FDA 510(k) Applications Received During October, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K072824 10/02/2007 FOX SV PTA CATHETER ABBOTT LABORATORIES GEORGE J PRENDERGAST
K072798 10/02/2007 VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE M TAYLOR
K073041 10/29/2007 RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER ACCLARENT, INC. KERI YEN
K072891 10/10/2007 SINUS SPACER ACCLARENT, INC. KERI YEN
K072836 10/05/2007 CHOLESTRAK HDL CHOLESTEROL HOME TEST ACCUTECH, LLC. GARY LEHNUS
K072850 10/04/2007 MRI SYSTEM, MODEL MAGFINDER II / AI 3200 ADVANCED IMAGING LABORATORY STEPHEN T MLCOCH
K072993 10/23/2007 REUSABLE HEADREST WITH NASAL SEAL AEIOMED, INC. GARY SYRING
K072816 10/02/2007 NIOX MINO AEROCRINE AB JOEL SLOMOFF
K072899 10/11/2007 ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K072887 10/12/2007 G-TRAINER MEDICAL ALTER-G, INC. GLEN MANGSETH
K072901 10/11/2007 AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 AMDL, INC. GARY DREHER
K073030 10/29/2007 AG-605 BLOOD GLUCOSE MONITORING SYSTEM ANDON HEALTH CO.,LTD MS. MONA
K073034 10/26/2007 AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) APPLIED MEDICAL TECHNOLOGY, INC. BRIAN BAKER
K073047 10/29/2007 APROXI 1100 AND 4000 SERIES DENTAL INLAYS APROXI APS KIRSTEN RONO
K072883 10/09/2007 ICE-SENSE ARBEL MEDICAL LTD. ZVI LADIN
K073019 10/29/2007 SILVERMED ANTIMICROBIAL SILVER HYDROGEL ARGENTIS BIOMEDICAL INCORPORATED TONI MILLER
K072865 10/05/2007 MODIFICATON TO: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K073010 10/25/2007 ROYALE AE 9036 LSP INJECTOR ASICO LLC RAVI NALLAKRISHNAN
K072974 10/22/2007 SURGIMESH XB ASPIDE MEDICAL HOWARD M HOLSTEIN
K073014 10/29/2007 INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN AUTOGENOMICS, INCORPORATED EVELYN G LOPEZ
K072876 10/09/2007 PRONTOSAN WOUND IRRIGATION SOLUTION B. BRAUN MEDICAL, INC. REBECCA STOLARICK
K073007 10/24/2007 CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K072875 10/09/2007 NIO 5MP DISPLAY, MODEL E5620 BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K073023 10/29/2007 STERILS SINGLE-USE I/A HANDPIECES BAUSCH & LOMB, INC. NED LUCE
K072825 10/02/2007 FINGERTIP PULSE OXIMETER, MODEL MD300I BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K073080 10/31/2007 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD LABORATORIES MARIA ZEBALLOS
K073063 10/30/2007 15W CERALAS D 1470NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K072804 10/01/2007 COMPREHENSIVE RS SHOULDER SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K072879 10/10/2007 INNERVUE DIAGNOSTIC SCOPE SYSTEM BIOMET ORTHOPEDICS, INC. SUSAN ALEXANDER
K072848 10/05/2007 ACTIVASCREW BIORETEC LTD MARI RUOTSALAINEN
K072892 10/16/2007 TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 BIOSITE INCORPORATED FIL V BUENVIAJE
K072862 10/25/2007 BOSTON-BAND CRANIAL REMODLING ORTHOSIS BOSTON BRACE INTL., INC. JAMES H WYNNE
K073018 10/25/2007 STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT BRAINLAB AG RAINER BIRKENBACH
K072964 10/19/2007 NICOLET CORTICAL STIMULATOR CARDINAL HEALTH, INC. GARY SYRING
K072800 10/01/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. JOHN CARLINE
K073038 10/30/2007 CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B CAREMATIX INC. SUKHWANT KHANUJA
K073054 10/30/2007 MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. DAVID J COLLETTE
