FDA 510(k) Decisions During July, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K011512 07/09/2001 MMODIFICATION TO LAMINARIA A & A MEDICAL, INC. JIHAD (JAY) MANSOUR
K003949 07/25/2001 TACKER, MODEL R65-933 A & A MEDICAL, INC. JIHAD MANSOUR
K012013 07/13/2001 LIFESOURCE MODELS UA-787, UA 787PC, UA-787T A & D ENGINEERING, INC. JERRY WANG
K011673 07/31/2001 ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K010841 07/09/2001 ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE ACON LABORATORIES, INC. ROBERT HUDAK
K011672 07/31/2001 ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K011353 07/30/2001 ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K011189 07/16/2001 VIADUCT MICROENDOSCOPE AND ACCESSORIES ACUEITY, INC. MARYBETH FECTEAU
K011422 07/10/2001 SURGICAL DRAPES ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K012219 07/31/2001 SCALPFIX CLIP SYSTEM AESCULAP, INC. LISA M MILLINGTON
K011824 07/02/2001 AGILENT M2636B TELEMON B MONITOR (TELEMON B) AGILENT TECHNOLOGIES, INC. DENISE HALEY
K012094 07/20/2001 MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K011078 07/13/2001 MALLEABLE SHAFT CLAMP ALLEGIANCE HEALTHCARE CORP. LANCE MARCONI
K012159 07/25/2001 RAPID DRUG SCREEN AMERICAN BIO MEDICA CORP. FRAN WHITE
K011910 07/13/2001 IN-FAST BONE SCREW SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K011581 07/17/2001 AMERITEK BRACHYTHERAPY TEMPLATE AMERTEK MEDICAL, INC. GREG WIITA
K010503 07/06/2001 AMIGO WHEELCHAIR AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K002336 07/27/2001 MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T APEX MEDICAL CORP. DANIEL LEE
K011552 07/18/2001 UROLOGICAL CATHETER APOGEE MEDICAL, INC. BRENT D ROBLING
K010006 07/25/2001 DRAINAGE CATHETER OR FOLEY CATHETER APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K011264 07/17/2001 MESH URETERAL STENT APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K003779 07/12/2001 IMMOBILIZATION SYSTEM FOR ENT ARPLAY MEDICAL S.A. RICHARD BORGI
K011279 07/19/2001 ENTEC EVAC PLASMA WAND ARTHROCARE CORP. BRUCE PROTHRO
K011808 07/10/2001 ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) ASIA-MED GMBH AND CO KG KEVIN WALLS
K011834 07/10/2001 BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K011779 07/13/2001 AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM AVID CARE CORP. JONATHAN S KAHAN
K011718 07/25/2001 BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT BAUSCH & LOMB, INC. DEBRA KETCHUM
K011199 07/02/2001 PROVIEW EYE PRESSURE MONITOR BAUSCH & LOMB, INC. DOUGLAS J FORTUNATO
K010668 07/05/2001 BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY BAYER CORP. WILLIAM J PIGNATO
K011982 07/17/2001 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE BD GREGORY W MORGAN
K011342 07/09/2001 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC. STAN SUGRUE
K010748 07/10/2001 SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K002099 07/09/2001 S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- BESCON CO., LTD. MARTIN DALSING
K001962 07/09/2001 S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- BESCON CO., LTD. MARTIN DALSING
K011853 07/17/2001 ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 BIO-RAD DONNA CHAPMAN
K011867 07/12/2001 LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 BIO-RAD DONNA CHAPMAN
K003851 07/20/2001 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 BIOCHECK, INC. ROBIN J HELLEN
K003954 07/12/2001 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT BIOCOMPOSITES LTD. J. STEPHEN BRATT
K002838 07/09/2001 GASTRIC SUCTION AND DRAINAGE CATHETER BIOENTERICS CORP. DAVID MUNJAL
