FDA 510(k) Decisions During May, 1999  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K973592 05/20/1999 WALKCARE P200 SYSTEM A. STEIN - REGULATORY AFFAIRS CONSULTING AHAVA STEIN
K990978 05/25/1999 ALBUMIN BCG, MODEL AL 103-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991111 05/25/1999 BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 A.P. TOTAL CARE, INC. LUIS P LEON
K990980 05/25/1999 BUN, MODEL BU 104-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991108 05/25/1999 CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991109 05/25/1999 CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 A.P. TOTAL CARE, INC. LUIS P LEON
K990981 05/25/1999 GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 A.P. TOTAL CARE, INC. LUIS P LEON
K991244 05/25/1999 TOTAL IRON, MODELS FE 109-01, FE 109-02 A.P. TOTAL CARE, INC. LUIS P LEON
K991247 05/25/1999 URIC ACID, MODEL UA112-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991010 05/19/1999 ACP ABBOTT DIAGNOSTICS MFG., INC. LINDA MORRIS
K990774 05/11/1999 ABBOTT ARCHITECT CEA ABBOTT LABORATORIES KAREN L GATES
K991501 05/13/1999 ACCLAIM INFUSION PUMP ABBOTT LABORATORIES JILL SACKETT
K991175 05/28/1999 MODIFICATION TO ALCYON DIRECT BILIRUBIN ABBOTT LABORATORIES MARK LITTLEFIELD
K990729 05/13/1999 FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES ACC INTL. ARTHUR K.K. MA
K990693 05/14/1999 FLEXNEEDLE PLUS ACT MEDICAL, INC. WENDY V SHOTTS
K984098 05/10/1999 ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS ADVENTURES IN COLOR TECHNOLOGY, LTD. MARTIN DALSING
K990093 05/11/1999 ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW AGILENT TECHNOLOGIES DUDLEY HARRIS
K990480 05/10/1999 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER ALCON LABORATORIES RALPH H LARSEN
K991435 05/20/1999 AII-PRO 100 PLUS AND ALL-PRO 200 ALL-PRO IMAGING CORP. FREDERICK R FISCHER
K991484 05/13/1999 AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K991589 05/18/1999 FLEXIBLE VASCULAR CLAMP, VERSION 2 ALLEGIANCE HEALTHCARE CORP. PATRICIA SHARPE-GREGG
K990507 05/07/1999 ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER ALTHIN BIOPHARM, INC. JEAN SAURIOL
K984486 05/13/1999 PULSEMASTER DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. JOHN G SULEWSKI
K990665 05/17/1999 BQ/BM INTEGRATED LASER DELIVERY SYSTEM AMERICAN LASER CORP. DANIEL HOEFER
K984269 05/11/1999 DBEST OCCULT BLOOD TEST KIT AMERITEK, INC. K C YEE
K991075 05/10/1999 ATLAST GLUCOSE CONTROL SOLUTION AMIRA MEDICAL, INC. NINA PELED
K990812 05/04/1999 POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA AMPRI RUBBERWARE INDUSTRIES SDN BHD PACK LOON TANG
K990901 05/04/1999 POWDER FREE LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. SON HONG LEE
K990879 05/17/1999 PRE POWDERED LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. SON HONG LEE
K983154 05/05/1999 CYSTIC DUCT BALLOON DILATING CATHETER APPLIED MEDICAL RESOURCES HOWARD V ROWE
K991431 05/26/1999 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT ARROW INTL., INC. THOMAS D NICKEL
K990829 05/04/1999 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD", MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 ARROW INTL., INC. THOMAS D NICKEL
K984022 05/18/1999 PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT ARROW INTL., INC. THOMAS D NICKEL
K983720 05/17/1999 ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- ASAHI MEDICAL CO., LTD. DAVID L WEST
K990957 05/11/1999 ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K ASTORIA-PACIFIC,INC. RAYMOND L PAVITT
K984496 05/05/1999 ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DEPAOLO
K990376 05/03/1999 BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN
K990710 05/20/1999 BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES BARRIERMED GLOVE CO. CARLO PONCIPE
K990346 05/21/1999 BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP. GABRIEL J MURACA, JR.
K983715 05/14/1999 THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP. GABRIEL J MURACA, JR.
