FDA 510(k) Applications Received During July, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K072055 07/26/2007 LAVA FRAME, LAVA FRAME SHADE 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K071852 07/05/2007 AAP APS SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K071788 07/02/2007 AVIATOR INSULIN PUMP ABBOTT DIABETES CARE INC. SARAH HARRINGTON
K071845 07/05/2007 RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A ACCLARENT, INC. KERI YEN
K071824 07/03/2007 ACME TALON PEDICLE SCREW ACME SPINE, LLC. J. D WEBB
K072019 07/23/2007 AKITA2 APIXNEB ACTIVAERO AMERICA, INC. PAUL DRYDEN
K071944 07/13/2007 ACUMED SMALL BONE LOCKING SYSTEM II ACUMED LLC ED BOEHMER
K071945 07/13/2007 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS KATHY A RACOSKY
K071983 07/19/2007 AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K071916 07/11/2007 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K071972 07/17/2007 ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS AGFA HEALTHCARE CORP. TOM HOLBROOK
K071849 07/05/2007 ALLOFUSE GEL AND PUTTY ALLOSOURCE, INC. PAMELA VETTER
K072035 07/25/2007 RESOLVE UVB PHOTOTHERAPY SYSTEM ALLUX MEDICAL LLOYD H GRIESE
K071890 07/09/2007 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K072081 07/30/2007 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K071990 07/20/2007 VALEO CERVICAL PLATE SYSTEM AMEDICA CORP. Glenn Stiegman
K072022 07/23/2007 VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. JUSTIN EGGLETON
K071902 07/10/2007 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K071959 07/16/2007 ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K071915 07/11/2007 CPAP MASK ARCIMED LABORATORIES LLC PAUL DRYDEN
K071803 07/02/2007 ARDS DENTAL IMPLANTS ARDS, LTD GEORGE J HATTUB
K071998 07/23/2007 ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT ARROW INTL., INC. KIRSTEN STOWELL
K071978 07/18/2007 MINI TIGHTROPE FT REPAIR KIT ARTHREX, INC. SALLY FOUST
K072089 07/30/2007 ARTHROCARE SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071963 07/16/2007 MODIFICATION TO: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071887 07/09/2007 SPORTMESH OR ARTELON TISSUE REINFORCEMENT ARTIMPLANT AB TERRY S POWELL
K071946 07/13/2007 ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS ATLANTIS COMPONENTS, INC. BETSY A BROWN
K071923 07/12/2007 PTFE FLIXENE GRADUATED WALL GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K071909 07/11/2007 PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R BARKEY GMBH & CO. KG THOMAS BARKEY
K071793 07/02/2007 CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR BARTON MEDICAL CORP. LAWRENCE W SWOL
K072087 07/30/2007 BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 BELIMED SAUTER AG HANS STADLER
K072068 07/27/2007 BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC JONATHAN KAHAN
K071952 07/16/2007 GRAFTLOCK SCREW, ST SCREW BIOCOMPOSITES LTD. SIMON FITZER
K072036 07/25/2007 ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 BIOKIT S.A. JOAN GUIXER
K072078 07/30/2007 QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 BIOKIT S.A. JOAN GUIXER
K072106 07/31/2007 150W CERALAS D 980NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K072082 07/30/2007 GUMEASE DENTAL MOUTHPIECE BIOMEDEVICE LTD. BRICE L YODER
K072038 07/25/2007 VITEK 2 GRAM NEGATIVE LEVOFLOXACIN BIOMERIEUX, INC. JOLYN TENLIADO
K071934 07/13/2007 MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT BIOMET MANUFACTURING CORP. MARY L VERSTYNEN
K071816 07/02/2007 HARPOON SUTURE ANCHOR BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K072054 07/26/2007 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K071863 07/06/2007 ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) BIORETEC LTD MARI RUOTSALAINEN
K071930 07/13/2007 ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C BLUE CROSS BIO-MEDICAL CO., LTD. HILDA HONG YANG
