FDA 510(k) Applications Received During June, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K091911 06/25/2009 BOLUS COMPENSATOR .DECIMAL, INC. DANIEL L BENNETT
K091632 06/04/2009 SPK SEALANT 3M COMPANY SHARI MYSZKA
K091826 06/19/2009 ELEGANT 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K091910 06/25/2009 PICCOLO MAGNESIUM TEST SYSTEM ABAXIS, INC. Dennis M Bleile
K091825 06/19/2009 HI-TORQUE PROGRESS GUIDE WIRE FAMILY ABBOTT VASCULAR INC. MICHELE WALZ
K091827 06/19/2009 S. AUREUS PNA FISH ADVANDX, INC. PAULA E BURGER
K091692 06/10/2009 AESCULAP PEEK CRANIOFIX AESCULAP, INC. LISA M BOYLE
K091859 06/19/2009 AESKU PR3 AESKU.DIAGNOSTICS SASCHA PFEIFFER
K091860 06/19/2009 AESKULISA MPO, MODEL 30-7303US AESKU.DIAGNOSTICS SASCHA PFEIFFER
K091688 06/10/2009 A-GRIX RESORBABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K091793 06/17/2009 AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 AGA MEDICAL CORP. DIANE CARROLL
K091777 06/17/2009 ALCON ULTRACHOPPER ALCON RESEARCH, LTD. MARTIN A KAUFMAN
K091711 06/10/2009 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K091699 06/10/2009 AMSURE HYDROPHILIC LATEX FOLEY CATHETER AMSINO INTERNATIONAL, INC. JESUS FARINAS
K091930 06/30/2009 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB ANCHOR PRODUCTS CO. GARY S THRUN
K091737 06/11/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 ANDON HEALTH CO.,LTD LIU YI
K091738 06/11/2009 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD ANDON HEALTH CO.,LTD LIU YI
K091739 06/11/2009 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 ANDON HEALTH CO.,LTD LIU YI
K091619 06/03/2009 ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) ANGLEFIX RICHARD JANSEN
K091647 06/09/2009 INJECTAFIL APEX DENTAL MATERIALS, INC. CHRIS KULTON
K091653 06/09/2009 ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K091884 06/24/2009 ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K091844 06/22/2009 ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS ARTHREX, INC. IVETTE GALMEZ
K091674 06/09/2009 ARTHROCARE COBLATOR IQ SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K091880 06/24/2009 CLAYTON INTRA-AURAL DEVICE (CID) ASCENTIA HEALTH INCORPORATED ROGER WIXTROM
K091854 06/19/2009 BIS CLICK SENSOR/CABLE ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K091631 06/03/2009 ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW ASPYRA, INC. MARTIN D SARGENT
K091920 06/30/2009 ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL ASTRA TECH, INC. BETSY A BROWN
K091863 06/23/2009 AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS AUBREY, INC. AUBREY WOODROF
K091783 06/17/2009 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM AVANTIS MEDICAL SYSTEMS, INC. AMRITA SETHI
K091718 06/11/2009 NEUTRASAL BARTOR PHARMACAL CO., INC. EDWARD D KOBUS
K091820 06/18/2009 CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM BAYER HEALTHCARE MARC HENN
K091742 06/16/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K091846 06/22/2009 SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 BECKMAN COULTER, INC. MARINE BOYAJIAN
K091670 06/09/2009 BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER BECTON DICKINSON & CO. JUSTICE ALDER
K091724 06/11/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON DICKINSON & CO. SABA MODJARRAD
K091758 06/16/2009 BD SPINAL NEEDLE 27G BECTON DICKSON & CO. PASQUALE AMATO
K091730 06/11/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K091855 06/23/2009 THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 BELMONT INSTRUMENT CORP. URAIWAN LABADINI
