FDA 510(k) Decisions During August, 1994  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K923889 08/29/1994 "O" BUTMENT ES IMPLANT "O" CO., INC. CONNIE WHITE
K941653 08/24/1994 SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION 3M HEALTH CARE, SARNS JOHN W TOIGO
K941614 08/18/1994 AXSYM TOBRAMYCIN ABBOTT LABORATORIES KATHY ZENG
K941615 08/16/1994 AXSYM VALPROIC ACID ABBOTT LABORATORIES KATHY ZENG
K942566 08/16/1994 IMX ULTRASENSISTIVE HTSH II ABBOTT LABORATORIES JOY C SONSALLA
K941684 08/03/1994 IVEX-2 EXTENSION SET WITH Y-INJECTION SITE ABBOTT LABORATORIES FREDERICK A GUSTAFSON
K936269 08/15/1994 CASPAR TITANIUM ALLOY BONE SCREWS AESCULAP, INC. VICTORIA MACKINNON
K935264 08/10/1994 CHILDREN'S SUNGLASSES AGGLO CORP. LTD. Y C LEE
K925819 08/02/1994 AKCESS0CATH KIT AKCESS MEDICAL PRODUCTS, INC. BALBIR KAPANY
K943330 08/24/1994 ACTION-LIFT CHAIR ALC, INC. JOHN A MAGES
K936121 08/02/1994 THAIRAPY SYSTEM AMERICAN BIOSYSTEMS, INC. PHILIP R ROSE
K942335 08/09/1994 ACI SILICATH THORACIC CATHETER AMERICAN CATHETER GEORGE N HALLACK
K935137 08/15/1994 TEFGEN-FD AMERICAN CUSTOM MEDICAL, INC. BRUCE G RUEFER
K942578 08/19/1994 ENTRAC URETERAL BALLOON DILATATION CATHETERS AMERICAN MEDICAL SYSTEMS, INC. SYLVIA L GUBBE
K941907 08/26/1994 APEX DISPOSABLE INSTRUMENTS APEX ENT., INC. AFTAB AHMED
K943489 08/09/1994 DISPOSABLE SURGICAL TROCAR APPLIED MEDICAL RESOURCES MARY JO STEGWELL
K925193 08/26/1994 AQUACISER II AQUACISER, INC. THOMAS H HOPKINS
K943210 08/01/1994 ARGESOL #1005Y ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943779 08/29/1994 ARGESOL #720 ARGEN PRECIOUS METALS, INC. MANOHAR L MALHOTRA
K943212 08/01/1994 ARGESOL #830Y ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943208 08/01/1994 ARGESOL 750PY ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943211 08/01/1994 ARGESOL 750Y ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943209 08/01/1994 ARGESOL PNP ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943213 08/01/1994 ARGIPLUS LO ARGEN PRECIOUS METALS, INC. MAN0HAR LAL MALHOTRA
K943214 08/01/1994 SOLDER #204 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943264 08/01/1994 SOLDER #205 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943271 08/01/1994 SOLDER #206 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943269 08/01/1994 SOLDER #209 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943266 08/01/1994 SOLDER #210 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K943267 08/01/1994 SOLDER #211 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K941681 08/25/1994 ARTHREX CIRCULAR HARVESTING SAW ARTHREX, INC. LEONARD E BALTZ
K942757 08/01/1994 ASHERMAN CHEST BANDAGE ASHERMAN MEDICAL PRODUCTS, LLC. H. CLAY WILSON
K942818 08/25/1994 DEEP SUTURE AUTOMATED MEDICAL PRODUCTS CORP. GREGORY DIAMANT
K943570 08/24/1994 AVL COMPACT 1 PH/BLOOD GAS ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K942841 08/09/1994 OEC 901 BALDWIN GREGORY J BUDNER
K935987 08/15/1994 FLEXTRANS BAXTER DIAGNOSTICS, INC. NANCY MALLINAK
K943594 08/17/1994 BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS BAXTER HEALTHCARE CORP. ROBERT E OLEWINE
K943605 08/17/1994 BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS BAXTER HEALTHCARE CORP. ROBERT E OLEWINE
K932208 08/09/1994 EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM BAXTER HEALTHCARE CORP. PAUL ZALESKY
K941950 08/11/1994 OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360 BAXTER HEALTHCARE CORP. NICOLE M CLARK
K941225 08/16/1994 UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT BAXTER HEALTHCARE CORP. THOMAS J HUMPHREY
K935267 08/17/1994 B-D DIGITAL THERMOMETER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL J ARNSBERGER
K940697 08/30/1994 BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL J ARNSBERGER
K940905 08/02/1994 MICROTAINER BRAND TUBE WITH EDTA(K2) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL J ARNSBERGER
K943149 08/26/1994 ACCESS RED BLOOD CELL FOLATE ASSAY BECKMAN COULTER, INC. KIM WALKER
K942204 08/26/1994 ARGON CURING LASER BIO-LASER TECHNOLOGY, INC. ROBERT S HEAD
K941532 08/02/1994 BIOCALEX 6/9 BIO-PROBE, INC. SAM ZIFF
K942812 08/01/1994 FLO-RESTER DISPOSABLE VESSEL OCCLUDER BIO-VASCULAR, INC. BRUCE A MACFARLANE, PH.D.
