FDA 510(k) Decisions During April, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K010781 04/13/2001 3M ESPE HAUR 3M COMPANY SCOTT ERICKSON
K010789 04/27/2001 CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 A & A MEDICAL, INC. JIHAD MANSOUR
K010363 04/09/2001 ETEST MEROPENEM AB BIODISK ANNE BOLMSTROM
K010670 04/26/2001 PICCOLO CHLORIDE TEST SYSTEM ABAXIS, INC. AMY LEVIN
K010924 04/06/2001 MODIFICATION TO PLUM XL INFUSION PUMP ABBOTT LABORATORIES FRANK POKROP
K010245 04/25/2001 ACTIVHEAL SCAR MANAGEMENT DRESSING ADVANCED MEDICAL SOLUTIONS LTD. CHRIS OAKES
K003740 04/27/2001 MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION AESCULAP, INC. DAVID W SCHLERF
K003463 04/11/2001 SOCON SPINAL SYSTEM AESCULAP, INC. DAVID W SCHLERF
K010275 04/27/2001 DRYSTAR 4500 PRINTER, MODEL 4500 AGFA MEDICAL IMAGING KIRSTEN PAULSON
K010046 04/05/2001 NUVOLASE 532 MEDICAL LASER SYSTEM AMERICAN LASER CORP. DANIEL HOEFER
K010931 04/09/2001 AMS SACRAL COLPOPEXY SLING, MODEL 72403501 AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K010192 04/02/2001 ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION ANTYLLOS MEDIZINTECHNIK GMBH HARALD JUNG
K010063 04/02/2001 COUCH FOR TOTAL BODY RADIATION ARPLAY MEDICAL S.A. RICHARD BORGI
K010172 04/18/2001 LEAD BLOCKS ARPLAY MEDICAL S.A. RICHARD BORGI
K010174 04/18/2001 TRAY ADAPTERS, MULTIPLE ARPLAY MEDICAL S.A. RICHARD BORJ
K010124 04/06/2001 ARTHREX UNIVERS 30 SHOULDER PROSTHESIS ARTHREX, INC. VERNON BROWN
K002627 04/26/2001 ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER ATRIUM MEDICAL CORP. REBECCA DOLLOFF
K010786 04/11/2001 ULNAR HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K010462 04/11/2001 AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) AVITA CORPORATION ALLEN REICH
K003986 04/03/2001 ULTRASOUND SCANNER TYPE 2102 B-K MEDICAL A/S VILLY BRAENDER
K010260 04/27/2001 HANSATOME MICROKERATOME BAUSCH & LOMB, INC. PAUL S KRAMSKY
K003412 04/13/2001 ADVIA CENTAUR RUBELLA IGG ASSAY BAYER CORP. William J Pignato
K010265 04/09/2001 BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 BAYLIS MEDICAL CO., INC. KRIS SHAH
K010765 04/13/2001 COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 BECKMAN COULTER, INC. STAN SUGRUE
K010236 04/05/2001 IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K010693 04/11/2001 VIGIL DNASE B CONTROL BECKMAN COULTER, INC. RICHARD T ROSS, RAC
K010890 04/19/2001 BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) BECTON DICKINSON AND CO. PETER ZURLO
K003542 04/06/2001 PREAMP CABLE, MODEL B400-1011PA BETA BIOMED SERVICES, INC. EJ Smith
K010623 04/05/2001 RECONSTITUTION KIT & VIAL CONNECTOR BIOJECT, INC. NANCY GERTLAR
K010550 04/24/2001 VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 BIOMERIEUX, INC. Nancy Weaver
K010664 04/05/2001 COPELAND RESURFACING HUMERAL HEADS BIOMET MANUFACTURING, INC. SARA A BAILEY
K010774 04/13/2001 AVL HINGE KNEE SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K003494 04/09/2001 MIMIX BONE REPLACEMENT SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K003077 04/26/2001 SMARTSCREW MODEL 222006...227510 BIONX IMPLANTS, LTD. GERARD S CARLOZZI
K010149 04/17/2001 WUJIN #3 FEMORAL NAIL BIOPRO, INC. ANGENA PAREKH
K010196 04/05/2001 TOTAL CURE BISCO, INC. CYNDY ORIS
K010955 04/26/2001 BMT ANSCORE HEALTH MANAGEMENT SYSTEM BOSTON MEDICAL TECHNOLOGIES, INC. CESIDIO TEMPESTA