K072049 07/25/2007 CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS BMEYE B.V. Jacqueline Emery
K071981 07/18/2007 BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART CO. LTD. ERIC L ONG
K071957 07/16/2007 PINNACLE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. MICHELLE BERRY
K072041 07/25/2007 BOVIE IDS-400 ELECTROSURGICAL GENERATOR BOVIE MEDICAL RICHARD A KOZLOFF
K072008 07/23/2007 BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K072046 07/25/2007 EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM BRAINLAB AG RAINER BIRKENBACH
K071995 07/20/2007 CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K072105 07/31/2007 ALARIS SYSTEM WITH MMS, MODEL 8XXX CARDINAL HEALTH 303, INC. STACY L LEWIS
K071904 07/10/2007 DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K071796 07/02/2007 CAPSEW PLICATION SYSTEM CAYENNE MEDICAL, INC. DAVID J COLLETTE
K071854 07/05/2007 AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K071984 07/19/2007 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB NANCY BLANCO
K071931 07/13/2007 CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 Codman & Shurtleff, Inc. EMILY E VALERIO
K071791 07/02/2007 MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 Codman & Shurtleff, Inc. RACHEL CREANE
K071938 07/13/2007 MONACO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K071907 07/10/2007 VCARE RETRACTOR/ELEVATOR CONMED CORPORATION BRIAN KILLORAN
K071783 07/02/2007 VERSAPOD (TM) INSTRUMENT TRAYS CONTAINMED, INC. TODD E BETTENHAUSEN
K072011 07/23/2007 COPD LIQUID OXYGEN PORTABLE, MODEL 300P COPD PARTNERS, INC. PAUL DRYDEN
K071962 07/16/2007 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) CORDIS NEUROVASCULAR, INC. Amarilys Machado
K072032 07/24/2007 IGG ANTI-ATHEROX TEST KIT CORGENIX, INC. DANIEL F SIMPSON
K071883 07/09/2007 IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 CYDEN LIMITED MICHAEL KIERNAN
K072086 07/30/2007 INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM D B ORTHODONTICS LTD ANNA M DYSON
K071980 07/18/2007 DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H DADE BEHRING, INC. ANNA MARIE ENNIS
K071811 07/03/2007 ETOH FLEX REAGENT CARTRIDGE (DF22) DADE BEHRING, INC. VICTOR M CARRIO
K071834 07/03/2007 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM DADE BEHRING, INC. GEORGE M PLUMMER
K071805 07/02/2007 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX DATASCOPE CORP. KATHLEEN KRAMER
K072052 07/26/2007 OSTEOGRAF/D-300 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072056 07/26/2007 OSTEOGRAF/D-700 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072057 07/26/2007 OSTEOGRAF/LD-300 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072058 07/26/2007 MODIFICATION TO: OSTEOGRAF/N-700 DENTSPLY INTERNTIONAL HELEN LEWIS
K071817 07/03/2007 OSTEOGRAF/N-300 DENTSPLY INTERNTIONAL HELEN LEWIS
K071830 07/03/2007 DEPUY DELTA TS CERAMIC FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071784 07/02/2007 DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K072083 07/30/2007 SMALL FRAGMENT LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K071927 07/12/2007 MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE, A JOHNSON & JOHNSON COMPANY SHARON STAROWICZ
K071860 07/05/2007 MODIFICATION TO: VIPER SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K071971 07/17/2007 DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL DIAZYME LABORATORIES CHARLES YU
K071787 07/02/2007 BEMITT, MODEL 0001 DJA DISTRIBUTORS, LLC BETH BROMBERG
K072002 07/23/2007 FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 DRAEGER MEDICAL AG & CO. KG KATHY ANDERSON
K071933 07/13/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K072023 07/23/2007 ELLIPSE JUVIA, MODEL 9EJU7465 ELLIPSE A/S OLE KOFOD
