FDA 510(k) Decisions During August, 1995  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K945660 08/11/1995 AUTOJECT 2 *OWNE MUMFORD USA, INC.** ROBERT E SHAW
K953543 08/23/1995 3M MODEL 8200P MULTIPRO BTE 3M COMPANY JOYCE K EYERLY
K944711 08/25/1995 W&H AIR MOTOR A25 A-DEC, INC. PATRICK RIDENOUR
K944714 08/25/1995 W&H CORSAIR SCALER A-DEC, INC. PATRICK RIDENOUR
K944713 08/28/1995 W&H MICRO AIR MOTOR LT25 A-DEC, INC. PATRICK RIDENOUR
K944712 08/25/1995 W&H MICRO MOTOR E25 (WITHOUT LIGHT) A-DEC, INC. PATRICK RIDENOUR
K953223 08/15/1995 PIPERACILIN TAZOBACTAM 4 UG AB BIODISK ANN BOLMSTROM
K945571 08/14/1995 ABBOTT TEST PACK STREP A TEST ABBOTT LABORATORIES MARY SPIEWAK
K953094 08/24/1995 AXSYM ACETAMINOPHEN ABBOTT LABORATORIES DOUG KENTZ
K951289 08/02/1995 AXSYM COCAINE METABOLITE ABBOTT LABORATORIES DOUG KENTZ
K951290 08/08/1995 AXSYM SALICYLATE ABBOTT LABORATORIES DOUG KENTZ
K953016 08/24/1995 AXSYM THEOPHYLLINE II ABBOTT LABORATORIES GRACE LEMIEUX
K951636 08/01/1995 IMX TOXO IGG ABBOTT LABORATORIES JOANNE RUPPRECHT
K951510 08/25/1995 ACE BONE SCREW TACKING KIT ACE SURGICAL SUPPLY CO., INC. J. E CARCHIDI
K953034 08/29/1995 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) ACKRAD LABORATORIES BERNARD ACKERMAN, PH.D.
K951116 08/11/1995 ACROMED PEDICLE SCREW ACROMED CORP. GREGORY CANNEDY
K951657 08/21/1995 VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) ACROMED CORP. GREGORY CANNEDY
K953459 08/23/1995 ACUFEX TAG ANCHOR ACUFEX MICROSURGICAL, INC. FREDERICK TOBIA
K951740 08/11/1995 INTRAMEDULARY FIXATION ROD ACUMED, INC. SHARI L JEFFERS
K952444 08/07/1995 SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA ADJACENT SURGICAL, INC. SHELLY Y MONFORT
K952353 08/10/1995 EZ-COMP ADM, INC. ROBERT W BAUER
K952205 08/04/1995 ACS POWERBASE GUILDING CATHETER ADVANCED CARDIOVASCULAR SYSTEMS, INC. MARTHA REITMAN
K952213 08/09/1995 ALCON SERIES 20000 LEGACY PHACOEMULSIFIER ALCON LABORATORIES DAVID KRAPF
K943516 08/31/1995 ROTACHROM HBPM/LMWH TEST KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC B LE
K943515 08/31/1995 ROTACHROM HEPARIN TEST KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC B LE
K952333 08/10/1995 PLASMA ARC CURING SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. MICHAEL YESSIK
K953481 08/16/1995 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. MARTINE D SCHNEIDER
K950825 08/28/1995 AM-YAG AMERICAN LASERS, INC. DAVID K QUON
K951232 08/25/1995 EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM AMERICAN MEDICAL ELECTRONICS, INC. MARY BIGGERS
K952348 08/21/1995 OGDEN ANCHOR AMERICAN MEDICAL ELECTRONICS, INC. MARY BIGGERS
K952331 08/16/1995 AOI LC-40 PHACOEMULSIFIER AMERICAN OPTISURGICAL, INC. GLENN A DUNKI-JACOBS
K953069 08/31/1995 AMERIMED AS110 AMERIMED SYSTEMS L.C. DARRELL R BRANHAGEN
K952112 08/11/1995 AMIGO GRAND TOUR AMIGO MOBILITY INTL., INC. ANDREA J LUPO
K945766 08/07/1995 HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES ANSELL, INC. KAY SMITH
K952841 08/18/1995 THE ASSISTANT APPLE MEDICAL CORP. SCOTT E COLERIDGE
K946140 08/28/1995 PRG BUTTON APPLIED MEDICAL TECHNOLOGIES DONNA BRESSAN
