FDA 510(k) Decisions During July, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K081325 07/24/2008 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML AB BIODISK ANETTE ENGELHARDT
K080739 07/10/2008 ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT ABBOTT MOLECULAR, INC. PAULA E MARTIN
K080200 07/10/2008 WATER WORKS DOUCHING DEVICE ABBOTT RESEARCH GROUP, INC. ROSINA ROBINSON
K080647 07/08/2008 ACCIN BIPOLAR HEAD SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITMITSKY
K080545 07/24/2008 ACTITRAINER ACTIGRAPH, LLC JOHN SCHEIDER
K081208 07/18/2008 CINCH ANCHOR, MODEL 1194 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K080995 07/30/2008 MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM AFFYMETRIX, INC. MAUREEN J MENDE
K080252 07/21/2008 MODIFICATION TO MAMMAPRINT AGENDIA BV GUIDO BRINK
K081963 07/25/2008 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS AGFA HEALTHCARE CORPORATION JEFFERY A JEDLICKA
K081976 07/28/2008 IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION AGFA HEALTHCARE CORPORATION
K072143 07/14/2008 S40 CLINICAL ANALYZER, S TEST ALB ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072678 07/02/2008 LAGUNA SIZE 8 PEDICLE SCREW ALLEZ SPINE, LLC HARTMUT LOCH
K080463 07/23/2008 ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES ALMA LASERS LTD. ANNE WORDEN
K081843 07/15/2008 ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 ALOKA CO., LTD. RICHARD CEHOVSKY
K081158 07/03/2008 ZODIC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K072901 07/01/2008 AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 AMDL, INC. GARY DREHER
K081841 07/16/2008 AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER AMPLIVOX, LTD. DANIEL KAMM
K080468 07/25/2008 LIASYS WITH MODELS LIASYS AMS S.R.L. ANALYZER MEDICAL SYSTEM STEFANO CORRADI
K073030 07/21/2008 AG-605 BLOOD GLUCOSE MONITORING SYSTEM ANDON HEALTH CO.,LTD MS. MONA
K080326 07/31/2008 KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD
K080319 07/02/2008 KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD MS. MONA
K080287 07/03/2008 ONCOBIONIC BIPOLAR ELECTRODE ANGIODYNAMICS, INC. TERI JUCKETT
K080451 07/03/2008 UNIBLATE ELECTROSURGICAL DEVICE ANGIODYNAMICS, INC. BRIAN KUNST
K082031 07/31/2008 APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES APPASAMY ASSOCIATES R.N. KASTHURI
K073621 07/03/2008 INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT ART OPTICAL CONTACT LENS, INC. MARTIN DALSING
K081497 07/28/2008 OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) ARTHROCARE CORP. LAURA N KASPEROWICZ
K081329 07/09/2008 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K081238 07/29/2008 REPROCESSED MASIMO PULSE OXIMETER SENSORS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K081718 07/25/2008 EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. KAREN HALL
K081323 07/22/2008 BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 B-K MEDICAL APS JENS RASMUSSEN
K080672 07/08/2008 BIRTHTRACK BARNEV, LTD. AHAVA STEIN
K081446 07/17/2008 BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 BECTON DICKINSON & CO. PASQUALE AMATO
K081125 07/02/2008 WRIST PULSE OXIMETER MD300W BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI WANG
K073341 07/09/2008 GENEX PUTTY BIOCOMPOSITES LTD. SIMON FITZER
K081015 07/08/2008 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC. JONATHAN S KAHAN
K080864 07/21/2008 CAM STRUCTSURE PRECISION MILLED BARS BIOMET 3I, INC. TAMARA WEST
K081172 07/17/2008 COMPOSITE HITCH SUTURE ANCHOR BIOMET MANUFACTURING CORP. BECKY EARL
