FDA 510(k) Applications Received During April, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K050862 04/05/2005 3TP WORKSPACE 3TP LLC MICHAEL KOCHIAN
K051041 04/25/2005 INSULIN PUMP ABBOTT DIABETES CARE INC. MARY ROSE
K050936 04/14/2005 ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE ACON LABORATORIES, INC. EDWARD TUNG
K050878 04/06/2005 ON CALL MULTI-DRUG HOME TEST CUP ACON LABORATORIES, INC. EDWARD TUNG
K050950 04/15/2005 MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS EFRAIM BIDAS
K051083 04/27/2005 ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K050922 04/13/2005 ANS SCS ACCESSORY KIT ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K050979 04/19/2005 S4 SPINAL SYSTEM AESCULAP, INC. JOYCE KILROY
K051054 04/26/2005 VISULIZE FACTOR IX ANTIGEN KIT AFFINITY BIOLOGICALS INC. DENISE FOULON
K051028 04/22/2005 BREEZE AFIKIM ELECTRIC VEHICLES AVNER FISHBEIN
K050953 04/15/2005 AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE AIR SAFETY LTD PAUL DRYDEN
K051101 04/29/2005 VERIFY FLASH INTEGRATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K051056 04/26/2005 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K050985 04/19/2005 GLUCODR SUPERSENSOR SYSTEM ALL MEDICUS CO., LTD JE YOUNG CHANG
K050830 04/01/2005 ZODIAC SPINAL FIXATION SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K051044 04/25/2005 ARCTEC SEMIRIGID PLATING SYSTEM ALTIVA CORP. JOHN KAPTIAN
K051031 04/22/2005 AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS AMERIWATER BRIAN R BOWMAN
K051059 04/26/2005 AMSURE 100% SILICONE FOLEY CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050919 04/12/2005 LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P ANALOGIC CORP. DONALD SHERRATT
K051060 04/26/2005 ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K051042 04/25/2005 METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 ANGIOMETRX INC. TIM VERSPAGEN
K050969 04/18/2005 INCLOSE SURGICAL MESH SYSTEM ANULEX TECHNOLOGIES, INC TIM MILLER
K050864 04/05/2005 PARALLAX ACRYLIC RESIN WITH TRACERS TA ARTHROCARE CORP. VALERIE DEFIESTA-NG
K051069 04/26/2005 NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER ARTHROTEK, INC. GARY BAKER
K050900 04/11/2005 MEDIOSTAR XT ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K051077 04/27/2005 E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 ASEPTICO, INC. GRANT RAMALEY
K050874 04/06/2005 ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE R MANNING
K051011 04/21/2005 ENDOSSEOUS DENTAL IMPLANT ABUTMENT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K051046 04/25/2005 PAINACEA MODEL XR8 INFRARED HEAT LAMP ATLANTIS LUMINESCENT PRODUCTS, LLC JAMES HARVEY KNAUSS
K050832 04/01/2005 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR, INC. DENNIS SALZMANN
K050948 04/15/2005 PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB, INC. ANNE ZAVERTNIK
K050881 04/07/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML BECTON, DICKINSON & CO. MONICA E GUIGUERE
K050946 04/15/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050865 04/05/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050982 04/19/2005 BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) BECTON, DICKINSON & CO. MONICA E GIGUERE
K051091 04/28/2005 SYNTHOGRAFT BICON, INC. VINCENT J MORGAN
K051072 04/26/2005 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM BIO-RAD LABORATORIES, INC. WILLIAM G GUSTAFSON
K051030 04/22/2005 COAG-A-MATE MTX III BIOMERIEUX, INC. JOHN CUSACK
K050976 04/18/2005 VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. Nancy Weaver
K050961 04/18/2005 RNA1C CONTROL FOR NYCOCARD HBA1C BIONOSTICS, INC. KATHLEEN STORRO