K010993 04/30/2001 ALIEN RX MICRO CANNULA, MODEL 4530 BOSTON SCIENTIFIC CORP. LIAS M QUAGLIA
K010956 04/13/2001 COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X BOSTON SCIENTIFIC CORP. ANDREA L RUTH
K010853 04/18/2001 GUIDER SOFTIP GUIDING CATHETER XF 5F BOSTON SCIENTIFIC, TARGET ROXANE K BAXTER
K010835 04/30/2001 POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 BUSSE HOSPITAL DISPOSABLES, INC. VICKI ATOR
K010778 04/13/2001 NIAGARA SLIM-CATH C.R. BARD, INC. PEGGY KEIFFER
K010756 04/12/2001 CH 2000 CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K010758 04/12/2001 HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS CAMBRIDGE HEART, INC. JOHN GREENBAUM
K010104 04/11/2001 CANDELA LONG PULSE ND:YAG CANDELA CORP. JOAN CLIFFORD
K010117 04/04/2001 GUIDANT AXIUS CORONARY SHUNT CARDIOTHORACIC SYSTEMS, INC. ANNE SCHLAGENHAFT
K010133 04/05/2001 VERSALUX CENTRIX, INC. JOHN DISCKO
K004046 04/26/2001 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K010823 04/27/2001 SPAZZ COLOURS 'N MOTION VICTOR R BOX
K001352 04/09/2001 REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K010776 04/06/2001 TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS CORIN U.S.A. JOEL BATTS
K010005 04/02/2001 CYNOSURE PHOTOGENICA DL CYNOSURE, INC. GEORGE CHO
K010314 04/20/2001 DIMENSION CTNI CALIBRATOR DADE BEHRING, INC. GEORGE PLUMMER
K010313 04/20/2001 DIMENSION CTNI FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE PLUMMER
K010912 04/05/2001 ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K010742 04/12/2001 MOSS MIAMI 5.5MM TITANIUM PIN NUT DEPUY ACROMED FRANK MAAS
K010810 04/18/2001 DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K010171 04/06/2001 DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K010878 04/18/2001 MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K010350 04/09/2001 STA -CALIBRATOR HBPM/LMWH KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B. LE
K010324 04/09/2001 STA-QUALITY HBPM/LMWH KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B. LE
K011003 04/20/2001 SAFESTING AND SAFESTING HUB DIASOL, INC. MONICA ABELES
K010792 04/03/2001 MAMMOGRAPH DIGITEC MEDICAL SERVICE CORP. JAMES J MCGINTY
K003272 04/04/2001 FLO-BOOT DISCOVERY GROUP LLC. RICHARD J FREER
K002929 04/17/2001 DORNIER COMPACT ALPHA LITHOTRIPTER DORNIER MEDTECH AMERICA, INC. CAROL WERNECKE
K010488 04/09/2001 ATAC PAK AST REAGENT KIT ELAN HOLDINGS, INC. WYNN STOCKING
K003126 04/11/2001 BIPOLAR TRIGGER-FLEX PROBE ELLMAN INTL., INC. FRANK LIN
K002973 04/26/2001 EMBOL-X INTRODUCER, MODEL CF00200 EMBOL-X, INC. ED LEE
K010112 04/02/2001 BIPOLAR COAGULATION SYSTEM ENABLE MEDICAL CORP. MARK L FRIEDMAN
K002981 04/09/2001 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 ETHICON ENDO-SURGERY, INC. RUTH A WOOD
K010722 04/27/2001 PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC. GREGORY R JONES
K011081 04/24/2001 ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS EXACTECH, INC. GARY J MILLER
K010086 04/09/2001 REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) EXCEL TECH. LTD. SONJA MARKEZ
K010092 04/02/2001 XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) EXCEL TECH. LTD. SONJA MARKEZ
K010268 04/27/2001 FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K002892 04/05/2001 FRSENIUS PD IQCARD CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFEILD
