FDA 510(k) Applications Received During September, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K082670 09/15/2008 MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET MEDTRONIC INC. BETH CLAAS
K082734 09/18/2008 A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K082716 09/17/2008 A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 A-DEC, INC. THOMAS H LOUISELL
K082827 09/25/2008 A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT A-DEC, INC. THOMAS H LOUISELL
K082714 09/18/2008 AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K082717 09/18/2008 AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K082762 09/22/2008 AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE AARDVARK MEDICAL
K082534 09/02/2008 ETEST VORICONAZOLE 0.002-32 UG/ML AB BIOMERIEUX ANETTE ENGELHARDT
K082668 09/18/2008 BIO-SCREEN ADDENT, INC. JOSHUA FRIEDMAN
K082887 09/30/2008 PM-1000F+PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLIAN
K081433 09/03/2008 EK/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K082612 09/09/2008 GBS PNA FISH ADVANDX, INC. PAULA E BULGER
K082529 09/04/2008 ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K082858 09/29/2008 EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER ALCAVIS INTERNATIONAL, INC. GARY J MISHKIN
K082845 09/26/2008 INFINITI VISION SYSTEM WITH OZIL IP ALCON RESEARCH, LTD. MICHAEL BUENGER
K082622 09/09/2008 ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE ALMA LASERS LTD. ANNE WORDEN
K082857 09/29/2008 RENEGADE WHEELCHAIR ALPHA ONE PATSY J TRISLER
K082898 09/30/2008 AMEDICA DRUG SCREEN TEST CUP AMEDICA BIOTECH, INC. JEFF CHEN
K082677 09/15/2008 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K082730 09/30/2008 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K082729 09/18/2008 RIMCLOSE BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K082575 09/05/2008 ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES APATECH LTD. CANDACE F CEDERMAN
K082846 09/29/2008 APK SPO2 PULSE OXIMETER SENSOR APK TECHNOLOGY CO., LTD DIANA HONG
K082504 09/02/2008 APOLLO ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC. PAMELA PAPINEAU, RAC
K082562 09/04/2008 APPLIED BIOSYSTEMS 7500 FAST DX APPLIED BIOSYSTEMS INC JOHN D'ANGELO
K082839 09/26/2008 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. BRYAN BABB
K082810 09/24/2008 ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW ARTHREX, INC. NANCY HOFT
K082666 09/12/2008 ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K082515 09/03/2008 ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX ASAHI KASEI MEDICAL CO., LTD. DAVID L WEST
K082910 09/30/2008 CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, "XYZ" SILVER BANDAGES ASO LLC JONATHAN WARD
K082748 09/30/2008 ATRIUM PROLITE S MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K082869 09/29/2008 AWBAT-S, AWBAT-D, AWBAT-M AUBREY, INC. STEPHEN MOSS
K082704 09/16/2008 BIRTHTRACK (A.K.A. CLM) BARNEV, LTD. AHAVA STEIN
K082589 09/08/2008 BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 BAROSENSE, INC DANIEL J BALBIERZ
K082749 09/19/2008 OMNI-TIGHT BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K082913 09/30/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K082852 09/29/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K082538 09/02/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST BECTON, DICKINSON & CO. MONICA E GIGUERE
K082787 09/23/2008 VITAL SIGNS MONITOR, MODEL: MD500B BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K082826 09/25/2008 VANGUARD CR STEM HOUSINGS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K082793 09/29/2008 INTERGRO DBM BIOMET SPINE KATHLEEN IDEO
K082757 09/19/2008 MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM BIOPLATE, INC. JESUS T FARINAS
K082705 09/16/2008 BIOPRO BIPOLAR HEAD, MODELS 18130-18152 BIOPRO, INC. DAVID MRAK
K082449 09/05/2008 BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 BISCO, INC. MICHELLE SCHILTZ-TAING
K082652 09/17/2008 BITTAR ZIRCONIA BLOCKS BITTAR ZIRCONIA BLOCK, LLC STUART R GOLDMAN
K082797 09/23/2008 BLACKSTONE PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K082841 09/26/2008 SPINAL FORAMINOSCOPE BLAZEJEWSKI MEDI-TECH GMBH ANGELIKA SCHERP
K082906 09/30/2008 UNITY BETA ANCHOR SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K082568 09/04/2008 SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE BOVIE MEDICAL RICHARD A KOZLOFF
K082345 09/04/2008 OXYGEN DEMAND VALVE BPR MEDICAL, LTD. BEN JOHNSON
K082886 09/30/2008 ZOOM-100DC BRAINSCOPE COMPANY, INC. MICHAEL E SINGER
K082508 09/02/2008 FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD BRANAN MEDICAL CORPORATION RAPHAEL WONG
K082582 09/08/2008 SENTINEL, MODEL SP-001 C-RAD POSITIONING AB CRISTINA SVENSSON
K082571 09/05/2008 AVAULTA SUPPORT SYSTEM C.R. BARD, INC. JOHN C KNORPP
K082687 09/15/2008 COLLAMEND FM IMPLANT C.R. BARD, INC. KEVIN G STEVENS
K082681 09/15/2008 VACORA VACUUM ASSISTED BIOPSY SYSTEM C.R. BARD, INC. CINDY MOSS
K082693 09/15/2008 RESOLUTIONMD, RELEASE 2.1 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K082521 09/02/2008 EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K082542 09/03/2008 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A CARDICARE COMPANY, LTD.