K080426 07/29/2008 MAESTRO WRIST FRACTURE IMPLANT BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K081501 07/02/2008 SOLITAIRE ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K081244 07/30/2008 LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS BIOMET TRAUMA PATRICIA S BERES
K080642 07/09/2008 COMPREHENSIVE REVERSE SHOULDER BIOMET, INC. PATRICIA S BERES
K081403 07/25/2008 GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. RANDY BYRD
K081177 07/23/2008 BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K080982 07/14/2008 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS BOSTON SCIENTIFIC CORP. MARK MURPHY
K081431 07/24/2008 MEG LAPAROSCOPIC ELECTRODES BOVIE MEDICAL RICHARD KOZLOFF
K081444 07/31/2008 BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM BRAEMAR, INC. DARREN DERSHEM
K081272 07/31/2008 PORCINE SURGICAL MESH; DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K080804 07/09/2008 BUSSE PLASTIC LOR SYRINGE BUSSE HOSIPITAL DISPOSABLES MUHAMAD ANSARI
K081288 07/18/2008 ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. BARD, INC. HENRY BOLAND
K080668 07/30/2008 G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K081157 07/22/2008 ACCUFRAME CAGENIX INC. LINDA K SCHULZ
K081836 07/30/2008 CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM CARESTREAM HEALTH,INC. CHRISTINE EHMANN
K070888 07/03/2008 COMBI 8 MAX CEC ELECTRONICA S.R.L. BENNY ARAZY
K081531 07/18/2008 AOC SOLUBLE IMPLANT MATERIAL CEREMED, INC. TADEUSZ WELLISZ
K081176 07/28/2008 FLOCHANNEL CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K081619 07/18/2008 CHROMOLITE EP CHROMOGENEX TECHNOLOGIES LIMITED PETER R BEVAN
K081677 07/22/2008 SAVI APPLICATOR KIT CIANNA MEDICAL, INC. GARY MOCNIK
K080445 07/16/2008 LION SE ONE STEP ORTHODONTIC ADHESIVE CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K080583 07/18/2008 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K072291 07/14/2008 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR CONMED LINVATEC JON WARD
K081113 07/30/2008 COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS COOK, INC. SUSANNE GALIN
K081690 07/14/2008 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER COOK, INC. NATHAN SIMON
K081249 07/21/2008 DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM DADE BEHRING, INC. ANNA MARIE KATHLEEN ENNIS
K081161 07/28/2008 DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST DADE BEHRING, INC. HELEN M LEE
K081829 07/11/2008 CAPIMAGE DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K081669 07/10/2008 IMPROVED COMFORT-FIT NIGHTGUARD DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K080991 07/02/2008 DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K072884 07/30/2008 FABIUS MRI DRAEGER MEDICAL AG & CO. KG KATHY ANDERSON
K071446 07/02/2008 ELECTRODE ARRAY CAP ELECTRODE ARRAYS ELVIRA GARCIA
K073616 07/23/2008 FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE ELECTROMEDICS CO. LTD. JOHN SCHOLZ
K081430 07/28/2008 ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING ELEKTA NEUROMAG OY DANIEL KAMM
K081565 07/02/2008 INTEGRE PRO, MODEL L2RY ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K080780 07/30/2008 ANCHORAGE SCOPE, MODEL 000003 EPITEK, INC. WERNER HAMPL
K081794 07/10/2008 MODEL 7340 ULTRASOUND SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K080972 07/03/2008 ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP ETHICON ENDO-SUGERY, LLC RUTH A WOOD
K080849 07/25/2008 MICROSHEATH LP AND LP-AT FLOWCARDIA, INC. DUSTIN MICHAELS