K011041 07/03/2001 WATERLASE, MILLENNIUM BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K011455 07/18/2001 BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER BIOMET, INC. TRACY J BICKEL
K012019 07/20/2001 COLOR BUFFED (CB) DDH FEMORAL STEM BIOMET, INC. DALENE T BINKLEY
K011110 07/02/2001 M2A ACETABULAR SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K011138 07/10/2001 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT BIOMET, INC. PATRICIA S BERES
K011522 07/31/2001 RESORBABLE BONE PINS BIOMET, INC. MARY L VERSTYNEN
K011216 07/18/2001 PVC FREE INTRAVASCULAR ADMINISTRATION SET BIOMETRIX LTD. MIRIAM ABUTBUL
K012000 07/18/2001 1.5MM BONE FIXATION KIT BIONX IMPLANTS, LTD. TUIJA ANNALA
K012001 07/18/2001 SMARTSCREW BIONX IMPLANTS, LTD. TUIJA ANNALA
K011525 07/16/2001 SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) BIOSAFE LABORATORIES, INC. LAURIE A WATERS
K002835 07/03/2001 BODYSTAT BODYSTAT LTD. I.J. MEEUWSEN
K011965 07/13/2001 IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 BOSTON SCIENTIFIC CORP. ROBERT J MICHALIK
K003285 07/31/2001 EXAC TRAC 2.0 (NOVALIS BODY MODULE) BRAINLAB, AG STEFAN VILSMELIER
K010734 07/30/2001 BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 BRANAN MEDICAL CORP. RAPHAEL WONG
K012035 07/27/2001 BRAUN PRECISION SENSOR PRO, MODEL BP 2590 BRAUN GMBH FRED SCHLADOR
K011728 07/09/2001 BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K011092 07/09/2001 CANDELA SPTL-1E PULSED DYE LASER CANDELA CORP. JOAN CLIFFORD
K003876 07/09/2001 US SENSOR #CG-930P; TOCO SENSOR CG-940P CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K011797 07/03/2001 BIOZTECT SENSOR AND BIOZTECT CABLE CARDIODYNAMICS INTERNATIONAL CORP. BRAIN PARK
K011689 07/25/2001 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT CATCH, INC. MARK E LEGAZ
K011419 07/16/2001 CAVEX COLORCHANGE CAVEX HOLLAND B.V. RICHARD WOORTMAN
K011452 07/19/2001 CAVEX STABISIL CAVEX HOLLAND B.V. RICHARD WOORTMAN
K011054 07/30/2001 RADS CHASON HEALTHCARE, LLC. CHARLES F NEILSON
K011243 07/06/2001 CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 CHATTANOOGA GROUP, INC. CHERYL L BAGWELL
K003438 07/03/2001 SMART RAD CMT MEDICAL TECHNOLOGIES, LTD. YESHAYAHU RAZ
K011481 07/02/2001 10% PVP; 10% PVP IN EBSS SOLUTION CONCEPTION TECHNOLOGIES GRACE HOLLAND
K011573 07/02/2001 HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM CONCEPTION TECHNOLOGIES GRACE HOLLAND
K001780 07/31/2001 COPAN VIRAL TRANSYSTEM COPAN DIAGNOSTICS, INC. MARY MCNAMARA-CULLINANE
K011131 07/31/2001 METHADONE MICROPLATE EIA URINE APPLICATION COZART BIOSCIENCE LTD. LESLY MOORE
K011112 07/17/2001 CYCLOSPORINE CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K011235 07/20/2001 SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K010871 07/09/2001 TGL FLEX REAGENT CARTRIDGE DADE BEHRING, INC. DONNA A WOLF
K010159 07/27/2001 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K012005 07/24/2001 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K011999 07/24/2001 MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K011436 07/05/2001 MOBILE-PATIENT VIEWER DATA CRITICAL CORPORATION FLORIN TRUUVERT
K011560 07/12/2001 TRUBYTE DENTURE BASE RESIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K011862 07/12/2001 DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT DENVER BIOMEDICAL, INC. BONNIE B VIVIAN
K010681 07/18/2001 SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM DEPUY ACROMED FRANK MAAS
