FDA 510(k) Decisions During August, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080395 08/13/2008 SUNIVF DISHES INTL., INC. MICHAEL D CECCHI
K081549 08/19/2008 RX ACCUNET LP EMBOLIC PROTECTION SYSTEM ABBOTT LABORATORIES VIRGINIA SINGER
K081622 08/29/2008 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM ABBOTT SPINE, INC. MARITZA ELIAS
K072708 08/18/2008 ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM ABBOTT VASCULAR-VASCULAR SOLUTIONS MICHELLE GROSSMAN
K073197 08/28/2008 SILVER ANTIMICROBIAL WOUND GEL ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K081973 08/07/2008 METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K080606 08/07/2008 ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K080063 08/15/2008 MASS CASUALTY VENTILATOR, MODEL MCV100 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K082100 08/06/2008 ALLTECH ECHOSTAR 1.5 T MR SYSTEM ALLTECH MEDICAL SYSTEMS AMERICA, INC. JOHN DURAJ
K082064 08/22/2008 RADVISION ET DIAGNOSTIC X-RAY SYSTEM ALMANA MEDICAL IMAGING DANIEL KAMM
K080847 08/06/2008 RFVISION, MODEL 9.9D ALMANA MEDICAL IMAGING DANIEL KAMM, P.E
K081936 08/13/2008 SOLEX CATHETER, MODEL SL2593 ALSIUS CORP. JOHN RIOLO
K080872 08/19/2008 AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ AMEDICA BIOTECH, INC. Jeff Chen
K080749 08/04/2008 RADIANCE AMERICAN ORTHODONTICS JEROME H SCHOMBERG
K082059 08/11/2008 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K080966 08/06/2008 HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM AOTI LTD. ROBBIE WALSH
K073677 08/01/2008 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES JEFF RYBERG
K081853 08/18/2008 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K073047 08/07/2008 APROXI 1100 AND 4000 SERIES DENTAL INLAYS APROXI APS KIRSTEN RONO
K082323 08/28/2008 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K081752 08/06/2008 EDGE PACS ASHVA TECHNOLOGIES, PVT. LTD CARL ALLETTO
K072974 08/18/2008 SURGIMESH XB ASPIDE MEDICAL HOWARD M HOLSTEIN
K073396 08/07/2008 ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG B. BRAUN MEDICAL, INC. REBECCA STOLARICK
K082132 08/28/2008 BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK BAUSCH & LOMB, INC NED LUCE
K081721 08/06/2008 TRICOS A RESORBABLE SUBSTITUTE BAXTER HEALTHCARE CORP. BARBARA K BARBEAU
K081289 08/04/2008 V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K081213 08/14/2008 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 BD Biosciences NOBUKO NAKAJIMA
K080634 08/11/2008 ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 BECKMAN COULTER, INC. LYNN WEIST
K081526 08/14/2008 FLOWCARE TLG REAGENT BECKMAN COULTER, INC. NANCY NADLER
K081980 08/04/2008 KYMCO FORU, MODEL EQ35 BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K081729 08/07/2008 MODIFICATION TO GFX NERVE ABLATION SYSTEM BIOFORM MEDICAL, INC. LORI HAYS
K081896 08/20/2008 BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH BIOGENICS, INC. LOU JONES
K080685 08/15/2008 HIPLOC COMPRESSION HIP SCREW BIOMET MANUFACTURING, INC. BECKY EARL
K081636 08/07/2008 PEEK-OPTIMA ALIF SPACER BIOMET SPINE VIVIAN KELLY
K082175 08/13/2008 MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION BIOPLATE, INC. JESUS T FARINAS
K081149 08/05/2008 BIOPRO GO-EZ SCREW BIOPRO, INC. DAVID MRAK
K080529 08/29/2008 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K081849 08/28/2008 BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K081550 08/28/2008 BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO BONART CO. LTD. ERIC L ONG
K080761 08/25/2008 BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES BONART CO. LTD. ERIC L ONG
