FDA 510(k) Applications Received During July, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K081975 07/11/2008 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) ABBOTT DIABETES CARE INC. ARUL STERLIN
K082032 07/17/2008 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) ABBOTT SPINE, INC. DAVID PADGETT
K082071 07/22/2008 ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT ADPHARMA, INC. VIVEK RAMANA
K082068 07/22/2008 E. COLI PNA FISH ADVANDX, INC. HENRIK STENDER
K082146 07/30/2008 METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K081973 07/10/2008 METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K081963 07/10/2008 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS AGFA HEALTHCARE CORPORATION JEFFERY A JEDLICKA
K081976 07/11/2008 IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION AGFA HEALTHCARE CORPORATION
K081935 07/07/2008 STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 AKTINA MEDICAL PHYSICS CORP. TONY SPACCAROTELLA
K082080 07/23/2008 ALCO TUBE PLUS ALCOTEST QUEBEC E.J. Smith
K081960 07/09/2008 INVISALIGN SYSTEM ALIGN TECHNOLOGY SANGEETA SACHDEVA
K082100 07/25/2008 ALLTECH ECHOSTAR 1.5 T MR SYSTEM ALLTECH MEDICAL SYSTEMS AMERICA, INC. JOHN DURAJ
K082064 07/21/2008 RADVISION ET DIAGNOSTIC X-RAY SYSTEM ALMANA MEDICAL IMAGING DANIEL KAMM
K081936 07/07/2008 SOLEX CATHETER, MODEL SL2593 ALSIUS CORP. JOHN RIOLO
K082037 07/17/2008 SEEPLATE CERVICAL PLATE SYSTEM AMEDICA CORP. ADAM HERDER
K082006 07/15/2008 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC. STEPHANIE GEORGE
K082144 07/30/2008 AMICAS PACS, VERSION 6.0 AMICAS, INC. PATRICE JC NEDELEC
K082059 07/21/2008 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K081979 07/11/2008 ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K082073 07/23/2008 ACTIFUSE FLOW BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K082114 07/28/2008 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K082102 07/25/2008 GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K082031 07/17/2008 APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES APPASAMY ASSOCIATES R.N. KASTHURI
K081893 07/03/2008 OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 ARTHROCARE CORP. LAURA KASPEROWICZ
K082023 07/16/2008 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K081880 07/02/2008 ATLAS SPINE SPACER ATLAS SPINE INC. JEANNETTE G DAILEY
K082074 07/23/2008 ATRICURE CRYO1 CRYO-ABLATION PROBE ATRICURE, INC. JAMES LUCKY
K081933 07/07/2008 AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR AVALON LABORATORIES, LLC LEE WIRTH
K081940 07/08/2008 AVALON ELITE VASCULAR ACCESS KIT AVALON LABORATORIES, LLC LEE WIRTH
K082044 07/18/2008 ACE STAPLER, MODEL F0031 BAROSENSE, INC DANIEL J BALBIERZ
K082132 07/29/2008 BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK BAUSCH & LOMB, INC NED LUCE
K081920 07/03/2008 BD GENEOHM CDIFF ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) RAYMOND BOULE
K082162 07/31/2008 COULTER BODY FLUID CONTROL BECKMAN COULTER, INC. LOURDES COBA
K081930 07/07/2008 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. LOURDES COBA
K082125 07/29/2008 N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT BEST GLOVE, INC NEIL DOW
K081980 07/11/2008 KYMCO FORU, MODEL EQ35 BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K082087 07/23/2008 EYEFEEL OPHTHALMIC WARMER BIO-LIPID, INC. PAMELA FURMAN
K082011 07/15/2008 MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K082036 07/17/2008 LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK Bio-Rad Laboratories ELIZABETH PLATT
K081896 07/03/2008 BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH BIOGENICS, INC. LOU JONES
K082141 07/30/2008 ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 BIOKIT S.A. JOAN GUIXER
K081952 07/09/2008 SYNERGY SPINAL SYSTEM (6.35 POLARIS) BIOMET SPINE VIVIAN KELLY
K082008 07/15/2008 BIONET BM3PLUS PATIENT MONITOR BIONET CO., LTD. YINGCHAO XIAO
K082109 07/25/2008 BOVIE ICON GENERAL PURPOSE RF GENERATOR BOVIE MEDICAL RICHARD A KOZLOFF
K082060 07/21/2008 CRANIAL IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG RAINER BIRKENBACH
K081961 07/09/2008 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER BRONTES TECHNOLOGIES JOHN GREENBAUM