K933549 08/02/1994 VIDAS CMV IGM ASSAY BIOMERIEUX VITEK, INC. VICKI ANASTASI
K932721 08/01/1994 ARTHROTEK SET SCREW BIOMET, INC. PATRICIA S BERES
K935045 08/19/1994 BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER BIOSEARCH MEDICAL PRODUCTS, INC. MARTIN DYCK
K920747 08/29/1994 PESSARY FLEXIBLE SILICONE DONUT RING BIOTEQUE AMERICA, INC. DENIS DORSEY
K941937 08/30/1994 PIKOS E 01-B BIOTRONIK, INC. LAUREN L FOOTE CHRISTENSEN
K924010 08/15/1994 REDINOV PERFUSION SET BIPRESS, INC. ELLEN R WIDOM
K943567 08/10/1994 FACONNABLE EYEWEAR BLINK DESIGNS, INC. BRIAN JABLON
K943568 08/11/1994 FACONNABLE EYEWEAR (SUNGLASSES) BLINK DESIGNS, INC. BRIAN JABLON
K932057 08/05/1994 BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHARLTON
K943737 08/17/1994 MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE BOSTON SCIENTIFIC CORP. JOSEPH J CURTIS
K940838 08/18/1994 MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM BOSTON SCIENTIFIC CORP. SHERI D O'BRIEN
K943191 08/29/1994 MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR BOSTON SCIENTIFIC CORP. CHRISTINE M HARRIS
K935721 08/22/1994 STONE EXTRACTOR BOSTON SCIENTIFIC CORP. LORRAINE M HANLEY
K942154 08/18/1994 SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS BOSTON SCIENTIFIC SCIMED, INC. TRACY MALM
K943326 08/10/1994 SPECTACLE FRAMES BUFFARD-LA-DOYE MARC AST
K942519 08/23/1994 UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS BULL FROG MFG. CO. CHARLES W HUTCHINS
K942438 08/05/1994 ALTAIR 6100 CASSETTE RECORDER BURDICK, INC. PAUL APPEL
K942926 08/03/1994 NEURO-AIDE BURKE NEUTECH, INC. ROBERT E BURKE
K934571 08/01/1994 BVR CONTRA-ANGLE HANDPIECE BVR AERO PRECISION CORP. GARY FREDERICK
K934781 08/05/1994 BVR HIGH TORQUE HEADS BVR AERO PRECISION CORP. GARY FREDERICK
K920757 08/05/1994 FILTRAL HEMODIALYZERS C.G.H. MEDICAL, INC. JEFFREY R SHIDEMAN
K910318 08/18/1994 BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER C.R. BARD, INC. DONNA J WILSON
K925490 08/01/1994 INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM CALCITEK, INC. KIMBERLY M CARLSON
K943364 08/03/1994 CORASSIST WOUND DRESSING CALGON CORP. ANNE SCHMITT
K942270 08/04/1994 SAF-GEL HYDRATING DERMAL WOUND DRESSING CALGON VESTAL DIV. MIKE EBERS
K941979 08/17/1994 VIDEO PLUS WITH ANALYTICAL WORKSTATION CAMTRONICS, LTD. ROBERT KRIEDERMANN
K942150 08/02/1994 CVD SMALL VESSEL BALLOON DILATION CATHETER CARDIO-DYNAMICS, INC. MICHAEL CROCKER
K940984 08/18/1994 CARDIOMETRICS DUALFLOW SWITCH BOX CARDIOMETRICS, INC. SUSAN E OSBORNE
K933320 08/17/1994 CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT CARDIOMETRICS, INC. SUSAN E OSBORNE
K942231 08/01/1994 MICROVIEW II/MICRORAIL II CATHETERS CARDIOVASCULAR IMAGING SYSTEMS, INC. REBECCA ANDERSEN
K943377 08/17/1994 SUNGLASSES (NON-PRESCRIPTION) CAROL WRIGHT SALES DESIREE M ELLIS-VIOLETTE
K941985 08/24/1994 MUELLER HINTON AGAR W/OXACILLIN CARR-SCARBOROUGH MICROBIOLOGICALS, INC. LESLIE C SCARBOROUGH,JR