K073382 07/28/2008 PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K080974 07/01/2008 TLS FIXATION SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K081870 07/31/2008 MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO GE HEALTHCARE FINLAND OY JOHN PENDERGAST
K081437 07/15/2008 MAC 1600 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARGARET MUCHA
K081916 07/22/2008 GE SIGNA MR ONCOLOGY PACKAGE GE MEDICAL SYSTEMS, LLC DANIEL BIANK
K080745 07/30/2008 GENADYNE A4 POWERED SUCTION PUMP GENADYNE BIOTECHNOLOGIES, INC. JOHN PAPPAN
K072977 07/16/2008 DIAZYME APOLIPOPROTEIN A-1 ASSAY GENERAL ATOMICS ABHIJIT DATTA
K082033 07/31/2008 NANNOLIGHT INTENSE PULSED LIGHT SYSTEM GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K080664 07/25/2008 RELIEVE LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K081391 07/03/2008 VIP ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K081234 07/14/2008 GN OTOMETRICS INSERT EARPHONES GN OTOMETRICS DANIEL SANSONETTI
K073246 07/23/2008 ZENIEVA GORBEC PHARMACEUTICAL SERVICES, INC. SANDRA R KIRCUS
K081954 07/31/2008 GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE GYRUS ACMI, INC. TERRENCE E SULLIVAN
K081263 07/01/2008 STARCERAM H.C. STARCK CERAMICS GMBH & CO.KG ROBERT N CLARK
K081061 07/18/2008 HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES HARVARD MEDICAL DEVICES LTD. PAUL AYLETT
K081171 07/22/2008 TRITANIUM ACETABULAR SHELL SYSTEM HOWMEDICA OSTEONICS CORP KIMBERLY LANE
K081284 07/18/2008 VARIAX DISTAL FIBULA PLATE HOWMEDICA OSTEONICS CORP. ANDREA M DWYER
K081506 07/25/2008 HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS HYPERBARIC AMERICA, LLC TOM WORKMAN
K080538 07/03/2008 IDEAL LIFE POD (MODEL ILP 0001) IDEAL LIFE INC. DIANE HORWITZ
K081630 07/29/2008 MAMMO WORKSTATION IMAGE DIAGNOST INTERNATIONAL GMBH PETER HEINLEIN
K081698 07/30/2008 MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) IMAGE STREAM MEDICAL, INC. CHAS BURR
K080633 07/15/2008 SCREWINDIRECT DENTAL IMPLANTS IMPLANT DIRECT LLC THOMAS GOTTENBOS
K072741 07/16/2008 PRE-VA VAGINAL LUBRICANT INGFERTILITY, LLC DENNIS CLIFTON
K071810 07/11/2008 INION SPINAL GRAFT CONTAINMENT SYSTEM INION LTD. KATI MARTTINEN
K073042 07/31/2008 HEMOSIL D-DIMER INSTRUMENTATION LABORATORY CAROL MARBLE
K081070 07/23/2008 INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM INTERLACE MEDICAL, INC. RON ADAMS
K080067 07/18/2008 ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER ISCIENCE INTERVENTIONAL GRACE BARTOO
K081112 07/29/2008 FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM ISODOSE CONTROL B.V. HUB VAN DE BERGH
K081218 07/21/2008 BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST IT-V MEDIZINTECHNIK, GMBH CORNELIA DAMSKY
K080220 07/28/2008 PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE ITALIA MEDICA S.R.L. BERTHOIN CLAUDE
K081655 07/21/2008 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K073074 07/10/2008 KEY LASER III 1243 US WITH DETECT KAVO AMERICA DANIEL KAMM
K080975 07/15/2008 FENCER 308 EXCIMER LASER SYSTEM KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP PAUL Y FANG
K081598 07/03/2008 SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE KFX MEDICAL GAYLE HIROTA
K081260 07/09/2008 KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES KIMBERLY-CLARK CORP. RICHARD V WOLFE
K081089 07/14/2008 KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM KIMBERLY-CLARK CORP. RICHARD V WOLFE
K081678 07/29/2008 CONMED BEAMER SYSTEM C600 KLS MARTIN GMBH + CO. KG BERNHARD HUG
