FDA 510(k) Decisions During February, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101910 12/08/2010 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS 3M COMPANY SUZANNE LEUNG
K093721 02/19/2010 COSP2 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K100715 12/23/2010 AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K101427 12/23/2010 AUDIT MICROCV HS-CRP LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K103122 12/30/2010 C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG AAT ALBER ANTRIEBSTECHNIK GMBH STEFANIE D BANKSTON
K093318 02/19/2010 ACCELERATOR APS ABBOTT LABORATORIES MARK LITTLEFIELD
K102705 12/07/2010 ARMANDA 14 PTA CATHETER ABBOTT VASCULAR INC. LAARNI RICAFORT
K103153 12/30/2010 VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER ABBOTT VASCULAR-CARDIAC THERAPIES SUZANNE REDMAN
K102981 12/20/2010 ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM ACE SURGICAL SUPPLY COMPANY INC. CAROL A HOUTS
K093192 02/12/2010 FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE ADVANCED VASCULAR DYNAMICS HERBERT SEMLER
K101558 12/16/2010 GNR TRAFFIC LIGHT PNA FISH ADVANDX, INC. HENRIK STENDER
K101815 12/20/2010 ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS KATHY A RACOSKY
K103284 12/02/2010 LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K102424 12/09/2010 PREVISION HIP SYSTEM WITH RECON RING AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K102057 12/21/2010 TARGON FN SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K091860 02/23/2010 AESKULISA MPO, MODEL 30-7303US AESKU.DIAGNOSTICS SASCHA PFEIFFER
K091363 02/04/2010 COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER AG INDUSTRIES IAN GORDON
K093476 02/05/2010 AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 AGA MEDICAL CORP. AMANDA JOHNSON
K092821 02/01/2010 TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 AGENCY FOR MEDICAL INNOVATIONS, INC. ANDREW BENDHEIM
K101806 12/07/2010 AIDERA DIASEND SYSTEM AIDERA AB ANDERS SONESSON
K102700 12/21/2010 LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN EDWARD BREHM
K100138 02/17/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K102609 12/09/2010 KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON MEDICAL CO., LTD. LIU YI
K102796 12/15/2010 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K093567 02/05/2010 ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM ANOVA IMPLANT SOLUTIONS, LLC WALTER SPIRES
K092733 02/26/2010 PYTON ARM MEDICAL DEVICES, INC. ANTHONY CALDERONI
K091006 02/25/2010 ITG VASCULAR ACCESS SYSTEM, MODEL 300 ARSTASIS, INC. DOMINIQUE FILLOUX
K101837 12/28/2010 ACL TIGHTROPE DOUBLE BUNDLE ARTHREX, INC. GEENA AUGUSTINE
K103466 12/22/2010 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. SALLY FOUST, RAC
K091188 02/26/2010 ASAHI ZENYTEEX GUIDING CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K102549 12/21/2010 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K091880 02/24/2010 CLAYTON INTRA-AURAL DEVICE (CID) ASCENTIA HEALTH INCORPORATED ROGER WIXTROM
K102279 12/29/2010 INCU I ATOM MEDICAL CORPORATION TSUYOSHI SUGINO
K102710 12/22/2010 NEO-SERVO I ATOM MEDICAL CORPORATION PAUL DRYDEN
K102624 12/16/2010 AVITA WRIST TYPE BLOOD PRESSURE MONITOR AVITA CORPORATION JENNIFER REICH
K103412 12/30/2010 AXIOM FASCIAL CLOSURE SYSTEM AXIOM TECHNOLOGY PARTNERS, LLC RICHARD RUSH
K083460 02/18/2010 DIALOG WITH ADIMEA OPTION B. BRAUN AVITUM AG BONNIE KINCAID, RAC