K990704 05/03/1999 ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K991249 05/05/1999 FALCON IVF FOUR WELL PLATE BECTON DICKINSON LABWARE DAVID BALL
K991251 05/05/1999 FALCON IVF ONE WELL DISH BECTON DICKINSON LABWARE DAVID BALL
K991253 05/05/1999 FALCON IVF ROUND DISH BECTON DICKINSON LABWARE DAVID BALL
K991120 05/19/1999 VACUTAINER BRAND CTAD TUBE (MULTIPLE) BECTON DICKINSON VACUTAINER SYSTEMS JAMES W HAYNES
K991088 05/28/1999 VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE BECTON DICKINSON VACUTAINER SYSTEMS ANDREA HRONCICH
K991527 05/27/1999 CHROMOPHARE D500, D530, D650 BERCHTOLD HOLDING GMBH WOLFRAM K HILL
K990955 05/18/1999 MODIFICATION OF:BIODERM FOAM WOUND DRESSING BIODERM, INC. GEORGE WORTHLEY
K991428 05/21/1999 ASCENT KNEE SYSTEM BIOMET, INC. DALENE HUFZIGER BINKLEY
K991298 05/14/1999 BONE MULCH SCREW SYSTEM BIOMET, INC. FRED MCCLURE
K990968 05/27/1999 E-SCAN BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K983831 05/19/1999 VECTORVISION2 BRAINLAB, AG
K990538 05/19/1999 BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE BRAINMASTER SUSAN D GOLDSTEIN-FALK
K990878 05/21/1999 BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K972803 05/11/1999 TRACER O-T-W MAPPING DEVICE CARDIMA, INC. SHELLEY TRIMM
K990566 05/14/1999 TAS ANALYZER, MODEL 1009 CARDIOVASCULAR DIAGNOSTICS, INC. PETER SCOTT
K990239 05/25/1999 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K984285 05/19/1999 OSTEOGRAM BONE DENSITOMETER COMPUMED, INC. T WHIT ATHEY
K991635 05/27/1999 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K990586 05/17/1999 CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES CONMED CORP. IRA D DUESLER
K990011 05/11/1999 CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR CONTINENTAL SOFT LENS, INC. KIM MCQUARRIE
K990964 05/18/1999 SIGNADRESS DUODERM DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS NANCY L WOLLEY
K990753 05/27/1999 GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER COOK, INC. APRIL LAVENDER
K991673 05/26/1999 CORDIS TEMPO ANGIOGRAPHY CATHETER CORDIS CORP. ARIEL MACTAVISH
K991070 05/11/1999 COULTER Z2 ANALYZER COULTER CORP. THOMAS J ENGLISH
K991182 05/19/1999 MODIFICATION OF N/T PROTEIN CONTROL SL DADE BEHRING, INC. CAROLYN K GEORGE
K983408 05/10/1999 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. SHAROLYN J LENTSCH
K991528 05/28/1999 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR DANEK MEDICAL, INC. RICHARD W TREHARNE
K983575 05/13/1999 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX DATASCOPE CORP. RUSSELL OLSEN
K990087 05/13/1999 DMD DIGITAL X-RAY SYSTEM DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. STEVE BRODY
K990844 05/28/1999 STARDENTAL AXCS STERILE WATER SYSTEM DENTALEZ GROUP FRANK OELLIG
K983665 05/17/1999 MANOMETRIC ASSEMBLIES DENTSLEEVE PTY., LTD. MARCUS TIPPETT
K990875 05/27/1999 DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K990891 05/27/1999 DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K990593 05/24/1999 PELVX INCONTINENCE DISH, MODEL 301-306 DESCHUTES MEDICAL PRODUCTS, INC. DENISE BESTWICK
K991094 05/13/1999 IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991096 05/13/1999 IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991459 05/14/1999 COPALIS EBV-M ANTIBODY ASSAY DIASORIN, INC. JUDITH J SMITH
K991172 05/17/1999 IONOSIT BOND DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH PAMELA PAPINEAU
K990669 05/17/1999 MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. PETER PARK
K990731 05/19/1999 EASTGATE PERSONAL MONITOR EASTGATE TRADING CORP. MORRIS CORN
K990748 05/04/1999 EDGE SYSTEMS STERILE TUBING EDGE SYSTEMS CORP. GARY MOCNIK
K991387 05/19/1999 ELAN ALKALINE PHOSPHATE REAGENT KIT ELAN HOLDINGS, INC. RALPH BOLSTAD