K952583 08/24/1995 AQUISEN AQUINTEL, INC. ROBERT K MITCHINER
K950255 08/24/1995 ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM ARGUS MEDICAL CO., INC. WILLIAM MEYER
K930665 08/28/1995 CENTURY BATHING SYSTEM ARJO-CENTURY, INC. JAMES L KADOW
K945229 08/08/1995 ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS ARROW INTL., INC. THOMAS D NICKEL
K952924 08/18/1995 ADI CATHETER WITH VALVE ASIA DYNAMICS, INC. CHRISTI GERARD
K953501 08/28/1995 ADI STERILE GAUZE SPONGES ASIA DYNAMICS, INC. CHRISTI GERARD
K953007 08/21/1995 EXCALIBUR PLUS ELECTROSURGICAL UNIT ASPEN LABORATORIES, INC. CHARLES M HART
K950416 08/29/1995 BAIR HUGGER MODEL 600 UNIT, BLANKETS AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K945965 08/02/1995 ATRAUMATIC PENCIL POINT SPINAL NEEDLE AVID N.I.T., INC. JOSEPH E HARMS
K945940 08/07/1995 COATEST(R) APC(TM) RESISTANCE AXIS-SHIELD DOC AS RONALD G LEONARDI
K936024 08/22/1995 ULTRASOUND SCANNER 2001 B & K MEDICAL A/S VILLY BRAENDER
K950882 08/17/1995 BRAUN SELECTIVE ANGIOGRAPHIC CATHETER B. BRAUN MEDICAL, INC. BARBARA ATZENHOEFER
K951949 08/11/1995 CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA. BAXTER HEALTHCARE CORP. VICKI L DREWS
K951413 08/18/1995 FOGARTY-HYDRAGRIP SURGICAL CLAMPS BAXTER HEALTHCARE CORP. NICOLE M CLARK
K950680 08/23/1995 INFANT HEEL WARMER BAXTER HEALTHCARE CORP. NICOLE M CLARK
K951529 08/04/1995 V. MUELLER OBSTETRICAL (OB) FORCEPS BAXTER HEALTHCARE CORP. NICOLE M CLARK
K944931 08/29/1995 BECTON DICKINSON BLUNT STEEL CANNULA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREG W MORGAN
K952568 08/08/1995 BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT BECKMAN INSTRUMENTS, INC. DON W HART
K952180 08/17/1995 CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS BECKMAN INSTRUMENTS, INC. DON W HART
K950057 08/22/1995 TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS ANNA M LONGWELL
K953455 08/23/1995 OPUS B12 BEHRING DIAGNOSTICS, INC. SHEILA KEADY
K953160 08/24/1995 OPUS T3 BEHRING DIAGNOSTICS, INC. SHEILA KEADY
K953097 08/24/1995 OPUS T4 CONTROLS BEHRING DIAGNOSTICS, INC. NANCY M JOHANSEN
K952526 08/14/1995 CUTINOVA CAVITY BEIERSDORF, INC. ELIZABETH H ANDERSON
K952546 08/07/1995 SILON SILICONE TEXTILE COMPOSITE BIO MED SCIENCES, INC. MARK E DILLON
K950598 08/23/1995 BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT BIO-INTERFACES, INC. JOHN F KAY
K951594 08/22/1995 BIO-LOGIC AUTOMATIC EVENT ANALYSIS BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K952817 08/01/1995 BIO-RAD URINARY 5-HIAA BY HPLC BIO-RAD JOHN W NELSON
K951321 08/24/1995 RADIAS NEONATAL T4 ENZYME IMMUNOASSAY BIO-RAD TREVOR WALL
K950227 08/15/1995 RUBELISA (RUBESTAT) BIO-WHITTAKER, INC., A CAMBREX CO. LEIF E OLSEN
K953064 08/07/1995 BIOACCESS MARROW HARVEST SYSTEM BIOACCESS, INC. PETER J CARNES
K952118 08/07/1995 ELMER BIOLOGICAL TECHNOLOGY CORP. ANDREW KIMMEL
K952732 08/31/1995 MEDICAL GRADE SILICONE BLOCK BIOPLEXUS CORP. JEFF S SCHLEUNING
K952274 08/29/1995 CHEMOGUARD, P2 HIRISK BIOSAFETY SYSTEMS, INC. DANIEL J KUN
K952471 08/07/1995 BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD BIOSCIENCE, INC. JONATHAN S KAHAN
