FDA 510(k) Decisions During December, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K110457 12/07/2011 3M TEGADERM MATRIX DRESSING 3M COMPANY MARIA RUIZ
K112316 12/14/2011 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-WEB, INC. RICH JANSEN, PHARM. D.
K110381 12/22/2011 CELL-DYN EMERALD 22 SYSTEM ABBOTT LABORATORIES MICHELLE B ROEDING
K111446 12/21/2011 SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC ROSANNE M YETEMIAN
K112430 12/20/2011 I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE ABBOTT PONT OF CARE INC YUKO HARTLEY
K111617 12/22/2011 PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 ACARE TECHNOLOGY CO., LTD. Diana Hong
K112317 12/21/2011 FM-9000 PLUS FETAL AND MATERNAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K103573 12/28/2011 ARTS2 SPINAL FIXATION SYSTEM ADVANCED MEDICAL TECHNOLOGIES J. D WEBB
K103544 12/07/2011 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D AGAMATRIX INC WILLIAM H MCGRAIL
K111324 12/22/2011 CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER AGFA HEALTHCARE N.V. PHIL CUSCUNA
K111313 12/14/2011 EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE ALCAVIS HDC LLC GARY J MISHKIN
K111680 12/23/2011 DR. GREENSBURG'S HYBRID ALWAYS MORE MARKETING INC JONATHAN GREENBURG
K110793 12/16/2011 AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS AMECO MEDICAL INDUSTRIES Ray Kelly
K110794 12/21/2011 AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS AMECO MEDICAL INDUSTRIES Ray Kelly
K113501 12/05/2011 AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) AMEDITECH, INC. BRETT CASEY
K113011 12/06/2011 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICH JANSEN
K111830 12/09/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO ANDON HEALTH CO., LTD LIU YI
K111826 12/09/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K112752 12/16/2011 TINNITUS THERAPY SYSTEM ANM T30 CR ANM ADAPTIVE NEUROMODULATION GMBH INGRID ROHM
K113400 12/16/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K112675 12/12/2011 ARROW-LOK DIGITAL SYSTEM ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC THOMAS J TWARDZIK
K112990 12/19/2011 ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE ARTHREX, INC. CHRISTINA FLORES
K112040 12/15/2011 ARTHREX BIOCOMPOSITE TRANSFIX ARTHREX, INC. SALLY FOUST
K112437 12/21/2011 ARTHREX FRACTURE SYSTEM ARTHREX, INC. COURTNEY SMITH
K112979 12/01/2011 ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K110700 12/06/2011 ASCENSION ATLAS HUMERAL PLATING SYSTEM ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K112138 12/01/2011 ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT ASTRA TECH, INC. BETSY A BROWN
K112443 12/19/2011 ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K100919 12/16/2011 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 B-K MEDICAL APS RANDI HAUERBERG
K112515 12/22/2011 PENCAN SPINAL NEEDLE B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K113227 12/08/2011 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K110615 12/02/2011 WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE BEBE TOYS MANUFACTORY LTD. PAUL A WARE
K112933 12/27/2011 ACCESS THYROGLOBULIN ANITBODY BECKMAN COULTER, INC. GERALDINE L BAGLIEN
K112412 12/23/2011 AU5800(R) CHEMISTRY ANALYZER BECKMAN COULTER, INC. DAVID G DAVIS
K102921 12/20/2011 ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES BEMA-GMBH & CO. KG ANGELIKA SCHERP
K112799 12/23/2011 MED-RX EXTENSION SET WITH T-CONNECTOR BENLAN INC CHERYL BROWN
K112623 12/16/2011 AIRLIGHT DENTAL HANDPIECE BEYES DENTAL CANADA INC ANTHONY HOPKINS