K011099 07/06/2001 GLOBAL FX POROUS-COATED HUMERAL STEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K011489 07/31/2001 SUMMIT DUOFIX HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K011505 07/02/2001 IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K011354 07/31/2001 HIGH TIBIAL OSTEOTOMY PLATING SYSTEM DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K012024 07/25/2001 EBI XFIX DFS SYSTEM EBI, L.P. JON CAPAROTTA
K012211 07/31/2001 EFILM WORKSTATION EFILM MEDICAL, INC. KATHY CHIN
K012175 07/31/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K011830 07/23/2001 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K011438 07/23/2001 BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE BUNDY
K012031 07/26/2001 MODIFICATION TO THERMAL ANGEL ESTILL MEDICAL TECHNOLOGIES, INC. DANIEL T KISTNER
K011257 07/13/2001 ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) ETHICON ENDO-SURGERY, INC. KATIE FORDYCE
K011501 07/19/2001 ENDOPOUCH RETRIEVER ETHICON ENDO-SURGERY, INC. DOUG KENTZ
K011114 07/03/2001 ETYMOTIC RESEARCH ER-10D OAE PROBE ETYMOTIC RESEARCH ERIK GUNDERSEN
K011976 07/16/2001 OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) EXACTECH, INC. GARY J MILLER
K012251 07/31/2001 OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES EXACTECH, INC. ROBERT PAXSON
K011291 07/12/2001 TEMPORALSCANNER THERMOMETER, SENSORTOUCH EXERGEN CORP. WILLIAM HARE
K011874 07/20/2001 FADASIS MEDICAL FM-1 NO BLENDER FADASIS MEDICAL, INC. RAYMOND RIDDLE
K003855 07/03/2001 HYALOMATRIX CO FIDIA ADVANCED BIOPOLYMERS SRL PAOLO RAMPAZZO
K001508 07/25/2001 LASERSKIN DRESSING FIDIA ADVANCED BIOPOLYMERS SRL PAOLO RAMPAZZO
K011517 07/10/2001 LUTE; CORE FIRST SCIENTIFIC LIMITED ADE AKINMADE
K011520 07/23/2001 RESTORE-X FIRST SCIENTIFIC LIMITED ADE AKINMADE
K010270 07/25/2001 TREMOROMETER FLEXABLE SYSTEMS, INC. ROBERT M TRIPP
K012178 07/23/2001 FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW FRESENIUS HEMOTECHNOLOGY, INC. TOM TROTTER
K011626 07/16/2001 CONCORD 72 GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K011628 07/16/2001 CONCORD 82 GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K003831 07/20/2001 ARTHROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003805 07/22/2001 GYNECOLOGICAL LAPAROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003802 07/22/2001 HYSTEROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K011786 07/12/2001 VACUETTE SAFETY BLOOD COLLECTION SET GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K011881 07/18/2001 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SABA MODJARRAD
K012002 07/26/2001 VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. STACEY SIMON
K011669 07/09/2001 BW ACUPUNCTURE NEEDLES H F INTL. CO. JOHN N POLITIS
K011032 07/03/2001 SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA HARVEST TECHNOLOGIES, CORP. ANNETTE FAGNANT
K003045 07/12/2001 HA-TI (HAND TITANIUM SCREW) IMPLANT HATI DENTAL AG. HEINZ E WICK
K011130 07/05/2001 PREMIUM HERAEUS KULZER, INC. RAPHAEL JUDKINS
K010541 07/31/2001 PREVISION CHEM HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K012027 07/20/2001 MODIFICATION TO XIA SPINE SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K011948 07/13/2001 HOFFMAN II HYBRID RING CLAMP HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012026 07/18/2001 TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K012060 07/27/2001 MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT HU-FRIEDY MFG. CO.,INC. KEITH DUNN
K011478 07/02/2001 I-STAT SYSTEM I-STAT CORP. PAUL VANDERWERF
K011155 07/12/2001 INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S IBT, INC. RUTH FEICHT
K011173 07/11/2001 TELEPAX IMED SYSTEMS & CONSULTING, LLC. KENNETH P BONNER
K011904 07/19/2001 NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) IMPLEX CORP. ROBERT A POGGIE