K950897 08/24/1995 BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) BIOSYSTEMS JANE E RUBINSTEIN
K950898 08/24/1995 BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) BIOSYSTEMS JANE E RUBINSTEIN
K943185 08/14/1995 BX-200 SC BLOOMEX INTERNATIONAL, INC. BENJAMIN LAROUX
K942195 08/14/1995 BX-400S BLOOMEX INTERNATIONAL, INC. BENJAMIN LAROUX
K941084 08/14/1995 SUNGLASSES BLUE GEM SUNGLASSES, INC. DAVID WEINSTEIN
K951331 08/11/1995 ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR BOEHRINGER MANNHEIM CORP. MIKE FLIS
K951887 08/24/1995 ADVANTAGE TEST STRIPS BOEHRINGER MANNHEIM CORP. MICHAEL FLIS
K952839 08/24/1995 BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K952221 08/11/1995 BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 BOSTON SCIENTIFIC CORP. LEO BASTA
K952968 08/10/1995 DILATATION CATHETER, BALLOON BOSTON SCIENTIFIC CORP. LORRAINE M HANLEY
K953338 08/02/1995 INJECTION NEEDLE BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K952828 08/18/1995 MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM BOSTON SCIENTIFIC CORP. CHRISTINE M HARRIS
K953119 08/28/1995 BOSWORTH RESIN II BOSWORTH CO. MILDRED M GOLDSTEIN
K952948 08/16/1995 SALINE DRESSING BUSSE HOSPITAL DISPOSABLES, INC. EILEEN RAMA
K951273 08/08/1995 BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER BUXTON MEDICAL SERVIC CORP. CARL B NEWMAN
K952268 08/11/1995 MODEL DELTA, OM OXYGEN CONCENTRATOR CAIRE, INC. LINDA CHJAPMAN
K952405 08/28/1995 CITRACE HOSPITAL GERMICIDAL DEODORIZER CALTECH INDUSTRIES, INC. DON JOHNSON
K952336 08/28/1995 DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH CALTECH INDUSTRIES, INC. DDONALD JOHNSON
K951512 08/07/1995 PRECISE HOSPITAL FOAM CLEANER DISINFECTANT CALTECH INDUSTRIES, INC. DONALD JOHNSON
K950155 08/02/1995 RAPID-TRAK(TM) INTRODUCER SHEATH CARDIO VASCULAR CONCEPTS, INC. JAY LENKER
K953658 08/21/1995 CORSSFIRE PLUS CARDIOGENES ANN-MARIE DE MERLIER
K953424 08/11/1995 ECLIPSE 3200 CARDIOGENES ANNE-MARIE DEMERLIER
K952562 08/29/1995 CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE CARDIOMETRICS, INC. MICHAEL J BILLIG
K945693 08/17/1995 CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER CARDIOVASCULAR DYNAMICS, INC. MICHAEL CROCKER
K952894 08/14/1995 VISULINK 900 ARGON CARL ZEISS, INC. KENNETH M NICOLL
K953473 08/07/1995 SUNGLASSES (NON-PRESCRIPTION) CBI DIST. JOANNE BALICE
K953031 08/22/1995 ZEIMER SELF TONOMETER CDS TECHNOLOGIES GEORGE JOST
K945188 08/02/1995 CEMAX VIPSTATION AND/OR SOFTWARE CEMAX, INC. DOUGLAS A MERK
K951020 08/28/1995 TRI-CEN GERMICIDAL DETERGENT CENTRAL SOLUTIONS, INC. GARY W HELTON
K951414 08/11/1995 CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR CHAMPION MFG. CORP. W J CHAMBERLAIN
K952501 08/24/1995 TOX PERFECT B TUBES AND REAGENTS CHIMERA RESEARCH & CHEMICAL, INC. CHARLES A HAY
K953020 08/02/1995 ACS GENTAMICIN CIBA CORNING DIAGNOSTICS CORP. STEVEN R RAKITIN
K946265 08/24/1995 FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 CLINICAL CONTROLS, INC. JAMES F GODFREY
K952327 08/25/1995 SMARTSAT PULSE OXIMETRY ANALYZER CLINICAL DYNAMICS CORP. LEO F COSTELLO, JR.