K103367 12/08/2010 SEEKER CROSSING SUPPORT CATHETER BARD PERIPHERAL VASCULAR, INC. CANDACE WADE
K090917 02/19/2010 SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM BAXA CORP. JIM MORGAN
K093120 02/17/2010 XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 BAXTER HEALTHCARE CORPORATION - RENAL DIVISION DIANE RENNPFERD
K100790 12/21/2010 COULTER LIN-X LINEARITY CONTROL, MODEL A81196 BECKMAN COULTER, INC. LOURDES M COBA
K100209 02/19/2010 BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY BECTON DICKINSON & CO. PASQUALE AMATO
K082315 02/01/2010 EC50 MICRO+ SMOKERLYZER BEDFONT SCIENTIFIC LTD. GLEN HILLSLEY
K101577 12/02/2010 MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K100700 12/13/2010 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES BENLAN, INC. CHERYL BROWN
K100092 02/23/2010 CORVUS RADIATION THERAPY PLANNING SYSTEM BEST NOMOS CHI PALKO
K091210 02/05/2010 ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT BEST SANITIZERS, INC. NORMAN MINER
K091766 02/24/2010 CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 BINAX, INC. SUZANNE M VOGEL
K093015 02/25/2010 BINDER INTERVERTEBRAL BODY FUSION DEVICE BINDER BIOMEDICAL, INC LAWRENCE BINDER
K092587 12/03/2010 BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM Bio-Rad Laboratories Patricia Klimley
K102755 12/16/2010 CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER BIOLITEC, INC. NANCY FOLEY
K102579 12/02/2010 HYPERQ AD-100 SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. GEORGE J HATTUB
K102607 12/03/2010 FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K091951 02/19/2010 HAMMERLOCK BIOMEDICAL ENT., INC. JOE W SOWARD
K102209 12/03/2010 ENCODE PATIENT SPECIFIC ABUTMENT BIOMET 3I, INC. SIMEON SIMONE
K100469 12/07/2010 ARCOS INTERLOCKING DISTAL STEMS BIOMET MANUFACTURING CORP. BECKY EARL
K100761 12/03/2010 BIOPRO POLAR HEAD BIOPRO, INC. DAVID MRAK
K093470 02/17/2010 CORE-FLO D/C BISCO, INC. Michelle Schiltz-Taing
K093379 02/09/2010 TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. MICHAEL MATHUR
K100044 02/04/2010 FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY BLACKSTONE WHITNEY TORNING
K100785 12/03/2010 BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES BONART CO. LTD. ERIC L ONG
K103668 12/30/2010 BNX FINE NEEDLE ASPIRATION SYSTEM BOSTON ENDOSCOPIC ENGINEERING ANNETTE M FAGNANT
K103008 12/10/2010 INZONE DETACHMENT SYSTEM BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K100078 02/12/2010 MODIFIED STRAIGHT FIRE LASER FIBER BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K093142 02/04/2010 TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K102764 12/22/2010 RESOLUTION II CLIP Boston Scientific Corporation ELENA NIEVES
K102525 12/02/2010 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
K093515 02/16/2010 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON BRIVANT, LTD. TOMAS FUREY
K103459 12/13/2010 VASCUTRAK PTA DILATATION CATHETER C. R. BARD, INC. CANDACE WADE
K102766 12/16/2010 COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD INC KETI SINO
K103109 12/22/2010 PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE C.R. BARD INC DENNIS SALZMANN
K093927 02/04/2010 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER C.R. BARD, INC. SARABJYOT MANKOO
K102391 12/22/2010 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. BARD, INC. SCOTT PEASE
K103359 12/27/2010 FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) C.R. BARD, INC. CINDY MOSS