K003326 04/11/2001 FUNET AMY MAMA BODY THERMOMETER FUNAI RADIO & COMMUNICATIONS CORP. JOHN LIN
K003613 04/03/2001 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL GE MEDICAL SYSTEMS LARRY A KROGER
K002997 04/11/2001 FIESTA IMAGING OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K010164 04/09/2001 ICG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K010829 04/05/2001 POWDER FREE ELASTIC VINYL EXAMINATION GLOVES GENERAL GLOVES CORP. JOHN CHEN
K010830 04/09/2001 POWDER FREE TEXTURED VINYL EXAMINATION GLOVES GENERAL GLOVES CORP. JOHN CHEN
K010779 04/10/2001 MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT GIBBONS SURGICAL CORP. LISA CRISSON
K003830 04/09/2001 ENT ENDOSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003812 04/30/2001 VACUETTE SPEEDY QUICK-RELEASE HOLDER GREINER VACUETTE NORTH AMERICA, INC. Judi Smith
K010684 04/12/2001 RX HERCULINK PLUS BILIARY STENT SYSTEM GUIDANT CORP. BYRON LAMBERT
K010822 04/18/2001 AB CARDIETTE START 200 HV H&C MEDICAL DEVICES SPA ATTILIO CASTELLI
K011086 04/26/2001 HARDYDISK BACITRACIN, 10MCG, MODEL Z927 HARDY DIAGNOSTICS MELISSA M TRAYLOR
K010767 04/10/2001 LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES HORIZON MEDICAL PRODUCTS, INC. PENNY M NORTHCUTT
K003023 04/30/2001 COBE HC 700 MIDI HEMOCONCENTRATOR HOSPAL INDUSTRIE BARBARA A WATSON
K010100 04/06/2001 AVON PATELLO-FEMORAL JOINT PROSTHESIS HOWMEDICA OSTEONICS CORP. ELIZABETH A STAUB
K010757 04/11/2001 LFIT V40 FEMORAL HEAD COMPONENTS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K010845 04/18/2001 MODIFICATION TO OSTEONICS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K010115 04/16/2001 REFLEX ANTERIOR CERVICAL PLATE SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K010801 04/06/2001 T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K010170 04/18/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K010889 04/25/2001 BABY DOPPLEX 3000 MK 2 (BD3000) HUNTLEIGH HEALTHCARE, INC. B.J. COLLEYPRIEST
K010894 04/25/2001 BABY DOPPLEX 3002 (BD3002) HUNTLEIGH HEALTHCARE, INC. B.J. COLLEYPRIEST
K010178 04/27/2001 SPERMICIDAL LUBRICATED MALE LATEX CONDOM INNOLATEX SDN. BHD CHANG AU-KAU
K010558 04/03/2001 QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K010379 04/13/2001 IL TEST FREE PROTEIN S INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K010220 04/09/2001 XTRACTOR, MODEL M143 INSTRUMENTS MEDICAUX G.B., INC. MARTIN PAQUETTE
K010708 04/30/2001 APPLICATOR TIP/DUAL SPRAYER KIT INTERPORE CROSS INTL. LYNN M RODARTI
K010531 04/18/2001 ILT DEFLECTING CATHETER, MODEL C114ND1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K003561 04/17/2001 INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 INVACARE CORP. RAE ANN FARROW
K010840 04/20/2001 SYNPLUG ISOTIS NV CYNTHIA J M. NOLTE
K010328 04/09/2001 MULTIPLE (IZON DNA BLOOD COLLECTION KIT) IZON BUSINESS PRODUCTS, INC. JACK WERTZ
K010114 04/11/2001 ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) JOHNSON & JOHNSON VISION CARE, INC. SHARON BRIGGS
K010569 04/09/2001 KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP KARL STORZ ENDOSCOPY JAMES A LEE
K003994 04/13/2001 KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K003325 04/27/2001 KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM KARL STORZ IMAGING, INC. TERRY FERNANDEZ