K091912 06/25/2009 B-GENIN AND R-GENIN BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K091766 06/17/2009 CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 BINAX, INC. SUZANNE M VOGEL
K091616 06/03/2009 BIOPLEX 2200 MMRV IGG Bio-Rad Laboratories DAVID BHEND
K091922 06/30/2009 WATERLASE C100, MODEL 7100104 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K091746 06/16/2009 WATERLASE MD, MODEL 7100102 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K091899 06/25/2009 VITEK 2 GRAM NEGATIVE MEROPENEM BIOMERIEUX, INC. Nancy Weaver
K091608 06/03/2009 COBALT MV BONE CEMENT BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K091722 06/11/2009 COAXIAL APPLICATOR SYSTEM BIOMET, INC. ELIZABETH WRAY
K091914 06/30/2009 OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION BIONOSTICS, INC. MINNA RANNIKKO
K091928 06/30/2009 10 X 10 VISION BIOPTICS, INC. AKIF BAYSAL
K091789 06/17/2009 CARTO RMT EP NAVIGATION SYSTEM V8 BIOSENSE WEBSTER, INC. DIANA THORSON
K091815 06/18/2009 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 Biotest Medical Corp. DIANE MANDELL HORWITZ
K091705 06/10/2009 PRIMER PLUS BISCO, INC. Michelle Schiltz-Taing
K091816 06/18/2009 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation JANIS TARANTO
K091841 06/22/2009 BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 BRIDGEPOINT MEDICAL JILL MUNSINGER
K091913 06/30/2009 HI TECH IMPLANT, HT PHYSIO IMPLANT BY DENTAL SRL DANIELE POLI
K091659 06/09/2009 BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 C.R. BARD, INC. GAIL DOW
K091943 06/30/2009 POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K091821 06/18/2009 COMMANDER 111, MODEL CD300-CD399 CARDIOCOM LLC JULIE BULVER
K091889 06/24/2009 DRX-EVOLUTION, MODEL VX3733-SYS CARESTREAM HEALTH, INC. CAROLYN WAGNER
K091702 06/10/2009 CDB FLIP-SIDE-CLIP BRACKET CDB CORPORATION CHARLES VERNON
K091636 06/04/2009 OSTENE CT, AOC CT, OSTEOTENE, CERETENE CEREMED INC. TADEUSZ WELLISZ
K091877 06/23/2009 CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K091926 06/30/2009 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM CHOICE SPINE, LP KAREN WARDEN
K091921 06/30/2009 CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP Codman & Shurtleff, Inc. PAUL AMARAL
K091703 06/10/2009 HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K091856 06/23/2009 CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES CONMED CORPORATION SANDRA COVELESKI
K091648 06/09/2009 NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K091767 06/17/2009 3 WAY SILICONE FOLEY BALLOON CATHETER COOK UROLOGICAL, INC. BRENDA DAVIS
K091637 06/04/2009 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K091762 06/16/2009 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE COVIDIEN MR. WING NG
K091900 06/25/2009 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES REBECCA RONNER
K091869 06/23/2009 SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K091626 06/03/2009 CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH CRYOLIFE, INC. JOHN FERROS
K091800 06/17/2009 LIPOEZE LASER ASSISTED ASPIRATION CANNULA CURVE MEDICAL F. DAVID ROTHKOPF
K091736 06/11/2009 SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 DANIELS CORPORATION PTY, INC. ANDREA ARREDONDO
K091834 06/22/2009 PASSPORT V MONITOR, MODEL 0998-00-6100 DATASCOPE CORP., PATIENT MONITORING DIVISION KATHLEEN KRAMER
K091732 06/11/2009 VRLXP, MODEL XP DEEP BREEZE LTD. JEFF BAETZ