K984328 05/21/1999 LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 ELEKTA INSTRUMENT AB CAROL PATTERSON
K990908 05/27/1999 MILLENNIUM ENDO TECHNIC CORP. ANDREW I KIMMEL
K991221 05/20/1999 VESTOGUM ESPE DENTAL AG ANDREAS PETERMANN
K991220 05/20/1999 VITRON H ESPE DENTAL AG ANDREAS PETERMANN
K990763 05/25/1999 VITRON M ESPE DENTAL AG ANDREAS PETERMANN
K991030 05/17/1999 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC. EDWIN O BILLIPS
K990645 05/19/1999 GALLINI ATRA-CUT NEEDLE GALLINI U.S., LLC. PAUL L HAWTHORNE
K990716 05/17/1999 GALLINI BYCUT NEEDLE GALLINI U.S., LLC. PAUL L HAWTHORNE
K990736 05/28/1999 GC RELINE SOFT/EXTRA SOFT GC AMERICA, INC. TERRY L JORITZ
K990550 05/11/1999 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K991369 05/10/1999 ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K991043 05/04/1999 LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN GLOVCO (M) SDN. BHD. TAN PENG HOCK
K991394 05/18/1999 STAPES PROSTHESES GRACE MEDICAL, INC. ANTHONY D PRESCOTT
K991156 05/28/1999 GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM GREAT SMOKIES DIAGNOSTIC LABORATORY STEPHEN BARRIE
K990699 05/17/1999 ORTHO-GLOW GLITTER HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K991430 05/28/1999 SMARTPREP CENTRIFUGE SYSTEM HARVEST TECHNOLOGIES, LLC. RICK LARIVIERE
K991324 05/18/1999 TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) HEINZ KURZ DAGMAR S MASER
K990756 05/07/1999 FLOW LINE HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K991129 05/13/1999 HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL HITACHI MEDICAL CORP. OF AMERICA GARY W ENOS
K991231 05/24/1999 HITACHI VERSIFLEX HITACHI MEDICAL SYSTEMS AMERICA, INC. T. WHIT ATHEY
K991461 05/17/1999 OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT HOWMEDICA OSTEONICS CORP. MARYBETH NAUGHTON
K990671 05/10/1999 DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE HURRICANE MEDICAL DAVID A CLAPP
K990672 05/18/1999 LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET HURRICANE MEDICAL DAVID A CLAPP
K990479 05/13/1999 HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR HYGENITEK, INC. KATIE LUBIN
K990585 05/17/1999 INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) DONNA WARD
K990652 05/17/1999 INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) DONNA WARD
K990848 05/17/1999 TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION IMMEDICA, INC. ROY BOGERT
K982925 05/18/1999 LAMINOSS DENTAL IMPLANT IMPLADENT, LTD. MAURICE VALEN
K990193 05/20/1999 IODINE BRACHYTHERAPY SEEDS, MODEL 3000 IMPLANT SCIENCES CORP. HOWARD L SCHRAYER
K990509 05/18/1999 OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 IMPLEMED, INC. ANTHONY L BLANK
K983551 05/27/1999 CRIT-SCAN II MONITOR IN-LINE DIAGNOSTICS CORP. MATTHEW L HAYNIE
K991515 05/28/1999 INSURE PREGNANCY TEST INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K990493 05/18/1999 INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE INNERDYNE, INC. RICK GAYKOWSKI
K984537 05/14/1999 KERATOME SYSTEM, MODEL K3000 INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. CHARLES VASSALLO
K981246 05/26/1999 BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) INTEGRA NEUROCARE LLC. LORI HAYS
K990515 05/13/1999 MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM INTERNATIONAL MEDICAL SYSTEMS
K983475 05/03/1999 HEMOCHRON RESPONSE INTERNATIONAL TECHNIDYNE CORP. JOHN M CLAY
K991404 05/14/1999 PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) ITL CORPORATION, PTY LTD. KENNETH A PALMER
K991224 05/14/1999 K-ASSAY CRP KAMIYA BIOMEDICAL CO. COLIN GETTY
K991210 05/11/1999 K-ASSAY CRP CALIBRATOR SET KAMIYA BIOMEDICAL CO. COLIN GETTY
K990411 05/11/1999 MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE KARL STORZ ENDOSCOPY KEVIN A KENNAN
K990073 05/11/1999 CALCITONIN KMI DIAGNOSTICS, INC. GOTTFRIED KELLERMAN