K082094 07/24/2008 BARD PTFE (TEFLON) COATED GUIDE WIRES C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION DEBORAH L HERRINGTON
K081924 07/07/2008 CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE CALHEALTH INC Ke-Min Jen
K082090 07/24/2008 9131 DEFIBRILLATION ELECTRODES CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K081944 07/08/2008 MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIO SYSTEMS, INC. DAVID D BROOKE
K082016 07/15/2008 GDX VCC WITH ECC SOFTWARE CARL ZEISS MEDITEC INC. JUDITH A BRIMACOMBE
K082118 07/28/2008 XPERT HEMOSIL FACTOR II & FACTOR V ASSAY CEPHEID RUSSEL K ENNS
K082140 07/30/2008 XPERT MRSA/SA BLOOD CULTURE ASSAY CEPHEID RUSSEL K ENNS
K082134 07/29/2008 CIRCULATOR BOOT CIRCULATOR BOOT CORP. RICHARD S DILLON
K082159 07/31/2008 CIVASTRING PD-103 CIVATECH ONCOLOGY, INC. LOIS V SMART
K081858 07/01/2008 RETCAM 3 OPHTHALMIC IMAGING SYSTEM CLARITY MEDICAL SYSTEMS GARY A SEEGER
K082038 07/17/2008 CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V CLARUS MEDICAL, LLC. THOMAS BARTHEL
K081908 07/03/2008 CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION CAROL RUGGIERO
K082107 07/25/2008 CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION CAROL RUGGIERO
K082034 07/17/2008 MODIFICATION TO MERCI RETRIEVER CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K081987 07/14/2008 UNISYN IMAGE FUSION, VERSION 1.0 CONVERGENT IMAGING SOLUTIONS MATHEW A THOMAS
K082058 07/21/2008 DYNAMATRIX COOK BIOTECH, INC. DAVID J COLLETTE
K082066 07/22/2008 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER COOK UROLOGICAL, INC. CINDY FOOTE
K081865 07/01/2008 PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR COOPERVISION, INC. BONNIE TSYMBAL
K082143 07/30/2008 MICRO GUIDE CATHETER XP CORDIS CORP. KAREN WILK
K082077 07/23/2008 BT3/6, BT12 CORSCIENCE GMBH & CO. KG PATRIK KAREM
K082051 07/18/2008 COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 COSMAN MEDICAL, INC. LOUIS FALCONE
K082012 07/15/2008 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN COSMAN MEDICAL, INC. LOUIS FALCONE
K082097 07/24/2008 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE DEMETECH CORP. ANTHONY J DIMERCURIO
K082137 07/29/2008 DLMS-ZIRBLOCKS DENTAL MILLING LABORATORY SUPPLIES (DLMS) SCOTT ATKIN
K082128 07/29/2008 DEPUY SPINE LATERAL CAGE SYSTEM DEPUY SPINE DENISE DUCHENE
K081917 07/03/2008 DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS DEPUY SPINE, INC. SHARON STAROWICZ
K081898 07/03/2008 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K081928 07/07/2008 D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K082049 07/18/2008 LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DIASORIN, INC. CAROL A DEPOUW
K082050 07/18/2008 LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DIASORIN, INC. CAROL A DEPOUW
K082001 07/14/2008 DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B DIAZYME LABORATORIES Abhijit Datta
K082167 07/31/2008 PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX DIGIMED CORPORATION SHIN KUK YOO
K081877 07/02/2008 ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV GER VIJFVINKEL
K081899 07/03/2008 ANYRAY PORTABLE X-RAY SYSTEM E-WOO TECHNOLOGY CO., LTD. DAVE KIM
K082139 07/29/2008 EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 EDWARDS LIFESCIENCES, LLC. DARYL RICHARDSON
K082040 07/18/2008 MINISILK FT EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K082039 07/18/2008 SYNCHRO HP PLATFORM EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K082106 07/25/2008 ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) ELCAM MEDICAL A.C.A.L. TALI HAZAN
K081998 07/14/2008 H-WAVE SPORT ELECTRONIC WAVEFORM LABORATORY, INC. RYAN P HEANEY
K082122 07/28/2008 MLCI2 ELEKTA LTD. PATRICK T HULL
K082121 07/28/2008 EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K082124 07/28/2008 CARDITTE MICROTEL ET MEDICAL DEVICES SPA LUIGI BUCCHI
K082130 07/29/2008 EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K082029 07/17/2008 SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K082022 07/16/2008 OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ EXACTECH, INC. GRAHAM CUTHBERT
K081934 07/07/2008 EXTREMITY MEDICAL COMPRESSION SCREW EXTREMITY MEDICAL LLC JAMY GANNOE
K081990 07/14/2008 LUBRICANO STERILE GEL FARCO PHARMA GMBH SETH A MAILHOT
K082041 07/18/2008 FIATLUX VISUALIZE FIATLUX IMAGING INC.