K012095 07/26/2001 THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) IMPLEX CORP. ROBERT A POGGIE
K011914 07/27/2001 HYDRO2, HS-75 INNOVISION, INC. DON M WOODFORD
K011566 07/09/2001 QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K011570 07/09/2001 QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K011140 07/27/2001 QUANTA PLEX ENA PROFILE 4 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K010599 07/02/2001 PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K004003 07/19/2001 PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 INTERPORE CROSS INTL. LYNN M RODARTI
K011692 07/25/2001 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT INTERSECT SYSTEMS, INC. MARK LEGAZ
K011281 07/24/2001 INTUITIVE SURGICAL ULTRASONIC SHEARS INTUITIVE SURGICAL, INC. MICHAEL YRAMATEGUI
K983024 07/12/2001 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A. JOHN B REISS
K011938 07/18/2001 OIL FOR EMBRYO CULTURE IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K011205 07/10/2001 ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 ISOAID ART WARD
K011492 07/05/2001 IN TEN-S IVOCLAR NORTH AMERICA, INC. ANDERJEET GULATI
K011596 07/17/2001 UREA NITROGEN (BUN) LIQUID REAGENT JAS DIAGNOSTIC, INC. DAVID JOHNSTON
K011599 07/20/2001 ALKALINE PHOSPHATASE LIQUID REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K011900 07/31/2001 GLUCOSE (HEXOKINASE) JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K011441 07/09/2001 JAS CALCIUM (ARSENAZO) REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K010546 07/10/2001 POWDER FREE LATEX EXAMINATION GLOVES JB STAR SDN BHD KEVIN WALLS
K003551 07/11/2001 VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 JOSTRA AG KATHLEEN JOHNSON
K011780 07/25/2001 K-ASSAY C1-INA KAMIYA BIOMEDICAL CO. COLIN GETTY
K011312 07/18/2001 BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR W T WORKMAN
K011713 07/05/2001 SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE KIMBERLY-CLARK CORP. MARCIA JOHNSON
K990667 07/27/2001 KLS-MARTIN TEMPORARY CONDYLAR IMPLANT KLS-MARTIN L.P. ARTHUR J WARD
K011968 07/25/2001 STREERABLE PTCA GUIDEWIRE LAKE REGION MFG., INC. JEFF PUMPER
K011207 07/24/2001 LASER PERIPHERALS REUSABLE HOLMIUM FIBER LASER PERIPHERALS, LLC. NANCY ARNOLD
K011987 07/11/2001 MODIFIED M-IV MAMMOGRAPHY SYSTEM LORAD, A HOLOGIC CO. ROAIDA RIZKALLAH
K010600 07/13/2001 SUPREMA POWERED WHEELCHAIR LUIGI CHINETTI LUIGI CHINETTI
K010911 07/20/2001 MACROPORE OS SPINAL SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K002207 07/11/2001 MACROPOREPX PEDIATRIC SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K011851 07/11/2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K983332 07/20/2001 NORTHEAST PROTON THERAPY CENTER MASSACHUSETTS GENERAL HOSPITAL JONATHAN S KAHAN
K011085 07/09/2001 GUIDEWIRE INTRODUCER SAFETY NEEDLE MEDAMICUS, INC. DENNIS S MADISON
K011740 07/02/2001 CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) MEDDEV CORP. SUZANNA BRICK
K011731 07/05/2001 TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 MEDICAL ANALYSIS SYSTEMS, INC. DARWIN RICHARDSON
K012006 07/13/2001 MEDICAL DEPOT POWER NEB 1 MEDICAL DEPOT, INC. ART WARD
K011325 07/25/2001 MEDIFIX URETEROSCOPE MEDIFIX, INC. GEORGE ALBULESCU
K011582 07/31/2001 QCU ANALYTICAL SOFTWARE PACKAGE MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.J. HOLLANDER
K011515 07/13/2001 MEDLINE GROUNDING PAD MEDLINE INDUSTRIES, INC. STACEY L BOLEN
K011998 07/26/2001 METRONIC SOFAMOR DANEK CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K011395 07/12/2001 MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B MEDTRONIC VASCULAR CHARLES DOWD