K081275 08/27/2008 BOSTON SCIENTIFIC SURGICAL MESH BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K081021 08/08/2008 KINETIX GUIDEWIRE, PLUS GUIDEWIRE BOSTON SCIENTIFIC CORP. CHRISTINE THOMAS
K081048 08/22/2008 PINNACLE PELVIC FLOOR REPAIR KIT II BOSTON SCIENTIFIC CORP. MICHELLE BARRY
K082306 08/28/2008 POWERLOC CLEAR SAFETY INFUSION SET C.R. BARD, INC. HENRY BOLAND
K082173 08/26/2008 Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K081464 08/28/2008 STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES Cardinal Health STEVE TAMSETT
K081837 08/13/2008 AVEA VENTILATOR CARDINAL HEALTH 207, INC. ANDRE VON MULLER
K081944 08/14/2008 MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIO SYSTEMS, INC. DAVID D BROOKE
K082191 08/19/2008 CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 CARDIOMEMS INC GRACE POWERS
K080276 08/04/2008 SELF-ADHESIVE ELECTRODES CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC BRANDON CHOI
K073334 08/22/2008 OHMNISCAN NG CHRISTINE VALMY INC PETER DEHAYDU
K081017 08/04/2008 TEMPLATE AND COUNTER-FIT CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. JEANETTE SMITH
K081606 08/28/2008 BAHA INTENSO COCHLEAR AMERICAS SEAN BUNDY
K080298 08/05/2008 DERMABIOSAFE COMPLETE PRODUCT RESOURCES JOHN WALSH
K080799 08/07/2008 ATLAS-BASED AUTOSEGMENTATION COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K082034 08/15/2008 MODIFICATION TO MERCI RETRIEVER CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K081337 08/08/2008 APPROACH CTO WIRE GUIDE COOK INCORPORATED KAREN BRADBURN
K080737 08/08/2008 MIRAFLEX HIGH FLOW MICROCATHETER COOK, INC. NATHAN SIMON
K080037 08/01/2008 MODIFICATION TO ZILVER 635 BILIARY STENT COOK, INC. STEPHANIE ROBERTS
K082143 08/25/2008 MICRO GUIDE CATHETER XP CORDIS CORP. KAREN WILK
K081237 08/25/2008 CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT CRAFTMASTER CONTOUR EQUIPMENT, INC. STUART R GOLDMAN
K081762 08/27/2008 CURBELL PATIENT MONITORING CABLES CURBELL ELECTRONICS INC. Kevin Walls
K080530 08/15/2008 MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. KATHY MAYNOR
K072950 08/22/2008 CYGNUS 12 LEAD ECG MODULE CYGNUS, LLC NARCIS NAYDENOV
K081844 08/29/2008 GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. ADRIENNE LENZ
K082239 08/29/2008 DEPUY C-STEM AMT DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K080990 08/08/2008 DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K081546 08/26/2008 SMALL BONE LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081432 08/29/2008 HEALOS II BONE GRAFT SUBSTITUTE DEPUY SPINE, INC. HANDE TUFAN
K073427 08/20/2008 MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC. THERON GOBER
K081405 08/21/2008 XERACEM DOXA DENTAL AB JONATHAN KAHAN
K081847 08/21/2008 PICASSO MASTER, ECT AND MASTER 3D E-WOO TECHNOLOGY DAVE KIM
K081899 08/21/2008 ANYRAY PORTABLE X-RAY SYSTEM E-WOO TECHNOLOGY CO., LTD. DAVE KIM
K082341 08/29/2008 DSA 2000EX EIGEN LLC ANIMESH KHEMKA
K082122 08/29/2008 MLCI2 ELEKTA LTD. PATRICK T HULL
K081652 08/28/2008 CLAROS NANO DENTAL LASER SYSTEM ELEXXION AG HOLGER ERNST
K073682 08/08/2008 EMBLETTA GOLD EMBLA SYSTEMS, INC. ROBERT G SCHUEPPERT
K081679 08/20/2008 REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K080102 08/20/2008 TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM ESCADA INTERNATIONAL, INC. Kevin Walls
K081934 08/29/2008 EXTREMITY MEDICAL COMPRESSION SCREW EXTREMITY MEDICAL LLC JAMY GANNOE
K073579 08/18/2008 DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL NEIL R ARMSTRONG
K082041 08/01/2008 FIATLUX VISUALIZE FIATLUX IMAGING INC.