K112869 12/16/2011 EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 BEYES DENTAL CANADA INC ANTHONY HOPKINS
K111831 12/19/2011 MX-7000 MICROXEL BIO-MED U.S.A., INC. YOUNG CHI
K112987 12/16/2011 TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARY HAYES
K110926 12/08/2011 BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC. Kevin Walls
K112567 12/23/2011 BIOMERIX ASSURE BIOMERIX CORPORATION CHRISTINA L KICHULA
K112499 12/23/2011 BIOMERIX COMPOSITE SURGICAL MESH BIOMERIX CORPORATION CHRISTINA L KICHULA
K113121 12/16/2011 COMPREHENSIVE REVERSE SHOULDER BIOMET MANUFACTURING, INC. PATRICIA S BERES
K111746 12/15/2011 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET, INC. PATRICIA SANDBORN BERES
K112352 12/23/2011 GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT BIONOSTICS, INC. RANDY BYRD
K113213 12/05/2011 LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 BIOSENSE WEBSTER, INC. JOHN JIMENEZ
K112857 12/13/2011 INTERFACE BONE VOID FILLER BIOSTRUCTURES, LLC KEVIN A THOMAS
K113493 12/21/2011 TCX-I REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. MICHEAL MATHUR
K110198 12/22/2011 BLUE SKY BIO TCP BLUE SKY BIO, LLC MICHELE VOVOLKA
K112543 12/29/2011 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM Boston Scientific Corporation THOMAS HIRTE
K102499 12/20/2011 DUOFERTILITY CAMBRIDGE TEMPERATURE CONCEPTS LTD. SCOTT R MACKIE
K113176 12/21/2011 MYSENSE HEART CARDIAC SCIENCE CORPORATION NEIL SHELLER
K111159 12/22/2011 HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. JONATHAN WARD
K112876 12/15/2011 CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K112743 12/16/2011 SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL CLEAN MEDICAL MANFACTURING CO;LTD AARON RICHARD
K113465 12/12/2011 ACCULIF TL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K112095 12/01/2011 ACCULIF TL-PEEK IBF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K112780 12/15/2011 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K113300 12/09/2011 ATB ADVANCE PTA DILATATION CATHETER COOK, INC. ELYSIA POOR
K112302 12/21/2011 PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES COOPER VISION, INC. LISA HAHN
K113245 12/02/2011 AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL COOPERVISION, INC. GWEN SHARP
K113267 12/02/2011 BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC COOPERVISION, INC. GWEN SHARP
K113468 12/20/2011 ELM PTA BALLON DILATATION CATHETER CREAGH MEDICAL LTD MAUREEN O'CONNELL
K111452 12/09/2011 PRESAGE ST2 ASSAY CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG JAMES SNIDER
K113543 12/16/2011 ONDEMAND3D CYBERMED, INC. YONG KI IM
K102494 12/09/2011 THE BUZZ FACIAL TONING SYSTEM DAKA INTERNATIONAL LTD. BOB WAGNER
K112722 12/16/2011 GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. JIM RASKOB
K111310 12/08/2011 BRUX MOUTHGUARDS DENTAL ARTE, INC. CAROLYN PRIMUS
K113534 12/20/2011 HEALIX KNOTLESS ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K112218 12/15/2011 ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K110701 12/02/2011 ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA GENOTEK INC CHANTAL HEMENS-DAVIS
K110881 12/16/2011 ULTRASONIC SURGICAL UNIT DONG IL TECHNOLOGY LTD. PETER CHUNG
K110364 12/07/2011 DORNIER MEDILAS D LITEBEAM+ 1470 DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K113040 12/28/2011 CERAMIR CROWN & BRIDGE DOXA DENTAL AB MARGARETH JORVID
K113182 12/07/2011 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K113226 12/17/2011 8MP COLOR LCD MONITOR,RADIFORCE RX840 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K112485 12/06/2011 H-WAVE ELECTRONIC WAVEFORM LAB, INC. RYAN P HEANEY
