FDA 510(k) Decisions During July, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K051790 07/25/2005 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 3M COMPANY GINGER CANTOR
K051797 07/21/2005 FUTURE WASH/YPS 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K050862 07/25/2005 3TP WORKSPACE 3TP LLC MICHAEL KOCHIAN
K051108 07/08/2005 PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM ABAXIS, INC. Dennis M Bleile
K051215 07/21/2005 CELL-DYN SAPPHIRE SYSTEM ABBOTT LABORATORIES MICHELLE ROEDING
K051381 07/15/2005 ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K051410 07/21/2005 ACUMED RIB CONGRIENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K042562 07/29/2005 LENS PLUS REWETTING DROPS ADVANCED MEDICAL OPTICS, INC. PETER XU
K043353 07/01/2005 OMEGA EXCEL/XP LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
K050979 07/27/2005 S4 SPINAL SYSTEM AESCULAP, INC. JOYCE KILROY
K051216 07/19/2005 HYDRALOK SYSTEM ALTIVA CORP. JOHN KAPITAN
K051621 07/11/2005 ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC. DONALD V CANAL
K041696 07/12/2005 RAPID READER AMERICAN BIO MEDICA CORP. FRAN WHITE
K051530 07/08/2005 MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. AMERICAN MEDICAL SYSTEMS, INC. DENISE THOMPSON
K050785 07/15/2005 AMSINO ENDOTRACHEAL TUBE AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K051142 07/13/2005 ANGIODYNAMICS TUMESCENT INFUSION DEVICE ANGIODYNAMICS, INC. TERI JUCKETT
K042791 07/01/2005 INSTANT-X, MODELS 1713 & 128 ANN ARBOR DIGITAL DEVICES WILLIAM J O'NEILL
K051795 07/14/2005 NOMAD DENTAL X-RAY SYSTEM ARIBEX, INC. D.CLARK TURNER
K051652 07/22/2005 ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT ATLANTIS COMPONENTS, INC. BETSY BROWN
K051011 07/12/2005 ENDOSSEOUS DENTAL IMPLANT ABUTMENT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K050687 07/28/2005 AXIOM EPS8000 AXIOM WORLDWIDE, INC. JAMES J GIBSON
K050574 07/22/2005 AFINION HBALC AXIS-SHIELD POC AS RONALD G LEONARDI
K033028 07/22/2005 ANEFIN, MODEL 100 AXON MEDICAL JOSEPH ORR
K050832 07/07/2005 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR, INC. DENNIS SALZMANN
K051253 07/15/2005 MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K051194 07/25/2005 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 BECTON DICKINSON & CO. LESLIE WOOD
K042472 07/07/2005 BD DIRECTIGEN EZ FLU A + B BECTON, DICKINSON & CO. GREG PAYNE
K051692 07/14/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051272 07/11/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051266 07/05/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051695 07/19/2005 MARROW PLUS (M+) BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K050135 07/13/2005 K-C HEMOSTATIC BIOPSY SYSTEM BIOENGINEERING CONSULTANTS LTD. WILLIAM R KRAUSE
K043428 07/12/2005 RELIADENT DENTAL IMPLANT SYSTEM BIOINFERA, INC. CHAN Q WANG
K050210 07/19/2005 DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES BIOMET, INC. LONNIE WITHAM
K051845 07/27/2005 THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM BIOPLATE, INC. JESUS T FARINAS
K051679 07/14/2005 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K051316 07/18/2005 X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. JOHN C KNORPP
K051359 07/13/2005 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY CANDELA CORP. LORRAINE CALZETTA PATROVIC
K050940 07/01/2005 PMP4 MEDICAL WEB CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K050808 07/28/2005 CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 CARDIO-OPTICS, INC. LARRY BLANKENSHIP