K073381 08/04/2008 PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K072293 08/06/2008 FOSSA URETERAL OPEN STENTS FOSSA MEDICAL, INC. GLORIA KOLB
K080273 08/08/2008 AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION FUJIREBIO DIAGNOSTICS TEXAS, INC. JOHN GORMLEY
K081915 08/08/2008 FDTX GLUCOSE CONTROL SOLUTION FUJIREBIO DIAGNOSTICS TEXAS, INC. JOHN GORMLEY
K081891 08/29/2008 FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR FUKUDA DENSHI USA, INC. SUSAN D GOLDSTEIN-FALK
K081393 08/21/2008 ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW G & H WIRE CO. CARRI GRAHAM
K082318 08/25/2008 CENTRICITY PACS IW GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS JILLIAN M REED
K081941 08/07/2008 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K082185 08/15/2008 GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA NICOLE LANDREVILLE
K081921 08/06/2008 GE VIVID E9 ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K081875 08/20/2008 GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS ERIC S GRUFF
K081200 08/08/2008 DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 GLOBAL TOP, INC. CLAUDE YANG
K082028 08/08/2008 LASERPEEL SOFT-MET MODIFIED ERBIUM LASER GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K081315 08/11/2008 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) GX CORPORATION SDN BHD FOO K PU
K082054 08/06/2008 GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 GYRUS ACMI, INC. TERRENCE E SULLIVAN
K081766 08/08/2008 PKS OMNI INSTRUMENT GYRUS-ACMI L.P. LORRAINE CALZETTA
K082075 08/15/2008 HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER HANSEN MEDICAL, INC. KATE WHITIN
K081159 08/08/2008 HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES HARVARD MEDICAL DEVICES LTD. PAUL AYLETT
K072486 08/06/2008 MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K081745 08/12/2008 ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K080710 08/13/2008 TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K080641 08/19/2008 TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K073158 08/27/2008 SCULPTURE 2.94 ER:YAG SYSTEM HOYA CONBIO, INC LIZA BURNS
K082009 08/22/2008 HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS HSINER CO., LTD. TOM SHANKS
K082025 08/13/2008 BODY-JET HUMAN MED AG INGE MATTHIESEN
K081361 08/28/2008 CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX ICU MEDICAL INC TRACY BEST
K080554 08/27/2008 INAREX, MODEL 2D-LX INAREX CORPORATION BRANDON CHOI
K073664 08/08/2008 FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER INJECTIMED, INC. RICHARD G HUNTER
K080809 08/11/2008 IEC MEDSIGHT AND MEDBRIGHT INNOVATIVE ENDOSCOPY COMPONENTS, LLC. GERALD GOIFITZER
K080484 08/06/2008 INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS DAVID TRUEBLOOD
K081691 08/28/2008 INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS LLC DAVID TRUEBLOOD
K081651 08/08/2008 INSTRUMED RONGEUR INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K081459 08/13/2008 CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K072629 08/06/2008 DIGIMATCH ROBODOC SURGICAL SYSTEM INTEGRATED SURGICAL SYSTEMS, INC. RUSS HIBBERT
K073112 08/01/2008 DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K071687 08/07/2008 FAMILI OF IRIDEX IQ LASER SYSTEMS IRIDEX CORP. DAVID BUZAWA
K082061 08/19/2008 INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER IRVINE BIOMEDICAL, INC. JEANETTE HENDRICKSON