K050877 04/06/2005 CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR BIOSENSE WEBSTER, INC. MICHAEL JOHNSON
K050971 04/18/2005 BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K050840 04/01/2005 MODIFICATION TO DUET SYSTEM BIOVIEW LTD. DORIT WINITZ
K050892 04/08/2005 HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K050964 04/18/2005 PV 1900 SYNCHRO 0.016 GUIDEWIRE BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K050863 04/05/2005 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. Diane Brinza
K050996 04/20/2005 O-ARM IMAGING SYSTEM BREAKAWAY IMAGING, LLC WOLFGANG KRULL
K050931 04/14/2005 6 FR DL POWERPICC CATHETER C.R. BARD, INC. PEGGY KEIFFER
K050875 04/06/2005 U-BALLOON DILATION CATHETER C.R. BARD, INC. JOHN C KNORPP
K050987 04/19/2005 DIGITAL RADIOGRAPHY MODEL CXDI-40EG CANON, INC. SHEILA DRISCOLL
K050940 04/14/2005 PMP4 MEDICAL WEB CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K050853 04/04/2005 PMP4 SPIROPRO CARD GUARD SCIENTIFIC SURVIVAL, LTD. NA'AMA OREN
K050994 04/19/2005 AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Cardinal Health SHARON NICHOLS
K050939 04/14/2005 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM CARDIOMEMS INC CAROL VIERLING
K051055 04/26/2005 INTRABEAM SYSTEM CARL ZEISS SURGICAL GMBH ROSINA ROBINSON
K050844 04/04/2005 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K051013 04/21/2005 SPINEMED S200B/S200C CERT HEALTH SCIENCES, LLC TIM R EMSKY
K050826 04/01/2005 FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS CETRO AMERICA MAYA CIANCIOLO
K050828 04/01/2005 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K050951 04/15/2005 MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 CIBERNET SYSTEMS CORP. ERIC LICHTENSTEIN
K051038 04/25/2005 506 PATIENT MONITOR CIRITICARE SYSTEMS, INC. ALEX KAPLAN
K051089 04/28/2005 GII SPINAL FIXATION SYSTEM CO-LIGNE AG DAVID W SCHLERF
K051085 04/28/2005 DOPPLER-BOX COMPUMEDICS GERMANY GMGH GEROLD WIDENHORN
K050998 04/20/2005 CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 CONFLUENT SURGICAL,INC ERIC P ANKERUD
K050992 04/19/2005 CONMED IRRIGATION NOZZLE CONMED CORP. IRA DUESLER
K050829 04/01/2005 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K050923 04/13/2005 LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR CONMED LINVATEC ELIZABETH PAUL
K051048 04/25/2005 SURGISIS STAPLE LINE REINFORCEMENT II COOK BIOTECH, INC. MARK BLEYER
K050889 04/06/2005 FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH CRS MEDICAL DIAGNOSTICS INC. JOSEPH M MATTANO
K051081 04/27/2005 ESSENPACS CYMED ENGINEERING, INC. CARL ALLETTO
K050928 04/14/2005 DADE THROMBIN REAGENT DADE BEHRING, INC. KATHELEEN A DRAY-LYONS
K051087 04/28/2005 DIMENSION VISTA INTEGRATED SYSTEM DADE BEHRING, INC. LORRAINE H PIESTRAK
K050860 04/05/2005 GE DATEX-OHMEDA CENTIVA/5 VENTILATOR DATEX-OHMEDA, INC. DAN KOSEDNAR
K050851 04/04/2005 DELTA PUNCTUM PLUG DELTA LIFE SCIENCE, INC. GEORGE W MURRAY
K050959 04/18/2005 DELTON ILLUMINATING PIT AND FISSURE SEALING DENTSPLY INTERNATIONAL HELEN LEWIS
K050880 04/06/2005 DYRACT EXTRA RESTORATIVE DENTSPLY INTL. HELEN LEWIS
K051084 04/28/2005 DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE DENVER BIOMEDICALS, INC. NANCY SAUER
K050991 04/19/2005 THE ODFS DROPPED FOOT STIMULATOR DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. TINA LECHMAN
K051024 04/22/2005 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K050888 04/07/2005 INTEGRA IMMOBILIZATION SYSTEM DIACOR, INC. GLENN N WATERMAN
K050827 04/01/2005 NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) DIALYSIS SOLUTIONS, INC. MARCY MACDONALD
