FDA 510(k) Decisions During December, 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
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
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
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
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
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
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
K102549 12/21/2010 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
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
K103367 12/08/2010 SEEKER CROSSING SUPPORT CATHETER BARD PERIPHERAL VASCULAR, INC. CANDACE WADE
K100790 12/21/2010 COULTER LIN-X LINEARITY CONTROL, MODEL A81196 BECKMAN COULTER, INC. LOURDES M COBA
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
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
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
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
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
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
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
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
K102382 12/03/2010 SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT CENDRES & METAUX SA TANJA BONGNI
K102989 12/09/2010 OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC BOB LEIKER
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
K103568 12/22/2010 RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH COLOPLAST A/S JANELL A 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
K101126 12/02/2010 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS CORE ESSENCE ORTHOPAEDICS, INC. JEFF MILLER
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
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
K101996 12/15/2010 DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND) RHONDA MYER
K101433 12/10/2010 DEPUY ATTUNE KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. KATHY BOGGS
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
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
K102639 12/01/2010 SL3 DISCUS DENTAL, LLC CLARK D VONAHSEN
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
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
K103235 12/23/2010 ERBEFLO 2 DISPOSABLE TUBING SYSTEM ERBE USA, INC. JOHN TARTAL
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
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
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
K100837 12/03/2010 PACENTRIC CONNECT, TRAVELER AND WEB FIMREITE SOFTWARE AS SVEIN FIMREITE
K100205 12/13/2010 FRONTIER DEVICES NEURO SYSTEM FOLSOM METAL PRODUCTS, INC. DON PETERSON
K101715 12/21/2010 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE RANDOLPH QUINN
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
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
K103034 12/10/2010 GENESYS SPINE INTERBODY FUSION SYSTEM GENESYS SPINE JOSH KAUFMANN
K102242 12/21/2010 OSOM C. DIFFICILE TOXIN A/B TEST GENZYME CORPORATION CAROL C RYERSON
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.
K102313 12/03/2010 PATRIOT TRANSCONTINENTAL M SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
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
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
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
K100103 12/15/2010 SPECIALTY ASSAYED CONTROL-2 HELENA LABORATORIES PATRICIA FRANKS
K102459 12/03/2010 NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE HEMOSTASIS, LLC BERNARD HORWATH
K102770 12/21/2010 FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K102977 12/20/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEZE JUXINYUAN FOOD CO., LTD CHU XIAOAN
K102976 12/13/2010 POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) HEZE JUXINYUAN FOOD CO., LTD CHU XIAOAN
K102783 12/22/2010 HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS HINSON AND HALE MEDICAL TECHNOLOGIES, INC JEFFREY O STULL
K102889 12/20/2010 HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGH THISTLETHWAITE
K102768 12/02/2010 SECRMARK BIOPSY SITE MARKING SYSTEM HOLOGIC, INC. ALYSSA M LOBO
K103344 12/10/2010 INFUSION SETS HOSPIRA, INC. REBECCA ANDERSEN
K102282 12/07/2010 THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE FITTS
K102992 12/22/2010 T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES HOWMEDICA OSTEONICS CORP. AVITAL MERL-MARGULIES
K100937 12/21/2010 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE i-SENS, Inc. HYUN OH
K100576 12/17/2010 HIGH PRESSURE SETS-400 PSI ICU MEDICAL, INC. TRACY BEST
K101319 12/09/2010 IMMULISA DSDNA ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K102281 12/22/2010 THERMAL MASSAGE BED, MODEL 2D-GX INAREX CORPORATION EILEEN YANG