K091660 06/09/2009 CUSTOM COMFORT NIGHTGUARD VERSION 2 DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K091706 06/10/2009 QUATTRO PORCELAIN SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K091751 06/16/2009 DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K091760 06/16/2009 DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) DERMAPORT, INC JENNIFER HESSEL
K091753 06/16/2009 ELVIS HSV ID AND D3 TYPING TEST SYSTEM DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K091700 06/10/2009 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC CHRISTINE OTIS
K091747 06/16/2009 FLAATZ 500 DRTECH CORP. BEOM-JIN MOON
K091680 06/10/2009 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. WILLIAM STERN
K091709 06/10/2009 MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC EDWARDS LIFESCIENCES, LLC. JASON SMITH
K091871 06/23/2009 DK50 DS EKOM S.R.O. PAUL DRYDEN
K091832 06/22/2009 ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER ENDOGASTRIC SOLUTIONS, INC. STEVE HOFFMAN
K091681 06/10/2009 FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) Entellus Medical, Inc. DEBORAH I NEYMARK
K091607 06/03/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K091729 06/11/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K091824 06/19/2009 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 ETHICON ENDO-SURGERY, INC. GLENDA MARSH
K091657 06/09/2009 IMMUNOSCAN CCPLUS EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K091596 06/02/2009 EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC CINDY MORROW
K091577 06/02/2009 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K091591 06/02/2009 FLEXICARE MEDICAL ENDOTRACHEAL TUBES FLEXICARE MEDICAL LTD. DAVID MOYNHAM
K091723 06/11/2009 FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 FREEDOM SCIENCES, LLC EDWARD A KROLL
K091727 06/11/2009 MEDICAL TREATMENT CHAIR, T400, T500,T600 FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. RAM KAMATH
K091812 06/18/2009 FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS FRONTIER DEVICES, INC. DON PETERSEN
K091773 06/16/2009 FUJINON STERILE OVERTUBES FUJINON, INC. JOSEPH M AZARY
K091806 06/18/2009 POGO SCREW INSTRUMENTATION TRAY FXDEVICES RICH LIPSCHUTZ
K091658 06/09/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE HEALTHCARE ALAN TOTAH
K091594 06/02/2009 HEART-EXERCISE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH PATRICIA TAIGE
K091673 06/09/2009 GE LIGHTSPEED ACT FP16 GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K091833 06/22/2009 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. GEMORE TECHNOLOGY CO., LTD. BODEN LAI
K091615 06/03/2009 MED CONTOUR GENERAL PROJECT S.R.L. MAUREEN O'CONNELL
K091918 06/30/2009 ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO GENORAY CO., LTD. SHIN KUK YOO
K091878 06/23/2009 OSSEOLINK DENTAL IMPLANT SYSTEM GLOBAL IMPLANT SOLUTIONS, LLC STUART R GOLDMAN
K091782 06/17/2009 REVERE 6.35 STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K091717 06/11/2009 ANY PLUS SPINAL FIXATION SYSTEM GS MEDICAL CO., LTD. WILLIAM F GREENROSE
K091643 06/04/2009 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD FOO KHON PU
K091851 06/22/2009 STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD FOO KHON PU
K091808 06/18/2009 SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 HANSEN MEDICAL, INC. KATE WHITIN
K091881 06/24/2009 RPL/CPL VERTICAL PLATFORM LIFTS HARMAR SUMMIT LLC KEVIN KAMINSKI