K010994 04/23/2001 TAKE ONE BITE MODIFIED KERR CORP. COLLEEN BOSWELL
K010199 04/05/2001 PJUR EROS WATER FORMULATION L.C.C. PJUR GROUP GERMANY RICHARD HARRIS
K010860 04/03/2001 LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) LAGLOVE (M) SDN. BHD. G BASKARAN
K010861 04/03/2001 LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) LAGLOVE (M) SDN. BHD. G BASKARAN
K010113 04/12/2001 LASER MECHANISMS LASER SCANNING SYSTEM LASER MECHANISMS, INC. JEFFREY HOCKING
K010859 04/05/2001 THE LIBERATOR WHEELCHAIR LIBERATOR WHEELCHAIRS, INC. RICARDO KAUFMANN
K011016 04/27/2001 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT LSI SOLUTIONS CHRISTINE E EHMANN
K010252 04/26/2001 MAGNUM MAGNUM EQUIPMENT L.L.C. MONTE REGAL
K010296 04/11/2001 UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 MARINA MEDICAL INSTRUMENTS, INC. JIHAD (JAY) MANSOUR
K003521 04/19/2001 DISPO-MED 7.6 LITER SHARPS CONTAINER MASTER BENEFITS, INC. JOHNNY TABOADA
K010225 04/24/2001 DOSIMETRY CHECK MATH RESOLUTIONS, LLC. WENDEL D RENNER
K010353 04/27/2001 MED-LOGICS DISPOSABLE ALK TUBING MED-LOGICS, INC. GARY MOCNIK
K010821 04/11/2001 ECHOSEED/IODINE-125 SEEDS, MODEL 6733 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING SUBHASH PATEL
K010074 04/03/2001 MODEL 455GE PHASED ARRAY WRIST COIL MEDICAL ADVANCES, INC. MICHAEL LEIGH
K000442 04/24/2001 ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX MEDICAL CONCEPTS DEVELOPMENT, INC. DAVID PADGET
K011053 04/20/2001 OPTIMA MEDICAL INDUSTRIES AMERICA, INC. LEE SMITH
K010259 04/26/2001 MEDIFACE PACS MEDIFACE CO., LTD. CARL PERSON
K010900 04/05/2001 STS-T LITHOTRIPTER, MODEL STS-T MEDSTONE INTL., INC. RONALD BERGESON
K010561 04/05/2001 VERDICT -II BAR/BZO MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K010959 04/13/2001 VERDICT -II BAR; VERDICT -II BZO MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K010564 04/05/2001 VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K010737 04/04/2001 SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 MEDTRONIC CARDIAC SURGICAL PRODUCTS MARIE HOLM
K010341 04/20/2001 MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, MEDTRONIC PS MEDICAL JANET MCAULEY
K010529 04/27/2001 TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE
K010720 04/11/2001 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K010906 04/05/2001 MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 MEDTRONIC VASCULAR KAREN CLEMENT
K010709 04/23/2001 MENTOR STERILE SALINE MAMMARY VOLUME SIZERS MENTOR CORP. DONNA CRAWFORD
K010377 04/05/2001 MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 MINIMED, INC. JENNIFER LYONS
K010570 04/09/2001 BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 MRI DEVICES CORP. THOMAS SCHUBERT
K010309 04/18/2001 SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR MUTOH AMERICA CO., LTD. DANIEL] KAMM
K000592 04/12/2001 UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K002617 04/05/2001 PERIFORM PERINEOMETRIC PROBE, MODEL 8300 NEEN DESIGN LTD. MARK READ
K002889 04/06/2001 PNS MAGNETIC STIMULATOR SYSTEM NEOTONUS, INC. SHEILA HEMEON-HEYER
K010264 04/27/2001 NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET NIPRO MEDICAL CORP. RICHARD D BLISS, JR
K010451 04/25/2001 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS NOVAMETRIX MEDICAL SYSTEMS, INC. ROBERT H SCHIFFMAN, R.A.C.