K050913 04/12/2005 DICK'S FORMALWEAR MALE LATEX CONDOM DICK'S FORMALWEAR INC. CURT STRENK
K050890 04/08/2005 ECC.O SYSTEM DIDECO S.R.L. BARRY SALL
K050974 04/18/2005 DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS Draeger Medical Systems, Inc. PENELOPE H GRECO
K051014 04/21/2005 SILENT PARTNER SERIES OSA APPLIANCES DREAMWRX DENTAL LABORATORY NICOLAAS BESSELING
K050921 04/13/2005 EASYSTIM NMS-28 EASYMED INSTRUMENT CO., LTD. JEFFERY WU
K051022 04/22/2005 GAMMAPLAN ELEKTA INSTRUMENT AB PETER LOWENDAHL
K051075 04/27/2005 ENCORE REVERSE SHOULDER PROSTHESIS ENCORE MEDICAL, L.P. CHRISTIE SHUMAKER
K051002 04/20/2005 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K051036 04/25/2005 HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P ETHICON ENDO-SURGERY, INC. RACHEL D AUSTIN
K050845 04/04/2005 MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, INC. JENNIFER M PAINE
K050904 04/11/2005 CPAP HUMIDIFIER, MODEL HC238JHU FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K050927 04/13/2005 RT019 INSPIRATORY/EXPIRATORY FILTER FISHER & PAYKEL HEALTHCARE, LTD. RENETA MONEY
K050997 04/20/2005 EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE FLEXUSPINE, INC. COREY HARBOLD
K051062 04/26/2005 VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO FLOWCARDIA, INC. RICHARD SPANO
K050907 04/11/2005 FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P FUJINON, INC. JOSEPH AZARY
K051052 04/25/2005 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) GALIL MEDICAL LTD. JONATHAN S KAHAN
K051092 04/28/2005 DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC GE HEALTHCARE JOEL C KENT
K050835 04/01/2005 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K050837 04/01/2005 REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE GE HEALTHCARE JOEL KENT
K051026 04/22/2005 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K050943 04/14/2005 GE VIEWPOINT GENERAL ELECTRIC CO. ALLEN SCHUH
K050850 04/04/2005 XPAND CORPECTOMY SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K051103 04/29/2005 HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY HAAG-STREIT USA, INC. EDUARDO MARCH
K050932 04/14/2005 DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM HAND INNOVATIONS, INC. ERNIE HERNANDEZ
K050858 04/05/2005 ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM HEARTLAB, INC. RICHARD PETROCELLI
K051006 04/20/2005 IBOND NEXT GENERATION HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K050854 04/04/2005 PALACOS LV+G HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K050855 04/04/2005 PALAMED G HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K051025 04/22/2005 FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM HOLOGIC, INC. DANIEL F PHELAN
K051079 04/27/2005 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY HOSPICARE, INC. Yuliya Matlin
K050852 04/04/2005 CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH ALBERT LIPPINCOTT
K050926 04/13/2005 TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 IDEV TECHNOLOGIES, INC. SHANNON HURD
K050983 04/19/2005 IRMA TRUPOINT CREATININE CONTROL KIT INTERNATIONAL TECHNIDYNE CORPORATION NANCY RING
K050861 04/05/2005 PEEK CAS INTERPORE CROSS INTL. WENDY SPIELBERGER
K050970 04/18/2005 MILO DENTAL IMPLANT SYSTEM INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K050915 04/12/2005 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K050916 04/12/2005 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K051037 04/25/2005 IMAGEQUBE PACS INTUITIVE IMAGING INFORMATICS, LLC DONALD MUNDT
K050838 04/01/2005 THE LF-P CERAMIC SYSTEM JENSEN INDUSTRIES, INC. GARY PHELPS
K050999 04/20/2005 YI XIN STERILE SYRINGE FOR SINGLE USE JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP YUN YUAN GAO