K011864 07/09/2001 TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B MEDTRONIC VASCULAR MARIE HOLM
K011254 07/10/2001 EAR THERMOMETER, MODELS ST613C AND ST613F MESURE TECHNOLOGY PHIL ZULUETA
K011955 07/16/2001 MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K003966 07/17/2001 WUNDCATH CONDUCTION CATHETER MICOR, INC. JEREMIAH COSTELLO
K010008 07/16/2001 AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX MICRONET MEDICAL, INC. CHARLES LEHMAN
K012028 07/27/2001 ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 MISONIX, INC. ALBERT F CLANCY
K003254 07/09/2001 CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 MISSION MEDICL DEVICES DONALD V CANAL
K011734 07/03/2001 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX MOGUL ENTERPRISES JAMIL MOGUL
K011117 07/09/2001 MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS MPS ACACIA FERGIE F FERGUSON
K011360 07/19/2001 MTP LAPAROMAT DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH JAMES A LEE
K011293 07/10/2001 POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES MULTISAFE SDN BHD ABD HADI BIN HUSIN
K011135 07/26/2001 GSI AUDERA NICOLET BIOMEDICAL DAVID W WAGNER
K011606 07/12/2001 PURESPERM BUFFER NIDACON INTERNATIONAL AB DANIEL KAMM
K011310 07/20/2001 NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 NIEN MADE ELECTRNICS CORP. JAMES M DELANEY
K012194 07/20/2001 BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 NIHON SEIMITSU SOKKI CO., LTD.
K011557 07/12/2001 PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NUMED, INC. NICHELLE R LAFLESH
K011549 07/19/2001 OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM OHMEDA MEDICAL ALBERTO F PROFUMO
K011498 07/09/2001 EASY CONTROL MICRO INSERTER, MODEL ON385 OPHTEC USA, INC. RICK MCCARLEY
K010107 07/31/2001 R STENT BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES ROBERT FRECHETTE
K011668 07/09/2001 VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI ORIDION MEDICAL 1987 LTD. SANDY BROWN
K010235 07/09/2001 TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K011350 07/03/2001 STARBAND CRANIAL ORTHOSIS ORTHOMERICA PRODUCTS, INC. WILLIAM H VON OEHSEN
K003823 07/11/2001 SCS DT-02 TRANSVERSE CONNECTOR ORTHOTEC, L.L.C. PATRICK BERTRANOU
K010964 07/05/2001 AUTO-DRIVE LAG SCREW SYSTEM OSTEOMED CORP. DAWN T HOLDEMAN
K011118 07/20/2001 NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM OSTEOMEDICS ALBERT ENAYATI
K011052 07/30/2001 OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE OSTEX INTL., INC. NANCY JS MALLINAK
K011997 07/10/2001 MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX PAJUNK GMBH MARTIN HAUGER
K012133 07/20/2001 LIVESURE BARBITURATES SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K012131 07/20/2001 LIVESURE BENZODIAZEPINES SCREEN TESTS PAN PROBE BIOTECH, INC. ALICE H YU
K012107 07/20/2001 LIVESURE PHENECYCLINE (PCP) SCREEN TESTS PAN PROBE BIOTECH, INC. ALICE H YU
K011206 07/18/2001 PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES PARALLAX MEDICAL, INC. RICHARD M RUEDY
K011311 07/10/2001 UROLOGIC PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD CENGIZ KABAKCI
K010317 07/23/2001 AV 800 VENTILATOR PENLON LTD. ANTHONY PARSONS
K010318 07/23/2001 PRIMA OXYGEN MONITOR PENLON LTD. ANTHONY PARSONS
K012057 07/19/2001 CASCADE BATH, MODEL 6900 PENNER MANUFACTURING, INC. VICKIE J BRADY
K012061 07/19/2001 SUPERIOR BATH, MODEL 6300 PENNER MANUFACTURING, INC. VICKIE BRADY
K011296 07/19/2001 INFINION ENHANCEMENT PACKAGE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE PRASCHAN
K011719 07/02/2001 PLUS CANCELLOUS BONE SCREWS PLUS ORTHOPEDICS HARTMUT LOCH, RAC
K011993 07/13/2001 QUANTUM BLAST PRIDE MOBILITY PRODUCTS CORP. GENE R KULON