K102867 12/03/2010 IROOT FS INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K103392 12/17/2010 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER INOVO, INC. MICHAEL T DILDINE
K101465 12/13/2010 STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR INSTITUT STRAUMANN AG JANET KAY
K102875 12/20/2010 CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C INTEGRA LIFESCIENCES CORPORATION DONNA MILLISKY
K102364 12/23/2010 NYDIAG 200 INTERACOUSTICS A/S ERIK NIELSEN
K102969 12/20/2010 IMC PISTON SYRINGES INTERNATIONAL MEDSURG CONNECTION PETER KIM
K102718 12/13/2010 DIGITAL THERMOMETER; DIGITAL THERMOMETER INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) JACOB CHANG
K101563 12/17/2010 SMARTO JEIL MEDICAL CORPORATION KIM SEONG NAM
K102956 12/15/2010 V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING KCI USA, INC. (KINETIC CONCEPTS, INC.) Shannon Scott
K093298 12/10/2010 PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 KEELER INSTRUMENTS, INC. EUGENE VAN ARSDALE
K103311 12/10/2010 U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS KIMBERLY CLARK CORPORATION CHERYL SANZARE
K103406 12/23/2010 MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS KIMBERLY-CLARK CORP. DAVID M LEE
K101609 12/09/2010 SELF RETAINING SOFT TISSUE RETRACTOR KOROS USA, INC. TIBOR KOROS
K102166 12/10/2010 ELECTRO INTERSTITIAL SCAN L.D. TECHNOLOGY, LLC RICHARD CLEMENT
K103356 12/08/2010 PRUITT CAROTID KIT LEMAITRE VASCULAR, INC. VIC ZHANG
K102007 12/22/2010 PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, LIFE-TECH, INC. JEFF KASOFF
K103357 12/27/2010 LIFEBRIDGE LIFEBRIDGE MEDIZINTECHNIK AG KATHLEEN JOHNSON
K103214 12/01/2010 M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 LIFELINE SYSTEMS, INC. CARLOS O ACOSTA
K100858 12/10/2010 LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, LIMA-LTO S.P.A. CHERYL HASTINGS
K102210 12/28/2010 LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS Lin-Zhi International, Inc. BERNICE LIN
K093715 12/22/2010 EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL DON CAMPBELL
K102659 12/08/2010 MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER MANUKA MEDICAL LIMITED James Smith
K101153 12/08/2010 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K102837 12/23/2010 HIROLLER ELEVATING WHEELCHAIR MAX MOBILITY, LLC WILLIAM M RICHTER
K103189 12/20/2010 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K102537 12/10/2010 APTUS 1.5 TRILOCK MEDARTIS AG KEVIN A THOMAS
K102966 12/21/2010 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC MEDCOMP JEAN CALLOW
K102595 12/27/2010 MEDISTIM VERIQC SYSTEM MEDI-STIM ASA CONSTANCE G BUNDY
K100372 12/14/2010 SAFECT MODEL VER 1.0 MEDIC VISION BRAIN TECHNOLOGIES LTD DAN LAOR
K100916 12/06/2010 MEDICON MOGEN CLAMP MEDICON, E.G. JOACHIM SCHMID
K102965 12/08/2010 CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K100646 12/16/2010 AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC. JEFFREY L KOLL
K103314 12/03/2010 CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL MEDTRONIC INC. JEFFREY L KOLL
K103313 12/01/2010 HEPARIN ASSAY CONTROLS MEDTRONIC INC. JEFFREY L KOLL
K103464 12/22/2010 PACIFIC XTREME PTCA BALLOON DILATATION CATHETER MEDTRONIC INC. HEATHER MOROSE
K103049 12/23/2010 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LILA JOE
K100779 12/13/2010 SUSTAIN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MICHELLE OBENAUER
K103147 12/16/2010 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM MEDYSSEY CO., LTD. PATRICK MOORE
K103272 12/29/2010 ZENIUS SPINAL SYSTEM MEDYSSEY CO., LTD. PATRICK MOORE
K102723 12/09/2010 MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS MEMTEC CORP. DENNIS GARBOSKI
K102688 12/03/2010 MERETE LOCKING BONE PLATE SYSTEM II MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K102777 12/20/2010 TWISTCUT ENDOSORB SCREWS MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K102818 12/03/2010 MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K100596 12/06/2010 CRYOPETTE MID-ATLANTIC DIAGNOSTICS, INC. ELISA D HARVEY
K102452 12/23/2010 DEFOGGING AND CLEANING SOLUTION- FLO-X MINIMALLY INVASIVE DEVICES LLC MARK L FRIEDMAN, PH.D
K101363 12/16/2010 VU CPOD INTERVERTEBRAL BODU FUSION DEVICE MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS Glenn Stiegman
K102663 12/30/2010 AED RESECTOSCOPE NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE BUTLER
K103342 12/23/2010 3.0T METAFLEXCOIL NEOCOIL, LLC BRIAN BROWN
K102641 12/20/2010 MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE NEOORTHO PRODUTOS ORTOPEDICOS S/A LINDA K SCHULZ
K100668 12/08/2010 NEMA-ST, MODEL V1.0.2 NERVOMATRIX LTD DAN LAOR
K102862 12/21/2010 NEUROVISION SE (NERVEANA) NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K101278 12/20/2010 INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC KAREN WARDEN
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