRO HEALTHCARE JEFFREY R SHIDEMAN, PH.D.
K962711 09/05/1996 GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS GELFLEX LABORATORIES PETER G BRYANT
K962710 09/05/1996 GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS GELFLEX LABORATORIES PETER G BRYANT
K961356 09/23/1996 MAMMARY SIZER GENERAL SURGICAL INNOVATIONS THERESA M NARAROFF
K962329 09/12/1996 GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 GLOBAL MEDICAL PRODS, INC. PETER CLARK
K963175 09/23/1996 GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING GLYCAR, INC. DIRK FRATER
K960860 09/05/1996 GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 GREINER AMERICA, INC. ED MAIER
K962613 09/27/1996 DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM GULMAY MEDICAL LTD. G. CONDLIFFE
K962506 09/16/1996 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] GYNECARE INNOVATION CENTER MICHAEL A DANIEL
K962798 09/09/1996 AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS HEARING SOLUTIONS, INC. EDOUARD A GAUTHIER
K962510 09/11/1996 HEARTPORT ENDOAORTIC CLAMP HEARTPORT, INC. ROBERT J CHIN
K962858 09/30/1996 HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM HEARTPORT, INC. ROBERT J CHIN
K955628 09/10/1996 FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS HEARTSTREAM, INC. LORI GLASTETTER
K962836 09/12/1996 HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K961312 09/24/1996 HEMOCUE B-HEMOGLOBIN SYSTEM HEMOCUE, INC. ROBERT J SLOMOF
K963383 09/23/1996 HICHEM ALP/AMP REAGENT KIT HICHEM DIAGNOSTICS WYNN STOCKING
K961969 09/05/1996 HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES J ROGERS
K962900 09/16/1996 SELF RETAINING MALE EXTERNAL URINARY CATHETER HOLLISTER, INC. JOSEPH S TOKARZ
K962026 09/10/1996 PREPOWDER VINYL PATIENT EXAMINATION GLOVES HONG HUANG TANG INDUSTRIAL CO., LTD. HUAN CHUNG LI
K961150 09/10/1996 DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA HUDSON RESPIRATORY CARE, INC. ARDEN MORLEY
K962680 09/30/1996 HYUNJAE DENTAL IMPRESSION MATERIALS HYUNJAE CORP. DANIEL G MODICA
K962751 09/30/1996 IDEAS' DUAL PORT IDEAS FOR MEDICINE, INC. ELIZABETH M PAUL
K960715 09/09/1996 PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F IDEAS FOR MEDICINE, INC. ELIZABETH M PAUL
K961716 09/19/1996 VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE IDEAS FOR MEDICINE, INC. ELIZABETH M PAUL
K963134 09/06/1996 DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) IGENICS, INC. G. THACHER STORM
K963275 09/13/1996 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM IMMUNO CONCEPTS, INC. ERIC S HOY
K962465 09/20/1996 TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K953567 09/25/1996 INCSTAR 25-HYDROXYVITMIN D 1251 RIA INCSTAR CORP. MARY ELLEN BEST
K963037 09/27/1996 PATRIOT INFIMED, INC. MORTEZA MINAEE
K961991 09/04/1996 ACL 6000 SYSTEM (ACL 6000) INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962199 09/25/1996 QUANTEX C3 INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962198 09/26/1996 QUANTEX C4 INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962200 09/25/1996 QUANTEX IGA INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962202 09/26/1996 QUANTEX IGG INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962201 09/25/1996 QUANTEX IGM INSTRUMENTATION LABORATORY CO. BETTY J LANE
K962315 09/03/1996 SELECT SHOULDER COCR HUMERAL STEM COMPONENT INTERMEDICS ORTHOPEDICS MITCHELL A DHORITY
K955548 09/20/1996 CHIPS POWERED WHEELCHAIR INTERNATIONAL HEALTHCARE SOLUTIONS, INC. FRED DI VITO