K050944 04/14/2005 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K050984 04/19/2005 BIOPLANT KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K050897 04/08/2005 NAVIPRO SHOULDER SOFTWARE MODULE KINAMED, INC. VINEET K SARIN
K050918 04/12/2005 KOO AMERICAS VALVE PEEP, MODEL KM-809 KOO AMERICAS, INC. WILLIAM SLEVIN
K051061 04/26/2005 KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. MEATHER VIELE
K051067 04/26/2005 PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LEMAITRE VASCULAR, INC. AMY WATZKE
K050989 04/19/2005 AWQ-104 LHASA OMS, INC. MARK W SHEEHAN
K051020 04/22/2005 ES-160 LHASA OMS, INC. MARK W SHEEHAN
K051058 04/26/2005 METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. CHENG-I LIN
K051088 04/28/2005 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. CHENG-I LIN
K050988 04/19/2005 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K050945 04/14/2005 ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS Lin-Zhi International, Inc. CHENG-I LIN
K051034 04/22/2005 URYXXON 200 URINE ANALYZER MACHEREY-NAGEL GMBH & CO., KG. EDUARDO MARCH
K050973 04/18/2005 MODIFICATION TO: VOYAGER LINUX MAKO SURGICAL CORP. WILLIAM F TAPIA
K050963 04/18/2005 GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN MDS NORDION ROSS KACHANIWSKY
K051065 04/26/2005 RAYCELL X-RAY BLOOD IRRADIATOR MDS NORDION ROSS KACHANIWSKY
K050934 04/14/2005 MODUS TITANIUM OSTEOSYNTHESIS SYSTEM MEDARTIS, INC. FLOYD G LARSON
K050873 04/06/2005 CANALIZER HYDROPHILIC GUIDE WIRE MEDICAL DEVICE TECHNOLOGIES, INC. KRISTINE LIBERACKI
K050990 04/19/2005 REMREST HEATED HUMIDIFIER MEDICAL INDUSTRIES AMERICA, INC. KEITH THEISEN
K050993 04/19/2005 MMS VIDEO OPTION MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K050933 04/14/2005 FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 MEDISURG LTD. RICHARD J FUGO
K051082 04/27/2005 MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K051040 04/25/2005 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC PERFUSION SYSTEMS BRUCE BACKLUND
K051039 04/25/2005 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K050981 04/19/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TRECHAME
K051029 04/22/2005 STELTHSTATION WIRELESS SURGEON MOUSE MEDTRONIC SURGICAL NAVIGATION TINA DREILING
K051018 04/21/2005 INTERMEZZO IMPLANT SYSTEMS MEGAGEN CO., LTD. DAE KYU CHANG
K050924 04/13/2005 MERETE DUOTHREADTM BONE SCREW MERETE MEDICAL GMBH JENIK RADON
K050962 04/18/2005 MERIT PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K051090 04/28/2005 X-CHANGE MEYRA KIRK MACKENZIE
K050941 04/14/2005 BRIX WHEELCHAIR MEYRA, INC. KIRK MACKENZIE
K051074 04/27/2005 MAS IMMUNOSUPPRESSANT CONTROLS MICROGENICS CORP. LISA CHARTER
K051100 04/29/2005 MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K050954 04/15/2005 MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K051073 04/26/2005 MIDIVIEW SERIES OF MICROENDOSCOPES MILLENNIUM DEVICES, INC. JOSEPH LIBRIZZI
K050952 04/15/2005 HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR MINNTECH CORP. LYNN LUEDERS
K051007 04/20/2005 ACCU02 SYSTEM MITI CORP. JONATHAN S KAHAN
K050842 04/01/2005 AGCEL WOUND DRESSING,AGCEL BURN DRESSING MODERN MEDICAL EQUIPMENT MFG., LTD. BOB STILLMAN
K050896 04/08/2005 H12+ HOLTER RECORDER MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K050975 04/18/2005 NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN NANO-DITECH CO. SUSAN D GOLDSTEIN-FALK
K050882 04/07/2005 NEWDEAL ANKLE NAIL NEWDEAL S.A. JUDITH E O'GRADY
K050833 04/01/2005 ELECTRODE JUNCTION BOX, MODEL JE-921A NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K050920 04/12/2005 CZR PRESS LF STAINS NORITAKE CO., INC. IVAN J WASSERMAN