K071869 07/06/2007 TENS/IF 14 EMSI CHERITA JAMES
K072005 07/23/2007 RK EPIDURAL NEEDLE EPIMED INTERNATIONAL KATIE ALEXANDER
K071996 07/26/2007 MYLAB30, MODEL 7300 ESAOTE S.P.A. Allison Scott
K071951 07/16/2007 COMFY SERIES: EV-804, EV-805 & EV-806 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K071858 07/05/2007 DENTAL MATRIX BAND FLY CAST TECHNOLOGIES, INC. MICHELE H VOVOLKA
K071826 07/03/2007 THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 FOX HOLLOW TECHNOLOGIES SRIDEVI SHESHADRI
K072093 07/30/2007 PRISMAFLEX SYSTEM, VERSION 3.20 GAMBRO THOMAS B DOWELL
K072100 07/31/2007 GC AADVA ABUTMENT GC AMERICA, INC. H. CARL JENKINS
K071889 07/09/2007 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE GE HEALTHCARE JOEL C KENT
K071828 07/03/2007 LULLABY GE HEALTHCARE CLINICAL SYSTEMS THALIA BRINE
K071982 07/19/2007 MODIFICATION TO: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K072102 07/31/2007 EPIVISION SL SYSTEM GEBAUER MEDIZINTECHNIK GMBH KIMBERLEY DONEY
K071985 07/19/2007 GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K072075 07/30/2007 MODIFICATION TO GE LOGIQ A3 GENERAL ELECTRIC CO. ALLEN SCHUH
K071781 07/02/2007 PF4 IGG GENETIC TESTING INSTITUTE SUZETTE C CHANCE
K071908 07/10/2007 DOCTOR'S LIGHT LED DENTAL CURING LIGHT GOOD DOCTORS CO., LTD. IAN P GORDON
K071778 07/02/2007 HERO VASCULAR ACCESS DEVICE GRAFTCATH INC. LAURIE LYNCH
K071910 07/11/2007 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K071875 07/06/2007 V-CATH POLY PICC HDC CORP. EARL SMART
K071851 07/05/2007 HDC STERILE SPIDER SCREW HDC S.R.L. GUIDO BONAPACE
K072104 07/31/2007 HEARTWAY POWER MOBILITY SCOOTER, PF6 HEARTWAY MEDICAL PRODUCTS CO., LTD. HSIANG-PIN HUANG
K071806 07/02/2007 ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K071779 07/02/2007 ABX PENTRA URINE CAL HORIBA ABX OLIVIER DUCAMP
K071991 07/20/2007 MODIFICATION TO SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP PATRICIA SETTI-LAPERCH
K072020 07/23/2007 RESTORATION ADM SYSTEM HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K071881 07/09/2007 TRIATHLON PKR SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K071894 07/09/2007 XEBRA DICOM IMAGE BROWSER HX TECHNOLOGIES, INC. CARL ALLETTO
K072101 07/31/2007 RIGI-FIX HIP STEM SYSTEM IMPLANTS INTL. LTD. MOHAN EMMANUEL
K071810 07/02/2007 INION SPINAL GRAFT CONTAINMENT SYSTEM INION LTD. KATI MARTTINEN
K071921 07/12/2007 INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) INNOVASIS, INC. WARREN DANSIE
K071911 07/11/2007 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR INNOVISION A/S RICHARD O WOOD
K071943 07/13/2007 SERENITY PRO PSF SYSTEM INOLASE 2002, LTD. GEORGE J HATTUB
K071966 07/16/2007 1.5T MRGFUS PELVIC COIL INSIGHTEC-TXSONICS, INC. Nadir Alikacem
K072071 07/30/2007 STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS INSTITUT STRAUMANN AG ELAINE ALAN
K071928 07/12/2007 THE INVACARE FLYER, MODEL IPC 100 INVACARE CORP. CARROLL MARTIN
K071799 07/02/2007 MODIFICATION TO BIOSTAR OIA SHIGATOX IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS ROBIN C HART
K071848 07/05/2007 IPS INLINE POM SYSTEM IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K071884 07/09/2007 BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 JAWON MEDICAL CO., LTD. Won-Hee Park
K071857 07/05/2007 DELTA SPINAL FUSION SYSTEM JEMO SPINE, LLC PATRICK MOORE
K071955 07/16/2007 WIM-PC, MODEL 1010 KARMEL SONIX YORAM LEVY
K071866 07/06/2007 NTRAINER SYSTEM KCBIOMEDIX, INC. JAMES E STANLEY
K072063 07/27/2007 KFX TISSUE FIXATION SYSTEM AND ACCESSORIES KFX MEDICAL M D HEAVEN
K072027 07/24/2007 FORU KV10HB KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K071877 07/09/2007 LANX SPINAL FIXATION SYSTEM LANX, LLC JANICE M HOGAN
K071905 07/10/2007 POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, LLC JANICE M HOGAN