K072960 10/19/2007 CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET CDP, LTD. DORON DAVID
K073016 10/25/2007 TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K073022 10/26/2007 CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 CLAREBLEND, INC. JILL CREASY
K073000 10/24/2007 LUMAPROBE CLAREBLEND, INC. JILL CREASY
K072947 10/24/2007 SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS CLEARSTREAM TECHNOLOGIES, LTD. IAN P GORDON
K072851 10/04/2007 POLYSTAR 79 DENTURE BASE RESIN CMP INDUSTRIES LLC. DEVON O HOWE
K073061 10/31/2007 THE PROXIVENT KIT COLL PARTNERS LTD. ELI M ORBACH
K072808 10/05/2007 SPEEDICATH COMPACT COLOPLAST CORP. REBEKA STOLTMAN
K073013 10/25/2007 CTU676 DEVICE COMPRESSION TECHNOLOGIES UNLIMITED, INC. DOUGLASS HALE
K072796 10/01/2007 MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K073009 10/25/2007 ONEPORT SURGICAL TROCAR SYSTEM CONMED CORPORATION BRIAN KILLORAN
K072962 10/19/2007 CABS'AIR COUSIN BIOTECH S.A.S. STEPHEN PLOQUIN
K072866 10/05/2007 ISSYS LP SPINAL FIXATION SYSTEM CUSTOM SPINE, INC. SAAD ATTIYAH
K072950 10/22/2007 CYGNUS 12 LEAD ECG MODULE CYGNUS, LLC NARCIS NAYDENOV
K072868 10/09/2007 ACCOLADE II LASER CYNOSURE, INC. GEORGE CHO
K073072 10/31/2007 DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B DADE BEHRING, INC. PAMELA A JURGA
K073055 10/30/2007 DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 DADE BEHRING, INC. VICTOR M CARRIO
K072965 10/29/2007 DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K072752 10/29/2007 BP LIMBO XL, BPTANGO XL, BP SALSA XL DATADANCER MEDICAL SYSTEMS MICHAEL KOHUT
K072930 10/24/2007 DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT DEMETECH CORP. A.J. DIMERCURIO
K072807 10/01/2007 I LIGHT DENT'N CO ALAN DONALD
K073067 10/30/2007 ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K073073 10/31/2007 ANKYLOS TEMPORARY ABUTMENT BALANCE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K073075 10/31/2007 FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072989 10/23/2007 AXIS SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K072832 10/03/2007 ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K072963 10/19/2007 DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K072956 10/19/2007 MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. MARY MCNAMARA-CULLINANE
K073488 10/22/2007 DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX DIAZYME LABORATORIES CHARLES YU
K073070 10/30/2007 DIO BIOTITE-H IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. STEVE CHANG
K072885 10/09/2007 CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 DRAEGER MEDICAL AG & CO. KG KATHY ANDERSON
K072884 10/09/2007 FABIUS MRI DRAEGER MEDICAL AG & CO. KG KATHY ANDERSON
K072985 10/23/2007 DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 DUCKWORTH & KENT, LTD. MARTIN LOCK
K073021 10/26/2007 MULTI-SPECT EAGLE HEART IMAGING, LLC JOHN KOSS
K072946 10/17/2007 HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM EMPI SANDRA WALROD
K072789 10/01/2007 DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES ENCISION, INC. JUDITH V KING
K072888 10/10/2007 REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) ENCORE MEDICAL, L.P. TIFFANY HUTTO
K072840 10/04/2007 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K072919 10/15/2007 VENDYS, MODEL 6000 B B/C ENDOTHELIX, INC. DOUG BLAKELY
K072890 10/10/2007 STASILON FR ENTEGRION, INC. E.S. ESKRIDGE, JR.