K955547 09/20/1996 CHIPS STANDUP WHEELCHAIR INTERNATIONAL HEALTHCARE SOLUTIONS, INC. FRED DI VITO
K962614 09/06/1996 SHIFA STERILE DISPOSABLE SYRINGES INTERNATIONAL REGULATORY CONSULTANTS WILLIAM H DAMASKA
K962878 09/25/1996 TARGIS SYSTEM IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K962757 09/25/1996 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP J.B.S., S.A. LIZA BURNS
K963334 09/11/1996 JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 JAMIESON FILM CO. GEORGE LEON
K962986 09/20/1996 MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES JOHNSON & JOHNSON MEDICAL, INC. MARGARET L MARSH
K962429 09/18/1996 SAFETY VEST JOHNSON & JOHNSON PROFESSIONALS, INC. JOHANNA ADLER
K962090 09/30/1996 KARL STORZ MODEL 203210 O1 UNIMAT PLUS KARL STORZ ENDOSCOPY-AMERICA, INC. RENATE A MACLAREN
K962595 09/04/1996 KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS KARL STORZ ENDOSCOPY-AMERICA, INC. MARIKA ANDERSON
K962393 09/17/1996 KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K954427 09/16/1996 HELPING HAND KINETIC REHABILITATION INSTRUMENTS, INC. TERRY G MAHN
K962853 09/12/1996 NEOSONO L.S. SCIENTIFIC LEONARD SALESKY
K962361 09/05/1996 TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND LAERDAL MEDICAL CORP. KENNETH B HERLAND
K962236 09/20/1996 SCARF THREAD-HEAD SCREW LANDOS, INC. NORMAN F ESTRIN
K963300 09/23/1996 DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K963299 09/30/1996 HWA-TO ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K962354 09/11/1996 DIOMED 15, 30, 60 SURGICAL DIODE LASER LIFESTREAM INT'L, INC. STEVEN CLARKE
K961049 09/18/1996 FLEX NEEDLE LIGHTHOUSE MEDICAL, INC. JENNA ANDELMAN
K961536 09/18/1996 FLEXSCOPE MATRIX MEDICA, INC. AMJAD AHMAD
K962513 09/12/1996 DERMAPLEX HYDROGEL WOUND DRESSING MAXXIM MEDICAL RICHARD A HAMER
K961105 09/05/1996 SKIN DOSE MONITOR MCMAHON MEDICAL MARTIN MCMAHON
K962342 09/10/1996 HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. SUSAN EICHLER-HUSTON
K960754 09/18/1996 SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M MECTA CORP. ROBIN H NICOL
K960457 09/06/1996 ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C MED LABS, INC. GLORIA NORVELL
K961075 09/06/1996 MEDCARE REGIONAL ANETHESIA KIT MEDCARE MEDICAL GROUP, INC. CRAIG J BELL
K962740 09/06/1996 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 MEDI-FLEX HOSPITAL PRODUCTS, INC. THOMAS VANNE
K962664 09/10/1996 ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. JOANN H LOPEZ
K961920 09/17/1996 CROSS PIN MEDICINE LODGE, INC. WADE FALLIN
K953823 09/23/1996 ARTERIAL VENOUS BLOOD TUBING SET MEDISYSTEMS CORP. SUZAN ONEL
K953974 09/09/1996 CAMVISION 1000 MEDIVISION MEDICAL IMAGING, LTD. RICHARD A DOMAINGUE
K962826 09/16/1996 MEDLINE RADIOLOGY-DIAGNOSTIC KITS MEDLINE INDUSTRIES, INC. LARA SIMMONS
K960759 09/18/1996 GONOPOX TEST KIT MEDTEX LABORATORIES, INC. KIRK C S. CHEN
K963246 09/23/1996 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT MEDTRONIC XOMED DAVID TIMLIN
K963066 09/27/1996 MENTOR INJECTION PORT DETECTOR (IPD) MENTOR CORP. RONALD F LAGERQUIST
K952220 09/17/1996 MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT MERETEK DIAGNOSTICS, INC. CLAUDIA T HITCHCOCK
K962520 09/12/1996 DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A MESURE TECHNOLOGY PHIL Z ULUETA
K962237 09/05/1996 THUMPER CARDIOPULMONARY RESUSCITATOR MICHIGAN INSTRUMENTS, INC. JAMES D MAATMAN
K963604 09/27/1996 DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION MIDWEST CITY HEARING AID CENTER FRANKLIN D CARTER
