FDA 510(k) Decisions During April, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K100470 04/21/2010 GTX 12 GIDEWIRE MEDTRONIC INC. COLLEEN MULLINS
K094007 04/08/2010 UNICEM 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K094064 04/30/2010 ILUMA VISION MODEL VERSION 2.2 3M IMTEC GINGER CANTOR, RAC
K100145 04/13/2010 A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 A&E BIOCERAMIC CO., LTD. MARZ CHIU
K093305 04/02/2010 ENHANCED ULTRA VIT PROBE ALCON RESEARCH, LTD. MARTIN A KAUFMAN
K094041 04/07/2010 ALPHA ORTHOPAEDICS AT3 SYSTEM ALPHA ORTHOPAEDICS GINA TO
K093186 04/16/2010 AMBU ASCOPE AND MONITOR AMBU A/S SANJAY PARIKH
K100108 04/14/2010 AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA AMEDICA BIOTECH, INC. JEFF CHEN
K093014 04/16/2010 AMERICAN DENTAL PRODUCTS SE BONDEASY AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K092066 04/12/2010 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE ANDREW TECHNOLOGIES, LLC JONATHAN S KAHAN
K100747 04/14/2010 CONTREX PLUS LOW CONTROL SOLUTION APEX BIO TECHNOLOGY CORP THOMAS Y.S. SHEN
K100959 04/22/2010 SPECIMEN RETRIEVAL SYSTEM APPLIED MEDICAL RESOURCES FRANS VANDENBROEK
K100120 04/02/2010 ALEXIS ORTHOPAEDIC WOUND RETRACTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K100215 04/07/2010 ARCHIMED REMEDY CERVICAL PLATE ARCHIMED, INC. BARRY AIKEN
K091472 04/27/2010 URITEST 50 AND URITEST 500 URINE ANALYZER ARJ MEDICAL, INC. AARON BEHAR
K092472 04/15/2010 NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT ASCEND EAGLE, INC. JANNA TUCKER
K093780 04/16/2010 ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K093431 04/20/2010 CLEARWAY OTW MODEL 85912 ATRIUM MEDICAL CORP. RAYMOND KELLY
K092031 04/16/2010 VAPOR-CLEAR, MODEL 100 AXON MEDICAL, INC. JOSEPH ORR
K100334 04/22/2010 DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 B. BRAUN AVITUM AG ANGELA J CARAVELLA
K100241 04/16/2010 CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K100005 04/15/2010 BD PEN NEEDLE BECTON, DICKINSON AND CO. JAMES HAYNES
K090301 04/14/2010 BINAXNOW PBP2A TEST, MODEL 890-000 BINAX, INC. SUZANNE VOGEL
K094018 04/16/2010 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K093321 04/02/2010 BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K100155 04/20/2010 TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM BIOMEDICAL SYSTEMS CORP. MICHAEL KROEHNKE
K093235 04/30/2010 RINGLOC + HYBRID ACETABULAR SYSTEM BIOMET, INC. GARY BAKER
K100264 04/09/2010 T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K092048 04/19/2010 ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP BIOSITE INCORPORATED LISA CHICORKA
K100701 04/08/2010 SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 BIOTEST MEDICAL CORP. MAGGIE CHU
K100892 04/12/2010 RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX BOSTON SCIENTIFIC CORP. SCOTT SEPPLE
K100663 04/16/2010 CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 BOSTON SCIENTIFIC CORPORATION DEBBIE MCINTIRE
K100528 04/23/2010 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S BREATHE TECHNOLOGIES, INC. SUZON LOMMEL
K100229 04/21/2010 VENTRIO HERNIA PATCH C.R. BARD, INC. MICHELLE GODIN
K100362 04/14/2010 CAMBRIDGE HEART OEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K100266 04/29/2010 ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 CAMNTECH, LTD HOWARD SMITH