K082539 09/03/2008 MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT CARDINAL HEALTH GERMANY 234 GMBH THOMAS RUST
K082829 09/25/2008 AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K082518 09/02/2008 DUAL NEEDLE SUTURE PASSER SYSTEM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K082629 09/09/2008 S12X WITH ESAX OPTION CHATTEN ASSOCIATES, INC. JOHN B CHATTEN
K082628 09/09/2008 CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 CIRCLE CARDIOVASCULAR IMAGING INC. SHIRANTHA SAMARAPPULI
K082134 09/11/2008 CIRCULATOR BOOT CIRCULATOR BOOT CORP. RICHARD S DILLON
K082556 09/09/2008 CLEARCORRECT CLEARCORRECT, INC. WILLIAM GREENROSE
K082599 09/08/2008 NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT CNSYSTEM MEDIZINTECHNIK AG SUMPER
K082640 09/10/2008 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM COLOPLAST MANUFACTURING US, LLC ANGELA BYLAND
K082641 09/11/2008 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K082682 09/15/2008 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG COOK BIOTECH, INC. DANIEL J DILLON
K082536 09/02/2008 COOK WIRE GUIDES COOK UROLOGICAL, INC. CINDY FOOTE
K082525 09/02/2008 CORIN METAFIX FEMORAL STEM CORIN USA ASHLEA BOWEN
K082659 09/12/2008 MODIFIED ENDO STICH COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K082619 09/09/2008 SILS PORT, MODELS SILSPT5, SILSPT12 COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K082849 09/29/2008 SILENT SLEEP CRANIOFACIAL PAIN CENTER OF IDAHO JAMISON R SPENCER
K082606 09/08/2008 COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) D3 RADIATION PLANNING NABIL ADNANI
K082731 09/18/2008 ML24000 UVA-1 PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. TARA MANSUR
K082784 09/23/2008 JUMAO MANUAL WHEELCHAIR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. QING WANG
K082843 09/30/2008 MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM DENTIS CO. LTD. JUNG BAE BANG
K082643 09/30/2008 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K082585 09/08/2008 DEPUY ASPHERE M-SPEC HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K082715 09/17/2008 DEPUY GLOBAL AP CTA HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K082675 09/15/2008 STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K082462 09/09/2008 GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ DIAMOND DIAGNOSTICS, INC. LIANN VOO
K082763 09/22/2008 DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B DIAZYME LABORATORIES ABHIJIT DATTA
K082904 09/30/2008 STASYS MOTION CORRECTION SOFTWARE DIGIRAD CORP. JOEL TUCKEY
K082588 09/08/2008 GAMMALOC SYSTEM, MODEL 03-00001 DILON TECHNOLOGIES LLC ELAINE DUNCAN
K082600 09/10/2008 OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) DRAEGER MEDICAL B.V. JOYCE KILROY
K082888 09/30/2008 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 DRAEGER MEDICAL SYSTEMS, INC. PRADEEP GUPTA
K082261 09/23/2008 DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS DXRAD SOLUTIONS LTD. DANIEL KAMM
K082899 09/30/2008 DYNAMIPEAK PEAK FLOW METER DYNAMITECH MEDICAL, INC KEITH LOWREY
K082863 09/29/2008 DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) DYNAREX CORPORATION JAMES HURLMAN
K082791 09/23/2008 EMS AIR-FLOW MASTER E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K082465 09/15/2008 EVERON EARLYSENSE LTD. DALIA ARGAMAN
K082602 09/08/2008 FETAL & MATERNAL MONITOR, MODEL F6, F9 EDAN INSTRUMENTS, INC. WILLIAM STERN
K082663 09/12/2008 COLOR LCD MONITOR EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K082834 09/26/2008 ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC ELLMAN INT'L INC. RICK EPSTEIN
K082601 09/08/2008 INSTA-CLOT, INSTA-CLOT OTC EMERGENCY MEDICAL DEVICES, LLC JACK MENTKOW
K082844 09/26/2008 BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE ENCORE MEDICAL, L.P. TEFFANY HUTTO
K082409 09/08/2008 SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 ENDOPHOTONIX, INC KIRK S HONOUR