K963607 09/20/1996 HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL MIDWEST CITY HEARING AID CENTER FRANKLIN D CARTER
K963070 09/13/1996 VENIPUNCTURE KIT MILLER PRODUCTS AND SERVICES CINDY MILLER
K955012 09/12/1996 MIZUHO RADIOLUCENT HEAD FRAME MIZUHO AMERICA, INC. LISA SCHWEITZER
K923880 09/30/1996 ORLAU SWIVEL WALKER MOPAC, LTD. JOHN STAHL
K962525 09/19/1996 ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM MORWEL CORP. BRENDA HUNT
K961525 09/05/1996 ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) MRI DEVICES CORP. THOMAS SCHUBERT
K960194 09/04/1996 MYELOTEC MYELOSCOPE MYELOTEC, INC. CAROLANN KOTULA
K962516 09/10/1996 TAP ANTI-SNORING DEVICE NELLCOR PURITAN BENNETT, INC. CHRIS HADLAND
K962319 09/13/1996 NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES NEOPROBE CORP. SUSAN TIEDY-STEVENSON
K955887 09/05/1996 NEWMED ABP-LITE NEWMED CORP. DONALD R STONE
K962033 09/27/1996 CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT NICHOLS INSTITUTE DIAGNOSTICS DAVE D SMITH
K962403 09/06/1996 NOBLEPHARMA WIDE ACCESSORIES NOBELPHARMA USA, INC. MARY EDWARDS
K962542 09/24/1996 AIR MOTOR HANDPIECE TN-102 NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K962543 09/11/1996 ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K962540 09/12/1996 E-TYPE CONTRA ANGLE NAC-E NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K960836 09/12/1996 DMS-9000 O.R. SOLUTIONS, INC. MARK LICATA
K950264 09/27/1996 MAGLIFE ODAM STEVEN CLARKE
K960964 09/27/1996 OHMEDA 7900 ANESTHESIA VENTILATOR OHMEDA MEDICAL CHARLES MORREALE
K962806 09/20/1996 OHMEDA-OHIO CAE PLUS INCUBATOR OHMEDA MEDICAL ALBERTO F PROFUMO
K963033 09/09/1996 BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES OLYMPUS AMERICA, INC. BARRY E SANDS
K961048 09/16/1996 OLYMPUS MH-246R BALLOON SHEATH OLYMPUS AMERICA, INC. BARRY E SANDS
K961176 09/04/1996 "OMNI COLD GEL PACKS" OMNI THERM, INC. MATT WALTERS
K955788 09/04/1996 IMNI HOT PACKS OMNI THERM, INC. MATT WALTERS
K963157 09/18/1996 ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) ORATEC INTERVENTIONS, INC. HUGH SHARKEY
K962104 09/11/1996 AIRLIFT BALLOON RETRACTON SYSTEM ORIGIN MEDSYSTEMS, INC. ANTHONY DURSO
K962448 09/19/1996 PRIMALOC CEMENTED HIP SYSTEM ORTHO DEVELOPMENT CORP. MICHELLE M PERRY
K962646 09/23/1996 PRIME MODULAR ENDO HEAD ORTHOPAEDIC INNOVATIONS, INC. CAROLYN M STEELE-HUSTEN
K960647 09/17/1996 OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS OSTEOIMPLANT TECHNOLOGY, INC. JOHN A ROBERTS
K962741 09/06/1996 TRI-PHASIX CHROMATIC ALGINATE PARKELL, INC. NELSON J GENDUSA
K962460 09/16/1996 EG-3800T, VIDEO GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K962274 09/12/1996 UNICAP 100 PHARMACIA, INC. KAREN E MATIS
K960192 09/12/1996 POSITRON COINCIDENCE DETECTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. NORMAN J YAGER
K960865 09/20/1996 STEP OPTION TO PRISM 2000 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. NORMAN J YAGER
K961420 09/10/1996 PROSTYLE COMPACT PLANMECA OY LARS MORING
K962991 09/12/1996 BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER POLYMEDICA INDUSTRIES, INC. JULIE CHAFFEE
K952975 09/25/1996 ANKLE CALF EXERCISER PHLEBOPUMP PREVENT PRODUCTS, INC. CAROL GARCIA
K960851 09/17/1996 THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR PRO-TECH SERVICES, INC. ANTHONY ZARAGOZA
K960055 09/30/1996 MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 PUDENZ-SCHULTE MEDICAL RESEARCH CORP. TOM HOLDYCH
K962747 09/30/1996 PULPDENT ENDODONTIC POST CEMENT KIT PULPDENT CORP. KENNETH J BERK