K101118 12/15/2010 ACTIVON TULLE CALIDAD SOLUTIONS, INC. JOHN BILLINGS
K103249 12/16/2010 NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM CARDINAL HEALTH, INC. TATYANA BOGDAN
K093463 02/26/2010 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION SHARON NICHOLS
K102179 12/02/2010 ENVIEW (TM) CAREFUSION 2200 PATRICIA A AYERS
K094030 12/23/2010 FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K102739 12/08/2010 HYDROCOLOR 5 CASCADES DEVICE CONSULTING ASSOCIATES GERALD W SHIPPS
K090068 02/24/2010 STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K102382 12/03/2010 SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT CENDRES & METAUX SA TANJA BONGNI
K083876 02/26/2010 SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT CENDRES & METAUX SA PETER W FLEETWOOD
K093696 02/12/2010 SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 CENTRAL MEDICARE SDN BHD NICK WANG
K102989 12/09/2010 OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC BOB LEIKER
K093059 02/04/2010 SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K093565 12/03/2010 PLEURAFLOW CATHETER SYSTEM CLEAR CATHETER SYSTEMS MONICA DOUGHERTY
K102035 12/01/2010 SLEEK OTW PTA CATHETERS CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K100218 02/17/2010 BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM COLOPLAST A/S REBEKA STOLTMAN
K103568 12/22/2010 RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH COLOPLAST A/S JANELL A COLLEY
K093112 02/01/2010 DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE COLOPLAST MANUFACTURING US, LLC JANELL COLLEY
K100703 12/21/2010 STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS COMED CO., LTD BRANDON CHOI
K102734 12/14/2010 COMFORT STANDING WHEELCHAIR, HERO SERIES COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K102410 12/21/2010 MATRYX INTERFERENCE SCREW (5.0-6.5MM) CONMED LINVATEC ASHLEA BOWEN
K102399 12/02/2010 CONSENSUS TAPERSET HIP SYSTEM Consensus Orthopedics, Inc MATTHEW HULL
K102536 12/01/2010 VITALA CONTINENCE CONTROL DEVICE CONVATEC INC CHARLES RYAN
K101450 12/30/2010 CANTATA MICROCATHETER COOK, INC. MIRONDA CARPENTER
K093209 02/26/2010 FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE COOK, INC. SEAN WERNER
K091077 02/04/2010 OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER CORDIS CORP., A JOHNSON & JOHNSON CO. KAREN WILK
K101126 12/02/2010 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS CORE ESSENCE ORTHOPAEDICS, INC. JEFF MILLER
K082525 02/04/2010 CORIN METAFIX FEMORAL STEM CORIN USA ASHLEA BOWEN
K100267 02/24/2010 FLEXIMARC, MODEL CM-0.9-2-10-GG-L CORTEX MANUFACTURING, INC. ANDREW JONES
K093174 02/26/2010 SPIROPALM COSMED S.R.L. ROBERT SCHIFF
K102605 12/22/2010 MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA Daniel Campion
K100850 12/20/2010 COWELL IMPLANT SYSTEM COWELLMEDI CO., LTD JOYCE BANG
K102645 12/10/2010 WILLOW/ELM PTA BALLOON DILATATION CATHETER CREAGH MEDICAL LTD MAUREEN O'CONNELL
K102214 12/16/2010 ENDO FLIP CROSPON, LTD. PAUL DRYDEN
K103303 12/23/2010 CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE CROSSTEX INTERNATIONAL, INC. RICHARD M ORMSBEE
K091298 02/24/2010 LUBREASE FEMALE LUBRICANT CURVES LIMITED NILUFER SMITH
K102937 12/27/2010 OSTEOPHIL BETA-TCP CYTOPHIL INC VICTOR M BOWERS
K093848 12/20/2010 PT-MULTI-CALIBRATOR, MODEL OPAT07 DADE BEHRING, INC. RADAMES RIESGO
K102761 12/20/2010 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC. HARRY BALA
K103667 12/29/2010 SAPPHIRE ST PORTABLE DIODE LASER DEN-MAT HOLDINGS, LLC ALAN B MATTHEWS