K010417 04/26/2001 CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 NUCLEAR ASSOC., DIV. INOVISION LP CHRISTINE G CASTLEBERRY
K010784 04/10/2001 PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 NUCLETRON CORP. ROBERT APPLEBAUM
K010880 04/20/2001 NUMED HIGH PRESSURE PTA CATHETERS NUMED, INC. NICHELLE R LAFLESH
K010795 04/11/2001 CAPNOPROBE SL, MODEL 2000 OPTICAL SENSORS, INC. Gary Syring
K003145 04/20/2001 ORIGEN BLADDER HOLDER ORIGEN BIOMEDICAL, INC. RICHARD MARTIN
K010273 04/25/2001 CRANIAL MOLDING ORTHOSIS ORTHOTIC SOLUTIONS, INC. JOSEPH F TERPENNING
K002036 04/17/2001 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD OSI MEDICAL, INC. JAMES R LEVANI
K002726 04/06/2001 TCOYF FERTILITY SOFTWARE VERSION 1.0 OVUSOFT, LLC. GENE GRANT
K992607 04/27/2001 SONICAID SYSTEM 8002 OXFORD INSTRUMENTS MEDICAL SYSTEMS E.J. Smith
K010537 04/24/2001 LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. AMANDA SHEPPARD
K010536 04/24/2001 MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. AMANDA SHEPPARD
K003350 04/05/2001 HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) PAMITEX INDUSTRIES SDN BHD SAID AWANG
K010967 04/17/2001 LIVESURE COCAINE SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K011011 04/13/2001 LIVESURE MORPHINE SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K010508 04/23/2001 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K011116 04/24/2001 PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST PASCO LABORATORIES, INC. LINDA DILLON
K010740 04/17/2001 FG-36UX, FIBER ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K010365 04/30/2001 ORTHO CONTROL FEMALE URINARY CONTROL DEVICE PERSONAL PRODUCTS CO. MARYLOU PANICO
K010719 04/10/2001 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR PERUSAHAAN GETAH ASAS SDN BHD KONG C TAN
K010653 04/05/2001 AT HOME DRUG TEST, MODEL 9068 T PHAMATECH CARL A MONGIOVI
K010654 04/05/2001 AT HOME DRUG TEST, MODEL 9078 T PHAMATECH CARL A MONGIOVI
K010655 04/05/2001 AT HOME DRUG TESTT, MODEL 9150 T PHAMATECH CARL A MONGIOVI
K010836 04/11/2001 AT WORK DRUG TEST, MODEL 9147T AWT PHAMATECH CARL A MONGIOVI
K010833 04/11/2001 AT WORK DRUG TEST, MODEL 9177T AWT PHAMATECH CARL A MONGIOVI
K010762 04/02/2001 PHILIPS BV LIBRA PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K003274 04/06/2001 LPC-PLUS ACETABULAR CUP PLUS ORTHOPEDICS HARTMUT LOCH
K010195 04/17/2001 PREMIER ULTRASONIC SCALER AND INSERTS PREMIER DENTAL PRODUCTS CO. WILLIAN FREZEL
K003842 04/13/2001 PRESCOTT'S SURGICAL SPEAR PRESCOTT'S, INC. PAUL REDNER
K010630 04/17/2001 Y-TZP POWDER AND PROCERA ALLZIRKON PROCERA SANDVIK, INC. MARTIN STERNER
K003206 04/25/2001 GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 PROXIMA THERAPEUTICS, INC. DEBORAH J MOORE
K010704 04/18/2001 DORNIR LC-1 CPAP SYSTEM PRYM MEDICAL LTD. SHOSHANA FRIEDMAN
K010486 04/10/2001 POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K010461 04/03/2001 ADVIA RETIC PLUS R & D SYSTEMS, INC. KENNETH T EDDS
K010926 04/12/2001 R-SI-LINE METAL-BITE R-DENTAL DENTALERZEUGNISSE GMBH ANDREAS SPRAFKE
K003809 04/20/2001 RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS RAPID DIAGNOSTICS, INC. CHARLES C.F. YU