K962383 09/03/1996 PULPDENT RESILUTE II PULPDENT CORP. KENNETH J BERK
K961053 09/04/1996 SERAQUEST RUBELLA IGG QUEST INTL., INC. ROBERT A CORT
K955002 09/13/1996 MAHURKAR 8 FR DUAL LEMEN CATHETER QUINTON, INC. LYNN LAYMAN-SPILLAR
K962425 09/11/1996 BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) RADI MEDICAL SYSTEMS AB PER EGNELOV
K962313 09/11/1996 MODIFIED LEVEEN NEEDLE ELECTRODE RADIOTHERAPEUTICS CORP. COLIN J NICHOLS
K962441 09/18/1996 PROSPORE(STEARO FOR STEAM STERILIZER) RAVEN BIOLOGICAL LABORATORIES, INC. KERRIE GROFF
K961046 09/18/1996 10B ARGININE BROTH REMEL, L.P. MARY ANN SILVIUS
K953930 09/30/1996 VIRTUOSO SMART CPAP SYSTEM RESPIRONICS, INC. RICHARD G CONFER
K962439 09/03/1996 DERMAPLEX HYDROGEL WOUND DRESSING (2"X2",4"X4",4"X8",6"X10") RICHARD HAMER ASSOC., INC. RICHARD A HAMER
K961674 09/27/1996 ROCHE UNIMATE FRUCTOSAMINE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC. MARIA FEIJOO
K962151 09/18/1996 RYDER LACRIMAL INTUBATIONSET RYDER INTL. CORP. DAN CLARK
K962487 09/09/1996 BREAST TREATMENT AID M200 S. AND H. ENGINEERING, INC. SYDNEY GOLDSTEIN
K962360 09/30/1996 IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES SCIMEDX CORP. GARY LEHNUS
K963006 09/20/1996 SCION SAPHENOUS VEIN HARVESTING SYSTEM SCION INTERNATIONAL, INC. FRANK GOLDFARB
K961985 09/05/1996 ELECT BLOOD GLUCOSE MONITORIG SYSTEM SELFCARE, INC. CAROL A ADILETTO
K962867 09/30/1996 SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES SENSITITRE ALAMAR REBECCA D FIELDS
K960942 09/17/1996 LATEX PATIENT EXAMINATION GLOVE SIAM SEMPERMED CORP. LTD. DON MORRIS
K962927 09/25/1996 IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K963093 09/03/1996 SIREMOBIL COMPACT SIEMENS MEDICAL SOLUTIONS USA, INC. KATHY RUTHERFORD
K960875 09/10/1996 KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT, PH.D.
K963534 09/30/1996 SIGMA DIAGNOSTICS CREATININE REAGENT KIT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K963540 09/27/1996 SIGMA DIAGNOSTICS ELECTROLYTE BUFFER SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K963542 09/27/1996 SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K961580 09/20/1996 PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS SIMS DELTEC, INC. LISA STONE
K962377 09/03/1996 3D-SPINE SKILL TECHNOLOGIES, INC.
K962541 09/17/1996 REFLECTION ACETABULAR REINFORCEMENT RINGS SMITH & NEPHEW RICHARDS, INC. THOMAS L GRAIG
K962462 09/23/1996 MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR SMITH AND NEPHEW DONJOY, INC. DAN W MILLER
K963519 09/27/1996 EUROLINE A-675 SERIS STARKEY LABORATORIES, INC. RICHARD A STROMBERG
K962843 09/18/1996 MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM STARPLEX SCIENTIFIC, INC. MEHDI KARAMCHI
K955577 09/20/1996 ECLIPSE VERSION 3.0 STELLATE SYSTEMS GEORGE PAPAGIANNIS
K962449 09/06/1996 OSTEO COMPACTION KIT STERI-OSS, INC. DON KENNARD
K963078 09/10/1996 STERI-OSS TEMPORARY IMPLANT CEMENT STERI-OSS, INC. DON KENNARD
K960061 09/18/1996 STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE STORZ INSTRUMENT CO. AUDREY SWEARINGEN
K960024 09/20/1996 STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH STORZ INSTRUMENT CO. MICHAEL H SOUTHWORTH
K962800 09/11/1996 STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES STRYKER INSTRUMENTS DIANE DAVIS
K962192 09/03/1996 SUNRISE CURING LAMP SUNRISE TECHNOLOGIES, INC. CAROL KIM
K962961 09/09/1996 SUSTAINED PHONATION SURFACE MOUNT TECHNOLOGY, INC. ROGER ZIMMERMAN