K924408 08/22/1995 COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE COLLA-TEC, INC. JUDITH E O'GRADY
K952407 08/07/1995 REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER CONTOUR FABRICATORS OF FLORIDA, INC. SCOTT WILLIAMS
K952406 08/07/1995 REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION CONTOUR FABRICATORS OF FLORIDA, INC. SCOTT WIL;LIAMS
K952396 08/15/1995 REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION CONTOUR FABRICATORS OF FLORIDA, INC. SCOTT WILLIAMS
K952395 08/15/1995 REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION CONTOUR FABRICATORS OF FLORIDA, INC. SCOTT WILLIAMS
K952208 08/15/1995 PROSYS LEG BAG CONVATEC, A DIVISION OF E.R. SQUIBB & SONS MARILYN DREYLING
K953024 08/18/1995 LINDNER/GOLOMB SP INTRODUCING SOUND COOK UROLOGICAL, INC. TAMMY BACON
K952185 08/02/1995 CORDIS BRITE TIP, ENVOY GUIDING CATHETER CORDIS CORP. KEVIN MACDONALD
K952874 08/21/1995 TRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARLENE WRIGHT VALENTI
K950910 08/08/1995 TRANSIT-2 INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARLENE W VALENTI
K951314 08/08/1995 TRUEFILL PVA PARTICLES CORDIS NEUROVASCULAR, INC. MARLENE W VALENTI
K952241 08/07/1995 PROTOUCH OVERGLOVE COTTRELL, LTD. FRANK S CASCIANI
K950742 08/25/1995 CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT COULTER CORP. BENITA B BOURQUE
K951227 08/11/1995 DX1 CREATIVE BIOMEDICS, INC. DANIEL BROWN
K951157 08/11/1995 DX1-PORTABLE CREATIVE BIOMEDICS, INC. DANIEL BROWN
K950684 08/16/1995 CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER CYNOSURE, INC. GEORGE CHO
K952698 08/14/1995 ENDOCARE ELECTROSURGICAL HANDPIECE CYTOCARE, INC. PAUL MIKUS
K944961 08/07/1995 PERSONAL ALARM SYSTEM (PAS) CYTOPROBE CORP. JOHN ZABSKY
K936307 08/14/1995 DYNA-LOK ANTERIOR PLATING SYSTEM DANEK GROUP, INC. RICHARD W TREHARNE,PH.D
K946161 08/23/1995 DMA TOTAL CHOLESTEROL PROCEDURE DATA MEDICAL ASSOCIATES, INC. C H MORRIS
K953425 08/21/1995 POLYETHYLENE TEREPHTHALATE (PET) PLEDGET DAVIS & GECK, INC. LYNNE A NEWQUIST
K953289 08/21/1995 TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET DAVIS & GECK, INC. LYNNE A NEWQUIST
K924695 08/24/1995 ASEPTECH PORTABLE RO+ SYSTEM DAYTON WATER SYSTEMS DIANE DOLAN
K953344 08/25/1995 DEGUBOND ULTRA DEGUSSA AG HOLGER MEINICKE
K950020 08/17/1995 HOLTER PACERCORDER(R) DEL MAR AVIONICS RAPHAEL HENKIN
K951299 08/29/1995 EASY PNEUMATIC CROWN AND BRIDGE REMOVER DENTCO, INC. PATRICK J LAMB
K952740 08/18/1995 DEPUY DURALOC 400 ACETABULAR CUP DEPUY, INC. CHERYL HASTINGS
K934552 08/09/1995 PERIPUMP DESCHUTES MEDICAL PRODUCTS, INC. MATTHEW W HOSKINS
K946095 08/24/1995 DEVILBISS MODEL 5500 DEVILBISS HEALTH CARE, INC. BARRY IDDON
K953243 08/28/1995 LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH DEVMED GROUP, INC. GREG WIITA
K953206 08/28/1995 DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) DHD DIEMOLDING HEALTHCARE DIV. JEAN WALLACE
K950112 08/16/1995 CENTRALITE(R)-DLL SERIES DIACOR, INC. GLENN N WATERMAN
K953014 08/15/1995 ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D
K952596 08/11/1995 THEOPHYLLINE ENZYME IMMUNOASSAY DIAGNOSTIC REAGENTS, INC. YUH-GENG TSAY
K952664 08/07/1995 SOLUTION ADMINISTRATION SET DISTRONIC STERILE PRODUCTS, INC. JOYCE MCDOUGALL
K953450 08/07/1995 CURASOL GEL WOUND DRESSING DPT LABORATORIES, LTD. RICHARD A HAMER