K942212 08/23/1994 OSTEOGRAF/LD-300 HYDROXYLAPATITE CERAMED CORP. BARBARA WATSON
K913255 08/05/1994 CERAMIC(TM) ABUTMENT CERAMIC CORE CORP. VINCENT PRESTIPINO
K943445 08/26/1994 MEGABEAM FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC. JONATHAN S KAHAN
K943444 08/26/1994 MEGABEAM LATERAL FIRE CERAMOPTEC, INC. JONATHAN S KAHAN
K943526 08/26/1994 MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC. JONATHAN S KAHAN
K931029 08/25/1994 DISPOSABLE CONCENTRIC NEEDLE ELECTRODE CHALGREN ENTERPRISES, INC. RICHARD KAISER
K942042 08/05/1994 POWDER FREE VINYL PATIENT EXAMINATION GLOVES CHEER & MERIT CO., LTD. SUSAN D GOLDSTEIN-FALK
K925606 08/29/1994 OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS CHIRON VISION CORP. CAROL L PATTERSON
K935228 08/01/1994 MODEL 644 SWEAT DILUENT CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K943183 08/04/1994 CIBA VISION(R) CONTACT LENS CASE CIBA VISION CORPORATION CLAY DIXON
K942933 08/25/1994 PRESSURE INFUSION CUFF CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K941111 08/02/1994 STREP-SURE A/E CLINICAL STANDARDS LABORATORIES, INC. JAMES R GREENWOOD, PH.D
K943110 08/19/1994 GAS SAMPLING INTERFACES COAST MEDICAL, INC. DOUGLAS R MONGEON
K933680 08/26/1994 GAMBRO LUNDIA PRO 200 DIALYZER COBE RENAL CARE, INC. JEFFREY R SHIDEMAN
K942203 08/10/1994 OTC DENTURE CLEANSER COMBE, INC. STEPHEN C PENNISI
K943490 08/11/1994 CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES CONTINENTAL SOFT LENS, INC. WALLY STIRLING
K942175 08/17/1994 LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 CONTINENTAL X-RAY CORP. OSCAR KHUTORYANSKY
K935631 08/23/1994 CONBIO MEDALEX LASER SYSTEM CONTINUUM BIOMEDICAL, INC. LAURIE A RIDENER
K943258 08/04/1994 HYDROCOLLOID WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS KAREN HORGAN
K940550 08/17/1994 COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH COOK, INC. APRIL LAVENDER
K942939 08/31/1994 CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM CORDIS CORP. KEVIN MACDONALD
K941464 08/05/1994 "BASICS" ENDOSCOPY SYSTEM COX MEDICAL ENT., INC. LANITA COX
K942284 08/26/1994 CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET CREATIVE LABORATORY PRODUCTS, INC. GARY PROKSCH
K942189 08/09/1994 CRYSTAL EAR CRYSTAL CARE INTL., INC. MICHAEL NEHR
K940518 08/18/1994 C-SECTION TRAY CUSH MEDICAL PRODUCTS STEVE B JOHNSTON
K941781 08/25/1994 RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM DACOMED CORP. MARY M WILEN
K943082 08/04/1994 SPECTACLE FRAME DAEWON OPTICAL CO. PEGGY CHAPLIN
K940178 08/09/1994 PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION DATASCOPE CORP. JOHN PICCIANO
K923172 08/09/1994 ANAESTHESIA RECORD KEEPER DATEX DIVISION INSTRUMENTARIUM CORP. HANNU AHJOPALO
K935477 08/01/1994 AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD DATEX DIVISION INSTRUMENTARIUM CORP. HANNU AHJOPALO
K942528 08/05/1994 INTEGRAPOST DENTAL LOGICS, INC. PHILIP KLEIN
K936151 08/01/1994 EXTRAORAL HEADGEAR DENTAURAUM, INC. JOHN J ROTH, JR.