K082825 09/25/2008 ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM ENERGIST, LTD. TIM MAJOR
K082569 09/05/2008 ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE ENTELLUS MEDICAL, INC. SEW-WAH TAY
K082750 09/19/2008 ENTACT SEPTAL STAPLER, MODEL 610-00100 ENTRIGUE SURGICAL, INC. GABRIELE G NIEDERAUER
K082655 09/12/2008 ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 ENVITEC-WISMAR GMBH STEPHEN GORSKI
K082609 09/08/2008 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL KEVIN WALLS
K082893 09/30/2008 PRAGER SHELL ESI, INC. GEORGE MYERS
K082579 09/05/2008 EVERCROSS .035 OTW PTA DILATATION CATHETER EV3 INC. DAVID WORRELL
K082854 09/29/2008 NANOCORSS .014 OTW PTA DILATATION CATHETER EV3 INC. DAVID WORRELL
K082702 09/16/2008 EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY EXACTECH, INC. SHING JEN TAI
K082875 09/29/2008 PORTABLE X-RAY SYSTEM, MODEL DXR -1 EXARO CO., LTD. SHIN KUK YOO
K082837 09/26/2008 STERILE FIELD SALINE PRE-FILLED SYRINGE(S) EXCELSIOR MEDICAL CORP. JOHN LINFANTE
K082656 09/12/2008 MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT FUKUDA DENSHI USA, INC. LORAN VAN NOY
K082768 09/23/2008 G-BOND PLUS GC AMERICA, INC. MARK HEISS
K082740 09/22/2008 GC AADVA ZR DISK GC AMERICA, INC. MARK HEISS
K082540 09/02/2008 GE ENTROPY SENSOR GE HEALTHCARE JOEL C KENT
K082781 09/22/2008 OEC 9900 ELITE GE HEALTHCARE SURGERY MARIA C FRAME
K082851 09/29/2008 MULTLINK CABLE AND LEADWIRE SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MATTHIAS BUERGER
K082816 09/25/2008 GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC STEVEN KACHELMEYER
K082761 09/22/2008 GE LIGHTSPEED 7.2 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
K082676 09/15/2008 GENADYNE A4 WOUND VACUUM SYSTEM GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K082789 09/24/2008 G1B PULSE OXIMETER GENERAL MEDITECH, INC. DIANA HONG
K081640 09/30/2008 GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS GIMMI GMBH KEN BLAKE
K082865 09/30/2008 MODIFICATION TO ZENIEVA GORBEC PHARMACEUTICAL SERVICES, INC. SANDRA R KIRCUS
K082286 09/03/2008 BIOACTYS GRAFTYS ANTHONY LE NAOUR
K082498 09/03/2008 GRAFTYS HBS GRAFTYS ANTHONY LE NAOUR
K082723 09/17/2008 GRINDGUARD GRIND GUARD TECHNOLOGIES, LLC BILL MCLAIN
K082891 09/30/2008 LENSTAR, MODEL LS900 HAAG-STREIT AG LENA SATTLER
K082616 09/09/2008 HASELMEIER PEN 8 HASELMEIER GMBH STEPHEN J GOLDNER
K082591 09/08/2008 FLEXITIME BITE HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION CHERYL V ZIMMERMAN
K082892 09/30/2008 REJUVENATE MONOLITHIC HIP SYSTEM HOWMEDICA OSTEONICS CORP DENISE DAUGERT
K082567 09/04/2008 STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K082883 09/29/2008 EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082880 09/29/2008 EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082879 09/29/2008 EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082806 09/24/2008 SPINNING SPIROS, MODEL CH-2000 ICU MEDICAL, INC TRACY BEST
K082836 09/26/2008 ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES ICU MEDICAL, INC. NILOUFAR SAMIMI
K082706 09/16/2008 INFINITT CARDIOLOGY PACS INFINITT CO., LTD. CARL ALLETTO
K082746 09/19/2008 ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 INSIGHTRA MEDICAL, INC. TOM COLONNA
K082853 09/29/2008 CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR INSPIRED TECHNOLOGIES, INC. PAUL DRYDEN
K082545 09/03/2008 STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG ELAINE ALAN
K082764 09/22/2008 STRAUMANN WN CARES TITANIUM ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K082859 09/29/2008 HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K082795 09/25/2008 SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT INTERVENTIONAL SPINE, INC. CAROL EMERSON
K082916 09/30/2008 HRB-127-32 HIGH RESOLUTION BRAIN COIL INVIVO JEFF WILKINSON