K100994 04/30/2010 PRELOADED TISSUE MARKER DEVICE CARBON MEDICAL TECHNOLOGIES, INC. TINA M WITTCHOW
K092484 04/02/2010 HELIOX LOW FLOW SENTRY BLENDER CARDINAL HEALTH 207, INC. MONTHER ABUSHABAN
K093288 04/08/2010 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION CARDIONET, INC KENT SAYLER
K094045 04/22/2010 MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM CARDO MEDICAL CORP. DAVE LAMB
K093229 04/08/2010 CATHETER CONNECTIONS DUALCAP CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K100723 04/30/2010 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. CHARLIE MACK
K093977 04/22/2010 ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX CHESTNUT MEDICAL TECHNOLOGIES, INC. DANIEL CHER
DEN090005 04/30/2010 PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. BRUCE KRATTENMAKER
K082289 04/30/2010 PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. BRUCE KRATTENMAKER
K090744 04/15/2010 CLARO CLRS TECHNOLOGY CORPORATION MAUREEN O'CONNELL
K100400 04/22/2010 PRESTODR PORTABLE CMT MEDICAL TECHNOLOGIES, LTD. SHLOMI DINES
K093243 04/07/2010 COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM COAGUSENSE, INC DOUGLAS PATERSON
K092391 04/01/2010 MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED CONCORD MEDICAL PRODUCTS RANDALL FINCKE
K083785 04/02/2010 VITALA CONTINENCE CONTROL DEVICE CONVATEC MARILYN KONICKY
K100283 04/23/2010 VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC COOK, INC. SUSANNE GALIN
K092076 04/02/2010 AEGIS & AEGIS II SPINAL SYSTEM CORENTEC CO., LTD ROBERT SCHIFF
K083312 04/05/2010 MINIHIP STEM CORIN U.S.A. ASHLEA BOWEN
K092198 04/15/2010 CORMET CEMENTLESS RESURFACING FEMORAL HEAD CORIN USA ASHLEA BOWEN
K100548 04/26/2010 VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR ANGELA VAN ARSDALE
K093871 04/22/2010 PERIOPHIL B-TCP CYTOPHIL INC VICTOR M BOWERS
K100633 04/01/2010 INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 D B ORTHODONTICS LTD ANNA DYSON
K100378 04/28/2010 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K100012 04/30/2010 GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K090975 04/12/2010 DEROYAL NON-LOCKING BONE FIXATION SYSTEM DEROYAL INDUSTRIES, INC. GRACIE GREENWAY
K093371 04/05/2010 MODEL DGH 6000 SCANMATE A DGH TECHNOLOGY, INC. M. LUTHER DETWEILER
K100312 04/20/2010 DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM DGIMED ORTHO, INC SCOTT P YOUNGSTROM
K093680 04/08/2010 DIAZYME CYSTATIN C ASSAY DIAZYME LABORATORIES ABHIJIT DATTA
K092911 04/26/2010 SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER DIAZYME LABORATORIES ABHIJIT DATTA
K100838 04/23/2010 ERGO IMAGING SYSTEM DIGIRAD CORP. JOEL TUCKEY
K093010 04/01/2010 MACH LED MC DR. MACH GMBH & CO. KG RAINER ADAMS
K093009 04/01/2010 MACH LED SC DR. MACH GMBH & CO. KG RAINER ADAMS
K100941 04/23/2010 INFINITY MCABLE - MAINSTREAM CO2 DRAEGER MEDICAL AG & CO. KG ULRICH SCHROEDER
K093632 04/05/2010 INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE DRAGER MEDICAL AG & CO. KGAA JOYCE KILROY
K093728 04/29/2010 BE MICRO, TREA EB NEURO, S.P.A. JAMIE AUSTIN
K093880 04/16/2010 PEANUT GROWTH CONTROL PLATING SYSTEM EBI, L.P. MARGARET F CROWE