K081982 08/14/2008 WATCH-PAT 200S-2 (WP200S-2) ITAMAR MEDICAL JONATHAN S KAHAN
K081247 08/25/2008 TM-400 ITO CO., LTD. KENNETH L BLOCK
K081657 08/20/2008 POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K082288 08/19/2008 HAIDA HD21 JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. JUNNATA CHANG
K082274 08/19/2008 HAIDA MODEL HD11 MANUAL WHEELCHAIR JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. JUNNATA CHANG
K080259 08/20/2008 JMEA CANNULATED BONE SCREW SYSTEM JMEA CORPORATION SAM SON
K080040 08/25/2008 ORTHO ALL-FLEX DIAPHRAGM JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. WILLIAM GREENROSE
K081695 08/12/2008 DMC COMPOSITE KERR CORP. Wendy Garman
K082157 08/06/2008 KETTOSIL AND SILGINAT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K081215 08/26/2008 VOLUMINA KJAYA MEDICAL, LLC KOVALAN MUNIANDY
K081708 08/26/2008 TAXI ENDOSCOPIC GUIDEWIRE LAKE REGION MFG., INC. DEEP PAL
K082194 08/28/2008 LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 LAURIMED LLC NANCY LINCE
K082067 08/22/2008 MSC LIPID CONTROL MAINE STANDARDS CO. HOLLY CRESSMAN
K082218 08/13/2008 MAX ADJUSTING INSTRUMENT MANNA OMNI INTERNATIONAL INC. STEPHEN TSAI
K081672 08/15/2008 C-INSIGHT MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K071961 08/25/2008 MESACUP MODELS BP180 AND BP230 ELISA KITS MBL INTERNATIONAL CORPORATION DANIEL KAMM
K080544 08/14/2008 UNASSIGNED MEDCOMP JEAN CALLOW
K081457 08/08/2008 ATRILAZE LASER ABLATION SYSTEM MEDICALCV, INC. KIRK S HONOUR
K081559 08/28/2008 GENESIS MEDISISS BRANDI JAMES
K080899 08/07/2008 ARCTIC BLAST INTRAVENOUS FLUID CHILLER MEDIVANCE, INC. LYNNE ARONSON
K081516 08/26/2008 MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT MEDSOURCE INTERNATIONAL, LLC.
K073523 08/01/2008 INTERCEPTOR PLUS CORONARY FILTER SYSTEMS MEDTRONIC INC. COLLEEN MULLINS
K081804 08/05/2008 PIONEER PLUS CATHETER MEDTRONIC INC. CATHERINE PRIESTLEY
K082127 08/27/2008 STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K081038 08/15/2008 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK CHRIS MCKEE
K082112 08/27/2008 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K081302 08/15/2008 RESCUE EXTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD JUNG B BANG
K080303 08/05/2008 EZ REGULAR MEINNTECH CO., LTD. DANIEL KAMM
K081465 08/19/2008 AXIUM DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. NEELU MEDHEKAR
K080861 08/27/2008 MICRUS ASCENT OCCLUSION BALLOON CATHETER MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K081180 08/26/2008 SKINSENSE POLYISOPRENE UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K080405 08/28/2008 SYGNAL DBM MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ JOY
K081075 08/22/2008 PAINSHIELD MD NANO VIBRONIX LTD. ELI ORBACH
K080546 08/29/2008 NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A NIHON KOHDEN AMERICA, INC. JACK COGGAN
K082373 08/29/2008 NORAS MR-BI320-PA 3T NORAS MRI PRODUCTS GMBH PATRICIA KRAPF
K081191 08/07/2008 TCM ENDO 20 NOUVAG AG ERICH FORSTER
K081939 08/12/2008 OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K082099 08/21/2008 VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K073685 08/29/2008 OTA COLLAGEN BIOMATERIAL OSSEOUS TECHNOLOGIES OF AMERICA DAVID J COLLETTE
K081876 08/01/2008 OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING OSTEOMED L.P. ALMA RELJA