K942666 08/10/1994 ORTHALGENAT IMPRESSION MATERIAL DENTAURAUM, INC. JOHEN J ROTH
K943574 08/23/1994 CAPTURE IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K940914 08/29/1994 NEW LUTING CEMENT MATERIAL (NLC) DENTSPLY INTL. P. JEFFERY LEHN
K943582 08/29/1994 SOFTWEAR PORCELAIN SYSTEM DENTSPLY INTL. P. JEFFREY LEHN
K942773 08/24/1994 CK-MB ASSAY, CATALOGUE NUMBER 317-10 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K932556 08/02/1994 AMMONIA ASSAY CAT. NO. 200-02 DIAGNOSTIC CHEMICALS, LTD. (USA) KAREN CALLBECK
K936271 08/26/1994 FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE DIAGNOSTIC HYBRIDS, INC. J.L. BROWN
K934318 08/22/1994 DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL DIAGNOSTIC INSTRUMENT CORP. R.M. BENEDICT
K935691 08/01/1994 MODEL GP-252 GENERAL PURPOSE COIL DIAGNOSTIC INSTRUMENT CORP. JOSEPH G KUBIT
K941001 08/30/1994 ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT DIAGNOSTIC SPECIALTIES RINALDO PAGNUCCO
K941453 08/16/1994 CHECK VALVE SOLUTION SET DOUGLAS MEDICAL PRODUCTS CORP. DOUGLAS JOHNSON
K940908 08/29/1994 DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS DUNHALL PHARMACEUTICALS, INC. MONTE J STAHA
K941219 08/09/1994 DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR DUPONT MEDICAL PRODUCTS REBECCA S AYASH
K942240 08/17/1994 DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN DUPONT MEDICAL PRODUCTS CAROLYN K GEORGE
K942241 08/18/1994 DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN DUPONT MEDICAL PRODUCTS CAROLYN K GEORGE
K943024 08/02/1994 KINASE ISOENZYME DUPONT MEDICAL PRODUCTS CATHY P CRAFT
K940573 08/25/1994 HEPA AIR CLEANER DURACRAFT CORP. ARTHUR WONG
K940124 08/26/1994 EY-20 REAGENT TUBES E-Y LABORATORIES, INC. LINDA M WERTZ
K934129 08/26/1994 STREP-A-CHEK E-Y LABORATORIES, INC. LINDA M WERTZ
K940020 08/26/1994 STREP-A-CHEK(TM) REAGENT STRIPS E-Y LABORATORIES, INC. LINDA M WERTZ
K935407 08/05/1994 STICKIT E.M. INNOVATIONS, INC. JOEL B CULP
K943339 08/23/1994 GAUZE SPONGE (E.W.A. LTD./VARIOUS) E.W.A., LTD. FRANK WELLS
K940670 08/04/1994 EARCRAFT HEARING AID EARCRAFT, INC. ERIC WEEKS
K940386 08/17/1994 KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP EASTMAN KODAK COMPANY NORMAL GEIL
K935026 08/24/1994 DIGITAL MEDIA CONVERTER (D-MC) EIGEN VIDEO MARK A HOFFMAN
K934831 08/23/1994 ADVANCED AUTOMATIC KV ELSCINT, INC. ROCHELLE M SOBEL
K935549 08/24/1994 GYREX 2T-SGR ELSCINT, INC. ROCHELLE M SOBEL