K073046 10/29/2007 ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 ETHICON ENDO-SURGERY, INC. GLENDA C MARSH
K072776 10/04/2007 THE CROSSER SYSTEM FLOWCARDIA, INC. DUSTIN MICHAELS
K072870 10/09/2007 MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) FOUNDRY NEWCO X, INC. GREGORY MATHISON
K072939 10/17/2007 HE4 EIA, MODEL: 404-10 US FUJIREBIO DIAGNOSTICS, INC. DIANA L DICKSON
K072908 10/12/2007 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS FEI LAW
K072986 10/23/2007 INTEGRADWEB PACS SYSTEM GE HEALTHCARE JILLIAN M REED
K072976 10/22/2007 MODEL 250CX SERIES MATERNAL/FETAL MONITOR GE HEALTHCARE AGATA SMIEJA
K072664 10/02/2007 GE LUNAR FEMUR STRENGTH SOFTWARE GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES RASKOB
K072998 10/24/2007 IDEAL SOFTWARE OPTION FOR GE MR SCANNERS GE MEDICAL SYSTEMS, LLC MARK M STAUFFER
K072977 10/22/2007 DIAZYME APOLIPOPROTEIN A-1 ASSAY GENERAL ATOMICS ABHIJIT DATTA
K072952 10/18/2007 GE ECHOPAC GENERAL ELECTRIC CO. ALLEN SCHUH
K072797 10/01/2007 GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K073062 10/30/2007 OMNI-VUE SYSTEM GENESIS DIGITAL IMAGING, INC. CARL ALLETTO
K072970 10/22/2007 PATRIOT SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
K072991 10/23/2007 PATRIOT SPACERS: COLONIAL ACDF GLOBUS MEDICAL, INC. KELLY J BAKER
K073064 10/30/2007 GRAFTYS BCP GRAFTYS ANTHONY LE NAOUR
K073044 10/29/2007 HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K072900 10/12/2007 EXCELARREST FOAM HEMOSTASIS, LLC KEITH ROBERTS
K073059 10/30/2007 PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM HITACHI, LTD., POWER SYSTEMS GROUP JONATHAN S KAHAN
K072847 10/04/2007 APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS HOLOGIC, INC. BRYAN COWELL
K072906 10/11/2007 SILK'N HOME SKINOVATIONS LTD. AMIR WALDMAN
K073076 10/31/2007 HOFFMANN LIGHT SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K072867 10/10/2007 IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K IMIX ADR FINLAND OY JAMES TAYLOR
K073033 10/26/2007 LEGACY DENTAL IMPLANTS IMPLANT DIRECT LLC THOMAS GOTTENBOS
K073049 10/29/2007 SCREWPLUS DENTAL IMPLANTS (HA) IMPLANT DIRECT LLC THOMAS GOTTENBOS
K072822 10/02/2007 FUNHALER, MODEL V-201E INFAMED LTD. JOHN GREENBAUM
K072932 10/16/2007 INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 INFRAREDX, INC. STEVEN J CHARTIER
K073060 10/30/2007 CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR INNOVA VISION INC. JENNIFER REICH
K072925 10/24/2007 CANDELA-INOLASE SERENITY PRO PSF SYSTEM INOLASE, LTD. GEORGE J HATTUB
K072944 10/17/2007 QUANTA LITE CCP3.1 IGG/IGA ELISA INOVA DIAGNOSTICS, INC. RUFUS BURLINGAME
K072967 10/30/2007 QUANTA LITE F-ACTIN IGA ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K073042 10/29/2007 HEMOSIL D-DIMER INSTRUMENTATION LABORATORY CAROL MARBLE
K072929 10/16/2007 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 INTEGRA LIFESCIENCES CORPORATION DARLENE M WELSH
K072863 10/05/2007 ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES INTERNACIONAL FARMACEUTICA, S.A. DE C.V. ALLAN P SCHWARTZ
K072859 10/05/2007 ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES INTERNACIONAL FARMACEUTICA, S.A. DE C.V. ALAN P SCHWARTZ
K072874 10/23/2007 LBS-127-16 BREAST ARRAY COIL INVIVO JEFF WILKINSON
K072873 10/22/2007 LBS-63-16 BREAST ARRAY COIL INVIVO JEFF WILKINSON
K072911 10/12/2007 ION MEDICAL BIPOLAR COAGULATION PEN ION MEDICAL, LLC KEITH HURON
K072833 10/04/2007 P-NAIN SYSTEM JEISYS MEDICAL, INC. KEVIN WALLS
K072914 10/16/2007 NATURAL BRIDGE LP TRANSVERSE CONNECTORS K2M, INC. RICHARD W WOODS
K072788 10/01/2007 STORZ MODULITH LITHOTRIPTER SLX-F2-F180 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K072811 10/01/2007 MARIONETTE SA, MODEL 001 001 & 001 002 KINETIC SURGICAL LLC JIM CAPUTO