K093748 02/24/2010 DD BIO Z AND DD BIO Z - TRANSPA DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) GERHARD DE BOER
K101996 12/15/2010 DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND) RHONDA MYER
K092836 02/04/2010 OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K101433 12/10/2010 DEPUY ATTUNE KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. KATHY BOGGS
K093474 02/02/2010 DEPUY FRACTURE AND FUSION PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K103408 12/16/2010 POSTERIOR LATERAL PLATES DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K101923 12/01/2010 CONCORDE CURVE SYSTEM DEPUY SPINE EUGENE BANG
K102249 12/16/2010 EXPEDIUM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY DAPHNEY GERMAIN
K100070 02/04/2010 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. CHRISTOPHER ROGERS
K101993 12/07/2010 VIPER SYSTEM, EXPEDIUM SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K101723 12/23/2010 COMPACT WHEELCHAIR PLATFORM DESIGN SPECIFIC FLETCHER RICHARD FLETCHER
K102765 12/07/2010 PRONEX DIREX SYSTEMS CORP. LARISA GERSHTEIN
K093208 02/12/2010 SIMPLISEAL DISCUS DENTAL, LLC CLARK D VONAHSEN
K102639 12/01/2010 SL3 DISCUS DENTAL, LLC CLARK D VONAHSEN
K093338 02/12/2010 SELF ADHESIVE COMPOSITE LUTING CEMENT DMG USA, INC. PAMELA PAPINEAU
K102252 12/03/2010 DMP PIT & FISSURE SEALANT DMP LTD DIMITRIS PRANTSIDIS
K102618 12/10/2010 VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K102408 12/27/2010 DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM CORPORATION CHARLIE MACK
K092574 02/04/2010 ESL SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K102830 12/02/2010 ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. YUE QIUHONG (TRACY)
K102854 12/03/2010 PC ECG EDAN INSTRUMENTS, INC. YUE QIUHONG (TRACY)
K102835 12/27/2010 VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. WILLIAM STERN
K100709 12/07/2010 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M EDWARDS LIFESCIENCES, LLC. PATRICIA MILBANK, JD
K100739 12/07/2010 VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 EDWARDS LIFESCIENCES, LLC. PATRICIA MILBANK
K092844 12/21/2010 GEOSOURCE ELECTRICAL GEODESICS, INC. PAUL HOLMAN
K103093 12/21/2010 LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB BO NILSSON
K103608 12/27/2010 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND ELLEX, INC. JONATHAN STRAWN
K103223 12/21/2010 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS ENCORE MEDICAL, L.P. ALBERT E ALONSO
K092144 02/22/2010 BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K093007 02/05/2010 ENTELLUS MEDICAL BALLOON DEVICE Entellus Medical, Inc. Sew-Wah Tay
K092894 02/24/2010 EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Y.C. LEI
K103235 12/23/2010 ERBEFLO 2 DISPOSABLE TUBING SYSTEM ERBE USA, INC. JOHN TARTAL
K093447 02/18/2010 CARRIGEN ETEX CORP. CHRISTOPHER KLACZYK
K100883 12/21/2010 CARRIGEN ETEX CORP. CHRISTOPHER KLACZYK
K102812 12/03/2010 GAMMA-BSM; BETA-BSM; EQUIVABONE ETEX CORPORATION CHRISTOPHER KLACZYK
K101520 12/10/2010 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH ETHICON ENDO-SURGERY, INC. RUTH WOOD
K092590 02/17/2010 PDS PLATES ETHICON, INC. LESLIE YOUNG
K093908 12/01/2010 CCPOINT EURO-DIAGNOSTICA AB ROBERT SCHIFF
K101413 12/16/2010 EUROMI EVA SP6 EUROMI SA CURTIS RAYMOND
K103322 12/06/2010 EVERCROSS 0.035 OTW PTA DILATION CATHETER EV3 INC DAVID WORRELL, MS, RAC