K941389 08/23/1994 EMPI TAPE PATCHES EMPI STACY MATTSON
K925079 08/24/1994 LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) ENDO TECHNIC CORP. DAN GUDEMAN
K943409 08/23/1994 SIDE-FIRING UROLOGIC REFRACTIVE FIBER ENERGY LIFE SYSTEMS CORP. HANY HUSSEIN
K940167 08/02/1994 DIAGNOSTIC I CATHETER EP TECHNOLOGIES, INC. ALAN MARQUARDT
K943475 08/12/1994 ULTRA HYDROPHILIC ALGINAE ESSENTIAL DENTAL SYSTEMS, INC. ANAND AKERKAR
K942450 08/05/1994 ENDOPATH ETHICON ENDO-SURGERY, INC. CLAUDIA L BERNER
K941027 08/23/1994 ENDOPATH OPTICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC. CLAUDIA L BERNER
K942746 08/24/1994 SUCKER ENDS (ZOELLNER) EXMOOR PLASTICS LTD. BRIAN EAST
K936125 08/04/1994 SPECTACLE FRAMES, SUNGLASSES EYEDESIGNS CORP. D H YOON
K915229 08/30/1994 SEMEN ANALYSIS KIT FERTILITY DIAGNOSTICS, INC. DEBRA BRYANT
K943504 08/17/1994 RSX-525HF FISCHER IMAGING CORP. WILLIAM J ENGEL
K941299 08/23/1994 FLARED PATCH FLARED PATCH, INC. RICHARD L STUDER
K926005 08/23/1994 FRESENIUS HEMOFLOW, VARIOUS MODELS FRESENIUS USA, INC. SCOTT N WALKER
K943823 08/22/1994 FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K943425 08/17/1994 FUJI HG-M INTENSIFYING SCREEN FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT UZENOFF
K943822 08/22/1994 FUJI UM MAMMO SERIES INTENSIFY SCREENS: FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K942235 08/17/1994 KYOKKO GREEN SERIES INTENSIFYING SCREENS FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K943821 08/22/1994 KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K933542 08/05/1994 MESIAL LOOP BAR GAC INTL., INC. ERNEST H BOHN
K934468 08/05/1994 SLIP-ON FIXATION SPLINT (SFS) GATEWOOD SPLINTS JOHN B GATEWOOD
K940295 08/22/1994 UROVIEW MODEL 2600 GE DEC MEDICAL SYSTEMS THOMAS R MEYERS
K940606 08/23/1994 HISPEED ADVANTAGE II GE MEDICAL SYSTEMS LARRY A KROGER
K943652 08/22/1994 VASCULAR MP X-RAY GENERATOR GE MEDICAL SYSTEMS LARRY A KROGER, PH.D.
K934959 08/15/1994 MODEL 118 FETAL/MATERNAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES BRIAN R BARRY
K941020 08/10/1994 DRUG RECONSTITUTION FILTER DEVICE GELMAN SCIENCES, INC. MITCHELL L EHRLICH
K943671 08/09/1994 GSI CANNULA REDUCER ACCESSORY GENERAL SURGICAL INNOVATIONS THOMAS J FOGARTY
K943008 08/08/1994 BIOSCAN REAGENT STRIPS GENESIS LABS, INC. MARTHA CORNELL
K942623 08/23/1994 TRIMPORT GERARD MEDICAL ENTERPRISES, INC. RICHARD CAYER JR.