K051681 07/27/2005 DERMILLUME RED, MODEL HR1000 CARE ELECTRONICS, INC. THOMAS O MOODY
K050951 07/19/2005 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
K033579 07/11/2005 REPROCESSED MULTIPLE CLIP APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K033578 07/11/2005 REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K050739 07/18/2005 CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. KAREN F JURCZAK
K050992 07/14/2005 CONMED IRRIGATION NOZZLE CONMED CORP. IRA DUESLER
K041849 07/21/2005 TURBO-FLO PICC COOK, INC. EARL E KNIGHT III
K051124 07/12/2005 ZILVER 635 BILIARY STENT COOK, INC. STEPHANIE ROBERTS
K050635 07/28/2005 ALLFIM IMPLANT SYSTEMS COWELL MEDI CO LTD. DAE KYU CHANG
K050379 07/12/2005 CS MEDICAL ADULT TTCF CATHETER CS MEDICAL INC. LEWIS WARD
K050381 07/13/2005 CS MEDICAL TTCF GAS DELIVERY SYSTEM CS MEDICAL INC. LEWIS WARD
K051443 07/22/2005 CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO CURASAN AG, FRANKFURT FACILITY ERIC WIECHERT
K050793 07/07/2005 LANDLEX MODEL S400X CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN-LAN
K050507 07/07/2005 SMARTECH, MODEL HOLI I CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN-LAN
K051087 07/11/2005 DIMENSION VISTA INTEGRATED SYSTEM DADE BEHRING, INC. LORRAINE H PIESTRAK
K051478 07/27/2005 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN DADE BEHRING, INC. ROBERT EUSEBIO
K051311 07/12/2005 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN DADE BEHRING, INC. ROBERT EUSEBIO
K051350 07/25/2005 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERTO EUSEBIO
K050620 07/14/2005 READMYHEART, MODEL RMH3.0 DAILYCARE BIOMEDICAL INC DANIEL J CHANG
K051707 07/15/2005 ECLIPSE BONDING AGENT DENTSPLY INTL. HELEN LEWIS
K051463 07/12/2005 XENO ADHESIVE WITH ACTIVATOR DENTSPLY INTL. HELEN LEWIS
K050991 07/15/2005 THE ODFS DROPPED FOOT STIMULATOR DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. TINA LECHMAN
K051024 07/06/2005 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K043406 07/15/2005 VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE,INC SHARON STAROWICZ
K051191 07/05/2005 DCL MICROALBUMIN ASSAY, MODEL 252-20 DIAGNOSTIC CHEMICALS LTD. PENNY WHITE
K051549 07/13/2005 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. Joel Tuckey
K051776 07/13/2005 PROTEGE ULTRASONIC INSERT DISCUS DENTAL INC. SUZANNE RIDGWAY
K051571 07/19/2005 SKYLIGHT LED CURING LIGHT DMETEC CO., LTD. CAROLANN KOTULA
K042522 07/06/2005 JAUNDICE METER, MODEL JM 103 DRAEGER MEDICAL INFANT CARE, INC. THOMAS M MCINTOSH
K051628 07/20/2005 INFINITY MONITORS WITH SCIO MODIFICATIONS Draeger Medical Systems, Inc. PENELOPE H GRECO
K051263 07/12/2005 EVITAXL WITH OPTION SMARTCARE DRAGER MEDICAL AG & CO. KGAA MONICA FERRANTE
K051261 07/25/2005 DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE DYNATRONICS CORP. RONALD J HATCH
K051724 07/19/2005 ACUMEN IMAGE GUIDED SURGICAL SYSTEM EBI, L.P. WHITNEY TORNING
K051746 07/25/2005 ELEKTA ESARTE FRAME SYSTEM ELEKTA INSTRUMENT AB PETER LOWENDAHL
K043238 07/06/2005 COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K051509 07/27/2005 ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES ERBE USA, INC. JULIE STEPHENS
K051837 07/20/2005 MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 ESAOTE, S.P.A. CARRI GRAHAM
K043055 07/25/2005 TERRAQUANT MQ2000 LASER THERAPY DEVICE ESCADA INTERNATIONAL, INC. MARY MCNAMARA-CULLINANE
K051764 07/13/2005 T-PLATE ANTERIOR FIXATION SYSTEM ESM TECHNOLOGIES CLIFF TRIBUS