K000266 07/12/2001 PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION PRIMARY CARE SOLUTIONS, INC. NORMAN RUEDT
K000265 07/12/2001 PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION PRIMARY CARE SOLUTIONS, INC. NORMAN RUEDT
K011532 07/30/2001 MITYVAC PRISM ENTERPRISES, INC. HOWARD M HOLSTEIN
K011171 07/02/2001 TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS PROCTER & GAMBLE CO. MARK M ANDERSON
K010400 07/24/2001 VACUUM ASSISTED CORE BIOPSY DEVICE PROMEX, INC. JOSEPH L MARK
K011712 07/17/2001 LATEX EXAMINATION GLOVES- POWDER FREE, BLUE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K011895 07/09/2001 POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH PWA INDUSTRIES SDN. BHD. K. KARUNAKARAN
K011995 07/31/2001 POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) QUALITY LATEX PRODUCTS MALAYSIA SDN BHD SHARENE WAN
K010337 07/25/2001 LIPOPRINT SYSTEM, LDL SUBFRACTIONS QUANTIMETRIX CORP. GEBHARD NEYER
K011401 07/13/2001 RAMBLER RAMBLER MOBILITY, INC. JOEL HUSTED
K011302 07/02/2001 RANDOX DIGOXIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K011303 07/02/2001 RANDOX PHENOBARBITAL RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K002580 07/03/2001 PRAIRIE CRUISER RAYE'S, INC. WILLARD L FRICKEY
K011345 07/20/2001 CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM REYNOLDS MEDICAL LTD. GEORGE MYERS
K011837 07/13/2001 LIFECARD CF 7 DAY REYNOLDS MEDICAL LTD. GEORGE MYERS
K011453 07/23/2001 TOOTH SHADE RESIN MATERIAL RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K011658 07/31/2001 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS ROCHDIAG HELEN T TORNEY
K011539 07/20/2001 ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K011352 07/20/2001 ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K010522 07/31/2001 SUREVUE URINE HCG SA SCIENTIFIC, INC. HARBI A SHADFAN
K011456 07/17/2001 DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES SAUFLON PHARMACEUTICALS, LTD. JOHN M SZABOCSIK
K011924 07/10/2001 POWDERED BLUE NITRILE EXAMINATION GLOVES SELTOM PACIFIC SDN. BHD. S SEGARAN
K011922 07/05/2001 POWDERED LATEX EXAMINATION GLOVES SELTOM PACIFIC SDN. BHD. S. SEGARAN
K011402 07/16/2001 BIOPSY SITE MARKER SENORX, INC. AMY BOUCLY
K012034 07/24/2001 MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT SENSORMEDICS CORP. ALEX STENZLER
K011883 07/17/2001 POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011884 07/17/2001 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011882 07/10/2001 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011885 07/16/2001 SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011141 07/03/2001 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC SHIMADZU CORP. MICHAEL FISHBACK
K012016 07/20/2001 INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K011825 07/11/2001 RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE SIGHTLINE TECHNOLOGIES LTD. SIMCHA EDELL
K011129 07/11/2001 SIGN IM NAIL SIGN, INC. JEANNE DILLNER
K011925 07/12/2001 HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO SIMS PORTEX, INC. BRAIN D FARIAS
K011256 07/17/2001 TORIC LITE LENS SOFLEX CONTACT LENS INDUSTRIES LTD. KEVIN WALLS
K010415 07/23/2001 ISODAN SPECIALITES SEPTODONT PETER S REICHERZ
K003662 07/09/2001 SPINE WORKS COLLAR SPINE WORKS DAN FARLEY
K011766 07/03/2001 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 ST. JUDE MEDICAL ANGELA BYLAND
K011319 07/20/2001 STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX STRYKER ENDOSCOPY RYAN YEARSLEY
K011499 07/17/2001 VISUALINE AMPHETAMINE DIPSTRIP ASSAY SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K011332 07/26/2001 RF-IVD WIRELESS DOSIMETER-MODEL 1133 SUN NUCLEAR CORP. WILLIAM E SIMON