K093869 04/01/2010 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. WILLIAM STERN
K093554 04/13/2010 RETROFLEX DILATOR KIT EDWARDS LIFESCIENCES, LLC. JASON K LYON
K100230 04/02/2010 SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V ELEME MEDICAL, INC. WILLIAM MCGRAIL
K092033 04/30/2010 VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR ELMED USA JONATHAN WARD
K100377 04/22/2010 DIAMONDBACK SPINAL SYSTEM EMINENT SPINE KAREN WARDEN
K100224 04/07/2010 ESTECH COBRA BIPOLSR II ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K100670 04/05/2010 S-SCAN, MODEL 9800020010 ESAOTE, S.P.A. ALLISON SCOTT
K100597 04/07/2010 HARMONIC FOCUS SHEARS ETHICON ENDO-SURGERY, LLC MARCIA ARENTZ
K093899 04/29/2010 MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K093932 04/09/2010 ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH ETHICON GMBH NEELU MEDHEKAR
K093845 04/07/2010 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 ETHICON, INC. JOSEPH KICEINA
K100789 04/21/2010 MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC KARUNA VELUSAMY
K093770 04/28/2010 EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K100662 04/07/2010 FEMVUE CORNUAL BALLOON CATHETER FEMASYS INC. LISA PEACOCK
K092579 04/02/2010 INTRAUTERINE INSEMINATION (IUI) CATHETER FERTILIGENT, LTD JOHN A STEEN
K094040 04/27/2010 F&P ICON SERIES CPAP FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K100881 04/14/2010 SYNAPSE OBLIQUUS MIP/MPR/FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K092171 04/26/2010 VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. JAE KIM
K092578 04/05/2010 LIFEGLOBAL PROTEIN SUPPLEMENT GENX INTL., INC. MICHAEL D CECCHI
K091958 04/30/2010 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM GLENVEIGH SURGICAL, LLC PENNY NORTHCUTT
K093904 04/14/2010 GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER GLENVEIGH SURGICAL, LLC PENNY NORTHCUTT
K093343 04/22/2010 GRAFTY QUICKSET GRAFTYS ANTHONY LE NAOUR
K100046 04/08/2010 M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K100135 04/16/2010 GDS-DC12 GUIDED DELIVERY SYSTEMS BONNIE L MCINERNEY
K092240 04/21/2010 ACUPUNCTURE NEEDLES HAENGLIM SEOWON MEDICAL CO. JEAN ASQUITH
K093241 04/27/2010 V7 PORTABLE SUCTION UNITS HERSILL, S.L. OSCAR JORDAN
K093889 04/22/2010 MODIFICATION TO: HG III ULTRA WIDE SYSTEM HIOSSEN INC. PATRICK LIM
K100745 04/15/2010 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. CINDY GREEN
K100273 04/22/2010 INSTAFLO BOWEL CATHETER SYSTEM KIT HOLLISTER, INC. BENJAMIN LICHTENWALNER
K100692 04/06/2010 DIGITAL SPOT MAMMOGRAPHY SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K090882 04/23/2010 FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE HOSPIRA, INC. KEITH DUNN
K091955 04/02/2010 STRYKER SONICPIN SYSTEM HOWMEDICA OSTEONICS CORP AVITAL MERL-MARGULIES
K100475 04/30/2010 AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K100915 04/30/2010 INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 HUTCHINSON TECHNOLOGY, INC. COLIN MCGRAW
K093706 04/02/2010 PROXISCAN MODEL 101 HYBRIDYNE IMAGING TECHNOLOGIES, INC BARRY S SALL, RAC
K100315 04/23/2010 12 LEAD GLOVE I NEEDMD, INC IRVING L WIESEN, ESQ
K093128 04/28/2010 ILLUMINA BEADXPRESS SYSTEM ILLUMINA, INC. DONALD R ELLIS
K093129 04/28/2010 ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II ILLUMINA, INC. DONALD R ELLIS