K990522 05/19/1999 WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS LA MONT MEDICAL, INC. TONY MONTGOMERY
K981549 05/24/1999 LACTATION TECHNIQUES MODEL B LACTATION TECHNIQUES, INC. MARK LELOUDIS
K990882 05/21/1999 LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) LAGLOVE (M) SDN. BHD. G. BASKARAN
K991462 05/28/1999 QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED LATEXX PARTNERS BHD. CHONG ENG LIM
K990560 05/20/1999 LIFE IMAGING SYSTEMS, MODEL L3DI LIFE IMAGING SYSTEMS, INC. KEVIN MORNINGSTAR
K984261 05/21/1999 SURESTEP BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. ROGER THIES
K991644 05/21/1999 MICROGAS 7650 TRANSCUTANEOUS MONITOR LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K984249 05/04/1999 SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE LONDON INTERNATIONAL GROUP, INC. NEIL ANDERSON
K990946 05/04/1999 BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES LONG FIRST (XIAMEN) CO.,LTD. STONE CHEN
K991085 05/05/1999 BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES LONG FIRST (XIAMEN) CO.,LTD. STONE CHEN
K991258 05/13/1999 NOVUS VERDI DELIVERY SYSTEMS LUMENIS, INC. KATHY A MAYNOR
K991640 05/28/1999 HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES M.R.G. INDUSTRIES BERHAD LIM CHONG
K991493 05/26/1999 BLUE POWDER-FREE NITRILE EXAMINATION GLOVES MASJU SDN. BHD. HENG CHENG HUI
K984189 05/05/1999 ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER MAXXIM MEDICAL EDDIE MONROE
K983982 05/04/1999 SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES MAXXIM MEDICAL JOYCE MOODY
K990839 05/20/1999 TRU-CORE I REUSABLE BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K990902 05/27/1999 MODIFICATION OF MLT R694 RUBY LASER SYSTEM MEDICAL LASER TECHNOLOGIES LTD. DAVID HAMILTON
K990663 05/27/1999 INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 MEDTECH LTD. JONATHAN S KAHAN
K991194 05/05/1999 MODIFICATION TO ULTRA-SELECT GUIDEWIRE MICROVENA CORP. ANGELA MALLERY
K990482 05/13/1999 3M CLINPRO PROPHY PASTE, MODEL 12611 MINNESOTA MINING AND MFG. CO. REBECCA L HANNACK
K990328 05/04/1999 DBC, DONG BANG ACUPUNCTURE NEEDLES MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC. AE-HOE KWON
K991136 05/11/1999 B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM OLYMPUS AMERICA, INC. LAURA STORMS TYLER
K990701 05/05/1999 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K990696 05/13/1999 OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K990702 05/04/1999 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K990698 05/13/1999 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K990695 05/04/1999 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K990344 05/04/1999 ORALGIENE TONGUE CLEANER ORALGIENE USA, INC. BILL MUCKLEROY
K990474 05/17/1999 ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES ORATEC INTERVENTIONS, INC. SHEILA RAMERMAN
K984497 05/26/1999 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K990016 05/19/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K983875 05/14/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K991732 05/21/1999 CENTRAFIX EXTERNAL FIXATOR OWANDAR MEDICAL LTD JOHN RADWELL
K984052 05/17/1999 SYNERGY IOM SYSTEM OXFORD INSTRUMENTS MEDICAL SYSTEMS E J SMITH
K991158 05/28/1999 LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE P. T. TATA RUBBERINDO INDUSTRIES EMMY TJOENG
K991270 05/21/1999 SMARTEMP PARKELL, INC. NELSON J GENDUSA
K990381 05/17/1999 TOTALBOND PARKELL, INC. NELSON J GENDUSA
K991048 05/14/1999 ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 PHARMACIA & UPJOHN CO. KAREN E MATIS
K991278 05/13/1999 PHILIPS TOMOSCAN AV-NT PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FRANK GIANELLI
K990455 05/12/1999 PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION PHILIPS MEDICAL SYSTEMS, INC. FRANK GIANELLI
