| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K103122 |
10/21/2010 |
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 |
| K103023 |
10/12/2010 |
UNIT, PHACOFRAGMENTATION |
ABBOTT MEDICAL OPTICS INC |
Evelyn De La Vega |
| K103195 |
10/29/2010 |
I-STAT 1 WIRELESS ANALYZER |
ABBOTT POINT OF CARE INC. |
LARRY W KRASLEY |
| K103101 |
10/20/2010 |
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE |
ABBOTT VASCULAR-CARDIAC THERAPIES |
KAY SETZER |
| K103110 |
10/08/2010 |
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER |
ABBOTT VASCULAR-CARDIAC THERAPIES |
SUZANNE REDMAN |
| K103153 |
10/14/2010 |
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER |
ABBOTT VASCULAR-CARDIAC THERAPIES |
SUZANNE REDMAN |
| K103165 |
10/27/2010 |
BLOOD SAMPLING SET |
ACACIA, INC. |
FERGIE FERGUSON |
| K102981 |
10/07/2010 |
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM |
ACE SURGICAL SUPPLY COMPANY INC. |
CAROL A HOUTS |
| K102938 |
10/04/2010 |
ACQPOINT THERMAJADE MASSAGE TABLE |
ACQPOINT, INC. |
MORRIS SHEPPARD |
| K102998 |
10/08/2010 |
CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
| K103043 |
10/14/2010 |
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH |
ADAPTA MEDICAL, INC |
NEIL BURRIS |
| K103003 |
10/12/2010 |
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K103112 |
10/21/2010 |
AFFYMETRIX GENE PROFILING REAGENTS |
Affymetrix, Inc. |
MAUREEN MENDE |
| K103050 |
10/15/2010 |
DX-D 300 |
AGFA HEALTHCARE N.V. |
PHIL CUSCUNA |
| K103058 |
10/14/2010 |
MULTIFUNCTION KEITO |
AGUIFLAI IBERICA S.L. |
XAVIER CASALS |
| K103036 |
10/13/2010 |
ALLOFUSE PLUS |
ALLOSOURCE, INC. |
PAMELA VETTER |
| K102906 |
10/01/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102930 |
10/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102939 |
10/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K103157 |
10/26/2010 |
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE |
ANGSTROM MFG., INC. |
CHRIS CARRON |
| K103158 |
10/26/2010 |
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER |
ANGSTROM MFG., INC. |
CHRIS CARRON |
| K103174 |
10/27/2010 |
APEX MEDICAL WIZARD SERIES CPAP MASK |
APEX MEDICAL CORP. |
ALAN CHANG |
| K103155 |
10/26/2010 |
SUMO ACCESS AND TISSUE RESECTION SYSTEM |
APOLLO ENDOSURGERY, INC. |
GREG MATHISON |
| K103143 |
10/25/2010 |
ARSTASIS ONE LATCHWIRE ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K103060 |
10/18/2010 |
ARTHREX TIBIAL GRAFTBOLT |
ARTHREX, INC. |
COURTNEY SMITH |
| K103057 |
10/15/2010 |
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K103020 |
10/12/2010 |
ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY BROWN |
| K103042 |
10/14/2010 |
ATMOS E 201 THORAX AND ATMOS S 201 THORAX |
ATMOS INC. |
MARCO SCHLEGEL |
| K103028 |
10/13/2010 |
EEVATM PETRI DISH |
AUXOGYN, INC. |
ROBERT NEWMAN |
| K102936 |
10/04/2010 |
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K102948 |
10/05/2010 |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K102921 |
10/01/2010 |
ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES |
BEMA-GMBH & CO. KG |
ANGELIKA SCHERP |
| K103044 |
10/14/2010 |
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K103116 |
10/21/2010 |
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K103031 |
10/12/2010 |
BMR FACE |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K103087 |
10/19/2010 |
COVAMAX RESORBABLE COLLAGEN MEMBRANE |
BIOM'UP SAS |
VALERIE CENTIS |
| K103081 |
10/19/2010 |
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE |
BIOM'UP SAS |
VALERIE CENTIS |
| K103061 |
10/18/2010 |
BIOMATE STERILE ACUPUNCTURE NEEDLE |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
MICHAEL LEE |
| K103145 |
10/25/2010 |
HAMMERLOC TM TIBIAL FIXATION DEVICE |
BIOMET SPORTS MEDICINE |
ROBERT FRIDDLE |
| K103008 |
10/12/2010 |
INZONE DETACHMENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
| K102912 |
10/01/2010 |
INTERLOCK FIBERED IDC OCCLUSION SYSTEM |
BOSTONSCIENTIFIC |
DEBBIE MCINTIRE |
| K102990 |
10/08/2010 |
BRAINLAB KNEE |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K103109 |
10/21/2010 |
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE |
C.R. BARD INC |
DENNIS SALZMANN |
| K103128 |
10/25/2010 |
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, |
CADWELL LAB, INC. |
CHRIS L BOLKAN |
| K103160 |
10/26/2010 |
NUPRO MODEL 13016901 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K103159 |
10/26/2010 |
CARDIO MED MODEL A102, H104, O101, P103, AND Z100 |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K103106 |
10/20/2010 |
CHLORASHIELD TM ANTIMICROBIAL DRESSING |
CARE FUSION 213 LLC |
ARLEN JOHNSON |
| K103064 |
10/18/2010 |
AVAMAX VERTEBRAL BALLOON |
CAREFUSION |
JOY GREIDANUS |
| K103140 |
10/25/2010 |
NICOLET WIRELESS EEG |
CAREFUSION 209, INC. |
ROBERT BURDGE |
| K103090 |
10/19/2010 |
SPECTRA OPTIA R APHERESIS SYSTEM |
CARIDIANBCT, INC. |
PATTI ARNDT |
| K103056 |
10/15/2010 |
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K103047 |
10/15/2010 |
CERETENE SOLUBLE IMPLANT MATERIAL |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K102989 |
10/06/2010 |
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS |
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC |
BOB LEIKER |
| K103196 |
10/29/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
CHANGDA PLASTIC PRODUCT CO., LTD |
WANG LIN |
| K103166 |
10/27/2010 |
CHEETAH RELIANT |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K103172 |
10/28/2010 |
CIV-OB (PLUS) |
CIVNET COMMUNICATION LTD |
NATHAN BEN-NATHAN |
| K103038 |
10/14/2010 |
DUET DRF |
CMT MEDICAL TECHNOLOGIES, LTD. |
SHLOMI DINES |
| K102961 |
10/05/2010 |
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM |
Codman & Shurtleff, Inc. |
JOCELYN RAPOSO |
| K102940 |
10/04/2010 |
VASCOPRESS SEQUENTIAL DVT PUMP |
COMPRESSION THERAPY CONCEPTS |
LEONARD NASS |
| K103117 |
10/21/2010 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K102927 |
10/04/2010 |
CONSENSUS KNEE SYSTEM |
Consensus Orthopedics, Inc |
MATTHEW HULL |
| K102973 |
10/06/2010 |
SILVER DENTAL ARREST |
COOLEY CONSULTING, INC. |
WILLIAM COOLEY |
| K102943 |
10/04/2010 |
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K102942 |
10/04/2010 |
CORELEADER ALGIPLASTER MODEL AP 050501 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K102946 |
10/04/2010 |
CORELEADER COLLA-PAD MODEL CS 03030 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K102944 |
10/04/2010 |
CORELEADER HEMO-PAD MODEL CPII 02030 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K103120 |
10/22/2010 |
CORIN BIOLOX DELTA FEMORAL HEADS |
CORIN USA |
LUCINDA GERBER |
| K103052 |
10/14/2010 |
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE |
Covidien LLC |
JENNIFER BRENNAN |
| K102913 |
10/01/2010 |
FORCETRIAD |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
BEN CORDILEONE |
| K102954 |
10/05/2010 |
CUTERA QSWITCH LASER SYSTEM |
CUTERA, INC. |
Connie Hoy |
| K102957 |
10/05/2010 |
CUTTING EDGE SPINE INTERBODY FUSION DEVICE |
CUTTING EDGE SPINE, LLC |
JOHN KAPITAN |
| K102937 |
10/04/2010 |
OSTEOPHIL BETA-TCP |
CYTOPHIL INC |
VICTOR M BOWERS |
| K103001 |
10/06/2010 |
ROCKWOOD CLAVICLE PINS |
DEPUY ORTHOPAEDICS, INC. |
SUZANNA OTANO |
| K103100 |
10/20/2010 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
EUGENE BANG |
| K103133 |
10/25/2010 |
VEPER SYSTEM, EXPEDIUM SYSTEM |
DEPUY SPINE, INC. |
EUGENE BANG |
| K102959 |
10/05/2010 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
LIANN VOO |
| K103146 |
10/25/2010 |
ISOGRAY TREATMENT PLANNING SYSTEM |
DOSISOFT SA |
ROBERT J MORTON |
| K103035 |
10/13/2010 |
SMARTPILOT VIEW MODEL MK04500 |
DRAEGER MEDICAL GMBH |
JOYCE KILROY |
| K102968 |
10/06/2010 |
INFINITY CNAP SMARTPOD |
Draeger Medical Systems, Inc. |
JOYCE KILROY |
| K103176 |
10/28/2010 |
FREQUENCER |
DYMEDSO INC. |
Jean Bigoney |
| K103076 |
10/18/2010 |
DYNAFLEX |
DYNAFLEX |
STUART R GOLDMAN |
| K103086 |
10/19/2010 |
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
DYNAREX CORPORATION |
DANIEL CONSAGA |
| K103094 |
10/19/2010 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
MARGUERITE THOMLINSON |
| K103093 |
10/19/2010 |
LEKSELL GAMMAPLAN |
ELEKTA INSTRUMENT AB |
BO NILSSON |
| K103068 |
10/18/2010 |
KING COBRA ANTERIOR CERVICAL PLATE |
EMINENT SPINE |
KAREN E WARDEN |
| K103152 |
10/26/2010 |
6250 ULTRASOUND SYTEMS |
ESAOTE, S.P.A. |
Allison Scott |
| K102917 |
10/01/2010 |
FIXTEMP C&B |
EXACTA DENTAL DIRECT, INC |
RICHARD KEEN |
| K103012 |
10/12/2010 |
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS |
EXACTECH, INC. |
LINDY KNISELY |
| K102951 |
10/05/2010 |
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K102975 |
10/06/2010 |
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K103067 |
10/18/2010 |
EXSALT SD7 WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
ROD PRECHT |
| K103134 |
10/25/2010 |
FUKUDA DENSHI |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K103073 |
10/18/2010 |
SUPER CHAIR FOR KIDS BY ORION |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K103070 |
10/18/2010 |
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + |
G SURGICAL CO., LTD. |
DONALD GRAFTON |
| K103129 |
10/22/2010 |
ENTROPY EASYFIT SENSOR |
GE HEALTHCARE |
JOEL KENT |
| K102933 |
10/04/2010 |
GEM-TONE BODY TRAINING SYSTEM |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S LAI |
| K102926 |
10/04/2010 |
GEMORE MUSCLE CONDITIONER; |
GEMORE TECHNOLOGY CO., LTD. |
BODEN LAI |
| K102911 |
10/01/2010 |
APTIMA TRICHOMONAS VAGINALIS ASSAY |
GEN-PROBE INCORPORATED |
MARIA CARMELITA S BALUYOT |
| K102952 |
10/05/2010 |
PRODESSE PROADENO |
GEN-PROBE PRODESSE, INC |
EMILY ZIELGER |
| K103034 |
10/13/2010 |
GENESYS SPINE INTERBODY FUSION SYSTEM |
GENESYS SPINE |
JOSH KAUFMANN |
| K103182 |
10/28/2010 |
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K103181 |
10/28/2010 |
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K103088 |
10/19/2010 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT |
GIVEN IMAGING LTD. |
Tim Thomas |
| K103025 |
10/12/2010 |
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES |
GIVEN IMAGING LTD. |
Tim Thomas |
| K103072 |
10/18/2010 |
REVERE SACRAL PLATES |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K103041 |
10/14/2010 |
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
| K102964 |
10/05/2010 |
EU-TTG IGA AND EU-TTG IGG |
GRIFOLS USA, INC. |
CATHERINE L WONG |
| K102970 |
10/06/2010 |
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
| K102922 |
10/01/2010 |
HARDYCHROM MRSA |
HARDY DIAGNOSTICS |
RENE CLASEN |
| K102977 |
10/06/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HEZE JUXINYUAN FOOD CO., LTD |
CHU XIAOAN |
| K102976 |
10/06/2010 |
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) |
HEZE JUXINYUAN FOOD CO., LTD |
CHU XIAOAN |
| K103184 |
10/29/2010 |
SILK'N FLASH N GO |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K103046 |
10/14/2010 |
HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE |
HOSMAN INTERNATIONAL CO., LTD |
JEN KE-MIN |
| K103104 |
10/20/2010 |
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K103010 |
10/12/2010 |
STRYKER PATIENT SPECIFIC POLYMER IMPLANT |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
STEPHANIE FITTS |
| K102992 |
10/08/2010 |
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K103118 |
10/21/2010 |
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR |
HOYA PHOTONICS, INC. |
DONNA TEMPLEMAN |
| K103175 |
10/28/2010 |
FILMARRAY RESPIRATORY PANEL (RP) |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K103192 |
10/29/2010 |
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES |
ILUMARK GMBH |
ANDRE WEINGERL |
| DEN100020 |
10/20/2010 |
DENV DETECT IGM CAPTURE ELISA |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
| K103037 |
10/14/2010 |
IND URINARY TRACT INFECTION (UTI) TEST STRIPS |
IND DIAGNOSTIC, INC. |
KAI LOU |
| K103130 |
10/22/2010 |
XELIS 3D |
INFINITT CO., LTD. |
CARL ALLETTO |
| K103021 |
10/12/2010 |
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K102875 |
10/01/2010 |
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C |
INTEGRA LIFESCIENCES CORPORATION |
DONNA MILLISKY |
| K102969 |
10/06/2010 |
IMC PISTON SYRINGES |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K103194 |
10/29/2010 |
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM |
INTRA-LOCK INTERNATIONAL, INC. |
ANGELA BLACKWELL |
| K103149 |
10/25/2010 |
1.5T 16-CHANNEL HAND-WRIST COIL |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K103054 |
10/15/2010 |
PERIOPATCH |
IZUN PHARMACEUTICALS CORPORATION |
IRVING WIESEN |
| K103084 |
10/19/2010 |
NEODENT GRAFT SCREW |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
DAVID J COLLETTE |
| K102947 |
10/04/2010 |
NON-CONTACT INFRARED THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K103169 |
10/27/2010 |
ALEUTTIAN |
K2M, INC. |
NANCY GIEZEN |
| K103027 |
10/13/2010 |
ELECTROTORQUE TLC |
KALTENBACH & VOIGT GMBH |
CLAUDIA ORTIZ |
| K102999 |
10/08/2010 |
TRIMOTION INJECTOR |
KANEKA CORP. |
TAMIJI FUJIMOTO |
| K102994 |
10/08/2010 |
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K102956 |
10/04/2010 |
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 |
| K103156 |
10/26/2010 |
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K103150 |
10/26/2010 |
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK |
KIMBERLY-CLARK |
ANN WATERHOUSE |
| K102935 |
10/04/2010 |
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A |
KINGTECH ENTERPRISE, LTD. |
JEN KE-MIN |
| K103019 |
10/12/2010 |
KJ MASK |
KJ MEDITECH CO., LTD |
Priscilla Chung |
| K103085 |
10/19/2010 |
VENUS BASIC SPINAL FIXATION SYSTEM |
L&K BIOMED CO., LTD |
HEE KYEONG JOO |
| K103026 |
10/12/2010 |
ELECTRO SENSOR -BODY COMPOSITION |
L.D. TECHNOLOGY, LLC |
RICHARD CLEMENT |
| K103091 |
10/19/2010 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K103040 |
10/13/2010 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, LLC |
DAMON BELLONI |
| K103080 |
10/19/2010 |
ALBOGRAFT VASCULAR PROSTHESIS |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K103186 |
10/29/2010 |
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K102919 |
10/01/2010 |
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K103191 |
10/28/2010 |
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K103136 |
10/25/2010 |
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K103170 |
10/27/2010 |
GMK REVISION KNEE SC LINERS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K103189 |
10/28/2010 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K102966 |
10/05/2010 |
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC |
MEDCOMP |
JEAN CALLOW |
| K103017 |
10/12/2010 |
MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE |
MEDERI THERAPEUTICS INC. |
CURT RAYMOND |
| K102996 |
10/07/2010 |
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR |
MEDIVATORS REPROCESSING SYSTEMS |
LYNN LUEDERS |
| K102965 |
10/05/2010 |
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K102953 |
10/04/2010 |
HEPARIN DOSE RESPONSE CARTRIDGE |
MEDTRONIC INC. |
JEFFERY L KOLL |
| K103095 |
10/08/2010 |
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON |
MEDTRONIC IRELAND |
GERARDINE FINN |
| K103049 |
10/15/2010 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LILA JOE |
| K103147 |
10/25/2010 |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K103077 |
10/18/2010 |
ECG PEN |
MERIDIAN DYNAMICS BIOMEDICAL, INC |
JENNIFER REICH |
| K103123 |
10/21/2010 |
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) |
MICRO-MEGA SOCIETE ANONYME |
CONCHE PHILIPPE |
| K102971 |
10/06/2010 |
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK |
MICROTEK MEDICAL, INC. |
THOMAS B BONNER, JR. |
| K103141 |
10/25/2010 |
LOW ADHERENT AFM AG DRESSINGS |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
RONALD S WARREN, RAC |
| K103014 |
10/13/2010 |
MIRADRY SYSTEM |
MIRAMAR LABS, INC. |
Kathy O'Shaughnessy |
| K103089 |
10/19/2010 |
SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS |
MIS - IMPLANT TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K102923 |
10/01/2010 |
BARRIER N95 PARTICULATE RESPIRATOR |
MOLNLYCKE HEALTHCARE |
CAITLIN SENTER |
| K103059 |
10/15/2010 |
TROPHON |
NANOSONICS LIMITED |
RON WEINBERGER |
| K103126 |
10/22/2010 |
TROPHON CHEMICAL INDICATOR |
NANOSONICS LIMITED |
RON WEINBERGER |
| K103022 |
10/12/2010 |
KIM |
NEOMEDIC INTERNATIONAL S.L. |
JEFFREY R SHIDEMAN |
| K102925 |
10/04/2010 |
NEXGEN EXPANDABLE CATHETER |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K102979 |
10/06/2010 |
NEXGEN PERIPHERAL GUIDE CATHETER |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K102945 |
10/04/2010 |
PEDIACYN ATOPIC DERMATITIS HYDROGEL |
OCULUS INNOVATIVE SCIENCES, INC. |
ANTOINETTE DOUGLAS |
| K103132 |
10/25/2010 |
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI |
OCULUS PRIVATE LIMITED |
Kevin Walls |
| DEN100025 |
10/13/2010 |
WIDEXLINK IN CLEAR SERIES HEARING AIDS |
OFFICE RESEARCH IN CLINICAL AMPLIFICTION |
FRANCIS KUK |
| K103032 |
10/12/2010 |
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ |
OLYMPUS WINTER & IBE GMBH |
STACY ABBATIELLO KLUESNER |
| K103161 |
10/27/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES |
OMEGA LABORATORIES, INC. |
ROBERT J BARD, JD |
| K103111 |
10/21/2010 |
FORZA SPACER SYSTEM |
ORTHOFIX INC. |
DARLA CHEW |
| K103015 |
10/12/2010 |
ODRC-DYNAMIC HIP SCREW SYSTEM |
ORTHOPAEDIC DEVICE RESEARCH CENTER |
CHENG-KUNG CHENG |
| K103173 |
10/28/2010 |
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
DEBORAH L JACKSON |
| K103114 |
10/21/2010 |
OSSPRAY SYLC CR |
OSSPRAY LTD |
IAN THOMPSON |
| K103105 |
10/20/2010 |
ORTHODONTIC SCREW |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K102910 |
10/01/2010 |
MODEL LUNA MANUAL WHEELCHAIR |
P.D.G., INC. |
EDWARD A KROLL |
| K103148 |
10/25/2010 |
AIDA DIAGNOSTIC ULTRASOUND SYSTEM |
PANASONIC HEALTHCARE CO., LTD. |
RAM BEDI |
| K103103 |
10/20/2010 |
PRESSON ELECTRODE |
PERSYST DEVELOPMENT CORP. |
SCOTT B WILSON |
| K103039 |
10/14/2010 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
PHADIA US INC. |
MARTIN MANN |
| K102974 |
10/06/2010 |
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 |
PHILIPS MEDICAL SYSTEMS |
GARY BECKER |
| K102958 |
10/04/2010 |
PHILIPS AVALON FETAL MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MICHAEL ASMALSKY |
| K103102 |
10/20/2010 |
LEUCADIA PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K102972 |
10/06/2010 |
LIFEPAK 12 |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K103115 |
10/21/2010 |
PRODIGY DIABETES MANAGEMENT SOFTWARE |
PRODIGY DIABETES CARE, LLC. |
E.J. Smith |
| K103185 |
10/28/2010 |
TOSHIBA 1.5T EXTRA LARGE KNEE COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K102908 |
10/01/2010 |
NOFACT IX |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K103097 |
10/20/2010 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
JAMES HUANG |
| K103004 |
10/08/2010 |
SNORE GUARD |
RANIR LLC |
GERARD J PRUD'HOMME |
| K103167 |
10/27/2010 |
STELLAR 150 |
RESMED GERMANY INC. |
SANDRA GRUNWALD |
| K102985 |
10/07/2010 |
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS |
RESPIRONICS CALIFORNIA, INC. |
TAMATHA LEY |
| K102914 |
10/01/2010 |
TQ HBA1C GEN3 |
ROCHE |
KATHIE J GOODWIN |
| K103171 |
10/27/2010 |
ELECSYS ANTI-TPO CALSET |
Roche Diagnostics |
Sarah Baumann |
| K103162 |
10/27/2010 |
ELECSYS PTH CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K103099 |
10/20/2010 |
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH |
Roche Diagnostics |
Susan Hollandbeck |
| K102984 |
10/07/2010 |
AURA |
SDI LIMITED |
RUTH EZEKIEL |
| K103009 |
10/12/2010 |
SENTICARE PILLSTATION |
SENTICARE, INC. |
SETH A MAILHOT |
| K102993 |
10/08/2010 |
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K103144 |
10/25/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
BOB LEIKER |
| K103119 |
10/22/2010 |
BILLY BOY MALE LATEX CONDOM |
SHEILA PICKERING PH.D. |
SHEILA W PICKERING |
| K102991 |
10/07/2010 |
M5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K102920 |
10/01/2010 |
ELECTRONIC BLOOD PRESSURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
Diana Hong |
| K102988 |
10/06/2010 |