K043032 07/19/2005 DEALIGHT IPL EUROPRO, INC. GREG KENNEBECK
K040283 07/22/2005 BIOPAD EURORESEARCH S.R.L. E. SMITH
K051550 07/12/2005 INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD. ROBBIE WALSH
K051393 07/27/2005 DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR EVER GLOBAL ENTERPRISE CORPORATION NICK BIEN
K051498 07/06/2005 DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR EVER GLOBAL ENTERPRISE CORPORATION NICK BIEN
K051682 07/19/2005 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM EXACTECH, INC. MARITZA ELIAS
K051446 07/14/2005 FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC INC. ROBERT J STAAB
K051062 07/15/2005 VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO FLOWCARDIA, INC. RICHARD SPANO
K051553 07/07/2005 FUJI SYNAPSE WORKSTATION SOFTWARE FUJIFILM MEDICAL SYSTEMS USA, INC. ROBERT BERRY
K051358 07/07/2005 NATURE-CRYL HI PLUS GC AMERICA, INC. TERRY L JORITZ
K051634 07/19/2005 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE HEALTHCARE JOEL C KENT
K051635 07/15/2005 DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K051673 07/18/2005 XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS LARRY A KROGER
K051026 07/19/2005 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K051518 07/08/2005 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K051490 07/07/2005 GE OEC EVERVIEW 7500 GE OEC MEDICAL SYSTEMS, INC. SUSAN SCHMIDT
K043035 07/11/2005 SEPRAGEL ENT BIORESORBABLE PACKING/STENT GENZYME CORPORATION BARBARA PIZZA
K051686 07/14/2005 CARDIOMEM CM 3000-12 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG CAROLANN KOTULA
K050391 07/21/2005 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K051668 07/08/2005 THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT GOODMARK USA, INC. ROBERT J MICHALIK
K051662 07/22/2005 VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) GRAND WORK PLASTIC PRODUCTS CO., LTD. MICKY LIN
K051429 07/29/2005 CLARIS NON-STICK BIPOLAR FORCEPS GUENTER BISSINGER MEDIZINTECHNIK GMBH CHRISTA HEITMANN-FRANKE
K043322 07/21/2005 MIRAMATIC SAFE SYRINGE SYSTEM HAGER WORLDWIDE, INC. JAMES DELANEY
K051728 07/20/2005 MODIFICATION TO SHOULDER FIXATION SYSTEM HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K051610 07/29/2005 HANS HERMANN LAPAROSCOPES AND ACCESSORIES HANS HERMANN GMBH HARALD JUNG
K051224 07/28/2005 BOSWORTH SEAL HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K051778 07/26/2005 NITRILE POWDERED EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD KUAN KAM HON
K050053 07/11/2005 HEMORAM/AGGRAM ANALYZER HELENA LABORATORIES PATRICIA FRANKS
K050854 07/07/2005 PALACOS LV+G HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K050855 07/07/2005 PALAMED G HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K051147 07/12/2005 SIDEKICK BLOOD GLUCOSE TEST SYSTEM HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K051588 07/12/2005 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051737 07/19/2005 MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051738 07/19/2005 SECUR-FIT MAX AND PLUS MAX HIP STEMS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051624 07/07/2005 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K051146 07/13/2005 TRIATHLON KNEE SYSTEM HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051590 07/29/2005 T2 ANKLE ARTHRODESIS NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K050410 07/14/2005 HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) HWANG SUN ENTERPRISE CO., LTD. SING-HONG YEUNG