K072037 07/25/2007 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML LIFE-SHIELD PRODUCTS, INC ROSINA ROBINSON
K072050 07/26/2007 PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS LIFE-TECH, INC. JEFF KASOFF
K071986 07/20/2007 LTM-RC SURGICAL MESH LIFECELL CORP. LORRAINE T MONTEMURRO
K072048 07/25/2007 LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE LYNTON LASERS LIMITED ANDREW JOHN BERRY
K072094 07/30/2007 CHOOSTENT M.I. TECH CO., LTD. DANIEL KAMM
K071802 07/02/2007 TESLA GUARD, MODEL EFT G04 MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH ROBERT N CLARK
K071961 07/16/2007 MESACUP MODELS BP180 AND BP230 ELISA KITS MBL INTERNATIONAL CORPORATION DANIEL KAMM
K071878 07/06/2007 DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB MED-LECTRIC CORPORATION M. LEE GUNTER
K072053 07/26/2007 SMARTBLOCK PAIN PUMP MEDICAL FLOW SYSTEMS LTD MARK DOLLINGER
K071870 07/06/2007 HEXAPOD RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K072079 07/30/2007 IGUIDE SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K071832 07/03/2007 MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM MEDICAL SCIENTIFIC, INC. PAUL NARDELLA JR
K072097 07/31/2007 BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 MEDICAL SELECT, INC. AMY JONES
K072040 07/25/2007 C-JAWS CERVICAL COMPRESSIVE MINI FRAME MEDICREA TECHNOLOGIES J.D. WEBB
K071960 07/16/2007 MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 MEDITECH KFT. BENNY ARAZY
K071813 07/02/2007 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K071942 07/13/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MICHELLE WILLIS
K071941 07/13/2007 MEMOMETAL BONE ANCHORS MEMOMETAL TECHNOLOGIES GILLES AUDIC
K071899 07/09/2007 BIS MODULE FOR ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. IFAT OREN
K071782 07/02/2007 MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES MICROMED S.P.A. MONICA CAMILLO
K071939 07/13/2007 HYDROCOIL EMBOLIC SYSTEMS (HES) MICROVENTION, INC. VINCENT CUTARELLI
K071964 07/16/2007 MIM 4.1 (SEASTAR) MIMVISTA CORP. PETER SIMMELINK
K071814 07/02/2007 LIGHT SABRE SPINAL ACCESS DEVICE MINRAD, INC. JOHN MCNEIRNEY
K072047 07/25/2007 MHI-TM2000 LINEAR ACCELERATOR SYSTEM MITSUBISHI HEAVY INDUSTRIES, LTD. TAKASHI YAMAKAWA
K071798 07/02/2007 MONDEAL DISTAL RADIUS SYSTEM MONDEAL MEDICAL SYSTEMS GMBH JAY EVANS
K071797 07/02/2007 MONDEAL HAND CONTOUR SYSTEM MONDEAL MEDICAL SYSTEMS GMBH JAY EVANS
K071819 07/03/2007 NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 NCONTACT SURGICAL, INC. JANE RICUPERO
K072021 07/23/2007 NEOPIP INFANT RESUSCITATOR NEOFORCE GROUP, INC. MONICA FERRANTE
K071838 07/05/2007 NEOSS VARIOUS TITANIUM ABUTMENTS NEOSS LTD FREDRIK ENGMAN
K072029 07/24/2007 PHENIX VERTEBRAL BODY REPLACEMENT NEW BUSINESS DEVELOPMENT, LLC TIM B LUSBY
K072060 07/27/2007 QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V NIHON KOHDEN AMERICA, INC. JACK COGGAN
K071969 07/17/2007 SEN-4100 ELECTRIC STIMULATOR NIHON KOHDEN AMERICA, INC. JACK COGGAN
K072024 07/24/2007 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 NIPRO MEDICAL CORP. JESSICA OSWALD
K071815 07/02/2007 NOVEON, MODEL LS1100-01-0968 NOMIR MEDICAL TECHNOLOGIES, INC. RICHARD BURTT
K071795 07/02/2007 NUVASIVE COROENT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071801 07/02/2007 VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 Ortho-Clinical Diagnostics, Inc. MARLENE HANNA
K071929 07/13/2007 NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K072076 07/30/2007 CYTOPLAST PTFE SUTURE OSTEOGENICS BIOMEDICAL, INC. DUSTYN WEBB
K072033 07/24/2007 OTODYNAMICS OTOPORT OTODYNAMICS, LTD. CHRISTINA NORRIS
K071867 07/06/2007 RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA PARAGONDX, LLC DEBORAH N KLOOS
K071912 07/11/2007 APACERAM BONE GRAFT SUBSTITUTE PENTAX CORP. PATSY J TRISLER
K071846 07/05/2007 MODIFICATION TO EZ HUBER SAFETY INFUSION SET PFM MEDICAL, INC SALVADORE PALOMARES
