| 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 |
ARMADA 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 |
| K102819 |
12/23/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. |
RICHARD LU |
| K102817 |
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 |
| K102106 |
12/17/2010 |
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K102376 |
12/07/2010 |
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K102436 |
12/09/2010 |
NOBEL ACTIVE 3.0 |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K102350 |
12/22/2010 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI M MITCHELL |
| K102715 |
12/17/2010 |
REGIONAL OXIMETER |
NONIN MEDICAL, INC. |
LORI M MITCHELL |
| K102473 |
12/09/2010 |
MULLINS-X PTV CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K102514 |
12/01/2010 |
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM |
NUVASIVE, INC. |
ELISA KETCHUM |
| K102201 |
12/15/2010 |
CONTOURS LAPIDUS PLATING SYSTEM |
ORTHOFIX INC. |
MARY BIGGERS |
| K101428 |
12/01/2010 |
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET |
OVESCO ENDOSCOPY AG |
ARNE BRIEST |
| K102910 |
12/23/2010 |
MODEL LUNA MANUAL WHEELCHAIR |
P.D.G., INC. |
EDWARD A KROLL |
| K102061 |
12/13/2010 |
TREVAIR CHAIR ADULT |
PATMONT MOTOR WERKS, INC. |
STEVEN J PATMONT |
| K102709 |
12/17/2010 |
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
AN NGUYEN |
| K102029 |
12/16/2010 |
PEAK PULSAR II GENERATOR MODEL PS100-102 |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K100999 |
12/15/2010 |
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
PHADIA AB |
MARTIN MANN |
| K102972 |
12/22/2010 |
LIFEPAK 12 |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K101835 |
12/03/2010 |
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 |
POREX SURGICAL, INC. |
STEPHANIE FULLARD |
| K100854 |
12/09/2010 |
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 |
PREMIUM PLUS INTERNATIONAL LIMITED |
DENNIS NG |
| K100932 |
12/27/2010 |
INCLUSIVE MINI IMPLANT |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K100993 |
12/28/2010 |
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K102749 |
12/10/2010 |
QUANTA CYBER TM 150W |
Quanta System SpA |
ISABELLA CARRER |
| K102027 |
12/22/2010 |
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM |
QUANTEL MEDICAL S.A. |
MICHAEL JOHNSON |
| K090105 |
12/30/2010 |
LUPOTEK KCT |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K103097 |
12/29/2010 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
JAMES HUANG |
| K102187 |
12/10/2010 |
RII INFRARED EAR THERMOMETER, |
RADIANT INNOVATION, INC. |
JAMES HUANG |
| K100777 |
12/10/2010 |
ABL837 FLEX ANALYZER |
RADIOMETER MEDICAL APS |
ROWENA JANSSON |
| K102348 |
12/22/2010 |
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
| K101189 |
12/22/2010 |
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC |
REAVILLMED |
MICHELE H VOVOLKA |
| K102842 |
12/02/2010 |
ADHESIVE ELECTRODES |
RENO MEDICAL LIMITED |
Diana Hong |
| K101682 |
12/07/2010 |
S 100 PEDICLE SCREW SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
J.D. WEBB |
| K102746 |
12/28/2010 |
MIRAGE FX |
RESMED LTD. |
DAVID D'CRUZ |
| K102224 |
12/10/2010 |
PIXI PEDIATRIC MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K102054 |
12/22/2010 |
V200 VENTILATOR |
RESPIRONICS CALIFORNIA, INC. |
TAMATHA LEY |
| K102502 |
12/22/2010 |
GOLIFE NASAL MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K103221 |
12/23/2010 |
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 |
Roche Diagnostics |
KELLY C O'MAINE ADAMS |
| K103099 |
12/06/2010 |
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH |
Roche Diagnostics |
Susan Hollandbeck |
| K102572 |