K112613 12/16/2011 INTEGRITY(TM) Elekta Limited ANDREW HEDGES
K113269 12/29/2011 ELITTECH CLINICAL SYSTEMS ALP IFCC SL ELITECHGROUP DEBRA K HUTSON
K112506 12/21/2011 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. KAREN E PETERSON
K103554 12/20/2011 METRON-CP/MD EPONATECH LLC K. BRIAN MATLOCK
K112901 12/23/2011 EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K112056 12/19/2011 ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K113004 12/20/2011 PDS(TM) BARBED SUTURES ETHICON, INC. PETER CECCHINI
K111751 12/02/2011 VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, INC. BRIAN A KANERVIKO
K112733 12/16/2011 ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. JACK KENT
K113309 12/08/2011 EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC. PATRICK HUGHES
K113564 12/15/2011 EXSALT T7 WOUND DRESSING EXCITON TECHNOLOGIES INC. MELANIE USSYK
K112832 12/05/2011 EYE CARE CURE CONTACT LENS CASE EYE CARE AND CURE LINDY V DALEN
K112522 12/30/2011 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K113591 12/22/2011 COLS PEEK FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K113427 12/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K112944 12/30/2011 FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. RAM KAMATH
K111646 12/08/2011 ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K113244 12/22/2011 SYNAPSE MPR FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOOK
K112521 12/21/2011 FUKUDA DENSHI VASERA MODEL VS-1500 FUKUDA DENSHI USA, INC. DOUG BLAKELY
K113350 12/05/2011 BRIVO NM 615 GE HEALTHCARE ELI WERNER
K113034 12/13/2011 GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM GE HEALTHCARE CAROL ALLOIAN
K113690 12/29/2011 GE LOGIQ I, LOGIQ E AND VIVID E GE HEALTHCARE BRYAN BEHN
K112572 12/28/2011 GEISTLICH COMBI-KIT COLLEGEN GEISTLICH PHARMA AG DANIEL A KRACOV
K112575 12/27/2011 GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO GEISTLICH PHARMA AG DANIEL A KRACOV
K110798 12/22/2011 SENOGRAPHE DS, SENOGRAPHE ESSENTIAL GENERAL ELECTRIC COMPANY STEVEN KACHELMEYER
K111132 12/09/2011 GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM GENESYS SPINE BRIAN J BERGERON
K110786 12/02/2011 ESENSOR WARFARIN SENSITIVITY SALIVA TEST GENMARK DIAGNOSTICS, INC JOHN RIOLO
K112126 12/01/2011 GENUINE FIRST AID CPR MASK GENUINE FIRST AID LLC Gary Lehnus
K113107 12/15/2011 MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K112028 12/09/2011 SI-LOK SACROILIAC JOINT FIXATION SYSTEM GLOBUS MEDICAL, INC. WENDY S HILLS
K111458 12/01/2011 GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. PENNY NORTHCUTT
K112501 12/14/2011 VENUS PEARL PLT REFILL A1 HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K111753 12/14/2011 HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA B AMMIRATI, RAC, MT (ASCP)
K110603 12/16/2011 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) I.E.M. GMBH PETER KNIPP
K102712 12/16/2011 MED GRAVITY SET, IMED PUMP SET IMED TECHNOLOGY, INC. BRANDON CONVERSE
K113143 12/02/2011 IMMULISA SCI-70 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K111995 12/12/2011 XINGTM SPINE SYSTEM IMPLANOVA CO. LTD APRIL LEE
K080377 12/13/2011 INFRASCANNER, MODEL 1000 INFRASCAN, INC. STEVEN B DATLOF
DEN100002 12/13/2011 INFRASCANNER, MODEL 1000 INFRASCAN, INC. STEVEN B DATLOF
K113317 12/28/2011 LIFECHOICE OXYGEN CONCENTRATOR INOVA LABS, INC. DAVID SHOCKLEY
K113111 12/08/2011 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION INOVO, INC. MICHAEL T DILDINE
K112610 12/05/2011 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) INPRO TECHNOLOGY DEVICE FACTORY MEIXIA WANG