K082416 09/03/2008 IBA PROTON THERAPY SYSTEM- PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN REISS
K082530 09/02/2008 APPLICATORS FOR AFTERLOADING BRACHYTHERAPY ISODOSE CONTROL B.V. HUB VAN DE BERGH
K082808 09/24/2008 IMAGESVR PACS JAGUAR TECHNOLOGY LIMITED KE-MIN JEN
K082911 09/30/2008 SMOOTHCOOL HR SYSTEM JEISYS MEDICAL, INC. KEVIN WALLS
K082882 09/30/2008 A.V. FISTULA BLUNT NEEDLE SET JMS NORTH AMERICA CORP. MARIA F GRIFFIN
K082698 09/17/2008 ALEUTIAN IBF SYSTEM K2M, INC. RICHARD WOODS
K082769 09/23/2008 MESA AND RANGE SPINAL SYSTEMS K2M, INC. RICHARD W WOODS
K082560 09/04/2008 PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K082824 09/25/2008 FLUID FILLED TEETHER KIDS II BILL YUNG
K082554 09/03/2008 KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 KIMBERLY-CLARK CORP. LISA PEACOCK
K082509 09/04/2008 EOS SPINAL SYSTEM KOREA BONE BANK CO., LTD JUNG BAE BANG
K082399 09/04/2008 PECTUS STRUT KOROS USA, INC. TIBOR KOROS
K082767 09/22/2008 KOWA NONMYD ALPHA-DIII KOWA CO. LTD. AKIHIRO FUJITA
K082900 09/30/2008 KYMCO FORU, MODEL EQ10 KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K082901 09/30/2008 KYMCO FORU, MODEL EQ20 KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K082752 09/19/2008 QUICKPIN LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K082614 09/09/2008 EVOX ELECTRO DIAGNOSTIC DEVICE LABORIE MEDICAL TECHNOLOGIES, INC. BARBARA MORNET
K082774 09/22/2008 LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE LANX, LLC ALAN BURKHOLDER
K082685 09/15/2008 GALAXY 55 LARSEN & TOUBRO LIMITED S.B. BHOSALE
K082592 09/08/2008 LDR SPINE EASYSPINE SYSTEM LDR SPINE USA NOAH BARTSCH
K082802 09/24/2008 MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B LEARNING CURVE BRANDS INC. THE FIRST YEARS SUPRAVAN KHONGKRUAPHAN
K082367 09/12/2008 INFANT SLEEP BEANIE LIFE INNOVATIONS LLC JANE SCOTT
K082772 09/22/2008 STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 LIFE-TECH, INC. JEFF KASOFF
K082513 09/02/2008 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. OYINKAN DONALDSON
K082590 09/08/2008 SYMPHONY METER REMOTE LIFESCAN, INC. MARTHA MURARI
K082586 09/08/2008 LIGHTWAVE PROFESSIONAL DELUXE LIGHTWAVE TECHNOLOGIES LLC MARIA F GRIFFIN
K082809 09/24/2008 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM LUMENIS, INC. FRANCES E HARRISON
K082700 09/15/2008 TEMPORARY COLD.V AND SELF-CURE DENTINE MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082520 09/02/2008 SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES MALLINCKRODT MEDICAL SCOTT D DICKERHOFF
K082544 09/03/2008 QUART ARTERIAL FILTER WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K082725 09/25/2008 GRAFTGUARD PRESSURE CONTROLLING SYRINGE MAQUET CARDIOVASCULAR, LLC CHRISTINA L ROWE
K082818 09/30/2008 SUBCUTANEOUS NEEDLE INFUSION SET MARCAL MEDICAL, INC. ARTHUR WARD
K082703 09/16/2008 MRDH BANDAGE MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K082856 09/29/2008 CARAPASTE ORAL WOUND DRESSING MCGRATH PHARMACEUTICALS, INC. PATRICK D MCGRATH
K082792 09/23/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K082541 09/02/2008 HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM MEDI NUCLEAR CORP., INC. JERRY SCHOEN
K082587 09/08/2008 AUTO-SAFETY INJECTOR-2 (ASI-2) MEDICAL HOUSE PRODUCTS LIMITED ROSE Y GUANG
K082472 09/05/2008 VIROCULT, MODEL MW950 MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD DAVID ELLIS
K082577 09/05/2008 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J D WEBB
K082514 09/02/2008 TENS/EMS COMBO, EMS, TENS MEDIHIGHTEC MEDICAL CO., LTD. MU-SHENG HUNG
K082657 09/12/2008 RTX RESPIRATOR MEDIVENT LIMITED SHAHAR HAYEK
K082905 09/30/2008 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC MEDRAD, INC. FORTUNATO ALDAPE
K082917 09/30/2008 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK RYAN MASSEY
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