K091652 06/09/2009 NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K091890 06/23/2009 EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT HEALTHPOINT, LTD. AMY CAMPBELL
K091690 06/10/2009 SHARP CHUTE HEATHROW SCIENTIFIC, LLC PETE HADJIS
K091635 06/04/2009 VENUS DIAMOND FLOW HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K091687 06/10/2009 PACSMATE, MODEL MMD-4300C/MMD-4300CX IEI TECHNOLOGY CORP. JENNIFER REICH
K091849 06/22/2009 IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET IMMUNODIAGNOSTIC SYSTEMS, INC. KEN GIBBS
K091933 06/30/2009 ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 INNO-HEALTH TECHNOLOGY, INC. TERRY C CHANG
K091743 06/16/2009 SEC VBR INNVOTEC SURGICAL, INC. JUSTIN EGGLETON
K091874 06/23/2009 INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 INOMED MEDIZINTECHNIK GMBH YOLANDA SMITH
K091701 06/10/2009 STRAUMANN MODIFIED DENTAL ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K091763 06/16/2009 MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 INSTRATEK, INC. Jeff Seavey
K091902 06/25/2009 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 INVIVO ELIZABETH WHEELER
K091629 06/03/2009 PROTEUS 235 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A. YVES JONGEN
K091787 06/17/2009 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR IVY BIOMEDICAL SYSTEMS, INC. JENNIFER LAINE
K091686 06/09/2009 LEFORTE NEUROSYSTEM BONE SCREW JEIL MEDICAL CORPORATION SHIN KUK YOO
K091679 06/09/2009 LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION SHIN KUK YOO
K091585 06/02/2009 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 KCI USA, INC. MARGARET MARSH
K091613 06/03/2009 TAKE 1 KERR CORP. COLLEEN BOSWELL
K091685 06/10/2009 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 KIMBERLY-CLARK CORP. LISA PEACOCK
K091749 06/16/2009 U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS KIMBERLY-CLARK CORP. CHERYL SANZARE
K091683 06/10/2009 KOWA VX-10 A KOWA CO. LTD. AKIHIRO FUJITA
K091818 06/18/2009 LAURIMED SPINAL INJECTION SYSTEM LAURIMED LLC SEVRINA CIUCCI
K091915 06/30/2009 FLUID ISOLATION DEVICE LENSTEC, INC. JIMMY CHACKO
K091568 06/02/2009 LH-75 PHOTOTHERAPY SYSTEM LERNER MEDICAL DEVICES, INC. ZAFIRIOS F GOURGOULIATOS
K091625 06/03/2009 EPICARE-DUO LASER SYSTEM LIGHT AGE, INC. ELIZABETH REDDINGTON
K091769 06/16/2009 TRUST DAM LINE ONE LABORATORIES, INC. ELI J CARTER
K091682 06/10/2009 LSVT C OR LSVT COMPANION, MODEL V.1 LSVT GLOBAL, LLC DAVID H MCFARLAND
K091667 06/09/2009 XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K091754 06/16/2009 LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 LUNE GROUP LTD. MORRIS WAXLER
K091733 06/11/2009 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 MAQUET CARDIOVASCULAR, LLC ARTIE KAUSHIK
K091586 06/02/2009 VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN MEDCOMP JEAN CALLOW
K091583 06/02/2009 MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE MEDEFIL, INC. PRADEEP AGGARWAL
K091875 06/23/2009 E-PULSE MEDEVICE CORPORATION TZVI MILSHTEIN
K091696 06/10/2009 SAVI WIRELESS, MODEL PM500 MEDICOMP, INC. SUSAN GOLDSTEIN-FALK
K091780 06/17/2009 GUIDED MEASUREMENT CATHETER (GMC) MEDIGUIDE, LTD. JONATHAN S KAHAN
K091781 06/17/2009 GUIDED MEDICAL POSITIONING SYSTEM (GMPS) MEDIGUIDE, LTD. JONATHAN S KAHAN
K091795 06/17/2009 MEDTRADE PRODUCTS CELOX TRAUMA GAUZE MEDTRADE PRODUCTS LTD. JONATHAN RANFIELD
K091813 06/18/2009 INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MIKE SCOTT