K051430 07/18/2005 EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) HYDROGEL VISION CORPORATION DONNA HOVANEC
K051412 07/11/2005 HUMERAL HEAD PLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K051110 07/06/2005 1,25-DIHYDROXY VITAMIN D EIA IMMUNODIAGNOSTIC SYSTEMS LTD. PAUL PUNTIN
K050395 07/13/2005 IMPEDIMED - BODY COMPOSITION ANALYSIS IMPEDIMED PTY LTD. NEVELLI BERTWISTLE
K051717 07/07/2005 RN SYNOCTA TEMPORARY MESO ABUTMENT INSTITUT STRAUMANN SA LINDA JALBERT
K041893 07/29/2005 INTRALASE FS LASER INTRALASE CORP. CHARLINE GAUTHIER
K050690 07/07/2005 CONNEXUS ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K043573 07/29/2005 DYNAGRAFT II DENTAL ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K051780 07/28/2005 JETLITE 5000 J. MORITA USA, INC. HOWARD ROWE
K051365 07/22/2005 COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 K-JUMP HEALTH CO., LTD. SUSAN D GOLDSTEIN-FALK
K051454 07/27/2005 ALEUTIAN SPACER SYSTEM K2M, LLC RICH WOODS
K051545 07/18/2005 L.E. DEMETRON II KERR CORPORATION (DANBURY) COLLEEN BOSWELL
K051418 07/01/2005 DIRECT DIGITIZER REGIUS MODEL 370 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI MAMANAKA
K051523 07/20/2005 REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K051538 07/21/2005 AVANTICARE, MODEL SA4022 LERADO CHINA LIMITED JEFF CHANG
K050018 07/01/2005 TESLAOXYSAT, MODEL EFOXYSATE MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH ROBERT N CLARK
K050542 07/26/2005 MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER MARIAN MEDICAL, INC. SANDRA WINKLER
K051439 07/15/2005 LNOP BLUE OXIMETRY SENSOR MASIMO CORPORATION JAMES J CRONIN
K051212 07/12/2005 MODIFICATION TO LNCS OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K051375 07/28/2005 VITAL SIGNS MONITOR MEDIANA CO., LTD. CHARLIE MACK
K051488 07/27/2005 MEDICINELODGE ZIPKNOT MEDICINELODGE, INC. M. MRY SINNOTT
K051745 07/14/2005 ECHOSYSTEM MEDSTRAT, INC. ROBERT J BISHOP
K051773 07/28/2005 MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS MEDTRONIC INC.,NEUROLOGICAL DIVISION PAULA CORDERO
K050651 07/27/2005 MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION MEDTRONIC NAVIGATION, INC. TINA DREILING
K051674 07/21/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K050436 07/27/2005 MS 9/5 HEMATOLOGY ANALYZER MELET SCHLOESING LABORATORIES USA JACKIE COLEMAN
K051323 07/07/2005 MERETE TWISTCUT SNAP-OFF BONE SCREW MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K051528 07/20/2005 MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE MEVIS TECHNOLOGY GMBH & CO. KG CARL ALLETTO
K051423 07/01/2005 MICK HDR INTERSTITIAL IMPLANT ACCESSORIES MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MIOK
K050570 07/25/2005 MILTEX RIGID STERILIZATION CONTAINER SYSTEM MILTEX, INC. LEE ZAGAR
K043528 07/19/2005 SPIROTEL MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K051625 07/14/2005 BARRIER SURGICAL DRAPES MOLNLYCKE HEALTH CARE, INC. JOHN CLAY
K051739 07/28/2005 POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. MULTIGON INDUSTRIES, INC. WILLIAM STERN
K042125 07/28/2005 AFT MUSCULOSKELETAL TRANSPLANT FOUNDATION KAREN HARDWICK
K050224 07/13/2005 3TEST GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC. Ke-Min Jen
K051765 07/14/2005 CERETOM, MODEL NL3000 NEUROLOGICA CORPORATION BRAHIM HADRI
K051599 07/19/2005 NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT NEURORECOVERY, INC. ROSINA ROBINSON
K050444 07/07/2005 NOBELREPLACE ADAPTER, MODEL 32412 NOBEL BIOCARE UAS INC ELIZABETH J MASON