K081996 07/14/2008 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN
K082163 07/31/2008 FLOWMEDICA BENEPHIT INFUSION SYSTEMS FLOWMEDICA, INC. JEFF ELKINS
K081915 07/03/2008 FDTX GLUCOSE CONTROL SOLUTION FUJIREBIO DIAGNOSTICS TEXAS, INC. JOHN GORMLEY
K081919 07/07/2008 UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM FUKUDA DENSHI CO., LTD. LORAN VAN NOY
K081891 07/02/2008 FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR FUKUDA DENSHI USA, INC. SUSAN D GOLDSTEIN-FALK
K082092 07/24/2008 DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE GALEMED CORP. THOMAS LOESCHER
K081870 07/01/2008 MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO GE HEALTHCARE FINLAND OY JOHN PENDERGAST
K081941 07/08/2008 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K082104 07/25/2008 GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM GE MEDICAL SYSTEMS, INC. STEVEN KACHELMEYER
K081985 07/14/2008 AW SERVER GE MEDICAL SYSTEMS, LLC STEPHEN SLAVENS
K081916 07/07/2008 GE SIGNA MR ONCOLOGY PACKAGE GE MEDICAL SYSTEMS, LLC Daniel Biank
K081921 07/07/2008 GE VIVID E9 ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K082027 07/17/2008 FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 GENESIS BPS LLC CAROLYN AMDITIS
K081875 07/02/2008 GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS ERIC S GRUFF
K081938 07/08/2008 ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 GENZYME DIAGNOSTICS P.E.I. INC. PENNY J WHITE
K081947 07/08/2008 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING GISH BIOMEDICAL, INC. HARVEY KNAUSS
K082082 07/23/2008 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING GISH BIOMEDICAL, INC. MARTIN SELLERS
K081881 07/02/2008 GISH TUBING AND CONNECTORS WITH HA COATING GISH BIOMEDICAL, INC. EDWARD F WADDELL
K081923 07/07/2008 ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD GLAXOSMITHKLINE CONSUMER HEALTHCARE ZINATARA A MANJI
K082028 07/17/2008 LASERPEEL SOFT-MET MODIFIED ERBIUM LASER GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K082033 07/17/2008 NANNOLIGHT INTENSE PULSED LIGHT SYSTEM GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K081906 07/03/2008 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K081889 07/02/2008 RHAPSODY CT GRANTADLER CORPORATION ARTHUR WARD
K082126 07/29/2008 RHAPSODY MRI GRANTADLER CORPORATION ARTHUR WARD
K081929 07/07/2008 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC. Judi Smith
K081954 07/09/2008 GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE GYRUS ACMI, INC. TERRENCE E SULLIVAN
K082054 07/21/2008 GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 GYRUS ACMI, INC. TERRENCE E SULLIVAN
K082075 07/23/2008 HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER HANSEN MEDICAL, INC. KATE WHITIN
K082018 07/16/2008 T2 FLEXIBLE NAIL HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K082009 07/23/2008 HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS HSINER CO., LTD. TOM SHANKS
K082025 07/17/2008 BODY-JET HUMAN MED AG INGE MATTHIESEN
K081932 07/07/2008 ENDEARE BREAST PUMP HYGEIA MEDICAL, INC. JASPER BENKE
K082020 07/16/2008 ENVISION BLOOD GLUCOSE TEST SYSTEM INFOPIA CO., LTD MARIA F GRIFFIN
K082111 07/28/2008 STRAUMANN MEMBRAGEL INSTITUT STRAUMANN AG LISA QUAGLIA
K081925 07/07/2008 SNAPSHOT INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K082147 07/30/2008 BODYMETRIX BX2000 INTELAMETRIX, INC HEIDI STARK
K082047 07/18/2008 SECURACATH CATHETER, MODEL SPK01 INTERRAD MEDICAL, INC. Sew-Wah Tay
K082061 07/21/2008 INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER IRVINE BIOMEDICAL, INC. JEANETTE HENDRICKSON
K081982 07/11/2008 WATCH-PAT 200S-2 (WP200S-2) ITAMAR MEDICAL JONATHAN S KAHAN
K081943 07/08/2008 MODEL ES-130 ITO CO., LTD. KENNETH L BLOCK
K081886 07/02/2008 KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED KAREX INDUSTRIES SDN BHD LENG KIAN GOH
K082046 07/18/2008 KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K082157 07/31/2008 KETTOSIL AND SILGINAT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K081981 07/11/2008 LANG DENTAL ACRYLIC PRIMER LANG DENTAL MFG. CO., INC. CHAH M SHEN
K081878 07/02/2008 LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM LEMAITRE VASCULAR, INC. ERIN DALY
K082056 07/21/2008 ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 LIFE-TECH, INC. JEFF KASOFF
K081864 07/01/2008 PROLONG LIFE-TECH, INC. JEFF KASOFF
