FDA 510(k) Applications Received During May, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K091354 05/18/2009 ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING ACRYMED, INC. CHARLES K GRIFFIN
K091326 05/05/2009 ACTIVAPATCH ACTIVATEK INC. JAMAL YANAKI
K091284 05/01/2009 VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA AFFINITY BIOLOGICALS INC. DENISE FOULON
K091363 05/13/2009 COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER AG INDUSTRIES IAN GORDON
K091369 05/08/2009 ELECTROFLUIDGRAPH AKERN USA, LLC KEVIN WELLS
K091327 05/05/2009 ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES ALDEN OPTICAL LABS., INC. CHARLES CREIGHTON
K091413 05/13/2009 S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) ALFA WASSERMANN, INC. HYMAN KATZ
K091544 05/27/2009 S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 ALFA WASSERMANN, INC. HYMAN KATZ
K091333 05/06/2009 S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 ALFA WASSERMANN, INC. HYMAN KATZ
K091548 05/28/2009 AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEXANDER B HENDERSON
K091278 05/01/2009 VALEO SPACER SYSTEM AMEDICA CORP. ROBERT M WOLFARTH
K091460 05/18/2009 ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K091306 05/04/2009 AMSURE PVC INTERMITTENT CATHETER AMSINO INTERNATIONAL, INC. HOLIVEN JI
K091500 05/21/2009 MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 ANDON HEALTH CO.,LTD LIU YI
K091432 05/14/2009 XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K091472 05/18/2009 URITEST 50 AND URITEST 500 URINE ANALYZER ARJ MEDICAL, INC. AARON BEHAR
K091503 05/21/2009 MAGNUM MP FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K091406 05/13/2009 ATLAS SPINE SPACER ATLAS SPINE LLC JEANNETTE DAILEY
K091552 05/27/2009 SWITCH TRT AUDIFON GMBH & CO. KG JANE PERRONE
K091285 05/01/2009 AL T LASER, MODEL AVI HPLL-12 AVICENNA LASER TECHNOLOGY, INC. BRUCE COREN
K091387 05/11/2009 BTI DENTAL IMPLANT 5.5-6.5 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ
K091321 05/05/2009 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC. HOWARD J SCHRAYER
K091377 05/11/2009 BD FLU+ SYRINGE BECTON DICKINSON & CO. EILEEN HILLER
K091292 05/04/2009 BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 BECTON DICKINSON AND COMPANY (BD) MARY ANN ALSBERGE
K091489 05/20/2009 CLEARVIEW ADVANCED STREP A , MODEL 737-430 BINAX, INC. ERIN E KENALEY
K091317 05/28/2009 LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K091303 05/04/2009 LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV BIO-RAD LABORATORIES SUZANNE S PARSONS
K091414 05/13/2009 VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH BIOCARE CORP. JUDY WEI
K091558 05/28/2009 BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM BIOPTICS, INC. CARLOS REYES
K091352 05/07/2009 SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 BIOSENSE WEBSTER, INC. BALAKA DAS
K091340 05/12/2009 THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K091510 05/27/2009 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 BOSTON SCIENTIFIC CORPORATION MARYBETH GAMBER
K091440 05/15/2009 LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L BOVIE MEDICAL RICHARD KOZLOFF
K091370 05/08/2009 RADIA STEERABLE DIAGNOSTIC CATHETER C.R. BARD, INC. JULIA BRODERICK
K091324 05/05/2009 SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET C.R. BARD, INC. RICK GAYKOWSKI
K091418 05/13/2009 C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION C.T.M. HOMECARE PRODUCT, INC. LINDA BOVARD
K091545 05/27/2009 DIGITAL RADIOGRAPHY CXDI-60C CANON INC. SHEILA DRISCOLL
K091435 05/14/2009 DIGITAL RADIOGRAPHY MODEL CXDI-55G CANON INC. SHEILA DRISCOLL
K091436 05/14/2009 DIGITAL RADIOGRAPHY, MODEL CXDI-55C CANON, INC. SHEILA DRISCOLL
K091300 05/06/2009 ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 CAO GROUP, INC. ROBERT LARSON
K091308 05/04/2009 ALARIS PC UNIT, MODELS 8000 AND 8015 CARDINAL HEALTH 303, INC. MICHELLE J BADAL
K091461 05/18/2009 BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE CARDIOPULMONARY CORP. JORDAN SCHRECK
K091396 05/10/2009 CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM CARDO MEDICAL CORP. DENISE DUCHENE