K051009 04/21/2005 HUBER CLEAR SAFETY INFUSION SET NOW MEDICAL DISTRIBUTION, INC. CHRISTINE EMANNUEL
K050857 04/05/2005 BIB PTA BALLOON CATHETER NUMED, INC. JODI GIJANTO
K050885 04/07/2005 OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K050856 04/05/2005 LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM OPHTHOCARE LTD. DORIT WINITZ
K051095 04/28/2005 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR OPTICAL CONNECTION, INC. GAROLD L EDWARDS
K050966 04/18/2005 PIVOT BIPOLAR FEMORAL HEAD ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K050868 04/06/2005 MAXLOCK ORTHOHELIX SURGICAL DESIGNS, INC. EDWARD A KROLL
K051032 04/22/2005 TITANIUM-HIP TOOL ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K051053 04/25/2005 OSCAR, MODEL OE3000DB ORTHOSONICS, LTD. T. WHIT ATHEY
K051047 04/25/2005 COLLOSS E BONE VOID FILLER OSSACUR AG KRISTI KISTNER
K051093 04/28/2005 OSTEOPORE PCL SCAFFOLD OSTEOPORE, INC. ALEXANDER YEO
K050866 04/05/2005 CENTRION 500 C-ARM SYSTEM OSTEOSYS CO., LTD. T. WHIT ATHEY
K050929 04/14/2005 THE HERMES SYSTEM PALAISTRA SYSTEMS INC. PATRIC GORA
K050980 04/19/2005 ULTRASONIC BIO-MICROSCOPE, MODEL P60 PARADIGM MEDICAL INDUSTRIES, INC. EDWARD A KROLL
K050955 04/15/2005 LIFESIGN DXPRESS, MODEL LSR2000 PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
K050968 04/18/2005 POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K051017 04/21/2005 R-X-FIX EXTERNAL FIXATOR R-X-FIX J.D. WEBB
K050869 04/06/2005 MODIFICATION TO ABL800 FLEX RADIOMETER MEDICAL APS MARK A HELLER
K050899 04/11/2005 BIOGEL LATEX STERILE POWDER-FREE GLOVE REGENT MEDICAL AMERICAS, LLC KATHLEEN HARRIS
K050841 04/01/2005 FRAXEL SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER
K050884 04/07/2005 ADAPTER CABLE REMINGTON MEDICAL, INC. DON ROSVOLD
K051097 04/29/2005 GERATHERM SOS-RESCUE BLANKET RG ENT., INC. RONALD G LETOURNEAU
K051102 04/29/2005 OMNIPICC PI RITA MEDICAL SYSTEMS, INC. DAVID SMITH
K050872 04/06/2005 ACCU-CHEK INTEGRA SYSTEM ROCHE DIAGNOSTICS CORP. Scott Thiel
K050910 04/11/2005 ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS ROEI MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHN
K050883 04/07/2005 SAFERSLEEP SYSTEM SAFER SLEEP LLC STEVEN CHERNOFF
K051012 04/21/2005 PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. SALIMETRICS LLC. VIRGINIA MCKAY MCKAY
K051019 04/22/2005 SAFETY NEEDLE SARSTEDT, INC. PETER RUMSWINKEL
K050895 04/08/2005 SURPASSON P5 NEWTRON SATELEC PASCAL DUPEYRON
K051050 04/25/2005 SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 SCHUTZ-DENTAL GMBH MICHAEL WIERZ
K051063 04/26/2005 POLYAXIAL HEMISPHERICAL SPINAL SCREWS SCIENT'X J.D. WEBB
K050836 04/01/2005 CRP DIAGNOSTIC ASSAY SENTINEL CH. SRL Maria E Donawa
K051010 04/21/2005 SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 SEPTODONT WAYNE H MATELSKI
K051021 04/22/2005 ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. SUSAN D GOLDSTEIN-FALK
K050925 04/13/2005 DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE SHIMADZU CORP. RANDAL WALKER
K050867 04/06/2005 SYNGO BODY PERFUSION-CT SIEMENS AG RUEDIGER KOERNER
K050849 04/04/2005 HA COATED LAG SCREW SMITH & NEPHEW, INC. DAVID HENLEY
K050938 04/14/2005 KNEE FUSION NAIL SMITH & NEPHEW, INC. LAURIE JORDAN
K051086 04/28/2005 SMITH & NEPHEW PATELLO-FEMORAL IMPLANT SMITH & NEPHEW, INC. GINO ROUSS
K050898 04/11/2005 SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX SMITH & NEPHEW, INC. KAREN PROVENCHER
K050870 04/06/2005 RIVA LIGHT CURE SOUTHERN DENTAL INDUSTRIES, INC. RAY CAHILL
K050871 04/06/2005 RIVA PROTECT SOUTHERN DENTAL INDUSTRIES, INC. RAY CAHILL