K082103 07/25/2008 LTM WOUND DRESSING LIFECELL CORP. MANAL MORCOS
K082096 07/24/2008 POWERLIPO LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K082035 07/17/2008 MAICO MB 11 WITH BERAPHONE PROBE MAICO DIAGNOSTICS DANIEL EGGAN
K082067 07/22/2008 MSC LIPID CONTROL MAINE STANDARDS CO. HOLLY CRESSMAN
K081884 07/02/2008 MAJOR.BASE 20 MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082153 07/30/2008 MAJOR.REPAIR MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082088 07/24/2008 MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II MAKO SURGICAL CORP. WILLIAM F TAPIA
K082081 07/23/2008 MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III MAKO SURGICAL CORP. WILLIAM F TAPIA
K081867 07/01/2008 MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 MAKO SURGICAL CORP. WILLIAM TAPIA
K082117 07/28/2008 QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K082052 07/21/2008 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK MASIMO CORPORATION MARGUERITE THOMLINSON
K082019 07/16/2008 FREEDOM TOTAL KNEE SYSTEM MAXX ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K081904 07/03/2008 PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) MEDCOMP JEAN CALLOW
K082069 07/22/2008 PASS 2 SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K081956 07/09/2008 MEDINOL X-SUIT NIR BILIARY METALLIC STENT MEDINOL LTD. LEO L BASTA
K082127 07/29/2008 STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K082166 07/31/2008 MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K082002 07/14/2008 PROGENIX PLUS MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K082112 07/28/2008 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K081950 07/09/2008 PROGENIX PLUS MEDTRONIC SOFAMOR DANEK, INC. RYAN MASSEY
K082149 07/30/2008 LYMPHA PRESS OPTIMAL, MODEL# 1201AP MEGO AFEK AC LTD AHAVA STEIN
K081962 07/09/2008 LAPEX BCS MERIDIAN CO., LTD. DANIEL KAMM
K082063 07/21/2008 PRELUDE SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K081913 07/03/2008 METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER META BIOMED CO., LTD. TAE-HOON KIM
K081965 07/10/2008 MPOWRX SNORING SOLUTION MPOWRX HEALTH AND WELLNESS PRODUCTS INC. JEAN ASQUITH
K081871 07/01/2008 UNIVERSAL ELECTRODES NEUROMETRIX, INC. RAINER MAAS
K081972 07/10/2008 BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K081970 07/10/2008 BIOCLEAN CHEMO SHIELD NITRITEX (M) SDN. BHD. DEREK WATTS
K081971 07/10/2008 BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K081861 07/01/2008 HOLTER LX ANALYSIS NORTH EAST MONITORING INC. JOSEPH AZARY
K082113 07/28/2008 NOX T3, NOXTURNAL (PC APPLICATION) NOX MEDICAL KOLBRUN E OTTOSDOTTIR
K082070 07/22/2008 NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K081939 07/08/2008 OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K081900 07/03/2008 TEMPORARY TOOTH REPLACEMENT ORMCO CORP. Wendy Garman
K082099 07/25/2008 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
K081994 07/14/2008 STARLIGHT ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K081986 07/14/2008 SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE Oscor Inc. MILA DOSKOCIL
K081876 07/02/2008 OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING OSTEOMED L.P. ALMA RELJA
K082004 07/14/2008 SMOOTHKIT+ OSYRIS JAOUAD ZEMMOURI
K082108 07/25/2008 OBC BONE ANCHORED HEARING AID SYSTEM OTICON MEDICAL AB KAROLIN ISBERG
K082164 07/31/2008 PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K081887 07/02/2008 LUTE-IT II VENEER CEMENT, MODEL NO6 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K082138 07/29/2008 AIRGENT, MODEL AG7000010 PERFACTION, INC. JONATHAN S KAHAN
K081964 07/10/2008 K450 POWERED WHEELCHAIR PERMOBIL AB JAN ASTROM
K081983 07/11/2008 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 PHILIPS MEDICAL SYSTEMS CLAIRE ARAKAKI
K081937 07/07/2008 PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH JENS-PETER SEHER
K081989 07/14/2008 MODIFICATION TO FETCH ASPIRATION CATHETER POSSIS MEDICAL, INC. MIKE BURNSIDE
K082150 07/30/2008 MODIFICATION TO PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH WENDY BALLESTEROS
K082089 07/24/2008 PRUMYX CREAM PRUGEN, INC. ROBERT L KNECHTEL
K081946 07/08/2008 SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR QUANTEL MEDICAL GEORGE MYERS
K081948 07/08/2008 RAYPAX SYSTEM RAYPAX, INC. CHRIS CHUNG
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