K953816 08/28/1995 DCURASOL GEL WOUND DRESSING DPT LABORATORIES, LTD. RICHARD A HAMER
K943531 08/25/1995 OXYLOG 2000 DRAGER, INC. HARALD KNEUER
K950920 08/11/1995 DUPONT DIMENSION TOTAL PROTEIN METHOD DUPONT MEDICAL PRODUCTS CATHY P CRAFT
K952815 08/31/1995 DUPONT LIPASE CALIBRATOR DUPONT MEDICAL PRODUCTS CAROLYN K GEORGE
K953540 08/25/1995 EEE EDENTEC CORP. CHRIS HADLAND
K952363 08/15/1995 OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) ELA MEDICAL, INC. CAHTERINE GOBLE
K953052 08/15/1995 AM 260 K-AMP ELECTONE, INC. JIM NEE
K953054 08/15/1995 AM 260 OHM ELECTONE, INC. JIM NEE
K953053 08/15/1995 AM 260 PP ELECTONE, INC. JIM NEE
K953047 08/22/1995 Z20 ELECTONE, INC. JIM NEE
K953048 08/15/1995 Z22 ELECTONE, INC. JIM NEE
K953049 08/15/1995 Z24 ELECTONE, INC. JIM NEE
K953050 08/22/1995 Z33 ELECTONE, INC. JIM NEE
K953051 08/15/1995 Z35 ELECTONE, INC. JIM NEE
K953026 08/28/1995 MINIPIEZON ELECTRO MEDICAL SYSTEMS SA STEVEN CLARKE
K951531 08/24/1995 SWISS LITHOCLAST LITHOTRIPTER ELECTRO MEDICAL SYSTEMS SA JAMES R VEALE
K952110 08/14/1995 ELMED THERMO-FLUX ELMED, INC. WERNER HAUSNER
K953510 08/09/1995 HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS ENCORE ORTHOPEDICS, INC. J.D. WEBB
K952671 08/18/1995 RATESAVER PLUS ENTRACARE CORP. AL BOEDEKER
K945873 08/18/1995 HYPEX(TM) JET INJECTOR EQUIDYNE SYSTEMS, INC. JAMES BARLEY
K950493 08/07/1995 PHOTODERM VL. ESC, ENERGY SYSTEMS CORP. LYNN GOLUIMBIC
K953374 08/18/1995 PERMADYNE GARANT 2:1 ESPE GMBH & CO. KG. BARBARA WAGNER
K952693 08/18/1995 RAMITEC PENTA ESPE GMBH & CO. KG. BARBARA WAGNER
K952758 08/07/1995 GOUVERNEUR AUDIGIER ETS GOUVERNEUR-AUDIGIER GUSTAV M HEIMBUCHER
K945374 08/09/1995 ACU-HALT EVA-HEALTH USA, INC. CAL H RIFKIN
K952430 08/18/1995 FINESSE GUIDEWIRE CORONARY FLEXMEDICS DEBRA K FRITZ
K944305 08/28/1995 FRIEDRICH ELECTRONIC AIR CLEANER FRIEDRICH AIR CONDITIONING CO., INC. TERRY LEIBY
K953066 08/14/1995 SERODIA ATG FUJIREBIO AMERICA, INC. ROBERT SCJOFF
K944492 08/28/1995 DIALYZER REPROCESSING SYSTEM G.E.M. WATER SYSTEMS JACK ENKOWITZ
K945504 08/18/1995 ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE GANZ INDUSTRIES SDN. BHD.
K945505 08/18/1995 ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE GANZ INDUSTRIES SDN. BHD.
K945730 08/09/1995 SIGNA PROFILE GE MEDICAL SYSTEMS LARRY A KROGER
K952617 08/07/1995 BIO-OSS GEISTLICH-PHARMA PETER S REICHERTZ
K952618 08/28/1995 BIO-OSS GEISTLICH-PHARMA PETER S REICHERTZ
K952619 08/28/1995 BIO-OSS CERAMIC GEISTLICH-PHARMA PETER S REICHERTZ
K952278 08/07/1995 THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA GENERAL SURGICAL INNOVATIONS THERESA NAZAROFF
K952971 08/11/1995 DIA SCREEN REAGENT STRIPS GENESIS LABS, INC. JOHN MURRAY
K953491 08/25/1995 HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE GIBECK, INC. BRIAN GRIGSBY
K953544 08/25/1995 HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT GIBECK, INC. BRIAN GRIGSBY
K944721 08/11/1995 9000 INFUSION PUMP GRASEBY MEDICAL LTD. J WEYMAN
K941198 08/23/1995 EBV LGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K932333 08/15/1995 PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR GULL LABORATORIES, INC. FRED W RACHFORD
K941624 08/04/1995 RUBELLA IGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD, PH.D.