K091471 05/19/2009 PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL CARTAGLOVES S.A. SAM KAO
K091452 05/19/2009 FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K091380 05/13/2009 CORDCAP CENTRIX, INC. JOHN DISCKO
K091559 05/28/2009 MARKSMANN CATHETER CHESTNUT MEDICAL TECHNOLOGIES, INC. DANIEL CHER
K091531 05/26/2009 CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER CHOICE SPINE, LLP G.TODD HAWKINS
K091346 05/07/2009 CODMAN HAKIM MICRO II VALVE CODMAN & SHURTLEFF, INC. SHARON MCDERMOTT
K091287 05/01/2009 VS-SENSE TEST COMMON SENSE, LTD. NATASHA LESKOVSEK
K091315 05/08/2009 COVIDIEN EXTENDED TIP APPLICATOR CONFLUENT SURGICAL,INC SEAN REYNOLDS
K091355 05/08/2009 DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 CONMED ENDOSCOPIC TECHNOLOGIES, INC. KAREN PROVENCHER
K091527 05/26/2009 ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. NATHAN SIMON
K091385 05/10/2009 APPROACH HYDRO ST WIRE GUIDE, MODEL HMW COOK, INC. KAREN BRADBURN
K091325 05/05/2009 TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS COOPER SURGICAL THOMAS G WILLIAMS
K091339 05/06/2009 BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. LISA HAHN
K091298 05/04/2009 LUBREASE FEMALE LUBRICANT CURVES LIMITED NILUFER SMITH
K091537 05/26/2009 CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH CYNOSURE, INC. ANTHONY BURNS
K091482 05/19/2009 HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD JIUGUANG (JOE) SONG
K091449 05/18/2009 DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 DATASCOPE CORP., CARDIAC ASSIST DIVISION DOLLY MISTRY
K091294 05/04/2009 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K091453 05/18/2009 LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K091310 05/04/2009 ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 DFINE, INC. SANDEEP SABOO
K091309 05/04/2009 REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX DGIMED ORTHO, INC SCOTT YOUNGSTROM
K091455 05/18/2009 DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL DIAZYME LABORATORIES ABHIJIT DATTA
K091430 05/14/2009 CARE PAL, MODEL CPW-10X DIGIO2 INTERNATIONAL CO., LTD JENNIFER REICH
K091382 05/11/2009 KRYPTONITE BONE CEMENT DOCTORS RESEARCH GROUP, INC. JUSTIN EGGLETON
K091358 05/08/2009 ECSCOPE 100 DYANSYS, INC. SRINI NAGESHWAR
K091397 05/12/2009 ECSCOPE 200 DYANSYS, INC. SRINI NAGESHWAR
K091305 05/04/2009 CLEARPATH EASYGLIDE LTD. PAUL DRYDEN
K091381 05/11/2009 IBEX SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K091513 05/22/2009 SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 EDAN INSTRUMENTS, INC. WILLIAM STERN
K091393 05/11/2009 ELEKTA NEUROMAG WITH MAXFILTER ELEKTA NEUROMAG OY DANIEL KAMM
K091497 05/20/2009 K-LASER K-1200, MODEL 12 W ELTECH, S.R.L. RICHARD ALBRIGHT
K091000 05/29/2009 KNEEKG EMOVI EMMANUEL MONTINI
K091350 05/08/2009 ESTECH HAWKEYE INTRODUCER SYSTEMS ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K091336 05/06/2009 IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V ENTHERMICS MEDICAL SYSTEMS, INC. EMALEE G MURPHY
K091229 05/05/2009 GLUCOMANAGER DATA MANAGEMENT SOFTWARE EPS BIO TECHNOLOGY CORP. Y.C. LEI
K091322 05/05/2009 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G ETHICON ENDO-SURGERY, INC. ASIFA VONHOF
K091290 05/01/2009 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 ETHICON ENDO-SURGERY, INC. TOM BOSTICCO
K091458 05/18/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 EV3 NEUROVASCULAR TOM DAUGHTERS
K090277 05/08/2009 NATUS SLEEPWORKS, MODEL 104017 EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K091362 05/08/2009 CERAMIC PEDATRIC PREFORMED CROWN EZ-PEDO INC JEFFREY FISHER
K091488 05/19/2009 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C FOOTPRINT MEDICAL CLYDE BAKER
K091533 05/26/2009 SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 GARRISON DENTAL SOLUTIONS JOSEPH AZARY
K091388 05/11/2009 GCUC-505 GC AMERICA, INC. MARK HEISS
K091374 05/11/2009 GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K091536 05/26/2009 OPTIMA MR450W GE MEDICAL SYSTEMS, LLC MARK STAUFFER