K940870 08/02/1994 UMBILI-CATH GESCO INTL., INC. CLYDE N BAKER
K940953 08/02/1994 UMBILI-CATH-S GESCO INTL., INC. CLYDE N BAKER
K941661 08/23/1994 GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT GM ENGINEERING, INC. DAVID C STEFFIN
K942703 08/19/1994 GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA GM ENGINEERING, INC. DAVID C STEFFIN
K922553 08/23/1994 CLA-COMPUTERIZED LARYNGEAL ANALYZER H.I.L. RESEARCH, LTD. FRANK FERGUSON
K943509 08/05/1994 7300 NASAL CPAP SYSTEM HEALTHDYNE TECHNOLOGIES, INC. TIMOTHY Y COWART
K943656 08/15/1994 ALPHA SOLAR SYSTEM TANNING BED HEARTLAND TAN SYSTEMS KRISTIN A TIFFANY
K940224 08/17/1994 CARDIO REP LD HELENA LABORATORIES PAT FRANKS
K943624 08/10/1994 ELMED PNEUMOPERITONEUM NEEDLES HENKE-SASS WOLF, GMBH. RANDAL CHINNOCK
K942887 08/15/1994 MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM HEWLETT-PACKARD CO. MONICA FERRANTE
K940561 08/04/1994 SUNGLASSES HIBISCUS IND. CO. LTD. DONALD TANG
K941433 08/02/1994 HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH HICHEM DIAGNOSTICS WYNN STOCKING
K942627 08/15/1994 454A ELECTROSURGICAL ANALYZER HOGAN & HARTSON HOWARD M HOLSTEIN
K942597 08/15/1994 CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR HOLMED CORP. RUSSELL HOLMES
K934059 08/01/1994 DALL MILES SYSTEM GROOVED BUTTON HOWMEDICA CORP. ROBERT E SMITH
K942419 08/05/1994 HYDRO-S WOUND GEL HYMEDIX INTL., INC. KEN BLASHKA
K941987 08/15/1994 HEAT AND MOISTURE EXCHANGERS AND FILTERS ICOR AB ANDRAS GEDEON
K942190 08/17/1994 ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE IMAGE DIAGNOSTICS, INC. REMO J ROSSI
K940425 08/01/1994 IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING IMAGYN MEDICAL, INC. GUY R LOWERY
K942441 08/23/1994 IMEXDOP CT+ IMEX MEDICAL SYSTEMS, INC. DENNIS NEWMAN
K941960 08/17/1994 IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II IMPLANTECH ASSOCIATES, INC. EDWARD M BASILE
K932168 08/24/1994 HEXLOCK/HEXLOCK SCREW IMTEC CORP. GILLESPIE
K942217 08/03/1994 PULSEJET DENTAL LASER SYSTEM INCISIVE TECHNOLOGIES, INC. MICHAEL YESSIK
K943693 08/22/1994 PULSEMASTER S SERIES INCISIVE TECHNOLOGIES, INC. MICHAEL YESSIK
K940271 08/02/1994 INCSTAR ACTH IRMA INCSTAR CORP. MARY ELLEN BEST
K940750 08/23/1994 INNERVISION,INC. LAPAROSCOPIC ELECTRODES INNERVISION, INC. FRANK M LEWIS
K935298 08/03/1994 INSTA-NERVE(TM) NERVE CONDUCTION MONITOR INSTA NERVE CANADA, INC. RICHARD A HAMER
K941227 08/18/1994 SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL INSTANTRON STEPHEN A BONZAGNI
K941938 08/05/1994 THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE INTERCARE DIAGNOSTICS, INC. ANTHONY DIKE
K940370 08/17/1994 AMERICAN CATHETER E.R.C.P. CANNULA INTL. MEDICAL, INC. PETER H WETTERMANN
K943117 08/04/1994 INTRA-SONIX UROFIBER INTRA-SONIX, INC. DANIEL MCNULTY
K942478 08/05/1994 VISARD FRAMES IRIS OPTICAL, INC. HERNAN PINEDA
K941849 08/17/1994 PROVIPONT C&B IVOCLAR USA, INC. LLOYD V ZIEMENDORF
K940547 08/11/1994 FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED J-LLOYD MEDICAL, INC. JAMES L SKAGGS
K943328 08/04/1994 EVERYTHING KIDS JCC CO., INC. ALICE S MILLER
K943487 08/10/1994 BIO74-PF CROWN & BRIDGE ALLOY JENERIC/PENTRON, INC. LINDA D RIVARD
K943677 08/29/1994 SUNGLASSES JENN WEI GLASS COMPANY, LTD. SCOTT CHANG
K942383 08/22/1994 DERMIVIEW CLEAR TAPE JOHNSON & JOHNSON INTERNATIONAL RALPH H LARSEN