K082186 08/29/2008 MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K081887 08/29/2008 LUTE-IT II VENEER CEMENT, MODEL NO6 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K072213 08/29/2008 PERIMETRICS PERIOMETER PERIMETRICS, INC. ALBERT REGO
K081983 08/22/2008 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 PHILIPS MEDICAL SYSTEMS CLAIRE ARAKAKI
K081937 08/29/2008 PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH JENS-PETER SEHER
K081558 08/25/2008 PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC PIONEER SURGICAL TECHNOLOGY JONATHAN GILBERT
K081699 08/29/2008 PLANMECA SOVEREIGN PLANMECA USA, INC. BOB PIENKOWSKI
K081232 08/06/2008 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES PRAXIM ANNIE POLLIER
K080432 08/08/2008 MAPERSOL PRESERVATION SOLUTIONS, INC. NEIL BURRIS
K081633 08/11/2008 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS PRIMED MEDICAL PRODUCTS INC. RAYMOND G MARUSYK
K081388 08/21/2008 GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM PRONIA MEDICAL SYSTEM, LLC CYNTHIA J.M. NOLTE
K081488 08/28/2008 POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE PT. MAJA AGUNG LATEXINDO EMMY TJOENG
K082182 08/15/2008 AP 34 MULTI-THERAPY INFUSION PUMP Q-CORE, LTD ASHER KASSEL
K071023 08/28/2008 REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C REACH SURGICAL, INC RICH GRANT
K081756 08/07/2008 OCULAR RESPONSE ANALYZER REICHERT INC. SANDRA BROWN
K082197 08/22/2008 RHYTEC, INC., PORTRAIT PSR RHYTEC INCORPORATED Robert Zoletti
K081535 08/14/2008 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR RICH MOUNTAIN MEDICAL PRODUCTS, INC. MICHELLE SHIH
K080643 08/22/2008 ELECSYS ANTI-TSHR CALCHECK Roche Diagnostics STEPHANIE GREEMAN
K082043 08/01/2008 CARRIAZO-PENDULAR MICROKERATOME SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG ROLF SCHWIND
K081085 08/01/2008 STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS SENORX, INC. EBEN GORDON
K080364 08/11/2008 FINDRWIRZ GUIDE WIRE SYSTEM SENTREHEART INC. LINDA GUTHRIE
K081508 08/27/2008 HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN SHENYANG CANTA MEDICAL TECH CO., LTD. Diana Hong
K081859 08/04/2008 MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES, INC. SUZANNE SCHWALLER
K081182 08/08/2008 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN SIEMENS LIBBY WARRINER
K080167 08/08/2008 ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS SIEMENS HEALTHCARE DIAGNOSTICS PHILIP LIU
K081731 08/29/2008 DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 SIEMENS HEALTHCARE DIAGNOSTICS VICTOR M CARRIO
K081319 08/04/2008 DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 Siemens Healthcare Diagnostics Inc. GEORGE M PLUMMER
K082030 08/22/2008 DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 Siemens Healthcare Diagnostics Inc. YUK-TING LEWIS
K081992 08/05/2008 DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 Siemens Healthcare Diagnostics Inc. YUK-TING LEWIS
K081299 08/08/2008 DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA Siemens Healthcare Diagnostics Inc. RADAMES RIESGO
K081722 08/22/2008 YSIO SIEMENS MEDICAL SOLUTIONS USA, INC. GARY JOHNSON
K081903 08/26/2008 XIOS PLUS WALL-MODULE SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K081511 08/26/2008 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S SMITH & NEPHEW, INC. JANICE HASELTON
K081566 08/21/2008 SMITH & NEPHEW OXINIUM DH FEMORAL HEADS SMITH & NEPHEW, INC. JASON SELLS
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