K091797 06/17/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK BRAD SHEALS
K091883 06/24/2009 T2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. THERESA LEISTER
K091582 06/02/2009 GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 MEDTRONIC VASCULAR COLLEEN MULLINS
K091798 06/17/2009 MERETE COMPRESSION SCREWS MERETE MEDICAL GMBH JORG MIETZNER
K091584 06/02/2009 MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K091716 06/10/2009 MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K091589 06/02/2009 MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K091882 06/24/2009 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM MICROVENTION, INC. Naomi Gong
K091641 06/04/2009 HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) MICROVENTION, INC. Naomi Gong
K091866 06/24/2009 PROGENY VANTAGE PANORAMIC X-RAY SYSTEM MIDMARK ALAN KREMA
K091887 06/24/2009 LED CURING LIGHT, MODEL GT-1500 MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K091645 06/04/2009 GOLD ANCHOR NASLUND MEDICAL AB TOMAS NASLUND
K091634 06/04/2009 NMI FC NAVILYST MEDICAL, INC. SHILPA PREM
K091734 06/11/2009 SONIC SHOT GX NEMOTO KYORINDO CO., LTD. MASAHIRO SAKAKIBARA
K091721 06/11/2009 CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 NEW MEDICAL TECHNOLOGIES GMBH VINCE D'ALESSANDRO
K091609 06/03/2009 NEWDEAL COMPRESSION PLATE NEWDEAL SAS JUDITH E O'GRADY
K091788 06/17/2009 PANTA NAIL (DIA. 10MM), PANTA NAIL XL NEWDEAL SAS JUDITH O'GRADY
K091803 06/16/2009 SMARTTRACK SYSTEM NEXUS6, LTD. GARTH SUTHERLAND
K091936 06/30/2009 BLADE ANTERIOR CERVICAL PLATE SYSTEM NEXXT MEDICAL INC KAREN E WARDEN
K091848 06/22/2009 NOBEL/PROCERA IMPLANT BRIDGE NOBEL BIOCARE AB HERBERT CRANE
K091907 06/25/2009 NOBELPROCERA IMPLANT BRIDGE ZIRCONIA NOBEL BIOCARE AB HERBERT CRANE
K091756 06/16/2009 NOBELPROCERA TI ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K091904 06/25/2009 NOBELPROCERA ZI ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K091579 06/02/2009 FORESEE HOME NOTAL VISION LTD. Judy Gordon
K091853 06/23/2009 WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 NSPIRE HEALTH, INC. KIMBERLY STARK
K091598 06/03/2009 LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS NUCLETRON CORP. ELAINA COLBY
K091623 06/03/2009 LAMINOPLASTY FIXATION SYSTEM NUVASIVE, INC. HAN FAN
K091937 06/30/2009 OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM OBP CORPORATION KEITH ISAACSON
K091838 06/22/2009 OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK OBP MEDICAL KEITH LARSON
K091759 06/16/2009 SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K091676 06/09/2009 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 OMRON HEALTHCARE, INC. PAUL DRYDEN
K091602 06/03/2009 MUCHECK V8 ONCOLOGY DATA SYSTEMS, INC. VINCE RUMINER
K091829 06/19/2009 PLS PORTABLE LIGHT SOURCE OPTIM, INC. ROBERT KRUPA
K091666 06/09/2009 PASCAL PHOTOCOAGULATOR, PASCAL-US OPTIMEDICA CORPORATION DARLENE CROCKETT-BILLIG
K091656 06/09/2009 SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L ORGAN RECOVERY SYSTEMS, INC. PJ PARDO
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K091618 06/03/2009 VITOMATRIX ORTHOVITA, INC. DEBORAH L JACKSON
K091678 06/10/2009 HG II SHORT FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K091614 06/03/2009 OSTEOMED FOOT PLATING SYSTEM OSTEOMED L.P. ALMA RELJA
K091944 06/30/2009 MODIFICATION TO: DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC ADAM HERDER
K091600 06/03/2009 DIRECTVISION GUIDE SYSTEM PERCUVISION LLC ERROL O SINGH, M.D.