K091359 05/08/2009 GSO PCT SPINAL SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K091187 05/06/2009 GRACE DYNAMIC TORP GRACE MEDICAL, INC. JEFF COBB
K091367 05/08/2009 GDS-DCS GUIDED DELIVERY SYSTEMS BONNIE MCINERNEY
K091519 05/22/2009 HAEMOBAND MULTI-LIGATOR HAEMOBAND SURGICAL LTD. PAUL DRYDEN
K091338 05/13/2009 COLLASORB COLLAGEN WOUND DRESSING HARTMANN-CONCO INC. E.J. SMITH
K091390 05/11/2009 HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 HDC S.R.L. GUIDO BONAPACE
K091491 05/20/2009 HERO VASCULAR ACCESS DEVICE HEMOSPHERE INC W. ALLEN PUTNAM
K091494 05/20/2009 FLEXITIME FLOW HERAEUS KULZER, INC. CHERYL ZIMMERMAN
K091378 05/11/2009 MAMMOSITE II RADIATION THERAPY SYSTEM HOLOGIC, INC. JENNIFER SULLIVAN
K091368 05/08/2009 R2 DIGITALNOW HD(DIGITALNOW HD) HOLOGIC, INC. MICHAELA MAHL
K091529 05/22/2009 ICAD VERALOOK CTC CAD SOFTWARE ICAD, INC. JOHN A DELUCIA
K091522 05/22/2009 IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K091520 05/22/2009 IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K091556 05/27/2009 HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K091302 05/04/2009 INTEGRA MOZAIK AND OS MOLDABLE MORSELS INTEGRA LIFESCIENCES CORPORATION PETER ALLAN
K091465 05/18/2009 MYOSURE ROD LENS HYSTEROSCOPE INTERLACE MEDICAL, INC. JOHN VOZELLA
K091323 05/05/2009 MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) INTERMEDIC ARFRAN, S.A. ANNE WORDEN
K091539 05/26/2009 IQ 200 URINE ANALIZER BODY FLUIDS MODULE IRIS DIAGNOSTICS WILLIAM M DOUGHERTY
K091253 05/05/2009 THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2M, INC. RICHARD W WOODS
K091486 05/19/2009 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR KAMIYA BIOMEDICAL CO. SHAWN KAPLAN
K091499 05/21/2009 MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) KENSEY NASH CORP. ALYSSA SCHWARTZ
K091357 05/08/2009 MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 KIMBERLY-CLARK CORP. DAVID M LEE
K091562 05/28/2009 DOCTOR SMILE A-810 AND B-980 LASERS LAMBDA SCIENTIFIC SPA BOSCHI ALESSANDRO
K091366 05/11/2009 INSUFLOW DEWHEART LEXION MEDICAL, LLC. BERNARD HORWATH
K091301 05/04/2009 LIFE SPINE STAND-ALONE SPACER SYSTEM LIFE SPINE MICHAEL S BUTLER
K091534 05/26/2009 LIGHTLAS MODEL 532 LIGHTMED CORP. ANITA CHEN
K091549 05/27/2009 CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM LINVATEC CORP. JOHN CUSACK
K091047 05/29/2009 NEONATE ARRAY COILS LMT MEDICAL SYSTEMS GMBH KRISTINA LUETJE
K091320 05/05/2009 SPECTRA SP II, SPECTRA DENTA II LUTRONIC CORPORATION MAUREEN O'CONNELL
K091474 05/29/2009 EASY.TOUCH INSULIN SYRINGE MASTERS HEALTHCARE, LLC. DANIEL KAMM
K091280 05/01/2009 FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT MAXX ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K091518 05/22/2009 CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM MCUBE TECHNOLOGY CO., LTD. CHARLIE MACK
K091400 05/12/2009 MODIFICATION TO AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K091479 05/19/2009 APTUS FOOT SYSTEM MEDARTIS AG LINDA SCHULZ
K091466 05/18/2009 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 MEDCOMP SUSAN PILEGGI
K091557 05/27/2009 LUNG FLUTE THERAPEUTIC MEDICAL ACOUSTICS NICOLAAS J SMIT
K091454 05/18/2009 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K091312 05/04/2009 PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY JEFFERY HENDERSON
K091365 05/08/2009 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOAFAMOR DANEK MELISA LANSKY
K091442 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK BRAD SHEALS
K091445 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K091540 05/26/2009 MTD 4000 METTLER ELECTRONICS CORP. ROBERT FLEMING
K091288 05/19/2009 MEDI-6000 MEDICAL IMAGE DIGITIZER MICROTEK INTERNATIONAL, INC. HUI-CHEN KAI
K091504 05/21/2009 MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 MICRUS ENDOVASCULAR CORPORATION TED RUPPEL
K091496 05/20/2009 MEP-90 HAIR GROWTH STIMULATION SYSTEM MIDWEST R.F. LLC. HELMUT KEIDL
K091511 05/29/2009 MODERN MEDICAL RESECTOSCOPE ELECTRODES MODERN MEDICAL EQUIPMENT MFG., LTD. EUGENE YEUNG
K091425 05/13/2009 QUANTUM M COMPOSITE NAILING SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD. JONATHAN S KAHAN