K073008 10/24/2007 KFH ENERGY, MODEL: E1 KINGFISHER HEALTHCARE NV NEIL R ARMSTRONG
K072795 10/01/2007 MODELS EMS 5.0, EMS 5.1 KOALATY PRODUCTS, INC. JEFF LENOIR
K073032 10/29/2007 PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS LIFECORE BIOMEDICAL, INC. JUDITH MEDLOCK-HAYES
K072926 10/15/2007 HELONTIX VENT LINDE GAS THERAPEUTICS ANN-CATHRIN JAREMAN
K072995 10/23/2007 TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER LUMEN DEVELOPMENT AND MANUFACTURING, INC. CALVIN D OSTLER
K072806 10/02/2007 MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) MAKO SURGICAL CORP. WILLIAM TAPIA
K073024 10/26/2007 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION MARGUERITE THOMLINSON
K072857 10/05/2007 TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT MEDACTA INTERNATIONAL, SA PAMELA J WEAGRAFF
K072898 10/11/2007 HEXAPOD EVO RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K073051 10/29/2007 MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY MEDRAD, INC. LESLIE S O'NAN
K072886 10/09/2007 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T MEDRAD, INC. LISA M CASAVANT
K072972 10/22/2007 MEDSTREAMING MEDICAL OFFICE SOFTWARE MEDSTREAMING, LLC KARLA PATTEN
K072990 10/24/2007 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID MEDTRONIC INC. KAREN A BROZOWSKI
K073058 10/30/2007 RESCUE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. STEVE CHANG
K072823 10/03/2007 MERILAS 532A MERIDIAN AG KEVIN WALLS
K073035 10/29/2007 PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS MERIT MEDICAL SYSTEMS, INC. SHIRLEY HYINK
K072978 10/22/2007 TENDER ORTHO BOND-ENA BOND-ENA ETCH MICERIUM S.P.A. EUGENIO MICELI
K072979 10/22/2007 SPIROBANK G MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K072793 10/03/2007 LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 MOELLER MEDICAL GMBH & CO. KG BILL KELLEY
K072931 10/16/2007 MC 3003G-32R HEAD COIL MR INSTRUMENTS, INC. MARK WATSON
K072881 10/09/2007 NEOMED FEEDING TUBE NEOMED, INC. PENNY NORTHCUTT
K072997 10/24/2007 NEOMED URINARY CATHETER NEOMED, INC. PENNY NORTHCUTT
K072905 10/11/2007 3TEST SUPREME GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC. KE-MIN JEN
K072841 10/04/2007 NEUVIZ SPIRAL CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN TANFANG
K072984 10/23/2007 SATURN 9000-550 NEW MEDICAL CO., LTD. YOUNG-HOON SHIN
K072983 10/23/2007 SATURN 9000-750 NEW MEDICAL CO., LTD. YOUNG-HOON SHIN
K072831 10/03/2007 FROG NEWBY-COOMBS, LLC KARLA COOMBS
K072843 10/04/2007 YG-125T AND YG-135T NASAL ADAPTER NIHON KOHDEN AMERICA, INC. JACK COGGAN
K072988 10/23/2007 NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 NIPRO MEDICAL CORPORATION JESSICA OSWALD
K072980 10/23/2007 NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS NOBEL BIOCARE AB KAM LEUNG
K072917 10/16/2007 JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM ODONTIT SA MARIO GERSBERG
K072937 10/16/2007 OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET OLSEN MEDICAL JOHN P WATERS
K072957 10/24/2007 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K073045 10/29/2007 SAPPHIRE CERAMIC BRACKET ORTHO TECHNOLOGY, INC PAUL WILLIAMS
K072882 10/09/2007 PAIN VISION, MODEL PS-2100 OSACHI CO., LTD. JAMES R GREENWOOD
K072770 10/10/2007 TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) OSCOR INC. MILA DOSKOCIL
K072896 10/11/2007 GS FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD KIM M JOO
K072959 10/19/2007 MS SYSTEM (DENTURE) OSSTEM IMPLANT CO.,LTD MIN JOO KIM
K072871 10/10/2007 MS SYSTEM (PROVISIONAL) OSSTEM IMPLANT CO.,LTD CATHRYN N CAMBRIA
K073065 10/30/2007 OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM OSTEOMED L.P. PIEDAD PENA
K072969 10/22/2007 DSS PARADIGM SPINE, LLC JUSTIN EGGLETON