K091933 04/02/2010 ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 INNO-HEALTH TECHNOLOGY, INC. TERRY C CHANG
K093922 04/15/2010 INOMAX DS INO THERAPEUTICS LARRY LEPLEY
K100517 04/29/2010 INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K100096 04/22/2010 LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART INTEGRA RADIONICS, INC. HELDER A SOUSA
K100417 04/08/2010 XKNIFE 5 INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K100208 04/20/2010 IMC SURGICAL DRAPE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K100921 04/30/2010 ADMIRAL XTREME PTA BALLOON DILATATION CATHETER INVATEC S.P.A. JOHN CLAY
K092335 04/09/2010 PEAK EXPIRATORY FLOW METER, KN-9710 K-JUMP HEALTH CO., LTD. JASON CHENG
K091486 04/29/2010 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR KAMIYA BIOMEDICAL CO. SHAWN KAPLAN
K100526 04/22/2010 AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE KENTEC MEDICAL, INC. KEITH ROOKS
K100347 04/30/2010 OPTIBOND SE KERR CORPORATION WENDY GARMAN
K100803 04/22/2010 OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 KEYMED, INC. RONALD WARREN
K092765 04/07/2010 LANX ANTERIOR PLATING SYSTEM LANX, INC. MICHAEL FUNK
K100191 04/15/2010 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, INC. ANDREW LAMBORNE
K093017 04/29/2010 STELLAR 300 LARSEN & TOUBRO LIMITED E.J. SMITH
K100116 04/15/2010 LASERTOUCHONE (OTC) LASER HEALTH TECHNOLOGIES, LLC PATSY J TRISLER
K091987 04/23/2010 ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP LEMAITRE VASCULAR, INC. ERIN E DALY
K094052 04/23/2010 LENSX 550 LASER SYSTEM. MODEL 550 LENSX LASERS, INC. JUDY GORDON
K093857 04/30/2010 C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES LIGHTLAB IMAGING,INC. CHRISTINE BRAUER
K093207 04/26/2010 ENDURAMESH, MODEL 762.XXX LUCERO MEDICAL, LLC JENNIFER PALINCHIK
K100415 04/21/2010 ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM LUMENIS AHAVA STEIN
K100384 04/12/2010 FIBERLASE C02 LASER WAVEGUIDE LUMENIS, LTD. AHAVA STEIN
K100278 04/30/2010 QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K093806 04/08/2010 MYKNEE CUTTING BLOCKS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K100673 04/06/2010 EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 MEDICA CORP. PHOTIOS MAKRIS
K092542 04/23/2010 M MEDISCITEC INC. KEVIN WALLS
K100284 04/09/2010 LIQUIBAND ULTIMA, LUT 003 MEDLOGIC GLOBAL LIMITED MICHAEL BROWNE
K100023 04/05/2010 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K094025 04/26/2010 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK JENNIFER HACKNEY
K091797 04/30/2010 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK BRAD SHEALS
K093913 04/06/2010 MERCURY MEDICAL T-PIECE RESUSCITATOR MERCURY MEDICAL, INC. PAUL DRYDEN
K100319 04/28/2010 MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L MERIT MEDICAL SYSTEMS, INC. JEFF CARLSTROM
K091716 04/02/2010 MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K100454 04/22/2010 HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V MICROVENTION, INC. LARAINE PANGELINA
K092387 04/05/2010 MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM MINNTECH CORP. RICHARD M ORMSBEE
K100449 04/23/2010 MINXRAY MODEL CMDR-2S MINXRAY, INC. DANIEL KAMM, P.E.