ELECTRONIC BLOOD PRESURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
Diana Hong |
| K102904 |
10/01/2010 |
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K103127 |
10/22/2010 |
SOMATOM DEFINITION AS |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ALICIA BUSTOS-JUERGENSEN |
| K103179 |
10/28/2010 |
PRELUDE II TOUNGE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K103190 |
10/28/2010 |
PROFIL COMPOSITES (PROFIL, PROFIL FLOW) |
SILMET LTD. |
MOSHE ZALSMAN |
| K102982 |
10/07/2010 |
ENDOBUTTON DIRECT |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K102967 |
10/05/2010 |
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 |
SMITH & NEWPHEW, INC |
SHEREEN MYERS |
| K102909 |
10/01/2010 |
SOMNOBRUX SPLINTS |
SOMNOMED INC |
BRADLEY SOUTHWORTH |
| K103168 |
10/27/2010 |
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K102983 |
10/07/2010 |
VASCUCLEAR PRECISION BIPOLAR |
SORIN GROUP USA, INC. |
SCOTT LIGHT |
| K103142 |
10/25/2010 |
SPACELABS MULTI-PARAMETER MODULE |
SPACELABS HEALTHCARE, INC. |
THOMAS KROENKE |
| K102995 |
10/08/2010 |
TALON SPINAL SYSTEM |
SPINE360 |
DAVE LAMB |
| K103083 |
10/19/2010 |
AGILIS ES STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
| K103193 |
10/29/2010 |
DOSEVIEW 3D |
STANDARD IMAGING, INC. |
RAYMOND T RIDDLE |
| K103053 |
10/15/2010 |
VERIFY 270FP CHALLENGE PACK |
STERIS Corporation |
ROBERT SULLIVAN |
| K103000 |
10/08/2010 |
SMART READ BIOLOGICAL TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
SUZANNE DENNIS |
| K102949 |
10/05/2010 |
COLONOSCOPY ASSISTANT |
STI MEDICAL SYSTEMS, LLC |
ROLF WOLTERS |
| K103124 |
10/22/2010 |
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS |
STRYKER CORPORATION |
ESTELA CELI |
| K103002 |
10/08/2010 |
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K103007 |
10/12/2010 |
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K103183 |
10/28/2010 |
TRILLIANT SURGICAL SUBTALAR IMPLANT |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
| K103011 |
10/12/2010 |
ULTICARE SAFETY INSULIN SYRINGE |
ULTI-MED INTL., INC. |
MARY BETH HENDERSON |
| K102997 |
10/07/2010 |
SONIXTABLET ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K102916 |
10/01/2010 |
G-CATH TISSUE ANCHOR DELIVERY CATHETER |
USGI MEDICAL |
MARY L MOONEY |
| K102931 |
10/04/2010 |
G-CINCH SUTURE GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
| K102934 |
10/04/2010 |
INFRARED EAR THERMOMETER, MODEL IR-04MT |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K103113 |
10/21/2010 |
VASCULAIRE COMPRESSION SYSTEM |
VENOUS HEALTH SYSTEMS, INC. |
Albert Boniske |
| K103121 |
10/22/2010 |
ECO-S |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K103164 |
10/27/2010 |
VONFLEX HEAVY, VINFLEX LIGHT |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K103137 |
10/25/2010 |
VENUS ANTERIOR CERVICAL PLATE |
VERTICOR, LTD |
J.D. WEBB |
| K102915 |
10/01/2010 |
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM |
VIEWRAY INCORPORATED |
JANICE BROWNLEE |
| K103187 |
10/28/2010 |
TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM |
WILDCAT MEDICAL INC |
JOE ADKINS |
| K103198 |
10/29/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
YOUNGSHENGPLASTIC CO., LTD |
WU WEI |
| K103033 |
10/13/2010 |
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN M RUTHERFORD |
| K102907 |
10/01/2010 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