K011229 07/11/2001 DEVILBISS 9000 SERIES CPAP, MODEL 9001 SUNRISE MEDICAL HHG, INC. JIM FROEHLICH
K011170 07/05/2001 SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE SYNTHES (USA) THOMAS M MAGUIRE
K011969 07/19/2001 SYNTHES CERVIFIX SYSTEM SYNTHES (USA) JONATHAN GILBERT
K011334 07/27/2001 SYNTHES CURVED RECONSTRUCTION PLATE SYNTHES (USA) MATTHEW M HALL
K011335 07/27/2001 SYNTHS ONE-THIRD TUBULAR DCL PLATE SYNTHES (USA) MATTHEW M HULL
K011947 07/02/2001 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL SYVA CO. SUSAN L COLLINS
K011920 07/02/2001 EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 SYVA CO., DADE BEHRING, INC. SUSAN L COLLINS
K011429 07/13/2001 MODEL 100 ACTIVITY MONITOR TELECOM MEDICAL, INC. THOMAS C WEHMAN
K012191 07/26/2001 TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES TERATECH CORP. CHARLES F HOTTINGER
K011804 07/09/2001 CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K011253 07/20/2001 FLAVORED MALE LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., LTD. ELI J CARTER
K011663 07/30/2001 MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS THE BINDING SITE, LTD. JAY H GELLER
K011662 07/30/2001 MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL THE BINDING SITE, LTD. JAY H GELLER
K011869 07/25/2001 XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K004026 07/09/2001 BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K004025 07/19/2001 SPLITTABLE SHEATH INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. KIMBERLY A FISCHER
K012207 07/23/2001 ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K011497 07/10/2001 CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE TILLOTSON HEALTHCARE CORP. THOMAS N TILLOTSON
K003818 07/05/2001 TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS TITAN IMPLANTS LYNETTE L HOWARD
K011685 07/31/2001 BISTITE II DC TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K011942 07/13/2001 AEQUALIS PRESS-FIT SHOULDER PROSTHESIS TORNIER IRENE GOSSET
K012099 07/31/2001 MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K012097 07/12/2001 VORTEX ULTRAVISUAL MEDICAL SYSTEMS GARY J ALLSEBROOK
K003580 07/31/2001 UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER UNISENSOR AG ROBERT N CLARK
K003709 07/18/2001 SURGICAL DYNAMICS MESH CAGE SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER E SCHUCK
K012017 07/12/2001 VARISEED 7.0 VARIAN MEDICAL SYSTEMS LINDA S NASH
K011957 07/18/2001 IVENT 201 PORTABLE VENTILATOR VERSAMED LTD. KEN RAICHMAN
K011787 07/06/2001 PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE VIDAMED, INC. YI CHEN
K012171 07/24/2001 MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS VISICU, INC. MICHAEL BRESLOW
K003364 07/18/2001 VIVO 200 DPS VIVOSCAN VIVOSONIC, INC. RICHARD KEEN
K011756 07/18/2001 ADMIRA FLOW VOCO GMBH EVAN DICK
K012072 07/12/2001 VOXAR VC, MODEL 1.0 VOXAR LIMITED CONRAD CHIN
K011076 07/16/2001 LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW WALTER LORENZ SURGICAL, INC. KIM REED
K002874 07/27/2001 WELL-TENS WELL-LIFE CONSULTANT KEVIN CHIU
K004043 07/13/2001 METAL TRANSCEND ARTICULATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K011482 07/09/2001 DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K010051 07/13/2001 POLY-TAPES WITH THE FASTLOK FIXATION DEVICE XIROS PLC JIM ROWLAND
K011865 07/31/2001 ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION ZOLL MEDICAL CORP. PAUL DIAS
K011847 07/13/2001 ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE ZYNERGY CARDIO VASULAR (ZCV), INC. JING ZHANG


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