12/27/2010 |
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT |
SAINATH INTELLECTUAL PROPERTIES, LLC |
CHRISTOPHER PARADIES, PH.D. |
| K102587 |
12/01/2010 |
LLX240AB01 |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K102984 |
12/08/2010 |
AURA |
SDI LIMITED |
RUTH EZEKIEL |
| K101267 |
12/03/2010 |
PREMIO 10 MOXA |
SEDATELEC |
Kevin Walls |
| K101690 |
12/03/2010 |
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE |
SENTEC AG |
STEPHEN H GORSKI |
| K100525 |
12/15/2010 |
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
SEPPIM S.A.S. |
Debra Hutson |
| K103583 |
12/27/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K103360 |
12/17/2010 |
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL |
SIEMENS CORP. |
ROSE T MARINELLI |
| K103179 |
12/20/2010 |
PRELUDE II TOUNGE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K102103 |
12/07/2010 |
SKELETAL DYNAMICS STERILIZATION TRAYS |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K102180 |
12/20/2010 |
RHEAD RADIAL HEAD EXTENDED STEMS |
SMALL BONE INNOVATIONS, INC. |
JAMES O'CONNOR |
| K102616 |
12/30/2010 |
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K102660 |
12/13/2010 |
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHLEEN SOLOMON |
| K101046 |
12/09/2010 |
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K102422 |
12/07/2010 |
SPACELABS MEDICAL PATIENT MONITORS |
SPACELABS MEDICAL INC. |
DAVID J GERAGHTY |
| K102488 |
12/10/2010 |
APEX SPINE SYSTEM W/ COCR RODS |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K101982 |
12/21/2010 |
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 |
ST JUDE MEDICAL, CRMD |
Gina Correa |
| K101782 |
12/22/2010 |
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE |
STAAR JAPAN |
JACK COGGAN |
| K103193 |
12/27/2010 |
DOSEVIEW 3D |
STANDARD IMAGING, INC. |
RAYMOND T RIDDLE |
| K102244 |
12/03/2010 |
RELIANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
ROBERT F SULLIVAN |
| K090324 |
12/20/2010 |
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY |
STI MEDICAL SYSTEMS |
ROLF WOLTERS |
| K101956 |
12/16/2010 |
STRAUMANN MEMBRAGEL |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
JANET C KAY |
| K103536 |
12/16/2010 |
IBED WIRELESS WITH IBED AWARENESS |
STRYKER CORPORATION |
Diane Horwitz |
| K101870 |
12/20/2010 |
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE |
SUNMAX VIETNAM CO. LTD |
JIGAR SHAH |
| K093491 |
12/09/2010 |
HIP SEXTANT INSTRUMENT SYSTEM |
SURGICAL PLANNING ASSOCIATES |
JOSEPH AZARY |
| K102143 |
12/08/2010 |
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
JOSEPH AZARY |
| K102095 |
12/07/2010 |
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
CURTIS RAYMOND |
| K102694 |
12/09/2010 |
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES |
SYNTHES (USA) |
CHRISTOPHER HACK, ESQ |
| K102656 |
12/20/2010 |
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM |
SYNTHES (USA) |
ALAN T HALEY |
| K093299 |
12/16/2010 |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
SYNTHES (USA) |
ALAN T HALEY |
| K093762 |
12/20/2010 |
SYNTHES ZERO-P |
SYNTHES SPINE |
AMNON TALMOR |
| K101012 |
12/15/2010 |
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 |
TaiDoc Technology Corporation |
TELING HSU |
| K093641 |
12/08/2010 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
LORI HOLDER |
| K101401 |
12/07/2010 |
NEUMOVENT GRAPHNET MODEL 3179L1V |
TECME S.A. |
RAYMOND KELLY |
| K100261 |
12/10/2010 |
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K102658 |
12/10/2010 |
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS |
THAYER MEDICAL CORP. |
JAMES M STRICKLAND |
| K102323 |
12/16/2010 |
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K103247 |