K080862 07/21/2008 SONICWELD RX (RESORB-X) KLS-MARTIN L.P. TOM FAUCETT
K081637 07/01/2008 LASER IMAGER DRYPRO MODEL 873 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K080178 07/28/2008 VALVULOTOME BY KOVEN KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K081583 07/28/2008 CLEARFIL SA CEMENT KURARAY MEDICAL INC. KOJI NISHIDA
K081781 07/09/2008 NUWAV LABORIE MEDICAL TECHNOLOGIES, CORP BARBARA MORNET
K081552 07/31/2008 SKYLINE 55 LARSEN & TOUBRO LIMITED A B DESHPANDE
K063841 07/23/2008 NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS LIPOSCIENCE MARK A DEL VECCHIO
K071759 07/30/2008 LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) LIVE TISSUE CONNECT, INC. HOWARD M HOLSTEIN
K080496 07/07/2008 MOSAIC ECO2 LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K081402 07/18/2008 SIMPLANT ORTHO ; VISTADENT 3D MATERIALISE DENTAL NV CARL VAN LIERDE
K080357 07/24/2008 MEDELA INVIA WOUND THERAPY MEDELA AG BRUNO GRETLER
K080212 07/23/2008 MEDELA THOPAZ, MODEL 200 0288 MEDELA AG BRUNO GRETLER
K080969 07/25/2008 HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 MEDI NUCLEAR CORP., INC. JERRY SCHOEN
K081593 07/23/2008 POWER ASPIRATOR, MODEL LS2 OR LS2DP MEDICAL DEVICE RESOURCE CORP. MEL KIMSEY
K080878 07/17/2008 MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) MEDICAL TECHNOLOGIES OF GEORGIA, INC. CINDI SARTAIN
K073555 07/11/2008 INSULIN PROTECTOR MEDICOOL, INC. EUGENE CHANG
K081676 07/02/2008 SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K080097 07/09/2008 MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K081512 07/18/2008 STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE MEDTRONIC NAVIGATION, INC. KEVIN MORNINGSTAR
K081950 07/18/2008 PROGENIX PLUS MEDTRONIC SOFAMOR DANEK, INC. RYAN MASSEY
K081513 07/18/2008 MERETE 3.0 AND 3.5 MM LOCKING SCREWS MERETE MEDICAL GMBH JORG MIETZNER
K080512 07/23/2008 REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT METRO OPTICS OF AUSTIN, INC. MARTIN DALSING
K080666 07/11/2008 HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS MICROVENTION, INC. KEVIN E DALY
K081039 07/10/2008 LIPO CANNULA MILLENNIUM MEDICAL TECHNOLOGIES, INC. GREGORY M MILES
K070779 07/09/2008 SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM MISONIX, INC. RONALD MANNA
K081356 07/09/2008 OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS, LLC SCOTT EDWARDS
K073678 07/10/2008 VARIOSURG NAKANISHI, INC. KEITH BARRITT
K081366 07/15/2008 KUMAR T-ANCHORS HERNIA SET NASHVILLE SURGICAL INSTRUMENTS SARBJEET KUMAR
K081515 07/21/2008 NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 NEOMED, INC. PENNY NORTHCUTT
K080695 07/01/2008 MOBILE I.V. SYSTEMS 10,20,60 NORTHWIND TECHNOLOGIES, CORP. DAWN I MOORE
K081680 07/10/2008 NUCLEUS-X, MODEL 230X NUMED, INC. NICHELLE LAFLESH
K080807 07/18/2008 BLOOD TUBING SETS (STERILE FLUID PATH) NXSTAGE MEDICAL, INC. MICHAEL DOYLE
K081043 07/07/2008 LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K081140 07/17/2008 VISENSIA OBS MEDICAL WAYNE NETHERCUTT
K081561 07/28/2008 OSFERION D OLYMPUS TERUMO BIOMATERIALS CORPORATION STACY A KLUESNER
K081776 07/22/2008 CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM OMEGA CRITICAL CARE LIMITED ALAN SHORT
K081407 07/22/2008 ORTHOPEDIATRICS PEDIPLATES SYSTEM ORTHOPEDIATRICS, CORP. GARY BARNETT
K073720 07/17/2008 ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT OSMETECH MOLECULAR DIAGNOSTICS ROBERT DICHECK
K080744 07/17/2008 HG II FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K081078 07/15/2008 NT/IT SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K081227 07/22/2008 PLEXUR M OSTEOTECH, INC. CHRIS TALBOT