K003417 04/04/2001 MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K002000 04/10/2001 MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K003676 04/09/2001 RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR RITA MEDICAL SYSTEMS ERIN MAZZONE
K010255 04/20/2001 CAVITY VARNISH RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K004010 04/26/2001 ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS ROCHE DIAGNOSTICS CORP. LUANN OCHS
K010593 04/05/2001 SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT SA SCIENTIFIC, INC. ARBI A SHADFAN
K004038 04/30/2001 TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 SCANTIBODIES LABORATORY, INC. RICHARD LENART
K010625 04/24/2001 EUROSPITAL EU-TTG IGA UMANA SCIMEDX CORP. Gary Lehnus
K010726 04/26/2001 MODIFICATION TO MIRAGE SEGAMI CORP., INC. PHILIPPE A BRIANDET
K000889 04/27/2001 SENOJ IMPLANT SYSTEM SENOJ BIOCARE, INC. PENNY WOLLUM
K003701 04/05/2001 SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) SENTECH MEDICAL SYSTEMS, INC. LYDIA BIGGIE
K010110 04/03/2001 POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE SHEN WEI (USA), INC. BELLE L CHOU
K010626 04/23/2001 POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. JAMES CHU
K010627 04/24/2001 POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. JAMES CHU
K010628 04/23/2001 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. JAMES CHU
K010914 04/20/2001 BEAUTIFIL SHOFU DENTAL CORP. CINDKY RHOADES
K003559 04/26/2001 TCI (TINNITUS CONTROL INSTRUMENT) SIEMENS HEARING INSTRUMENTS, INC. DAVID S SLAVIN
K003558 04/24/2001 TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) SIEMENS HEARING INSTRUMENTS, INC. DAVID S SLAVIN
K010942 04/12/2001 U04 SIEMENS MEDICAL SOLUTIONS USA, INC. AMY SHAW HOSLER
K010489 04/10/2001 DYONICS VISION 111 MOBILE VIDEO UNIT SMITH & NEPHEW, INC. STEVEN JACKSON
K010509 04/27/2001 CEDARS-SINAI BPGS AND MOCO SMV AMERICA PAULA MCLEAN
K002856 04/02/2001 AT3C70 TRANSDUCER SONORA MEDICAL SYSTEMS COLLEEN HITTLE
K994083 04/04/2001 STANNAH POWER CHAIR, MODEL 201 STANNAH POWER CHAIRS LTD. CHARLES EDGELL
K010647 04/13/2001 SIMPLICITY INFUSER INFUSION SET STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K010846 04/12/2001 SIMPLICITY SILVER SET SOFT INFUSION STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K010788 04/20/2001 SIMPLICITY SOFT QD EASY INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K010886 04/30/2001 SIMPLICITY WING INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLASS
K010676 04/18/2001 SIMPLICITY WINGED QD INFUSION SET STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K010969 04/20/2001 NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES STRYKER INSTRUMENTS ROBIN L ROWE
K010839 04/18/2001 CLS VARUS STEM/CLS 135 STEM SULZER ORTHOPEDICS, INC. BRUCE WALDON
K010371 04/27/2001 LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT SURETEX, LTD. LON D MCILVAIN
K010637 04/20/2001 SONOTOME ULTRASONIC ASPIRATOR TIPS SYNERGETICS, INC. ALAN T BECKMAN
K003527 04/09/2001 MODIFICATION TO SYNTHES (USA) POLYPIN SYNTHES (USA) THOMAS M MAGUIRE
K010527 04/25/2001 SYNTHES (USA) IMF SCREWS SYNTHES (USA) THOMAS M MAGUIRE
K003275 04/23/2001 SYNTHES SYNMESH SPACER SYSTEM SYNTHES (USA) JONATHAN GILBERT
