FDA 510(k) Applications Received During October, 2010

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
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