K941046 08/24/1995 VZV IGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD, PH.D
K950098 08/11/1995 NEEDLE SAFETY COVER HAMMER-PLANE, INC. DAVID DELAPLANE
K945480 08/28/1995 MOSS(R) STEEL BREAKAWAY(R) INTRODUCER HARRY A. SCHLAKMAN HARRY A SCHLAKMAN
K944724 08/30/1995 HEALTH IMAGE INC. HI STAR HEALTH IMAGES, INC. RICHARD E HALBACH
K952253 08/24/1995 ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT HELIX DIAGNOSTICS, INC. VIRGINIA L CAPPEL
K952734 08/08/1995 HENNERT SA HENNERT S.A. VERONIQUE DAMAR
K952173 08/11/1995 HEWLETT-PACKARD MODEL M1264B CATHSTATION HEWLETT-PACKARD CO. ROB BUTLER
K950120 08/11/1995 SMART PLUG HGM, INC. C L CHRISTMAN
K952468 08/24/1995 HI-LINE MEDICAL PHACOEMULSIFIER TIP HI-LINE MEDICAL GLENN A DUNKI-JACOBS
K951751 08/02/1995 HICHEM AST REAGENT KIT HICHEM DIAGNOSTICS WYNN STOCKING
K946186 08/14/1995 CHAL-2500 HOGAN & HARTSON HOWARD M HOLSTEIN
K953232 08/18/1995 HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE HOLLISTER, INC. JOSEPH S TOKARZ
K941362 08/30/1995 BONE MINERAL DENSITOMETER HOLOGIC, INC. ERIC V STETTEN,PH.D
K945807 08/07/1995 HOMEVUE WOUND MONITORING SYSTEM HOMEVUE HEALTH SYSTEMS, INC. STEVEN C MILLER
K951814 08/29/1995 TRIUMPH-1 PORT HORIZON MEDICAL PRODUCTS, INC. RODDY J. H CLARK
K953619 08/25/1995 WARM N WET HME W/LUER ADAPTER HOSPITAK, INC. WILLIAM LACCY
K953620 08/25/1995 WARM N WET HMEF W/LUER ADAPTER HOSPITAK, INC. WILLIAM LACCY
K936008 08/09/1995 DURACON BASEPLATES HOWMEDICA CORP. ROBERT E SMITH
K953067 08/21/1995 HIP FRACTURE STEM FENESTRATION PLUG HOWMEDICA CORP. MARY C SPICER
K934060 08/18/1995 HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE HOWMEDICA CORP. ROBERT E SMITH
K936292 08/18/1995 PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS HOWMEDICA CORP. ROBERT E SMITH
K953009 08/11/1995 FORMULATION HWS-128 EPA REG. NO. 47371-130 HUNTINGTON LABORATORIES, INC. SALLY HAYES
K953010 08/11/1995 FORMULATION HWS-256 EPA REG. NO. 47371-129 HUNTINGTON LABORATORIES, INC. SALLY HAYES
K953011 08/11/1995 FORMULATION HWS-64 EPA REG. NO. 47371-131 HUNTINGTON LABORATORIES, INC. SALLY HAYES
K950194 08/25/1995 TAMPON, UNTREATED HYGIEIA HEALTHCARE LTD. P BRENIKOV
K952760 08/18/1995 FIXED FLOW RATE GRAVITY ADMINISTRATION SETS I-FLOW CORP. ROBERT J BARD
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K945773 08/07/1995 SIEMENS SONOLINE VERSA SIEMENS MEDICAL SOLUTIONS USA, INC. STEVE HESLER
K951584 08/11/1995 ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K953387 08/09/1995 ECTRA LIGAMENT RELEASE SYSTEM SMITH & NEPHEW DYONICS, INC. ELIZABETH A RYAN
K950093 08/15/1995 AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES SMITH & NEPHEW RICHARDS, INC. JEFF COBB
K951987 08/22/1995 GENESIS II TOTAL KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC. THOMAS L CRAIG