K991429 05/19/1999 DIAMOND II VALVE PHOENIX BIOMEDICAL CORP. COURTNEY SMITH
K983393 05/05/1999 LIFEPAK 500 BIPHASIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K990935 05/17/1999 JACKSON ESOPHAGEAL DILATOR PILLING WECK SURGICAL ELIZABETH LAZARO
K990561 05/14/1999 OPTICAL FORCEPS PILLING WECK SURGICAL ELIZABETH LAZARO
K990045 05/24/1999 BERACLAMP, MODEL BC-1 POAMAX L.L.C. MICHAEL J PALMER
K990247 05/28/1999 MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K990383 05/05/1999 APOLLO 5, APOLLO 10 PRECITRON A.B. KJELL WESTERLUND
K991299 05/28/1999 MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI PRINCETON BIOMEDITECH CORP. JEMO KANG
K984241 05/12/1999 ROCS ULTRASEED RADIATION ONCOLOGY COMPUTER SYSTEMS CHARLENE NEBLETT
K983862 05/24/1999 CLOUD 1 HUMIDIFICATION SYSTEM RESPIRATORY SUPPORT PRODUCTS, INC. GORDON SHIGEZAWA
K984407 05/19/1999 BIPAP HARMONY S/T, MODEL 1001445 RESPIRONICS, INC. DAVID J VANELLA
K991648 05/28/1999 REUSABLE CONTOUR II NASAL MASK RESPIRONICS, INC. DAVID J VANELLA
K990574 05/24/1999 STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 RESPIRONICS, INC. DAVID J VANELLA
K991627 05/17/1999 WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 RESPIRONICS, INC. BETSY CORTELLONI
K990963 05/26/1999 RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) RIVERSTONE RESOURCES SDN. BHD. CHU MEE CHONG
K984614 05/27/1999 NORMAL SALINE FLUSH SYRINGE ROCAP DIV. OF SABRATEK CORP. AVIA TONEY
K983698 05/03/1999 MODIFICATION TO ABUSCREEN ONLINE BARBITURATES ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K974342 05/28/1999 ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC. ALEX WESOLOWSKI
K984270 05/20/1999 VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 ROGER L. GOODMAN, D.D.S., P.C. ROGER L GOODMAN
K990684 05/10/1999 MODIFICATION OF SAS SERUM/URINE HCG SA SCIENTIFIC, INC. JOSH WESSLING
K991193 05/04/1999 SAS HCG-CHECK SA SCIENTIFIC, INC. J. WESSLING
K990741 05/10/1999 SAS ONE-STEP PREGNANCY SA SCIENTIFIC, INC. HARBI A SHADFAN
K991039 05/21/1999 EASYSAFE RETRACTING NEEDLE SYRINGE SAF-T-MED, INC. JAMES ERBS
K991317 05/21/1999 POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM SAFESKIN CORP. EUGENE V GOORCHENKO
K990678 05/07/1999 PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) SALTER LABS DUANE KAZAL
K984229 05/17/1999 LATEX EXAMINATION GLOVES (POWDERED) SAMA KEJURUTERAAN SDN.BHD. KUAN TECK
K983216 05/17/1999 CVS PERSONAL LUBRICANT SAN-MAR LABORATORIES, INC. IRWIN SILVERBERG
K990441 05/12/1999 INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 SANDHILL SCIENTIFIC, INC. LINDA L DIEDERICH
K990734 05/28/1999 DPD-12PCC SCANDITRONIX MEDICAL AB EVA LARSTEN
K983039 05/07/1999 EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF SCHNEIDER/NAMIC KARIN L SMITH
K990721 05/27/1999 ISOLOCK SPINAL SYSTEM SCIEN'TX USA INC. DEBBIE DE LOS SANTOS
K973078 05/20/1999 WRIST BLOOD PRESSURE METER MODEL SE-330 SEIN ELECTRONICS CO., LTD. BRENDA M KELLY
K991466 05/25/1999 EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) SELFCARE, INC. CAROL ADILETTO
K991386 05/25/1999 EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) SELFCARE, INC. CAROL ADILETTO
K984161 05/05/1999 CTS-310(B) SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS ROBERT MORTON
K990426 05/12/1999 CALCIUM SCORING SIEMENS MEDICAL SOLUTIONS USA, INC. ALICIA BUSTOS-JUERGENSEN
K991661 05/28/1999 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K984141 05/28/1999 GBACT + KIT SIENCO, INC. BARBARA DEBIASE
K984169 05/26/1999 "DIGI-SNAP" SNAP LABORATORIES, L.L.C. GIL RAVIV
K991460 05/19/1999 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM SOFAMOR DANEK RICHARD W TREHARNE
K991364 05/19/1999 MODIFICATION TO TENOR SPINAL SYSTEM-PLATES SOFAMOR DANEK USA,INC. BAILEY LIPSCOMB