K071993 07/20/2007 T-PORT HP INFUSION PORT PFM MEDICAL, INC SALVADORE PALOMARES
K071913 07/11/2007 IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 PHADIA AB KARL-ERIK BACKLUND
K071885 07/09/2007 ANTIMICROBIAL AND SINGLE-PATIENT CUFFS PHILIPS MEDICAL SYSTEMS PETER SCHIPELLITI
K071800 07/02/2007 PHILIPS AVALON FETAL MONITORS FM20 AND FM30 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MICHAEL ASMALSKY
K072070 07/30/2007 PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K071949 07/13/2007 VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K071827 07/03/2007 ALWAYS MENSTRUAL PADS PROCTER & GAMBLE, INC. LENORE FAULHABER
K072034 07/25/2007 DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K072010 07/23/2007 QUANTUM DIREX SYSTEM QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
K072096 07/31/2007 CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 R & D SYSTEMS, INC. NANCY C RING
K071839 07/05/2007 SOCT COPERNICUS, MODEL 15205 REICHERT, INC. SANDRA BROWN
K071808 07/02/2007 MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K071786 07/02/2007 PORTRAIT PSR RHYTEC INCORPORATED Robert Zoletti
K072026 07/24/2007 RNK ELECTRONIC STETHOSCOPE RNK PRODUCTS, INC. CHARLES R ABBRUSCATO
K071922 07/12/2007 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC RSB SPINE LLC. KAREN E WARDEN
K071953 07/16/2007 RTX3370 RTX HEALTHCARE A/S NIELS O ANDERSON
K071965 07/16/2007 I-SURGE SATELEC STEVE SALESKY
K072030 07/24/2007 IMPLANT CENTER SATELEC-ACTEON GROUP STEVE SALESKY
K072051 07/26/2007 NOVATOME, MODEL: SU101-50 SCHOLTEN SURGICAL INSTRUMENTS, INC. JIM VAN ANDEL
K071891 07/09/2007 STATIS DENTAL HANDPIECES SCICAN LTD. BRENDA MURPHY
K071847 07/05/2007 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD SONGTAO ZHANG
K071882 07/09/2007 MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD SONGTAO ZHANG
K071886 07/09/2007 SELF SEAL STERILIZATION POUCH SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. LONGFU SONG
K072018 07/23/2007 BS-200 CHEMISTRY ANALYZER, MODE BS-200 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K072006 07/23/2007 DAR-9400F SHIMADZU CORP. DON KARLE
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K071925 07/12/2007 MAGNETOM ESSENZA SIEMENS MEDICAL SOLUTIONS USA, INC. JUDITH CAMPBELL
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K072090 07/30/2007 SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI KRISTEN DORROUGH
K072107 07/31/2007 PERIOSCAN, MODEL: D 3496 SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K071790 07/02/2007 GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM SMITH & NEPHEW, INC. JASON SELLS
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K071958 07/16/2007 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS SMITHS MEDICAL ASD, INC. CHRISTINE LLOYD
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K071809 07/02/2007 ENSPLINTRX BONE FIXATION SYSTEM SONOMA ORTHOPEDIC PRODUCTS, INC. CHARLES L NELSON
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K071970 07/17/2007 CLEAR IMAGE ALIGNER SPECIALTY APPLIANCE WORKS, INC. JAMES W KOLKA
K071914 07/11/2007 MERCURY SPINAL SYSTEM SPINAL ELEMENTS, INC. KERRI DIMARTINO
K071833 07/03/2007 MOSAIC DEVICES SPINAL ELEMENTS, INC. KERRI DIMARTINO
K071818 07/03/2007 ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL KAREN J MCKELVEY
K072012 07/23/2007 REFLEXION SPIRAL VARIABLE RADIUS CATHETER ST. JUDE MEDICAL Laura Moen-Ftacek
K072072 07/30/2007 HARMONY LED-1 SURGICAL LIGHTING SYSTEM STERIS Corporation JOHN SCOVILLE
K071895 07/09/2007 VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR STERIS Corporation JOHN SCOVILLE
K071888 07/09/2007 STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES STRAUMANN USA ELAINE ALAN
K071919 07/12/2007 P.004 ABUTMENTS STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) PAIGE SWEENEY