K051256 07/21/2005 SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. WILLIAM F MCNALLY
K042875 07/01/2005 NAVIGATOR NOMOS CORP. LEIGH SPOTTEN
K051486 07/06/2005 NORWOOD ABBEY CENTURION SES EPIKERATOME NORWOOD ABBEY , LTD. PAUL CLARK
K051009 07/12/2005 HUBER CLEAR SAFETY INFUSION SET NOW MEDICAL DISTRIBUTION, INC. CHRISTINE EMANNUEL
K050857 07/28/2005 BIB PTA BALLOON CATHETER NUMED, INC. JODI GIJANTO
K051343 07/28/2005 MINI GHOST PTA CATHETER, MODEL 507 NUMED, INC. NICHELLE LAFLESH
K051384 07/11/2005 MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K051541 07/01/2005 GF-UE160-AL5 ULTRASOUND ENDOSCOPE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K050502 07/08/2005 SINGLE USE BALLOON DILATOR MAXPASSTM OLYMPUS WINTER & IBE GMBH LAURA STORMS-TYLER
K041008 07/01/2005 EYE-CEPT REWETTING DROPS OPTICS LABORATORY, INC. J.R. CHEN
K051255 07/01/2005 LUMIPHASE-R OPUSMED INC. IAN GORDON
K050260 07/15/2005 BIORESORB MACRO PORE ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH CHAD BARTEE
K050966 07/07/2005 PIVOT BIPOLAR FEMORAL HEAD ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K051751 07/22/2005 EQUA-PULL SAFETY RELEASE MODULE ORTHO TECHNOLOGY STEVE KLAMIC
K051162 07/19/2005 GENEROS SB SMALL BONE DISTRACTION IMPLANT ORTHONETX, INC. TERRY KNAPP
K051053 07/21/2005 OSCAR, MODEL OE3000DB ORTHOSONICS, LTD. T. WHIT ATHEY
K051664 07/20/2005 SCAN300FP / RETROPAN (VDC) OY AJAT, LTD. CLAUDE D BERTHOIN
K051465 07/12/2005 POWDERED LATEX PATIENT EXAMINATION GLOVES P.T. ANLIS ABADI INTERNASIONAL HUAN-CHUNG LI
K051106 07/01/2005 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HAUKE SCHIK
K051372 07/07/2005 POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
K050968 07/12/2005 POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K051767 07/29/2005 LTV 1000 VENTILATOR PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
K050449 07/07/2005 QUANTUM VERTEBRAL BODY REPLACEMENT QUANTUM ORTHOPEDICS, INC. JASON BLAIN
K042725 07/06/2005 QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) QUEST DIAGNOSTICS, INC. JAMES A BOURLAND
K042726 07/28/2005 QUEST DIAGNOSTICS HAIRCHECK-DT (PCP QUEST DIAGNOSTICS, INC. JAMES A BOURLAND
K051339 07/12/2005 R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL R & D SYSTEMS, INC. RALPH E HOGANCAMP
K051743 07/25/2005 R2 BREAST IMAGING WORKSTATION R2 TECHNOLOGY, INC. DENISE F GOTTFRIED
K051268 07/06/2005 RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT RADIANCY, LTD. JONATHAN S KAHAN
K051309 07/11/2005 ROI FUSION RODS & PLATES REILEY ORTHOPAEDICS, INC. J.D. WEBB
K050841 07/05/2005 FRAXEL SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER
K051314 07/15/2005 RES TRAXX DATA CENTER RESMED LTD. DAVID D'CRUZ
K051262 07/08/2005 ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARY FUNK
K051752 07/11/2005 ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) Roche Diagnostics THERESA M AMBROSE
K051185 07/06/2005 ELECSYS CA 19-9 CALCHECK ROCHE DIAGNOSTICS CORP. CORINA HARPER
K050231 07/06/2005 ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K051517 07/05/2005 ELECSYS PRECICONTROL ANEMIA ROCHE DIAGNOSTICS CORP. CORNIA HARPER
K051687 07/25/2005 ELECSYS PRECICONTROL UNIVERSAL ROCHE DIAGNOSTICS CORP. CORINA HARPER
K051012 07/19/2005 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
K051581 07/27/2005 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 SANARUS MEDICAL, INC. TRENA DEPEL
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