K091845 06/22/2009 CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM PHADIA US INC. MARTIN ROBERT MANN
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K091572 06/02/2009 DISPOSABLE SPO2 SENSOR M1134A PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN JENS-PETER SEHER
K091927 06/30/2009 INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
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K091693 06/10/2009 TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK POU YU BIOTECHNOLOGY CO., LTD. DANIEL TSAO
K091578 06/02/2009 LIFT CHAIR, MODEL T3 PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
K091628 06/04/2009 OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX PROTEC GMBH & CO. KG JOCHEN KRUPP
K091786 06/17/2009 PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) PULSION MEDICAL SYSTEMS AG Jamie Sulley
K091909 06/25/2009 LITHO LASER SYSTEM QUANTA SYSTEM, S.P.A. ISABELLA CARRER
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K091719 06/11/2009 NEOSALUS LOTION QUINNOVA PHARMACEUTICALS SHAHBAZ KHAN
K091792 06/17/2009 REST ASSURED GENERATION II DENTAL PROTECTOR RANIR CORPORATION JEFF FISHER
K091852 06/23/2009 BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 REFRACTRON TECHNOLOGIES CORP. JOHN GAGLIARDI
K091791 06/17/2009 PROVANT SYSTEM, MODEL 4201 REGENESIS BIOMEDICAL, INC. RICHARD ISENBERG
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K091947 06/30/2009 S8 ASPEN WITH H4I PLUS RESMED LTD. DAVID D'CRUZ
K091843 06/22/2009 COMFORT TWIN NASAL MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K091741 06/16/2009 TINA-QUANT CERULOPLASMIN Roche Diagnostics KATHIE J GOODWIN
K091601 06/03/2009 ELECYS ANTI-CCP CALCHECK ROCHE DIAGNOSTICS CORP. Sarah Baumann
K091735 06/11/2009 DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT S & C POLYMER GMBH CHRISTIAN BOETTCHER
K091828 06/19/2009 SHEATHESISO ULTRASOUND TRANSDUCER COVER SHEATHING TECHNOLOGIES, INC. JENNIFER DOWNING
K091664 06/09/2009 GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C SHENZHEN GSD TECH. CO., LTD. Diana Hong
K091941 06/30/2009 DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TAN CHUANBIN
K091772 06/16/2009 POWDER-FREE VINYL EXAM GLOVES SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD. Kevin Walls
K091770 06/16/2009 VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD. Kevin Walls
K091672 06/09/2009 DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. Diana Hong
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K091916 06/30/2009 INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN ANN DRAY-LYONS
K091720 06/11/2009 SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM SKLAR CORP. NATALYA VALERIO
K091714 06/10/2009 ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 SKYFINE INC. LIMITED MICHAEL LEE
K091627 06/03/2009 SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW, INC. CHRISTINA FLORES
K091908 06/25/2009 M3 MONITOR SPECTRUM MEDICAL LTD STEVE TURNER
K091587 06/02/2009 MERCURY SPINAL SYSTEM SPINAL ELEMENTS, INC. KERRI DIMARTINO
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K091638 06/04/2009 DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 SPINEFRONTIER, INC. JOHN SULLIVAN
K091865 06/19/2009 SPORT-ELEC BODY CONTROL SYSTEM SPORT-ELEC KIMBERLY JONES
K091731 06/11/2009 AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation ROBERT F SULLIVAN
K091794 06/17/2009 CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 STEVE ISLAVA JIM BARLEY
K091606 06/03/2009 VERTAPLEX HV (SINGLE PACK AND DUAL PACK) STRYKER CORP. BECKY E DITTY
K091946 06/30/2009 VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX STRYKER SPINE KIMBERLY LANE
K091858 06/23/2009 PINNACLE STAIR WAY LIFT SUMMIT HARMAR, LLC EDWARD KROL
K091919 06/30/2009 DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST SUNRISE MEDICAL BETTY L MILLER