K072982 10/23/2007 PARI HYDRATE V PARI INNOVATIVE MANUFACTURERS, INC. MIKE JUDGE
K073057 10/30/2007 PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 PEAK SURGICAL, INC. GRACE CARLSON
K072830 10/03/2007 RM BOND, MODEL J032 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K072813 10/01/2007 EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) PHASEIN AB DAVID WEISSBURG
K072812 10/01/2007 PHILIPS HEARTSTART SMARTPADS III PHILIPS MEDICAL SYSTEMS LARRY WALKER
K072869 10/09/2007 POINTCARE NOW SYSTEM POINTCARE TECHNOLOGIES INC. MAURICE N DOIRE
K073001 10/24/2007 IDRIVES, IDRIVEC, IDRIVEF POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K073039 10/29/2007 SPERMCHECK VASECTOMY PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
K073029 10/29/2007 PROFLU+ ASSAY PRODESSE, INC. KAREN HARRINGTON
K072487 10/09/2007 FAST1 INTRAOSSEOUS INFUSION SYSTEM PYNG MEDICAL CORP. MAYA BUTTERFIELD
K072935 10/17/2007 SPEEDER 1.5T WRIST ARRAY COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K073066 10/30/2007 308 DERMATOLOGICAL EXCIMER SYSTEM QUANTEL MEDICAL, INC. GEORGE MYERS
K072846 10/11/2007 CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 R & D SYSTEMS, INC. NANCY C RING
K072953 10/18/2007 REDLINE ALCOHOL BREATH TESTER REDLINE PRODUCTS (PTY) LTD. HUGH A BUTLER
K072827 10/03/2007 RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE REMEL, INC. ANDRE HSIUNG
K072940 10/17/2007 MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K072996 10/24/2007 REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM RESPIRONICS, INC. ZITA A YURKO
K072753 10/02/2007 REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES RG MEDICAL USA WINFRIED REICH
K072920 10/15/2007 HANDHELD BASE UNIT ROCHE DIAGNOSTICS CORP. JASON FISHER
K073048 10/29/2007 PETERIO UNIVERSAL LASER SCANNING HANDPIECE SCILEX, LTD. ALEX RAPOPORT
K073043 10/29/2007 SET PP SDI LTD. RAY CAHILL
K072729 10/11/2007 SIERRA SEASPINE, INC. ETHEL BERNAL
K072909 10/12/2007 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL SIEMENS AG, MEDICAL SOLUTIONS LUTZ MAHN
K072794 10/01/2007 IMMULITE 2500 OM-MA, MODEL L5KOP SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MAYA MAHUE-GIANGRECO
K072786 10/01/2007 ACUSON S2000 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K073003 10/24/2007 SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY SIEMENS MEDICAL SOLUTIONS, INC. CORRINE MCLEOD
K073040 10/29/2007 SMH FLEX "S" SMH BIOMATERIAL AG ASHLEY TRUITT
K072785 10/01/2007 TWINFIX FT PK SMITH & NEPHEW INC., ENDOSCOPY DIVISION DEANA BOUSHELL
K072817 10/02/2007 ECHELON TITANIUM HIP SYSTEM SMITH & NEPHEW, INC. MARLON D RIDLEY
K072818 10/02/2007 PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS SMITH & NEPHEW, INC. DAVID HENLEY
K072852 10/10/2007 SL-PLUS STANDARD AND LATERAL HIP STEMS SMITH & NEPHEW, INC. NICHOLAS B TABRIZI
K072858 10/05/2007 TC-PLUS PRIMARY KNEE SYSTEM SMITH & NEPHEW, INC. RISHI SINHA
K072783 10/02/2007 SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K072955 10/19/2007 CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) SMITHS MEDICAL MD, INC. DAVID H SHORT
K072904 10/11/2007 SONOCA 180/195 WOUND CARE SYSTEM SOERING GMBH CARL THOMAS
K073004 10/24/2007 SOMNOMED BFLEX SOMNOMED INC. ASHLEY TRUITT
K072912 10/12/2007 SOPRO 225 DUAL HALOGEN LIGHT SOURCE SOPRO STEVE SALESKY
K073050 10/29/2007 SAFESTEP MAX POWER-INJECTABLE INFUSION SET SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. MARK NELSON
K072750 10/19/2007 SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 SPECTRANETICS CORP. MICHAEL K HANDLEY
K072961 10/19/2007 LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) SRA DEVELOPMENTS, LTD. MICHAEL J.R. YOUNG
K072864 10/05/2007 ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI COLLEEN CANAN