K962616 09/03/1996 SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K962484 09/05/1996 SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) SYNTHES (USA) ANGELA J SILVESTRI
K961522 09/23/1996 KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN SYNVASIVE TECHNOLOGY, INC. MICHAEL G FISHER
K962712 09/10/1996 YSANPOINT) (MENSTRUAL) DIGITAL TAMPON TALBOT S. LINDSTROM TALBOT S LINDSTROM
K962503 09/20/1996 GUGLIELMI DETACHABLE COIL TARGET THERAPEUTICS LARAINE PANGELINA
K961629 09/11/1996 THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST TECO DIAGNOSTICS K C CHEN
K961382 09/25/1996 MT1A THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961384 09/25/1996 MT-2 THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961386 09/25/1996 MT-2A THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961385 09/25/1996 MT-3A THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961387 09/25/1996 MT-X THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961383 09/25/1996 MT1 THE EMERGING TECHNOLOGIES GROUP JACK T KRAUSER
K961410 09/03/1996 DURASIL (MODIFICATION) THE S. F. GROUP, INC. PAULE STIEFLER
K961466 09/12/1996 PERCUTANEOUS INTRODUCER SET THOMAS MEDICAL PRODUCTS, INC. THOMAS J CHAPMAN
K962496 09/03/1996 SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) TISSUE TECHNOLOGIES, INC. JESSE KRAMER, PH.D.
K962890 09/27/1996 CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) TRACE SCIENTIFIC LTD. DAVID JOHNSTON
K961449 09/13/1996 TRACHEOSTOMY TUBES TRACOE-FLEX TRACOE MEDICAL GMBH FRANZ WALDECK, M.D., PH.D.
K961597 09/04/1996 GATED MIBI 3-D EJECTION FRACTION PROCESSING TRIONIX RESEARCH LABORATORY, INC. CHUN B LIM
K961826 09/23/1996 DIGIPAN TROPHY RADIOLOGIE MARIE-PIERRE LABAT-CAMY
K962494 09/20/1996 PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE U.S. BIOMATERIALS CORP. DAPHNA R ARIEL
K962910 09/05/1996 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY UNI-PATCH, INC. THOMAS O MOORE
K962935 09/03/1996 UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE UNIMED SURGICAL PRODUCTS, INC. RONALD R FROEMMING
K955067 09/13/1996 CLEARVIEW C. DIFF A UNIPATH LTD. LOUISE ROBERTS
K962388 09/16/1996 "IN THE EAR" HEARING AID UNIQUE HEARING TECHNOLOGY, INC. LARRY LERITZ
K962043 09/23/1996 AUTO SUTURE MODIFIED VCS CLIP APPLIER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K961771 09/25/1996 AUTO SUTURE SURGIWAND UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K963122 09/06/1996 UNITRON MODEL ICON KR UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K941782 09/10/1996 VENTANA ANTI-CD5 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN TILLSON
K961800 09/11/1996 HEAD MOUNTED DISPLAY VISTA MEDICAL TECHNOLOGIES, INC. DEBBIE IAMPIETRO
K962401 09/03/1996 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
K961628 09/05/1996 MINI FLEX COIL W.L. GORE & ASSOCIATES,INC KEN DAVIS
K961625 09/10/1996 QUATROLOC FEMORAL COMPONENT & HEAD WHITESIDE BIOMECHANICS, INC. MICHAEL C WALL
K962267 09/10/1996 PERFECTA PS REVISION STEM WRIGHT MEDICAL TECHNOLOGY, INC. CRISITIE MANUEL
K960087 09/20/1996 SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) WRIGHT MEDICAL TECHNOLOGY, INC. JUDY ENGLISH
K961572 09/17/1996 VERSALOK SCREW ASSEMBLY (PROPOSED NAME) WRIGHT MEDICAL TECHNOLOGY, INC. JUDY ENGLISH
K960785 09/03/1996 LFS LIPOGEL ASSAY KIT ZAXIS, INC. KENNETH W EGGER
K962561 09/25/1996 SUPRACONDYLAR INTRAMEDULLARY NAIL ZIMMER, INC. LYNETTE WHITTAKER
K962692 09/19/1996 ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE ZOMED INTL. THOMAS C WEHMAN, PH.D.,CQE, CQA


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