K010814 04/13/2001 EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K010984 04/20/2001 EMIT 2000 GENTAMICIN PLUS ASSAY SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K010812 04/13/2001 EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K010934 04/20/2001 EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K010960 04/26/2001 EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K010962 04/26/2001 EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K001915 04/27/2001 GRAFT MARKER RING T. KOROS SURGICAL INSTRUMENTS CORP. TIBOR KOROS
K010578 04/25/2001 TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 TAGA MEDICAL TECHNOLOGIES, INC. GARY AUSTIN
K003987 04/26/2001 URS-1K (KETONE TESST) TECO DIAGNOSTICS DINDO CARRILLO
K010412 04/02/2001 FLEXIBLE ENDOSCOPIC SCISSORS TELEMED SYSTEMS, INC. MICHAEL CARROLL
K010383 04/18/2001 TEMP SCAN TENGHI CO. LTD TONY C S. CHANG
K010883 04/06/2001 TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE TERATECH CORP. CHARLES F HOTTINGER
K010441 04/26/2001 FREELITE KAPPA FREE KIT THE BINDING SITE, LTD. JAY H GELLER
K010440 04/26/2001 FREELITE LAMBDA FREE KIT THE BINDING SITE, LTD. JAY H GELLER
K002902 04/09/2001 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS THE KENDALL COMPANY FRANK J FUCILE
K010283 04/26/2001 THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 THERAGENICS CORP. JANET E ZEMAN
K010271 04/03/2001 THINKINGNET THINKING SYSTEMS CORP. J B WANG
K003731 04/10/2001 SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K010662 04/27/2001 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL TISSUELINK MEDICAL, INC. ROBERTA THOMPSON
K010671 04/09/2001 POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE TONG RUHN MEDICAL PRODUCTS CO., LTD. ANTONIO L GIACCIO
K010129 04/05/2001 EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K010665 04/27/2001 TRANSAMERICA DIGITAL EMS TRANSAMERICA MEDICAL SYSTEMS JOHN F DUNN
K010782 04/27/2001 TRANSAMERICAN TENS TRANSAMERICA MEDICAL SYSTEMS JOHN F DUNN
K010909 04/09/2001 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE TYCO HEALTHCARE GROUP, LP ROBERT ZOTT
K003381 04/23/2001 SHIELDING NEEDLE HOLDER U.S. SAFETY SYRINGES CO., INC. DAVID A HOINES
K010035 04/04/2001 IVS TUNNELLER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHESTER MCCOY
K010213 04/20/2001 MODIFICATION TO CAVERMAP SURGICAL AID UROMED CORP. FREDERICK TOBIA
K010010 04/02/2001 VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR VALLEYLAB, INC. JULIE ROSS
K010507 04/12/2001 VISTAKON (METHAFILCON A) CONTACT LENSES VISTAKON MICHAEL J TERSAK
K010288 04/13/2001 ANEUVYSION MULITICOLOR DNA PROBE KIT VYSIS RUSSEL K ENNS
K002131 04/13/2001 LACTOSORB ETHMOID STENT WALTER LORENZ SURGICAL, INC. TREVOR BYRD
K001997 04/02/2001 WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) WHITE KNIGHT HEALTHCARE, INC. ART WARD
K001892 04/03/2001 WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) WHITE KNIGHT HEALTHCARE, INC. ART WARD
K001893 04/02/2001 WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) WHITE KNIGHT HEALTHCARE, INC. ART WARD
K010421 04/13/2001 WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K003440 04/20/2001 SOFTLASE - SURGICAL DIODE LASER SYSTEM ZAP LASERS, INC. DAVID W SCHLERF
K010685 04/02/2001 MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) ZIMMER, INC. STEPHEN H MCKELVEY


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