K100063 02/02/2010 HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL EV3 INC Laura Heaton
K102600 12/22/2010 SIMPLYGO BREAST PUMP EVENFLO COMPANY, INC. AMY NEFF
K103419 12/13/2010 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC. PATRICK HUGHES
K100126 12/03/2010 STELLATE GRIDVIEW EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K092192 02/12/2010 WAYPOINT STEREOTACTIC SYSTEM FHC, INC. LEE D MARGOLIN
K100837 12/03/2010 PACENTRIC CONNECT, TRAVELER AND WEB FIMREITE SOFTWARE AS SVEIN FIMREITE
K092175 02/17/2010 THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 FLOWCARDIA, INC. Dustin Michaels
K100205 12/13/2010 FRONTIER DEVICES NEURO SYSTEM FOLSOM METAL PRODUCTS, INC. DON PETERSON
K093026 02/24/2010 FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER FOOTPRINT MEDICAL CLYDE BAKER
K101715 12/21/2010 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE RANDOLPH QUINN
K091806 02/22/2010 POGO SCREW INSTRUMENTATION TRAY FXDEVICES RICH LIPSCHUTZ
K100451 12/21/2010 GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K102808 12/22/2010 MI VARNISH GC AMERICA INC. MARK HEISS
K093749 12/06/2010 GC AADVA IMPLANT SYSTEM GC AMERICA, INC. CARL JENKINS
K092369 02/24/2010 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOE LUCAS
K103432 12/17/2010 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC ROBERT CASARSA
K102952 12/03/2010 PRODESSE PROADENO GEN-PROBE PRODESSE, INC EMILY ZIELGER
K092970 02/02/2010 GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H GENERAL MEDITECH, INC. LEE FU
K103034 12/10/2010 GENESYS SPINE INTERBODY FUSION SYSTEM GENESYS SPINE JOSH KAUFMANN
K100090 02/02/2010 IMPLANTABLE CLIP GENICON GARY HABERLAND
K102242 12/21/2010 OSOM C. DIFFICILE TOXIN A/B TEST GENZYME CORPORATION CAROL C RYERSON
K092421 02/12/2010 ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC GIMMI GMBH KEN BLAKE
K102543 12/01/2010 BRAVO PH MONITORING SYSTEM AND ACCESSORIES GIVEN IMAGING LTD. Tim Thomas
K102392 12/22/2010 MICROFUSE PUTTY AND MICROFUSE ST MIS GLOBUS MEDICAL INC. KELLY J BAKER PH.D.
K093294 02/17/2010 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER, PH.D
K102313 12/03/2010 PATRIOT TRANSCONTINENTAL M SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
K093751 02/24/2010 CL-DC20, CL-DC21 GOOD DOCTORS CO., LTD. KEVIN WALLS, RAC
K101224 12/03/2010 SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS GRIFFITHS AND NIELSEN LTD EDWIN LINDSAY
K100516 12/03/2010 ANYPLUS PEEK CAGES GS MEDICAL CO., LTD. DONALD W GUTHNER
K093759 02/19/2010 MULTIPLE NAME MODEL MULTIPLE GX CORPORATION SDN BHD (PLANT 1) CHO SOW FONG
K093181 02/24/2010 GYRUS ACMI PK BUTTON ELECTRODE GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K101907 12/03/2010 HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. GREG CALDER
K103538 12/17/2010 HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 HARDY DIAGNOSTICS WENDY HADLEY
K100731 12/03/2010 BOSWORTH AIR POLISHER HARRY J. BOSWORTH CO. GARY CHUVEN
K103340 12/06/2010 SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM HARVEST TECHNOLOGIES, CORP. JOHN D BONASERA
K102305 12/03/2010 HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P HASS CORP. Priscilla Chung
K093824 02/16/2010 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT HEALTH & LIFE CO., LTD. SARAH SU
K102817 12/23/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. RICHARD LU
K102819 12/23/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. RICHARD LU
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