K080731 07/17/2008 PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE OSYRIS JAOUAD ZEMMOURI
K073386 07/30/2008 JOINT STIM, MODEL 1000 PAIN MANAGEMENT TECHNOLOGIES JOSHUA LEFKOVITZ
K071668 07/02/2008 ORTHOBIOM SPINAL SYSTEM PARADIGM SPINE MARCI HALEVI
K081328 07/17/2008 PATHWAY PV ATHERECTOMY SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K080896 07/30/2008 PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST PATHWORK DIAGNOSTICS, INC. ERIKA B AMMIRATI
K073057 07/22/2008 PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 PEAK SURGICAL, INC. GRACE CARLSON
K081964 07/29/2008 K450 POWERED WHEELCHAIR PERMOBIL AB JAN ASTROM
K081802 07/11/2008 CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. ROB BUTLER
K073089 07/29/2008 LIFEPAK 20E PHYSIO-CONTROL, INC. MICHELLE ACKERMANN
K081826 07/25/2008 INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K080689 07/09/2008 SPECTRA THERAPY SYSTEM A1000 LASER DEVICE PREMIER DYNAMICS, INC. JOHN J STEPHAN
K073693 07/03/2008 COSTORSOL PRESERVATION SOLUTIONS, INC. NEIL BURRIS
K080848 07/25/2008 ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR Q3 INNOVATIONS, LLC DANIEL KAMM
K080905 07/16/2008 QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI QUANTUM MEDICAL IMAGING, LLC. PAMELA PAPINEAU
K080813 07/01/2008 PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER RADI MEDICAL SYSTEMS AB BJORN PALMGREN
K072109 07/31/2008 STATMAP, MODEL 7200 RAMSEY MEDICAL, INC. DARRYL PARMET
K081383 07/02/2008 RELIANCE VBS SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K080915 07/01/2008 FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER MACFALLS
K080797 07/09/2008 HUMIDAIRE 2I RESMED LTD. DAVID D'CRUZ
K081206 07/28/2008 HOMELOX RESPIRONICS, INC. ZITA A YURKO
K063662 07/21/2008 RAMP NT-PROBNP ASSAY RESPONSE BIOMEDICAL CORP. KEN PILGRIM
K081389 07/15/2008 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS SCOTT THIEL
K080092 07/28/2008 ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB ROCHE DIAGNOSTICS CORP. STEPHANIE GREEMAN
K080914 07/15/2008 ULTRASHARP CONCENTRIC NEEDLES ROCHESTER ELECTRO MEDICAL, INC. CHARLES C BERKINS
K080922 07/25/2008 SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR SALTER LABS, DIVISION OF REGULATORY AFFAIRS DUANE KAZAL
K073500 07/03/2008 ACTIVE ANTERIOR CERVICAL PLATE SYSTEM SANACOR MIKE ENSIGN
K081273 07/10/2008 ULTRACAPS S SDI LTD. RAY CAHILL
K080916 07/01/2008 CAPILLARYS URINE SEBIA KAREN ANDERSON
K080370 07/31/2008 ABL 80 CO-OX SYSTEM SENDX MEDICAL, INC. MARK A DZENDZEL
K081370 07/11/2008 SERIM DISINTEK OPA TEST STRIP SERIM RESEARCH CORP. PATRICIA RUPCHOCK
K081873 07/16/2008 EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. CHENG GUIYUAN
K080047 07/11/2008 CARDIOSEN'C SHL TELEMEDICINE INTERNATIONAL LTD. YORAM LEVY
K071074 07/02/2008 MYKRES SPINAL SYSTEM SHOWA IKA KOHGYO CO.,LTD. FLOYD G LARSON
K072334 07/18/2008 SIALO DRAIN SIALO TECHNOLOGY, LTD. AHAVA STEIN
K081734 07/03/2008 SYNGO IMAGING (VERSION V31) SIEMENS AG, MEDICAL SOLUTIONS
K081643 07/03/2008 DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 SIEMENS HEALTHCARE DIAGNOSTICS YUK-TING LEWIS
K081300 07/02/2008 DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS PAMELA A JURGA
K081683 07/07/2008 LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 SIEMENS HEALTHCARE DIAGNOSTICS YUK-TING LEWIS
K081716 07/17/2008 ADVIA CENTAUR HAVM ASSAY SIEMENS HEALTHCARE DIAGNOSTICS INC. MARY SEEGER
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