K946088 08/08/1995 GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC. THOMAS L CRAIG
K951771 08/11/1995 COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM SMS TECHNOLOGIES, LTD. ALAN WENMAN
K950596 08/28/1995 GDLH POSTERIOR SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K950955 08/25/1995 PARAGON POSTERIOR SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K946348 08/07/1995 TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K950389 08/15/1995 SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR SORBA MEDICAL SYSTEMS, INC. JILL BARNEY
K952270 08/21/1995 DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN SORIN BIOMEDICAL, INC. SHARON THOMPSON
K945429 08/15/1995 SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) SPACELABS MEDICAL, INC. RUSS GARRISON
K942863 08/11/1995 EPIDURAL NEEDLE SPINAL SPECIALTIES, INC. ROBERT KEAHNEY
K952708 08/28/1995 PECTORALIS IMPLANT SPIRIT RIDGE TECHNOLOGIES KATHTY RICHARDSON
K952709 08/28/1995 PROTHESIS, CHIN, INTERNAL SPIRIT RIDGE TECHNOLOGIES KATHY RICHARDSON
K952707 08/28/1995 SILICONE ELASTOMER MALAR IMPLANT SPIRIT RIDGE TECHNOLOGIES KATHY RICHRDSON
K952705 08/28/1995 SPIRIT RIDGE NASAL IMPLANT SPIRIT RIDGE TECHNOLOGIES KATHY RICHARDSON
K952706 08/28/1995 SPIRIT RIDGE SILICONE CARVING BLOCK SPIRIT RIDGE TECHNOLOGIES KATHY RICHARDSON
K953169 08/08/1995 STELKAST ALL POLYETHYLENE ACETABULAR CUP STELKAST COMPANY DONALD A STEVENS
K953103 08/29/1995 LAPPING TOOL KIT STERI-OSS, INC. PAUL GASSER
K953078 08/07/1995 STORZ DP4101 BASIC I/A PACK STORZ INSTRUMENT CO. MICHAEL H SOUTHWORTH
K950824 08/25/1995 STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS STRYKER CORP. TAMMY LOUNDS
K944393 08/28/1995 STRYKER STERI-SHIELD SURGICAL APPAREL STRYKER CORP. TAMMY LOUDS
K943100 08/10/1995 STRYKER OPERATING LAPAROSCOPE STRYKER ENDOSCOPY LARRY VOSS
K953071 08/08/1995 STRYKER COMMAND2 OFFICE CONSOLE STRYKER INSTRUMENTS TAMMY LOUNDS
K952216 08/18/1995 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 SURGICAL LASER TECHNOLOGIES, INC. RICHARD G JONES
K952566 08/31/1995 OSCILFLATOR SURGICAL TECHNOLOGIES, INC. JOHN E LINCOLN
K951442 08/24/1995 FLOLAB SYNECTICS MEDICAL, INC. ANNA PETTERSSON
K953395 08/31/1995 SYNERMED CALCIUM REAGENT KIT SYNERMED, INC. MARCIA J ARENTZ
K951626 08/21/1995 SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM SYNTHES (USA) DIANE T BROWN
K951794 08/21/1995 SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) SYNTHES (USA) DIANE T BROWN
K952296 08/18/1995 SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW SYNTHES (USA) ANGELA J SILVESTRI
K943725 08/25/1995 UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM SYNTHES SPINE DIANE BROWN
K935554 08/30/1995 QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY SYNTRON BIORESEARCH, INC. JAMES P LEE, PH.D.