K071859 07/05/2007 STRYKER CROSSFIRE SYSTEM Stryker Endoscopy K. JEFFREY SEMONE
K072028 07/24/2007 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM SURGICAL SPECIALTIES CORP. LOIS SMART
K071989 07/20/2007 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL SURGICAL SPECIALTIES CORP. KEVIN BENTLEY
K071823 07/03/2007 PERMA FACIAL IMPLANTS SURGISIL CYNTHIA J NOLTE
K071872 07/06/2007 VELASHAPE SYNERON MEDICAL LTD. YONI IGER
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K071967 07/16/2007 SYSMEX XE-5000 SYSMEX AMERICA, INC. NINA M GAMPERLING
K072039 07/25/2007 ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F TaiDoc Technology Corporation ERICA LI
K072001 07/23/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K071999 07/23/2007 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K071977 07/17/2007 TARRY MEDICAL TEMPERATURE PROBES TARRY MEDICAL PRODUCTS, INC. JOSEPH M AZARY
K072016 07/23/2007 CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE TECHNOMED EUROPE MAURICE ROOST
K071807 07/02/2007 ORTHOMEND SOFT TISSUE MATRIX TEI BIOSCIENCES INC. KENNETH JAMES
K072064 07/27/2007 GRAVILAX TRACTION SYSTEM THERAPEUTIC CLINICAL TECHNOLOGIES, INC. DANIEL J MANELLI
K071918 07/12/2007 CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 THERMOGEAR, INC. WAYNE FIELDS
K071821 07/03/2007 COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 TONICA ELEKTRONIK A/S LISE TERKELSEN
K071948 07/13/2007 AEQUALIS REVERSED ADAPTER TORNIER Mireille Lemery
K072000 07/23/2007 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K071936 07/13/2007 WOUNDSTAT, MODEL TC1001 TRAUMACURE INC. CAMPBELL HUTTON
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K072062 07/27/2007 UCP MULTIPLE DRUG SCREEN TEST CUPS UCP BIOSCIENCES, INC. NANCY CHEN
K071920 07/12/2007 AUTOSUTURE ABSORBABLE TACK AND APPLICATOR UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC Daniel Campion
K071822 07/03/2007 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 UROPLASTY, INC. LISA GALLATIN
K071896 07/09/2007 FOX 940, MODEL 940 VALAM INC. KIRSTEN PAULSON
K071992 07/20/2007 HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) VARIAN MEDICAL SYSTEMS VY TRAN
K071873 07/06/2007 MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K071976 07/17/2007 VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES VECTEC DIANE M HORWITZ
K072069 07/30/2007 SPACER VERICOM CO., LTD. ALBERT REGO
K071973 07/17/2007 EPLEY OMNIAX VESTICON CATHRYN EPLEY
K072061 07/27/2007 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY VIASYS HEALTHCARE GMBH Yvette Lloyd
K072045 07/25/2007 ONCONTROL BONE MARROW BIOPSY SYSTEM VIDACARE CORPORATION GRACE HOLLAND
K071903 07/10/2007 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
K072088 07/30/2007 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS VISION-SCIENCES, INC. PAMELA PAPINEAU
K072073 07/30/2007 VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR VISION-SCIENCES, INC. PAMELA PAPINEAU
K072014 07/23/2007 VITASCORE VITASCORE B.V. WIM MARTENS
K071937 07/13/2007 BONALIVE GRANULES AND BONALIVE PLATES VIVOXID LTD. CONSTANCE G BUNDY
K072009 07/23/2007 WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG ECKHARDT ALBERS
K072092 07/30/2007 XPOD/XMAP NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. ROCHE VAN RENSBURG
K072085 07/30/2007 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) ZIBO HONGYE SHANGQIN PLASTIC RUBBERT CO LTD CHU XIAOAN
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K071880 07/09/2007 Optima ZS Transition Screw ZIMMER SPINE, INC NICOLE BOWDEN
K071879 07/09/2007 ZIMMER DTO IMPLANT ZIMMER SPINE, INC NICOLE BOWDEN
K071856 07/05/2007 ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES ZIMMER, INC. DALENE BINKLEY


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