K943667 08/18/1994 ESOPHAGOSCOPE AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. BETTY M JOHNSON
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K940801 08/03/1994 K-KLIP KATECHO, INC. LORNE SCHARNBERG
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K942754 08/05/1994 SUNGLASSES KIMBALL CORP. PETER LIU
K942421 08/08/1994 IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT KING & SPALDING EDWARD M BASILE
K942420 08/08/1994 IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT KING & SPALDING EDWARD M BASILE
K943402 08/19/1994 K.P.R. (KING PERSONAL RESUSCITATOR) KING SYSTEMS CORP. MICHAEL A LEAGRE
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K943758 08/22/1994 SURGICAL BUR KOMET MEDICAL COURTNEY S PARADICE
K943609 08/11/1994 SUNGLASSES KONWAN OPTICAL XIAMEN CO., LTD. TIM D J. WU
K943168 08/10/1994 CLEARFIL AP-X KURARAY COMPANY, LTD. KYOICHIRO SHIBATANI
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K942337 08/01/1994 CEDIA DAU MULTI-LEVEL THC ASSAY MICROGENICS CORP. BETSY SOARES-MADDOX
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K943281 08/24/1994 POLYETHYLENE VENT TUBES MICROMED DEVELOPMENT CORP. DAN H TREACE
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K942720 08/05/1994 NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 NEITZ INSTRUMENTS COMPANY, LTD. TRACY BERNS
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K942721 08/05/1994 NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 NEITZ INSTRUMENTS COMPANY, LTD. TRACY BERNS
K942717 08/05/1994 NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A NEITZ INSTRUMENTS COMPANY, LTD. TRACY BERNS
K942715 08/05/1994 NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC NEITZ INSTRUMENTS COMPANY, LTD. TRACY BERNS
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K943245 08/23/1994 SPIRIT MB SYBRON DENTAL SPECIALTIES, INC. JEFFREY A ANDERSON
K941235 08/15/1994 VISTA B12 ASSAY SYVA CO. PAUL L ROGERS
K942388 08/17/1994 TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE TECHNOLOGY MARKETING GROUP THOMAS HYNES
K940769 08/17/1994 DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR TERRAFLEX ELI M ORBACH
K941026 08/18/1994 THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR THAYER MEDICAL CORP. DAVID SLADEK
K943265 08/05/1994 N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO THE FIRST OPTICAL MANUFACTORY LTD. REGULATORY AFFAIRS PERSON
K941869 08/03/1994 SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG THE LIGHTHOUSE FOR THE BLIND, INC. RENEE OBRYCKI
K942789 08/12/1994 MISTASSIST THE MERLIN CORP. PAUL DWORK PHARMB
K943161 08/04/1994 ORVIS DRIVING GLASSES THE ORVIS CO., INC. TOM MCMILLEN
K942951 08/02/1994 ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS THE ORVIS CO., INC. TOM MCMILLEN
K943131 08/02/1994 ORVIS POLARIZED BI-FOCALS THE ORVIS CO., INC.
K942412 08/19/1994 THEREX LOW-PROFILE PORT - TITANIUM MODEL THEREX CORP. BRADLEY ENEGREN
K941540 08/02/1994 SUNGLASSES TONVIEW INTERNATIONAL CO., LTD. TONY WU
K941929 08/02/1994 SUNGLASSES TOP CHAMP, INC. JERRY HUANG
K935841 08/29/1994 DR KOOL TORONTO MEDICAL CORP. BARBARA HOLT
K940796 08/23/1994 ACCESS TOSHIBA AMERICA MRI, INC. JAVAD SEYEDZADEH
K943273 08/01/1994 TRI HAWK BUR, FG BUR TRI HAWK CORP. SOLEDAD ASHWORTH
K942221 08/05/1994 IRRIGATION TRAY WITH PISTON SYRINGE TRINITY LABORATORIES, INC. PARTH BASUMALLIK
K940969 08/16/1994 SUNGLASSES TZONG RONG SUNGLASSES MFG. CO., LTD.