K935475 08/30/1995 QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU SYNTRON BIORESEARCH, INC. JAMES P LEE
K950009 08/18/1995 POWERGRIP(TM) COMPRESSION FIXATION DEVICE SYNVASIVE TECHNOLOGY, INC. GARY A SEEGER
K951892 08/17/1995 ONE STEP URINE DRUG OF ABUSE COCAINE TEST TCPI, INC. CLECE W LAIRD
K952096 08/17/1995 ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) TCPI, INC. CLEVE W LAIRD
K952422 08/29/1995 ELASTIC IMPRESSION CREAM TELEDYNE WATER PIK CODY RILEY
K943861 08/15/1995 CAPIOX SP PUMP HEAD TERUMO CORP. SANDI HARTKA
K942200 08/07/1995 ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS THANTEX SPECIALTIES, INC. THOMAS BONNER
K953207 08/01/1995 HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) THE BINDING SITE, LTD. JAY GELLER
K952457 08/23/1995 RAPID-FOAM THE SOULE CO., INC. JERRY FLATT
K950290 08/24/1995 MEDI - PUMP THOMAS INDUSTRIES DAN PFISTER
K951729 08/21/1995 MEDI - PUMP THOMAS INDUSTRIES DAN P FISTER
K951474 08/18/1995 TLC SURGICAL DRAPES TLC TECH LAB CLOTHES, INC. DAWN ERICKSON-STEVENS
K951623 08/18/1995 TLC SURGICAL GOWNS TLC TECH LAB CLOTHES, INC. DAWN ERICKSON-STEVENS
K932571 08/31/1995 TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 TOMEY CORPORATION USA LORI TRUITT
K953164 08/09/1995 ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MARK STAUFFER
K952226 08/11/1995 C-FLEX SEPTAL SPLINTS TREBAY MEDICAL CORP. DAN H TREACE
K942353 08/15/1995 CENTURION UMBILICAL CATHETER TRI-STATE HOSPITAL SUPPLY CORP. GEORGE J PLUTA
K952041 08/14/1995 BODYFLEX MASSAGER TRURO'S ENT. DEREK PARNELL
K950647 08/15/1995 ULTRACELL NEURO SPONGES ULTRACELL MEDICAL TECHNOLOGIES, INC. GEORGE P KORTEWEG
K953527 08/29/1995 PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS ULTRADENT PRODUCTS, INC. L. M. CHATWIN
K953524 08/24/1995 ULTRA-BLEND ULTRADENT PRODUCTS, INC. L. M. CHATWIN
K953525 08/28/1995 ULTRADENT FLOWABLE COMPOSITE ULTRADENT PRODUCTS, INC. L. M. CHATWIN
K952748 08/10/1995 AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JANET G JOHNSON
K945285 08/21/1995 USSC MONOFILAMENT POLYSORB SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JONATHAN GILBERT
K951520 08/21/1995 USSC POLYSORB SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JONATHAN GILBERT
K953646 08/28/1995 UNITRON MODEL IKON AOHPL UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K940092 08/10/1995 USCI INPUT INTRODUCER SET USCI, DIV. C.R. BARD, INC. JANET D BENSON
K952981 08/28/1995 FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC UTAH MEDICAL PRODUCTS, INC. JOHN W SMITH
K953195 08/21/1995 VALLEYLAB FORCE 300 VALLEYLAB, INC. HERBERT W VINSON
K953737 08/23/1995 VL7600 REM PATIENT RETURN ELECTRODE VALLEYLAB, INC. PEGGY WALLINE
K952313 08/16/1995 VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION VARIAN ASSOC., INC. LUANNE TERMEER
K952907 08/07/1995 EX-111 WOUND DRESSING VARISEAL MANUFACTURING CORP. OWEN M GRANT, JR.
K946075 08/04/1995 VITALOGRAPH MODEL 2120 VITALOGRAPH, INC. GARY CASEY
K933847 08/15/1995 HYS-SURGIFLATOR VP W.O.M. WORLD OF MEDICINE, GMBH E. KEEFER
K914749 08/10/1995 WAVICIDE(R) -01 WAVE ENERGY SYSTEMS, INC. PENNY STAGLIANO
K950429 08/01/1995 VIDEO SIGMOIDOSCOPE WELCH ALLYN, INC. LAWRENCE E MAROCCO
K945047 08/11/1995 BCW 600 POWER WHEELCHAIR WHEELCHAIRS OF KANSAS LEE FRICKEY
K952508 08/25/1995 FLOW-THERME, WISAP #7642 WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH HORST SEMN
K951471 08/09/1995 STRICKLAND TRAPEZIAL IMPLANT WRIGHT MEDICAL TECHNOLOGY, INC. JUDY ENGLISH
K950074 08/11/1995 WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. ROBERT CHURINETZ
K952670 08/25/1995 CUPRALLOY WYKLE RESEARCH, INC. IRIS SHIMABUKURO
K953383 08/29/1995 WYNTEK OSOM HCG-URINE TEST WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K944417 08/01/1995 ZEUA MYCOPLASMA ZEUS SCIENTIFIC, INC. DONALD R TOURVILLE
K935898 08/22/1995 HYDROGUM ZHERMACK DENTAL PRODUCTION EVAN C DICK, PH.D.
K950395 08/18/1995 THERMOCOOL SYSTEM ZIMMER, INC. PAULA OSORIO


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