K111669 12/15/2011 FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS INSULET CORPORATION SUSAN FINNERAN
K113399 12/20/2011 IFS SUBTALAR IMPLANT INTERNAL FIXATION SYSTEMS, INC. CHRIS ENDARA
K113541 12/16/2011 CLEARSTART SVM SYSTEM INTIO INC. DAVID GUSTAFSON
K111985 12/30/2011 MYOGUIDE SYSTEM MODEL 8008 INTRONIX TECHNOLOGIES CORP. RICHARD VINCINS, CQA, RAC (US,EU)
K110639 12/28/2011 ENDOWRIST ONE VESSEL SEALER INTUITIVE SURGICAL, INC. BRANDON HANSEN
K112208 12/08/2011 INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. BRANDON HANSEN
K111673 12/23/2011 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL INVIVO CORPORATION ELIZABETH WHEELER
K112806 12/01/2011 JENSEN ZIRCONIA JENSEN INDUSTRIES, INC. GARY PHELPS
K113348 12/13/2011 COUGAR SYSTEM JOHNSON & JOHNSON KEVIN G STEVENS
K112913 12/16/2011 SPOTLIGHT ACCESS SYSTEM JOHNSON & JOHNSON LAURA BLEYENDAAL
K112920 12/21/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K102999 12/29/2011 TRIMOTION INJECTOR KANEKA CORP. TAMIJI FUJIMOTO
K112289 12/16/2011 DISPOSABLE THERMOMETER COVERS AND SHEATHS KANG ZE INDUSTRIAL CO. LIMITED DORIS DONG
K113061 12/07/2011 LARGE/EXTRA LAGRE CONDOM KAREX INDUSTRIES SDN BHD. LAI PENG
K112480 12/13/2011 VIEW 1 IMAGING KARL STORZ ENDOSCOPY AMERICA, INC. WINKIE WONG
K112093 12/08/2011 CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER KEELER INSTRUMENTS, INC. EUGENE R VANARSDALE
K112562 12/15/2011 BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER KIMBERLY-CLARK DAVID LEE
K110717 12/23/2011 KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. JILLIAN M REED
K112041 12/22/2011 KOO SMALL VOLUME NEBULIZER (SVN) KOO(SHANGHAI)INDUSTRIES CO., LTD. PAUL DRYDEN
K112388 12/16/2011 LANX CERVICAL SA LANx, Inc MICHAEL FUNK
K113434 12/19/2011 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, INC. MICHAEL FUNK
K113559 12/29/2011 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS LDR SPINE USA INC. KIERSTEN SODERMAN
K113523 12/20/2011 LIMACORPORATE SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. CHERYL HASTINGS
K111149 12/30/2011 HANAROSTENT BILIARY (NNN) M.I. TECH CO., LTD. PAUL SUMNER
K111403 12/30/2011 MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION ANIL BHALANI
K112402 12/14/2011 ULTRAMAXO2 OXYGEN ANALYER MAXTEC, LLC TAMMY LAVERY
K110325 12/08/2011 AQUA LUBE MAYER LABORATORIES, INC. DAVID P MAYER
K113228 12/01/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K112862 12/19/2011 MECTA-C MEDACTA INTERNATIONAL ADAM GROSS
K112559 12/02/2011 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. KENT DICKS
K112560 12/15/2011 APTUS(R) DISTAL HUMERUS SYSTEM MEDARTIS AG KEVIN A THOMAS
K111363 12/06/2011 PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL MEDICA CORP. Photios Makris
K111651 12/08/2011 SPLIT CATH III MEDICAL COMPONENTS INC JEAN CALLOW
K113028 12/20/2011 MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS MEDISISS JOYCE ELKINS
K110184 12/16/2011 LIQUIBAND FLOW CONTROL MEDLOGIC GLOBAL LIMITED MICHAEL BROWNE
K112907 12/22/2011 CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G MEDOS INTERNATIONAL SARL ROBIN DINARDO
K113428 12/02/2011 ANGIOJET ULTRA DVX THROMBECTOMY SET MEDRAD, INC. MIKE BURNSIDE
K113133 12/15/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE MEDRAD, INC. MIKE BURNSIDE
K113235 12/02/2011 PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS MEDTRONIC INC. AMRA RACIC
K113528 12/20/2011 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K112479 12/07/2011 DSJ MASSAGER MEGO AFEK AC LTD JAMES R RAVITZ, ESQ.