K100127 04/16/2010 ELI 230 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K100237 04/23/2010 DIALYSATE METER, MODEL D-6 MYRON L COMPANY RICHARD JAMES SPAHL
K100683 04/09/2010 NEUROLINK IP MODEL: PK1117 NATUS MEDICAL INCORPORATED GOLDY SINGH
K100195 04/21/2010 NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X NDS SURGICAL IMAGING JIM LENG
K092481 04/02/2010 HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 NEW AQUA LLC (DBA AQUA SYSTEMS) NEVIN RUDIE
K092382 04/26/2010 NEXUS PRESSURE RATED EXTENSION SETS NEXUS MEDICAL, LLC SUSAN CURRY
K093971 04/22/2010 DENTAL HANDPIECE NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. DIANA HONG
K100335 04/08/2010 ORS VISUAL OBJECT RESEARCH SYSTEMS, INC. ERIC FOURNIER
K090845 04/07/2010 APEX ARC HIP STEM OMNI LIFE SCIENCE, INC. WILLIAM MCCALLUM
K091404 04/22/2010 IVUE, MODEL 100 OPTOVUE, INC. AZIMUN JAMAL
K093611 04/15/2010 VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A HANNA
K100618 04/20/2010 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K090436 04/16/2010 AIRWAYEASE MAS ORTHOPLANT DENTAL LAB CHRISTOPHER KELLY
K100599 04/05/2010 CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K093974 04/22/2010 ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING OSMETECH MOLECULAR DIAGNOSTICS ROBERT S DICHECK
K093205 04/01/2010 PADCHECK PADTEST, LLC JAMES R GREENWOOD
K092984 04/07/2010 PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 PANPAC MEDICAL CORPORATION YEN-MING PAN
K100164 04/05/2010 MR INSPIRE WITH EXTENDED KIT PARAMED SRL JOE OUELLETTE
K093695 04/13/2010 PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE PEAK SURGICAL, INC. LOIS NAKAYAMA
K100272 04/14/2010 INTELLIVUE CLINICAL INFORMATION PORTFOLIO PHILIPS MEDICAL SYSTEMS TERESA SCHMIDT
K100939 04/30/2010 INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K093618 04/23/2010 BILI-MIRROR MODEL BLM-1 PHYSICIAN ENGINEERED PRODUCTS, INC. ROB ROSE, MD
K100292 04/30/2010 CAAS QVA 3D, CAAS QCA 3D PIE MEDICAL IMAGING B.V. SASKIA LLOYD
K100361 04/22/2010 NANOSS BONE VOID FILLER PIONEER SURGICAL TECHNOLOGY DAVID J COLLETTE, MD
K100104 04/14/2010 HYBERNITE RAINOUT CONTROL SYSTEM PLASTIFLEX GROUP NV WILLIAM GREENROSE
K092348 04/08/2010 POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS POLYREMEDY, INC. GARY MOCNIK
K092351 04/08/2010 POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS POLYREMEDY, INC. GARY MOCNIK
K093333 04/02/2010 PRIMUS STEAM STERILIZER PSS8-AA (16"X16X26" MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 PRIMUS STERILIZER COMPANY, LLC. CONNIE MANSFIELD
K100343 04/23/2010 PAP-CAP PUR-SLEEP, INC. PAUL DRYDEN
K093697 04/13/2010 VASHE WOUND THERAPY SOLUTION PURICORE INC. DENNIS MAHONRY
K093263 04/30/2010 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE QINGDAO LANG HUI IMPORT & EXPORT CO., LTD MARSHAL MA
K094038 04/22/2010 COMPACT TOUCH QUANTEL S.A. MIKE JOHNSON
K092901 04/28/2010 EPICAGE INTERBODY FUSION DEVICE R TREE INNOVATIONS RICHARD JANSEN
K100084 04/12/2010 MULTI FRAME WHEELCHAIR R82 A/S KIRK MACKENZIE
K100733 04/30/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) RAYEN SAFETY PRODUCTS LIMITED CHU XIAOAN
K091791 04/07/2010 PROVANT SYSTEM, MODEL 4201 REGENESIS BIOMEDICAL, INC. RICHARD ISENBERG
K093377 04/27/2010 POLARIS CONTACT LENS CASE RELIANCE DESIGN & MANUFACTURING CORP. TRAVIS HSU
K093555 04/02/2010 COBAS U411 TEST SYSTEM ROCHE DIAGNOSTICS JENNIFER TRIBBETT
K100810 04/26/2010 ELECSYS C-PEPTIDE CALCHECK 5 ROCHE DIAGNOSTICS KELLY ADAMS
K094031 04/27/2010 ELECSYS FOLATE III CALCHECK 5 ROCHE DIAGNOSTICS KELLY COLEEN O'MAINE ADAMS
K100594 04/01/2010 ELECSYS TROPONIN I CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
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