K935193 08/18/1994 CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM U.S. MEDICAL PRODUCTS, INC. STEVEN I WHITLOCK
K943373 08/23/1994 PERMAGEN F/DC ULTRADENT PRODUCTS, INC. L.M. CHATWIN
K942885 08/22/1994 AUTO SUTURE MODIFIED GRIP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JONATHAN GILBERT
K942606 08/24/1994 SURGICAL STAPLE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC DEBORAH ROCKAFELLOW
K926321 08/09/1994 VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) VARIAN ASSOC., INC. CHARLES H WILL
K934093 08/18/1994 580CDR DISPLAY DRIVER VIDCO, INC. BRADLEY A COHEN
K935693 08/25/1994 AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG, M.D.
K943280 08/18/1994 PROCEL BURN COVER/PROCEL BURN TREATMENT COVER W.L. GORE & COMPANY, GMBH TINA ROCHOLL
K942742 08/29/1994 ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV WALLACE A. ERICKSON & CO. GEORGE NICOLAE
K942727 08/23/1994 ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE WALLACE A. ERICKSON & CO. GEORGE NICOLAE, PH.D.
K935625 08/10/1994 ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE WALLACE A. ERICKSON & CO. GEORGE NICOLAE
K941272 08/02/1994 KLEENSPEC WELCH ALLYN, INC. LAWRENCE E MOROCCO
K943916 08/25/1994 VIDEOTOSCOPE WELCH ALLYN, INC. SCOTT P GUCCIARDI
K942510 08/05/1994 SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED) WEMBLEY RUBBER PRODUCTS (M) SDN BHD ONG GHEE CHEE
K943706 08/22/1994 AUDILENS LLK WIDEX HEARING AID CO., INC. RONALD MELTSNER
K942054 08/23/1994 SHARPS-TAINER WINFIELD INDUSTRIES DAVID OLMSTEAD
K943507 08/05/1994 WINK EYEWEAR WINK OPTICAL, INC. JULIE KOCH-BEINKE
K943085 08/04/1994 SPECTACLE FRAME WINNTICS OPTICAL INDUSTRY CO. LTD. PEGGY CHAPLIN
K942628 08/18/1994 ESOPHAGEAL INTUBATION DETECTOR BULB WOLFE TORY MEDICAL, INC. TIMOTHY R WOLFE
K933289 08/25/1994 THICK TIBIAL INSERT WRIGHT MEDICAL TECHNOLOGY, INC. DIANN ATCHISON
K933757 08/26/1994 HAND-HELD IRRIGATION PUMP XIMED MEDICAL SYSTEMS ASHVIN DESAI
K942759 08/31/1994 OPTICON(TM) CONNECTOR ADAPTER II XINTEC CORPORATION MARILYN M CHOU
K932771 08/24/1994 BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE XOMED-TREACE, INC. TERRY C MCMAHON
K934095 08/10/1994 IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS Y JENNIFER S HANKARD
K943229 08/19/1994 DISPOSABLE SURGICAL SCISSORS AND FORCEPS Y.M.K. INTERNATIONAL CO., LTD. Y. M KUNG
K935888 08/23/1994 ELITE FAST LIGHT BODY ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K935885 08/23/1994 ELITE FAST PUTTY SOFT ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K935886 08/23/1994 ELITE LIGHT BODY ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K931242 08/23/1994 ELITE PUTTY HARD ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K935884 08/23/1994 ELITE PUTTY SOFT ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K935887 08/23/1994 ELITE REGULAR BODY ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K935889 08/23/1994 OCCLUFAST ZHERMACK DENTAL PRODUCTION MONICA MARTELLO
K925560 08/30/1994 ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES ZINNANTI SURGICAL INSTRUMENTS, INC. TRISH WILLGING


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