K990572 05/21/1999 SONOTOME SONOKINETICS, INC. DEBBIE IAMPIETRO
K983691 05/05/1999 SCANFLEX SOLID COUPLANT MEMBRANE SONOTECH, INC. MARGARET J LARSON
K991363 05/13/1999 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU SORENSON MEDICAL, INC. R. DOUGLAS JACOB
K990650 05/14/1999 CONSEAL F SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K984395 05/21/1999 SURGEON'S GLOVES SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. N. PARAMASIVAN
K991612 05/28/1999 STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G STERILOGIC WASTE SYSTEMS, INC. CALVIN A ODHNER
K991436 05/07/1999 STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION STERNGOLD GORDON NELSON
K990936 05/18/1999 THE VAULT STIK STOPPERS, INC. DARRYL CRAWFORD
K984104 05/13/1999 ITI DENTAL IMPLANT SYSTEM STRAUMANN USA LINDA JALBERT
K991703 05/27/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K991415 05/26/1999 SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD STANLEY THAI
K990432 05/27/1999 SURGISORB SUTURES LTD. ELEANOR JONES
K990739 05/26/1999 QUANTEC-E ENDO SYSTEM SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K990568 05/14/1999 SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 SYNERGETICS, INC. KURT W GAMPP
K990577 05/04/1999 TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES TA CHIA RUBBER IND. CORP. CHIN-MING YANG
K990575 05/04/1999 TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES TA CHIA RUBBER IND. CORP. CHIN-MING YANG
K990015 05/27/1999 ELECTRODE NEEDLES TECHNOMED EUROPE HARRY KNUTH
K990841 05/17/1999 NUGARD NITRIL NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD CHIN-GUAN LOW
K990840 05/17/1999 NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD CHIN-GUAN LOW
K990488 05/28/1999 SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE TERANG NUSA SDN BHD CHIN GUAN LOW
K990894 05/19/1999 ETB TROCAR SYSTEM THE ALTOMEC CORP. JIM CHITTY
K991583 05/19/1999 NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR THE MAGSTIM COMPANY LTD. REZA JALINOUS
K982451 05/07/1999 TTCGHI-T AND TTCTN3-T-T TINNITUS TREATMENT CENTERS, INC. DAVID W HOLMES
K990690 05/20/1999 POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES TOP GLOVE SDN. BHD. LIM WEE CHAI
K990620 05/14/1999 EXCELART TOSHIBA AMERICA MRI, INC. HSU CHANG
K991057 05/20/1999 EXTRA LARGE BODY COIL FOR OPART (MRT-600) TOSHIBA AMERICA MRI, INC. KEN NEHMER
K991252 05/11/1999 AIA-PACK FT3 ASSAY TOSOH MEDICS, INC. LOIS NAKAYAMA
K990686 05/04/1999 POWDER FREE LATEX EXAMINATION GLOVES TOWER RUBBER INDUSTRIES SDN. BHD. S. VICKNESWARAN
K982226 05/13/1999 UROMED BRACHYTHERAPHY IODINE-125 SOURCES UROMED CORP. FREDERICK TOBIA
K990447 05/12/1999 1000 PRESSURE INFUSION SIGMACON 1000 VALLEY WEST, INC. C. KENNETH FRENCH
K990635 05/19/1999 VISTA STEREOSCOPE SYSTEM VISTA MEDICAL TECHNOLOGIES, INC. VICKI S ANASTASI
K991134 05/06/1999 ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. MARTINE D MARTINO
K990442 05/11/1999 ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 VITAL IMAGES, INC. ROBERT C SAMEC
K983840 05/20/1999 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K983728 05/13/1999 LORENZ IMF SCREW WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K983604 05/27/1999 INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER WASHINGTON REGULATORY SERVICES RANDOLPH L COOKE
K991550 05/14/1999 FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS WESLEY JESSEN CORP. JOSEPH FOOS
K984135 05/26/1999 THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K983805 05/26/1999 THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984120 05/26/1999 THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K972774 05/05/1999 GAS PLASMA STERILIZATION ZIMMER, INC. RALPH H LARSEN


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact