FDA 510(k) Applications Received During May, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K081325 05/12/2008 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML AB BIODISK ANETTE ENGELHARDT
K081231 05/01/2008 ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 ABBOTT LABORATORIES CAROL JOCHUM
K081495 05/29/2008 CELL-DYN EMERALD SYSTEM ABBOTT LABORATORIES MICHELLE B ROEDING
K081417 05/20/2008 FOXCROSS PTA CATHETER ABBOTT VASCULAR INC. NADINE SMITH
K081398 05/19/2008 ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES ADVANCED MEDICAL INNOVATIONS, INC. MARIA F GRIFFIN
K081363 05/15/2008 NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K081309 05/09/2008 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K081433 05/21/2008 EK/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K081293 05/07/2008 UNIVATION UNICONDYLAR KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K081251 05/02/2008 MODIFICATION TO AESKULISA DS DNA G AESKU.DIAGNOSTICS SASCHA PFEIFFER
K081304 05/08/2008 ALZ WEB PACS, VERSION 1.0 ALZ, INC. CYNTHIA NOLTE
K081472 05/27/2008 SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS ANGIODYNAMICS, INC. BRIAN KUNST
K081312 05/09/2008 ARAGON ONESHOT SYSTEM ARAGON SURGICAL INC. ALAN CURTIS
K081497 05/29/2008 OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) ARTHROCARE CORP. LAURA N KASPEROWICZ
K081329 05/12/2008 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K081238 05/01/2008 REPROCESSED MASIMO PULSE OXIMETER SENSORS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K081323 05/12/2008 BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 B-K MEDICAL APS JENS RASMUSSEN
K081289 05/07/2008 V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K081446 05/22/2008 BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 BECTON DICKINSON & CO. PASQUALE AMATO
K081522 05/30/2008 BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY BIO NUCLEAR DIAGNOSTICS, INC. SURENDER CHOUDHRY
K081362 05/15/2008 PLATELIA LYME IGM BIO-RAD FRAN WHITE
K081499 05/29/2008 HEALTH MANAGER, VERSION 1.1 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG MARION OTTO
K081498 05/29/2008 TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG Martin Gabler
K081428 05/21/2008 MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR BIOCOMPOSITES LTD. SIMON FITZER
K081501 05/29/2008 SOLITAIRE ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K081395 05/19/2008 SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K081243 05/01/2008 BIOMET PHOENIX ANKLE NAIL SYSTEM BIOMET TRAUMA SUSAN ALEXANDER
K081244 05/01/2008 LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS BIOMET TRAUMA PATRICIA S BERES
K081451 05/23/2008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K081450 05/23/2008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K081403 05/19/2008 GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. RANDY BYRD
K081478 05/27/2008 RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS BIONOSTICS, INC. KATHLEEN STORRO
K081392 05/19/2008 BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN BIORETEC LTD MARI RUOTSALAINEN
K081258 05/02/2008 VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 BIOSENSE WEBSTER, INC. NATALIE BENNINGTON
K081372 05/16/2008 GELX ORAL GEL BMG PHARMA LLC. WILLIAM A GOOLSBEE
K081275 05/05/2008 BOSTON SCIENTIFIC SURGICAL MESH BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K081431 05/21/2008 MEG LAPAROSCOPIC ELECTRODES BOVIE MEDICAL RICHARD KOZLOFF
K081444 05/22/2008 BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM BRAEMAR, INC. DARREN DERSHEM
K081272 05/05/2008 PORCINE SURGICAL MESH; DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K081288 05/07/2008 ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. BARD, INC. HENRY BOLAND
K081311 05/09/2008 POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER C.R. BARD, INC. JIHYUN KIM
K081253 05/02/2008 ZIRDENT CAD/CAM BLOCKS C5 MEDICAL WERKS, INC. HOMER GREGORY
K081324 05/12/2008 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS CANDELA CORP. LISA LACROIX
K081257 05/02/2008 CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K081464 05/27/2008 STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES Cardinal Health STEVE TAMSETT
K081264 05/05/2008 STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 CHILDREN'S HEALTH FIRST, INC. ROGER T VAUGHAN
K081255 05/02/2008 SCRAMBLER ST 5 TENS DEVICE COMPETITIVE TECHNOLOGIES,INC. MARY MCNAMARA
K081305 05/08/2008 MERCI RETRIEVER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K081337 05/13/2008 APPROACH CTO WIRE GUIDE COOK INCORPORATED KAREN BRADBURN
K081425 05/21/2008 COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT COOK VASCULAR, INC. JIM FERGUSON
K081237 05/01/2008 CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT CRAFTMASTER CONTOUR EQUIPMENT, INC. STUART R GOLDMAN
K081424 05/20/2008 AFFIRM CO2 AND AFFIRM CO2 HP CYNOSURE, INC. GEORGE CHO
K081249 05/02/2008 DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM DADE BEHRING, INC. ANNA MARIE KATHLEEN ENNIS
K081413 05/20/2008 TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM DAILIAN LATEX COMPANY, LTD.
K081286 05/07/2008 MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 DAKO NORTH AMERICA, INC. KELLY MILLER
K081259 05/02/2008 DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC Ed Horton
K081287 05/07/2008 SAPPHIRE PLASMA ARC DENTAL CURING LIGHT DEN-MAT HOLDINGS, LLC ALAN MATTHEWS
K081291 05/07/2008 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION DENTSPLY INTERNTIONAL HELEN LEWIS
K081252 05/02/2008 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K081432 05/21/2008 HEALOS II BONE GRAFT SUBSTITUTE DEPUY SPINE, INC. HANDE TUFAN
K081493 05/28/2008 INFILTRATION KIT DMG USA, INC. PAMELA PAPINEAU
K081405 05/19/2008 XERACEM DOXA DENTAL AB JONATHAN KAHAN
K081447 05/22/2008 FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO DRAEGER MEDICAL AG & CO. KG KARIN LUEBBERS
K081382 05/16/2008 DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 DUCKWORTH & KENT, LTD. MARTIN LOCK
K081385 05/16/2008 URESTA PESSARY EASTMED INC. SHIRLEY FURESZ
K081357 05/14/2008 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) EIZO GMBH JAMES BERGE
K081467 05/27/2008 EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION EKOS CORP. JOCELYN KERSTEN
K081430 05/21/2008 ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING ELEKTA NEUROMAG OY DANIEL KAMM
K081408 05/19/2008 ELLIPSE MULTIFLEX ELLIPSE A/S OLE KOFOD
K081448 05/23/2008 ENCORE SHOULDER REVISION GLENOID ENCORE MEDICAL, L.P. TEFFANY HUTTO
K081400 05/19/2008 FANNING-PAPPAS MODULAR KNEE BEARING ENDOTEC, INC. MICHAEL PAPPAS
K081394 05/19/2008 PTFE INTERLOCK PEELABLE INTRODUCERS ENPATH MEDICAL, INC. SHANNON SPRINGER
K081386 05/19/2008 MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) ESAOTE S.P.A. Allison Scott
K081274 05/05/2008 SURESKIN SILVER BANDAGES EUROMED, INC. SUBHASH CHANDER
K081308 05/09/2008 FUJIFILM FCR VIEW, MODEL CR-VW674 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBRA A PEACOCK
K081393 05/19/2008 ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW G & H WIRE CO. CARRI GRAHAM
K081437 05/22/2008 MAC 1600 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARGARET MUCHA
K081496 05/29/2008 OPTIMA PET/CT 560 GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K081391 05/19/2008 VIP ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K081234 05/01/2008 GN OTOMETRICS INSERT EARPHONES GN OTOMETRICS DANIEL SANSONETTI
K081315 05/09/2008 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) GX CORPORATION SDN BHD FOO K PU
K081263 05/05/2008 STARCERAM H.C. STARCK CERAMICS GMBH & CO.KG ROBERT N CLARK
K081521 05/30/2008 MODIFICATION TO HAMILTON-G5 HAMILTON MEDICAL AG JOERG SCHNEIDER
K081442 05/22/2008 HEART SYNC PEDIATRIC, MODEL PED-100 HEART SYNC LLC STEPHEN SHULMAN
K081327 05/12/2008 RELIMESH HERNIAMESH S.R.L. LORENA TRABUCCO
K081276 05/05/2008 ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H HORIBA ABX OLIVIER DUCAMP
K081412 05/20/2008 PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. DANIELA WEKSLER
K081278 05/06/2008 OMEGA 3 TROCHANTERIC STABILIZING PLATE HOWMEDICA OSTEONICS CORP. ANDREA DWYER
K081284 05/06/2008 VARIAX DISTAL FIBULA PLATE HOWMEDICA OSTEONICS CORP. ANDREA M DWYER
K081346 05/14/2008 HOYA IS INJECTOR SYSTEM HOYA SURGICAL OPTICS, INC. STEVEN L ZIEMBA
K081506 05/29/2008 HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS HYPERBARIC AMERICA, LLC TOM WORKMAN
K081361 05/15/2008 CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX ICU MEDICAL INC TRACY BEST
K081396 05/19/2008 SWISSPLANT DENTAL IMPLANT SYSTEM IMPLANT DIRECT LLC THOMAS GOTTENBOS
K081347 05/14/2008 ILUMA VISION IMTEC CORP. BRAD VANCE
K081248 05/02/2008 QUANTA LITE OMP PLUS ELISA INOVA DIAGNOSTICS, INC. ZAKERA SHUMS
K081419 05/20/2008 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LISA QUAGLIA
K081401 05/19/2008 MAYFIELD MR/X-RAY SKULL CLAMP INTEGRA LIFESCIENCES CORP. HELDER A SOUSA
K081477 05/27/2008 LUXTEC MLX LIGHT SOURCE INTEGRA LUXTEC, INC. RITA WADLEIGH
K081459 05/23/2008 CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K081399 05/19/2008 AVIATOR TRANSPORT INCUBATOR INTERNATIONAL BIOMEDICAL, LTD. AMY PIEPER
K081436 05/21/2008 INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES INVIRO MEDICAL DEVICES, INC. ROBERT N CLARK
K081262 05/05/2008 DC NEURO INVIVO CORPORATION THEODORE J REISKER
K081471 05/27/2008 ECARD AND CCARD IRHYTHM TECHNOLOGIES, INC. WILLIAM H RIGHTER
K081247 05/01/2008 TM-400 ITO CO., LTD. KENNETH L BLOCK
K081381 05/16/2008 RANGE SPINAL SYSTEM, LARGE DENALI SCREWS K2M, INC. RICHARD W WOODS
K081380 05/16/2008 THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS K2M, INC. RICHARD W WOODS
K081267 05/05/2008 HYGEIA-5 OXYGEN CONCENTRATOR KEDL INTERNATION LIMITED Lee Leichter
K081260 05/02/2008 KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES KIMBERLY-CLARK CORP. RICHARD V WOLFE
K081514 05/30/2008 TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER LANG DENTAL MFG. CO., INC. CHAH M SHEN
K081371 05/15/2008 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL LEONHARD LANG GMBH ELAINE DUNCAN
K081438 05/22/2008 MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT LifeNet Health ALYCE LINTHURST JONES
K081318 05/12/2008 ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM LIFESCAN, INC. FRANK PERALTA
K081483 05/28/2008 XTAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K081402 05/19/2008 SIMPLANT ORTHO ; VISTADENT 3D MATERIALISE DENTAL NV CARL VAN LIERDE
K081236 05/01/2008 K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME MCNEIL-PPC, INC. NADER FOTOUHI
K081269 05/05/2008 AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K081463 05/23/2008 MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP MEDEL S.P.A. TERRENCE O'BRIEN
K081505 05/29/2008 THERAGEM PROFESSIONAL T1002 MEDICA HEALTH, LTD TERRI CMOREY
K081473 05/27/2008 HERO, VERSION 2.0 MEDICAL PREDICTIVE SCIENCE CORP. WILLIAM E KING
K081457 05/23/2008 ATRILAZE LASER ABLATION SYSTEM MEDICALCV, INC. KIRK S HONOUR
K081355 05/14/2008 BIOFLEX LD-R100 TREATMENT HEAD MEDITECH INTERNATIONAL, INC. FRED KAHN
K081516 05/30/2008 MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT MEDSOURCE INTERNATIONAL, LLC.
K081512 05/30/2008 STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE MEDTRONIC NAVIGATION, INC. KEVIN MORNINGSTAR
K081297 05/07/2008 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K081475 05/27/2008 ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K081277 05/05/2008 XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K081302 05/08/2008 RESCUE EXTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD JUNG B BANG
K081443 05/22/2008 MENICON Z RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. BEVERLEY D VENUTI
K081484 05/28/2008 HORIZON XVU MENNEN MEDICAL LTD. IFAT OREN
K081266 05/05/2008 MERCURY MEDICAL PEEP VALVE MERCURY ENTERPRIZES DBA MERCURY MEDICAL BRIAN L MORRISON
K081513 05/30/2008 MERETE 3.0 AND 3.5 MM LOCKING SCREWS MERETE MEDICAL GMBH JORG MIETZNER
K081465 05/27/2008 AXIUM DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. NEELU MEDHEKAR
K081268 05/05/2008 SONIC AIR MM1500 + (MID), MODEL 50400014 MICRO-MEGA SOCIETE ANONYME ISABELLE BOURG
K081360 05/15/2008 PATHFAST CK-MB-II, PATHFAST MYO-II MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K081509 05/29/2008 MONTERIS MEDICAL AUTOLITT LASER PROBE MONTERIS MEDICAL CRAIG COOMBS
K081356 05/14/2008 OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS, LLC SCOTT EDWARDS
K081366 05/15/2008 KUMAR T-ANCHORS HERNIA SET NASHVILLE SURGICAL INSTRUMENTS SARBJEET KUMAR
K081503 05/29/2008 AED MONOPOLAR LAP ACCESSORIES NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE M BUTLER
K081480 05/27/2008 KEGEL8 PELVIC EXERCISER, MODEL OPH 400 NE SERVICES LTD. BRENT REIDER
K081515 05/30/2008 NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 NEOMED, INC. PENNY NORTHCUTT
K081285 05/06/2008 FINGER PULSE OXIMETER, MODEL 9560 NONIN MEDICAL, INC. LORI M ROTH
K081281 05/06/2008 OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) NUCLETRON CORPORATION LISA DIMMICK
K081377 05/16/2008 NUVASIVE SURGICAL MESH SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K081330 05/12/2008 CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) O-TWO MEDICAL TECHNOLOGIES, INC. PAUL DRYDEN
K081456 05/23/2008 OLYMPUS CHF TYPE V OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K081415 05/20/2008 DAMON 4CLEAR ORMCO CORP. Wendy Garman
K081411 05/20/2008 VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K081407 05/19/2008 ORTHOPEDIATRICS PEDIPLATES SYSTEM ORTHOPEDIATRICS, CORP. GARY BARNETT
K081439 05/22/2008 VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE ORTHOVITA, INC. DAVID J MCILHENNY
K081416 05/20/2008 PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K081328 05/12/2008 PATHWAY PV ATHERECTOMY SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K081518 05/30/2008 ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK PENTAX MEDICAL COMPANY PAUL SILVA
K081489 05/28/2008 L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS PETER LAZIC GMBH FRANZ MENEAN
K081426 05/21/2008 NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MELINDA NOVATNY
K081307 05/08/2008 OMNILUX CLEAR-U PHOTO THERAPEUTICS, INC. SUE DARCY
K081454 05/23/2008 GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE POSSIS MEDICAL, INC. MIKE BURNSIDE
K081460 05/23/2008 TDS ABUTMENT POU YU BIOTECHNOLOGY CO., LTD. LINDA K SCHULZ
K081232 05/01/2008 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES PRAXIM ANNIE POLLIER
K081388 05/19/2008 GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM PRONIA MEDICAL SYSTEM, LLC CYNTHIA J.M. NOLTE
K081488 05/28/2008 POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE PT. MAJA AGUNG LATEXINDO EMMY TJOENG
K081455 05/23/2008 RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 RAYNER SURGICAL INC ANDREW WELLS
K081383 05/16/2008 RELIANCE VBS SYSTEM Reliance Medical Systems, LLC Bret M Berry
K081321 05/12/2008 MODIFICATION TO MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K081420 05/20/2008 VANISHPOINT I.V. CATHETER RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K081410 05/20/2008 OPTION VENA CAVA FILTER REX MEDICAL LEO BASTA
K081256 05/02/2008 WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H RIO FLEXON TECHNOLOGY CO., LTD. CHI-HUNG LIAO
K081389 05/19/2008 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics Scott Thiel
K081338 05/13/2008 ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP Roche Diagnostics STEPHANIE GREEMAN
K081352 05/14/2008 PROFILE MULTI-PLATFORM SYSTEM SCITON, INC. JAY M PATEL
K081359 05/15/2008 GENESIS ECP SCOTTCARE CORPORATION RONALD J CLINES
K081273 05/05/2008 ULTRACAPS S SDI LTD. RAY CAHILL
K081469 05/27/2008 SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 SECTRA IMTEC AB CARL ALLETO
K081370 05/15/2008 SERIM DISINTEK OPA TEST STRIP SERIM RESEARCH CORP. PATRICIA RUPCHOCK
K081241 05/01/2008 WEIGAO EMPTY CARTRIDGE SYRINGE SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. Diana Hong
K081322 05/12/2008 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD CHARLES MACK
K081340 05/13/2008 PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD CHARLES MACK
K081508 05/29/2008 HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN SHENYANG CANTA MEDICAL TECH CO., LTD. Diana Hong
K081320 05/12/2008 DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K081300 05/08/2008 DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS PAMELA A JURGA
K081294 05/07/2008 ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS Siemens Healthcare Diagnostics Inc. PHILIP LIU
K081319 05/12/2008 DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 Siemens Healthcare Diagnostics Inc. GEORGE M PLUMMER
K081299 05/08/2008 DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA Siemens Healthcare Diagnostics Inc. RADAMES RIESGO
K081453 05/23/2008 BIOGRAPH HD FAMILY SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K081332 05/12/2008 ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM SIGNUS MEDIZINTECHNIK GMBH KAREN E WARDEN
K081466 05/27/2008 STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE SMART GLOVE CORP. SDN BHD FOO KHON PU
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