K091428 05/14/2009 EASYONE PRO RESPIRATORY ANALYSIS SYSTEM NDD MEDIZITECHNIK AG GERARD MASIELLO
K091155 05/11/2009 ASCEND NEUROMETRIX, INC. RAINER MAAS
K091457 05/18/2009 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM NEXSTIM OY CYNTHIA J NOLTE
K091279 05/01/2009 NIPRO DISPOSABLE SYRINGE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K091546 05/27/2009 NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K091547 05/27/2009 NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS NOVA BIOMEDICAL CORP. PAUL MACDONALD
K091484 05/19/2009 NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GALSSER
K091515 05/22/2009 SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM NOVADAQ TECHNOLOGIES, INC. JOHN FENGLER
K091360 05/08/2009 CLEARFLUX DIALYZER REPROCESSING SYSTEM NOVAFLUX TECHNOLOGIES MOHAMED E LABIB
K091422 05/13/2009 NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) NOVAPRO CO., LTD. ZHENZHONG CHENG
K091421 05/13/2009 NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) NOVAPRO CO., LTD. ZHENZHONG CHENG
K091502 05/21/2009 NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. HAN FAN
K091444 05/21/2009 PERFSCAPE OLEA MEDICAL NEAL KOLBER
K091495 05/27/2009 SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO
K091403 05/12/2009 MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY ONCOLOGY TECH, LLC SEAN COMER
K091404 05/12/2009 IVUE, MODEL 100 OPTOVUE, INC. AZIMUN JAMAL
K091411 05/13/2009 KNEEALIGN SYSTEM ORTHALIGN, INC AMY WALTERS
K091493 05/20/2009 ORTHO SELECT BONE PLATES AND SCREW SYSTEM ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT ANGELIKA SCHERP
K091398 05/12/2009 ARTHROSCOPE ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K091424 05/13/2009 OSTA MAXIGRO AND REGIGRO OSTA TECHNOLOGIES JAY MANSOUR
K091446 05/15/2009 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE, RAC, CCRA
K091509 05/22/2009 JETSTREAM G2 NXT SYSTEM, MODEL PV20300 PATHWAY MEDICAL TECHNOLOGIES, INC. BRIT BAIRD
K091478 05/19/2009 TREVAIR CHAIR PATMONT MOTOR WERKS, INC. STEVEN J PATMONT
K091512 05/21/2009 BUILD-IT LIGHT CURE PENTRON CLINICAL TECHNOLOGIES WENDY GARMAN
K091554 05/27/2009 PHARMAPAC PERSONAL LUBRICANT PHARMAPAC LLC TOM OTTO
K091395 05/11/2009 MP5 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K091389 05/11/2009 EQUALSHIELD LUER LOCK CONNECTOR PAIR PLASTMED, LTD. ELISSA BURG
K091296 05/04/2009 POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 POLYMAP WIRELESS PIERRE LANDAU
K091120 05/06/2009 MEDPOR CONTAIN IMPLANT POREX SURGICAL, INC. JERRI L MANN
K091392 05/21/2009 TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK POU YU BIOTECHNOLOGY CO., LTD. DANIEL TSAO
K091281 05/01/2009 TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA PROCTER & GAMBLE CO. KIMBERLY A NEMETH
K091433 05/13/2009 R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL R & D SYSTEMS, INC. NANCY RING
K091506 05/21/2009 DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 R4 VASCULAR, INC. LAURIE LEWANDOWSKI
K091507 05/21/2009 RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 RAYNER INTRAOCULAR LENSES LTD. ROYNAN H KERNAGHAN
K091319 05/05/2009 REMSTAR AUTO A-FLEX RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K091459 05/18/2009 PHILIPS NM3 MONITOR, MODEL 7900 RESPIRONICS NOVAMETRIX LLC KEVIN MADER
K091563 05/28/2009 RECRUIT MICROCATHETER REVERSE MEDICAL CORPORATION AMY ESKINA
K091409 05/13/2009 LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 ROCHE MOLECULAR SYSTEMS, INC. LARRY PIETRELLI
K091331 05/05/2009 PIEZOTOME 2 SATELEC RICK ROSATI
K091283 05/01/2009 CAPILLARYS NEONAT HB (PN 2006) SEBIA KAREN ANDERSON
K091541 05/26/2009 MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES SEQUAL TECHNOLOGIES CO., LTD CEARO HUANG
K091408 05/12/2009 DISPOSABLE PRESSURE TRANSDUCER SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD LEE FU
K091523 05/22/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG CENTURY PLASTIC CO., LTD CHU XIAOAN
K091521 05/22/2009 POWERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG CENTURY PLASTIC CO., LTD CHU XIAOAN
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