K051008 04/20/2005 SET SOUTHERN DENTAL INDUSTRIES, LTD. RAY CAHILL
K050957 04/15/2005 EUTROCHAR SPECIAL DEVICES, INC. JOSEPH J SPRANZA III
K051045 04/25/2005 SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 SPECTRX, INC. WILLIAM M VONDERSMITH
K051000 04/20/2005 FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE SPINAL CONCEPTS, INC. NOAH BARTSCH
K051096 04/29/2005 APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 ST. JUDE MEDICAL, DAIG DIVISION, INC. MIKE BURNSIDE
K050831 04/01/2005 STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A STELLARTECH RESEARCH CORP. JAMES SANTOS
K050956 04/15/2005 TBR IDEA CONIC/CONIC SUDIMPLANT SA DIDIER SAILHAN
K051027 04/22/2005 STALIF TT SURGICRAFT LTD. JANET M WEBB
K050967 04/18/2005 VARELISA RECOMBI CTD SCREEN, MODEL 13096 SWEDEN DIAGNOSTICS (GERMANY) GMBH MICHAEL LINSS
K051035 04/22/2005 SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS SYNERGEYES RICHARD E LIPPMAN
K051049 04/25/2005 SYNTHES (USA) LOW-PROFILE WRIST FIXATOR SYNTHES (USA) KATHY ANDERSON
K050891 04/08/2005 TOX A/B QUICK CHEK TECHLAB, INC. DAVID M LYERLY
K051094 04/28/2005 NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE TERANG NUSA SDN BHD LOW CHIN GUAN
K050846 04/04/2005 B-CAD SYSTEM, VERSION 1.0 THE MEDIPATTERN CORPORATION PATRICIA A MILBANK
K050847 04/04/2005 IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A THERATECH, INC. MICHAEL PRICE
K051066 04/26/2005 THERATEST EL-ANA PROFILES THERATEST LABORATORIES, INC. MARIUS TEDORESCU
DEN050004 04/05/2005 TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION NANCY KRUNIC
K051023 04/22/2005 TOPEZ TOTAL ANKLE REPLACEMENT TOPEZ ORTHOPEDICS, INC LEWIS WARD
K050848 04/04/2005 TORNIER ELBOW PROSTHESIS TORNIER Mireille Lemery
K050965 04/18/2005 TRANS1 AXIALIF SYSTEM TRANS1 INCORPORATED ROBERT L SHERIDAN
K050930 04/14/2005 E.P.T. CERTAINTY PREGNANCY TEST UNIPATH LTD. Louise Roberts
K050947 04/15/2005 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON L MURPHY
K051043 04/25/2005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K051169 04/29/2005 BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT VIRAMED BIOTECH AG BARRY E MENEFEE
K051071 04/26/2005 VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT VIRAMED BIOTECH AG BARRY E MENEFEE
K050972 04/18/2005 VISION-SCIENCES ENT-3000 SCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
K050906 04/11/2005 VITALCARE I.V. ADMINISTRATION SET VITALCARE GROUP, INC. MICHAEL MCAVENIA
K050995 04/20/2005 REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER VOLCANO CORPORATION LORRY HUFFMAN
DEN050002 04/07/2005 LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS WAKO CHEMICALS, USA, INC. TONYA MALLORY
K050960 04/18/2005 MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT WALLAC OY GUNNEL LAAKSONEN
K050903 04/11/2005 XAWEX G 100 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K050843 04/01/2005 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM XOFT, INC. Kathy O'Shaughnessy
K050887 04/07/2005 GONGDONG DISPOSABLE VAGINAL SPECULUM ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY WEIFENG ZHONG
K051064 04/26/2005 ZIEHM QUANTUM ZIEHM IMAGING, INC. RICHARD WESTRICH
K050937 04/14/2005 TRABECULAR METAL ACETABULAR REVISION SHELLS ZIMMER TRABECULAR MARCI HALEVI
K051098 04/29/2005 PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES ZIMMER, INC. LAURA D WILLIAMS
K051076 04/27/2005 ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES ZOLL MEDICAL CORPORATION SEAN REYNOLDS
K051068 04/26/2005 ZUTRON COLONOSCOPE STIFFENING DEVICE ZUTRON MEDICAL JORDAN HARTONG


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