K091574 06/02/2009 SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES SUPPLIDORES UNIDOS INTERNACIONALES, S.A. VICTOR PEREIRA
K091650 06/09/2009 AXS-590 SERIES SWR INTERNATIONAL, LTD MARTIN J LEIGHTON
K091689 06/10/2009 SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM SYNTHES (USA) STACEY BONNELL
K091644 06/04/2009 SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES SYNTHES (USA) KARL J NITTINGER
K091694 06/10/2009 MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) T.A.G. MEDICAL PRODUCTS GEORGIE J HATTUB
K091898 06/24/2009 BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 TaiDoc Technology Corporation ERICA LI
K091897 06/24/2009 BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 TaiDoc Technology Corporation ERICA LI
K091814 06/18/2009 FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE TaiDoc Technology Corporation ERICA LI
K091935 06/30/2009 LIPIVIEW OCULAR SURFACE INTERFEROMETER TEARSCIENCE, INC. CHRISTY STEVENS
K091761 06/16/2009 TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT Teleflex Medical, Inc. WILLIAM HEARD
K091633 06/04/2009 TEPHAFLEX SURGICAL FILM TEPHA, INC. MARY P LEGRAW
K091939 06/30/2009 THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 THERMEDX, LLC JEFF B WILLIAMS
K091617 06/03/2009 QMS LIDOCAINE CALIBRATORS, MODEL 0374678 Thermo Fisher Scientific JACK ROGERS
K091580 06/02/2009 PICA WHOLE BODY MRI SYSTEM TIME MEDICAL LIMITED Diana Hong
K091940 06/30/2009 MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION TONICA ELEKTRONIK A/S LISE TERKELSEN
K091870 06/23/2009 TORNIER, PITON FIXATION IMPLANT SYSTEM TORNIER HOWARD L SCHRAYER
K091697 06/10/2009 SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 TRANSENTERIX, INC. TAMMY CARREA
K091725 06/11/2009 PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) U&I CORP. SUNG YOUN CHO
K091588 06/02/2009 UCP HOME DRUG SCREENING TESTS UCP BIOSCIENCES, INC. NANCY CHEN
K091612 06/03/2009 UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; UCP BIOSCIENCES, INC. NANCY CHEN
K091726 06/11/2009 NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 USA LASER BIOTECH INC. JOYCE HEINRICH
K091750 06/16/2009 GUIDELINER CATHETER, MODELS 5571, 5572, 5573 VASCULAR SOLUTIONS, INC. LOUCINDA BJORKLUND
K091778 06/17/2009 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS VASCUTEK LTD. KAREN KELSO
K091924 06/30/2009 VPS CATHETER VASONOVA INC. KIM TOMPKINS
K091934 06/30/2009 IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 VERAN MEDICAL TECHNOLOGIES, INC. SCOTT WRIGHTSTONE
K091624 06/03/2009 STENT GRAFT BALLOON CATHETER VIA BIOMEDICAL, INC. FERNANDO DI CAPRIO
DEN090012 06/30/2009 VIRULITE COLD SORE MACHINE VIRULITE LLC BEKY PINE
K091765 06/17/2009 EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM VISGENEER, INC. EVONNE CHEN
K091768 06/16/2009 VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES VISION-SCIENCES, INC. LILLIAN QUINTERO
K091752 06/16/2009 VIZTEK WL VIZTEK, INC. DANIEL KAMM
K091894 06/24/2009 TEMPORARY C&B COMPOSITE VOCO GMBH T. GERKENSMEIER
K091757 06/16/2009 OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K091669 06/09/2009 OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III XIOAO MDT TECHNOLOGY CO LTD Diana Hong
K091796 06/17/2009 SOFTLASE PRO, ORTHOLASE AND HYGIENELASE ZAP LASERS, LLC JAY GOBLE
K091663 06/09/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. CHU XIAOAN
K091662 06/09/2009 POWDERED VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. CHU XIAOAN
K091661 06/09/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD. CHU XIAOAN
K091942 06/30/2009 POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES ZIBO INTCO MEDICAL PRODUCTS CO., LTD. JOHN ZHAO
K091799 06/17/2009 CABLE READY CABLE GRIP SYSTEM CABLE BUTTON ZIMMER, INC. ANTHONY FRANCALANCIA


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