K113303 12/09/2011 OSLEOBRIDGE IDSF SPACER CONECTOR MERETE MEDICAL GMBH EMMANUEL ANAPLIOIS
K112125 12/05/2011 ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT MERIDIAN BIOSCIENCE, INC. SUSAN D ROLIH
K112048 12/16/2011 IMMUNOCARD C. DIFFICILE GDH MERIDIAN BIOSCIENCE, INC. SUSAN BOGAR
K113337 12/30/2011 VISIA DYNAMIC REVIEW MEVIS MEDICAL SOLUTIONS AG THOMAS E TYNES
K112789 12/23/2011 EASY TOUCH MHC MEDICAL PRODUCTS, LLC DANIEL KAMM
K112845 12/05/2011 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K113457 12/16/2011 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K112181 12/01/2011 HYDROCOIL(R) EMBOLIC SYSTEM (HES) MICROVENTION, INC. VIN CUTARELLI
K112930 12/02/2011 MOBILE MIM MIM SOFTWARE INC. LYNN HANIGAN
K112203 12/14/2011 COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST MIRADOR BIOMEDICAL, INC. JUSTIN HULVERSHORN
K112782 12/01/2011 MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES MISONIX, INC. RONALD R MANNA
K112597 12/07/2011 SEITY 37% PHOSPHORIC ACID ETCHANT GEL MYCONE DENTAL SUPPLY CO., INC. WILLIAM EVANS
K112424 12/16/2011 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) NANOSPHERE, INC MARK DEL VECCHIO
K101257 12/01/2011 ADVANCED TRAUMA DRESSING (ATD) NANOSYS, INC. HUGH DANIELS
K112513 12/09/2011 EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD E.J. Smith
K111618 12/28/2011 AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION NATUS MEDICAL INCORPORATED CHARLES L MORIN
K103022 12/20/2011 KIM NEOMEDIC INTERNATIONAL S.L. JEFFREY R SHIDEMAN
K111146 12/01/2011 NEWPORT HT70 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K112637 12/09/2011 NETKONNECT REMOTE NETWORK EXTENSION NIHON KOHDEN STEVE GEERDES
K112770 12/16/2011 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER NINEPOINT MEDICAL, INC CINDY DOMECUS
K112428 12/16/2011 NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K112565 12/06/2011 NOVAPORT ONE VASCULAR ACCESS CANNULA NOVALUNG GMBH Leann Christman
K113102 12/12/2011 ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING NUCLETRON MICHEAL PAUL
K111811 12/05/2011 BENDINI(TM) SPINAL ROD BENDING SYSTEM NUVASIVE, INC. Elias Ketchum
K112546 12/27/2011 O_TWO CPAP SYSTEM O-TWO MEDICAL TECHNOLOGIES, INC. AMMAR AL-DOJAILY
K103161 12/13/2011 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES OMEGA LABORATORIES, INC. ROBERT J BARD, JD
K112779 12/02/2011 APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) OMNLIFE SCIENCE CHRISTINE NASSIF
K110068 12/08/2011 MODEL PM3030 OMRON HEALTHCARE, INC. PAUL DRYDEN
K113479 12/21/2011 OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION ALAN MARQUARDT
K112109 12/22/2011 THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE ORTHO KINEMATICS, INC. JOHN J SMITH
K110895 12/19/2011 ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K112658 12/12/2011 OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM OSTEOSPRING MEDICAL, INC J.D. WEBB
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K112672 12/13/2011 HEADLESS COMPRESSION SCREW SKELETAL DYNAMICS, LLC ANA M ESCAGEDO
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K112778 12/29/2011 SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS VY TRAN
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K113140 12/22/2011 VARI-LASE WIREFIBER LASER FIBER VASCULAR SOLUTIONS, INC. JENIFER RUETHER
K112783 12/22/2011 MANUJET III VBM MEDIZINTECHNIK GMBH ANKE BLOCHER
K113181 12/12/2011 CELLTRACKS ANALYER II VERIDEX, LLC PATRICIA HOJNOSKI
K092996 12/20/2011 VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 VIOGUARD CRAIG RANTA
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K111922 12/02/2011 VOCARE MYHEALTH TABLET VOCARE, INC STEVE PEABODY
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K112080 12/28/2011 PRESERVE HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. GREGORY NEAL
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K112592 12/05/2011 AXLE PEEK INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
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K112102 12/20/2011 MICHELE SLEEP SCORING SYSTEMS YOUNES SLEEP TECHNOLOGIES MAGDY YOUNES
K111248 12/01/2011 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) YTY INDUSTRY (MANJUNG) SDN. BHD. JANNA TUCKER
K112533 12/08/2011 ZAVATION CERVICAL PLATE SYSTEM ZAVATION LLC JOHN WALKER
K112664 12/23/2011 ZAVATION IBF SYSTEMS ZAVATION LLC JOHN WALKER
K102425 12/12/2011 ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K111853 12/08/2011 ANGLED TAPERED ABUTMENT ZIMMER DENTAL INC. MELISSA BURBAGE
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