K073017 10/25/2007 STRYKER STRI-SHIELD FLYTE TOGAS STRYKER INSTRUMENTS, INSTRUMENTS DIV. PAULETTE D JOHNSON
K072757 10/02/2007 DIVE AND SHALLOW AND GRAND DIVE SUMMIT TO SEA BRUCE MCKEEMAN
K072834 10/03/2007 SIBEL SA VASCULAR CLAMP SURGICAL INSTRUMENTS BELGIUM SA WILLIAM F GREENROSE
K072913 10/12/2007 SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY PAULA A GRAY
K072921 10/15/2007 DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM SYMBIOS MEDICAL PRODUCTS, LLC JEFFREY ALHOLM
K072787 10/01/2007 GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 SYNCRO MEDICAL INNOVATIONS, INC. WILLIAM MCLAIN
K072791 10/01/2007 ORACLE SPACER, OPAL SPACER SYNTHES SPINE STACEY BONNELL
K072981 10/31/2007 SYNTHES ZERO-P SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K072784 10/02/2007 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION ERICA LI
K073006 10/24/2007 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM TAKIRON CO., LTD KUNIHIRO HATA
K072894 10/11/2007 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V. M.J. AERTS
K072889 10/11/2007 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER THE BINDING SITE, LTD. JAY H GELLER
K072849 10/04/2007 MODIFICATION TO THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K073027 10/26/2007 SPECTRA MRSA THERMO FISHER SCIENTIFIC MARY ANN SILVIUS
K073025 10/30/2007 VASCUTRAK II PTA DILATATION CATHETER THERMOPEUTIX INC. DBA YMED INC. THOMAS SCHROEDER
K072933 10/16/2007 SPI CONTACT PLATFORM O 4.0 MM THOMMEN MEDICAL, AG FLOYD G LARSON
K072856 10/05/2007 SPI VARIOMULTI ABUTMENT THOMMEN MEDICAL, AG LINDA K SCHULZ
K072746 10/02/2007 E-1 ESTHETIC COMPOSITE SYSTEM TOKUYAMA DENTAL CORPORATION KEITH A BARRITT
K072971 10/22/2007 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS TOPCON MEDICAL SYSTEMS, INC. JONATHAN S KAHAN
K072826 10/03/2007 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K072918 10/15/2007 MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K072968 10/24/2007 STRESSGARD NIGHTGUARD TOTALGARD CORPORATION LOUIS P IZZI
K072922 10/15/2007 3S HEMI TOE TRILLIANT SURGICAL LTD JD WEBB
K072854 10/05/2007 DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. WEN-HAI TSAI
K072802 10/01/2007 SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE ULTRAWIN SDN BHD SIEW-HOE MAH
K073053 10/30/2007 COLPO-MASTER UNITED PRODUCTS & INSTRUMENTS, INC. GEORGE MYERS
K072845 10/04/2007 PRECISION FLOW VAPOTHERM, INC. JONATHAN S KAHN
K073020 10/26/2007 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K072916 10/12/2007 TRILOGY SYSTEM WITH RAPIDARC VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K072810 10/10/2007 PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 VASCULAR SOLUTIONS, INC. DORALIE POGANSKI
K073028 10/26/2007 VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 VENOWAVE, INC. JOHN SARINGER
K073069 10/30/2007 MODIFICATION TO AVEA VENTILATOR VIASYS RESPIRATORY CARE INC TOM GUTIERREZ
K073056 10/30/2007 DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 VIEWORKS CO., LTD. KIM RAZA
K072799 10/01/2007 TARGET STERILE ELECTRODE VISION QUEST INDUSTRIES, INC. JAIME X PULLEY
K072821 10/02/2007 VITREA 4DCT VITAL IMAGES, INC. TIMOTHY J KAPPERS
K072943 10/17/2007 BUTREX BUTTRESS PLATING SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN
K072860 10/05/2007 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 YA HORNG ELECTRONIC CO., LTD. KE-MIN JEN
K072878 10/09/2007 MODIFICATION TO: LOCATOR IMPLANT ANCHOR ZEST ANCHORS, INC. RICHARD OVERTON
K073005 10/24/2007 ELITE GLASS ZHERMACK S.P.A. GERALD W SHIPPS
K072923 10/17/2007 ZOLL E SERIES DEFIBRILLATOR ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS SEAN REYNOLDS


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