12/10/2010 |
VASCUCOMP |
THERMOTEK, INC. |
NIRAN BALACHANDRAN |
| K102599 |
12/01/2010 |
TOMOPHASE OCTIS |
TOMOPHASE CORPORATION |
DEREK BEAUPRE |
| K100445 |
12/03/2010 |
KLASSIC HD HIP SYSTEM |
TOTAL JOINT ORTHOPEDICS, INC. |
KIT CARIQUITAN |
| K101861 |
12/22/2010 |
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM |
TRUEVISION SYSTEMS, INCORPORATED |
BURTON TRIPATHI |
| K102367 |
12/08/2010 |
OPTIGEN TOTAL KNEE SYSTEM |
U&I CORP. |
GYEONG-JE KWON |
| K101522 |
12/23/2010 |
ULTRA SEAL STERILE LUBRICATING JELLY |
ULTRA SEAL CORPORATION |
JAMES DAVIS |
| K102997 |
12/21/2010 |
SONIXTABLET ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K100780 |
12/14/2010 |
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA |
UNILENE S.A.C. |
KEVIN WALLS, RAC |
| K102134 |
12/23/2010 |
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
DAVID O CHANG |
| K103239 |
12/30/2010 |
IRRIGATION SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103437 |
12/23/2010 |
US ENDOSCOPY CYTOLOGY BRUSH |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K102931 |
12/30/2010 |
G-CINCH SUTURE GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
| K100504 |
12/01/2010 |
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 |
VALERITAS, LLC |
SCOTT HUIE |
| K101294 |
12/27/2010 |
PT2 VARIAN PROTON THERAPY SYSTEM |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K103405 |
12/22/2010 |
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K101659 |
12/16/2010 |
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K103283 |
12/03/2010 |
PHYSIOFLOW ENDURO |
VASOCOM, INC. |
JAMES GUNNERSON |
| K102404 |
12/02/2010 |
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) |
VENTUS MEDICAL, INC. |
MICHAEL NEVARES |
| K103502 |
12/21/2010 |
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 |
VERIDEX, LLC |
SARAH MCMANUS |
| K102654 |
12/03/2010 |
VERTEX RAPID SIMPLIFIED |
VERTEX-DENTAL B.V. |
WILLIAM GREENROSE |
| K102341 |
12/16/2010 |
VIPI BLOCK |
VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE |
Kevin Walls |
| K100060 |
12/15/2010 |
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K101003 |
12/10/2010 |
RAPIDVIT BLAST, RAPIDWARM BLAST |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K102419 |
12/16/2010 |
GSP NEONATAL IRT KIT (3306-001U) |
WALLAC OY, SUBSIDIARY OF PERKINELMER |
SUSAN K HAMANN |
| K102111 |
12/07/2010 |
MEDICAL MAGNETIC TAPE RECORDER |
WPR MEDICAL AS |
CONSTANCE G BUNDY |
| K102565 |
12/22/2010 |
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K102352 |
12/02/2010 |
EVOLVE EPS ORTHOLOC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K103374 |
12/14/2010 |
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
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12/16/2010 |
STIMPOD NMS450 NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY), LTD. |
B ROTHMAN |
| K103198 |
12/20/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
YOUNGSHENGPLASTIC CO., LTD |
WU WEI |
| K100040 |
12/03/2010 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
CODE CUBITT |
| K102593 |
12/20/2010 |
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K102724 |
12/20/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUQUN NEW MATERIAL SCIENCE AND TECHNOLOGY CO |
FRANK LIU |
| K102896 |
12/13/2010 |
TRABECULAR METAL TIBIAL CONE AUGMENTS |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
| K101730 |
12/03/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS |
ZIMMER, INC. |
BRADLEY STRASSER |
| K101229 |
12/03/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER |
ZIMMER, INC. |
REBECCA BROOKS |
| K102907 |
12/14/2010 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
