| 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 |
