| 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 |
| 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 |
| K102898 |
12/15/2011 |
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE |
Panpac Medical Corporation |
Yen-Ming Pan |
| K111055 |
12/21/2011 |
GALAXY SYSTEM; JUPITER |
PERSONAL HEALTH INSTITUTE INTERNATIONAL |
KUMAR KULKARNI |
| K103103 |
12/08/2011 |
PRESSON ELECTRODE |
PERSYST DEVELOPMENT CORP. |
SCOTT B WILSON |
| K111919 |
12/22/2011 |
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS |
PHADIA US INC. |
MARTIN MANN |
| K111168 |
12/13/2011 |
PRECISION SKIN EMULSION |
PRECISION DERMATOLOGY INCORPORATED |
RONALD M GURGE, PH.D |
| K110392 |
12/14/2011 |
PSM LOMAS / BENEFIT SCREWS |
PSM MEDICAL SOLUTIONS |
ANDREA PECSI |
| K112946 |
12/09/2011 |
ACTIV VARNISH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K112490 |
12/15/2011 |
QUIDEL MOLECULAR HMPV ASSAY |
QUIDEL CORP. |
Ronald H Lollar |
| K112172 |
12/22/2011 |
QUIDEL MOLECULAR INFLUENZA A + B ASSAY |
QUIDEL CORP. |
RONALD LOLLAR |
| K102908 |
12/19/2011 |
NOFACT IX |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K102851 |
12/19/2011 |
NOFACT VIII |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K111637 |
12/06/2011 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
LYNN CHEN |
| K112337 |
12/01/2011 |
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K113630 |
12/29/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA |
RAYENCE CO., LTD |
DAVE KIM |
| K113105 |
12/15/2011 |
TEMPUSIC PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K113084 |
12/09/2011 |
RENOVIS CANNULATED SCREW SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
DAVID F ROTHKOPF |
| K112489 |
12/07/2011 |
SWIFT FX BELLA |
RESMED LTD. |
KIM K LEE |
| K112914 |
12/29/2011 |
VPAP TX |
RESMED LTD. |
DAVID D'CRUZ |
| K113201 |
12/01/2011 |
NARVAL CC |
RESMED SAS |
DAVID D'CRUZ |
| K113068 |
12/16/2011 |
REMSTAR AUTO A-FLEX HT |
RESPIRONICS, INC. |
FRANK KADI |
| K111776 |
12/28/2011 |
DELTAVIEW MODEL 2.1 |
RIVERAIN MEDICAL GROUP,LLC |
JENNIFER V BUTSCH |
| K110726 |
12/23/2011 |
ROCHE ACETAMINOPHEN ASSAY |
Roche Diagnostics |
ANGELO PEREIRA |
| K110313 |
12/23/2011 |
TINA-QUANT HBA1C GEN.2 |
Roche Diagnostics |
Susan Hollandbeck |
| K112991 |
12/08/2011 |
MODIFIED ROG SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K113299 |
12/15/2011 |
ROG SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K112423 |
12/22/2011 |
COLLAGEN TENDON SHEET |
ROTATION MEDICAL, INC. |
JEFF SIMS |
| K110046 |
12/07/2011 |
ATHENA PEDICLE SCREW SYSTEM |
ROYAL OAK MEDICAL DEVICES |
MATHEW KROLL |
| K112822 |
12/27/2011 |
SLEEPSTRIP II |
S.L.P LTD. |
NOAM HADAS |
| K111732 |
12/05/2011 |
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER |
SALIENT SURGICAL TECHNOLOGIES, INC. |
MARTIN J LEIGHTON |
| K113381 |
12/29/2011 |
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K111013 |
12/19/2011 |
ACEM |
SANDHILL SCIENTIFIC, INC. |
LEWIS WARD |
| K110379 |
12/08/2011 |
AIR-N-GO |
SATELEC |
RICK ROSATI |
| K111483 |
12/07/2011 |
JOULE CLEARSENSE LASER SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K111671 |
12/28/2011 |
SEASPINE MONOPOLAR PROBE SYSYEM |
SEASPINE, INC. |
DAN MILLER |
| K111915 |
12/02/2011 |
MAGNESIUM ASSAY |
SEKISUI DIAGNOSTICS P.E.I. INC. |
PENNY J WHITE |
| K111907 |
12/02/2011 |
DYNAMIC DU SERIES PORTABLE DENTAL UNIT |
SHANGHAI DYNAMIC INDUSTRY CO., LTD. |
DORIS DONG |
| K112057 |
12/14/2011 |
KDL SYRINGES AND NEEDLE |
SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO., |
Diana Hong |
| K111303 |
12/21/2011 |
DERMATOLOGICAL TREATMENT DEVICE FAMILY |
SHARPLIGHT TECHNOLOGIES LTD. |
ILAN SHARON |
| K113647 |
12/16/2011 |
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K113373 |
12/30/2011 |
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K113448 |
12/17/2011 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K113179 |
12/07/2011 |
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
ROBERT F LAWRENCE |
| K113342 |
12/29/2011 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
KIM MANGUM |
| K112997 |
12/17/2011 |
HD-IVUS ULTRASOUND IMAGING SYSTEM |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
RICHARD E ANDERSON |
| K112387 |
12/27/2011 |
PROCEDURE REHEARSAL STUDIO(TM) |
SIMBIONIX LTD. |
SHOSHANA FRIEDMAN |
| K112672 |
12/13/2011 |
HEADLESS COMPRESSION SCREW |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K111068 |
12/30/2011 |
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO, ESQ |
| K111514 |
12/16/2011 |
SBV2, MULTICHARGER MODEL MC10V2 |
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE |
MARC GOODMAN |
| K112941 |
12/20/2011 |
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K111170 |
12/15/2011 |
PICO |
SMITH & NEPHEW, INC. |
TERRY MCMAHON |
| K112683 |
12/14/2011 |
SMI CARDIOVASCULAR PACH |
SOLIMAS MEDICAL, INC. |
MICHEAL KOLBE |
| K113680 |
12/29/2011 |
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT |
SOMA ACCESS SYSTEMS LLC |
GENOA ATWOOD |
| K102909 |
12/13/2011 |
SOMNOBRUX SPLINTS |
SOMNOMED INC |
BRADLEY SOUTHWORTH |
| K093477 |
12/08/2011 |
SHIELD KYPHOPLASTY SYSTEM |
SOTEIRA, INC. |
PAMELA PAPINEAU |
| K110633 |
12/15/2011 |
LANCER PEDICLE SCREW SYSTEM |
SPINAL SOLUTIONS, LLC |
J.D. WEBB |
| K111418 |
12/13/2011 |
STAXX(R) XD SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K113032 |
12/01/2011 |
SNAP WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH CANIO |
| K112813 |
12/01/2011 |
AMSCO V-PRO |
STERIS CORP. |
ROBERT SULLIVAN |
| K112055 |
12/16/2011 |
AMSCO CHIMERON MEDIUM STEAM STERILIZER |
STERIS Corporation |
ROBERT F SULLIVAN |
| K113283 |
12/28/2011 |
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K111204 |
12/22/2011 |
CELL-DYN 22 PLUS CALIBRATOR |
Streck |
Deborah Kipp |
| K111211 |
12/22/2011 |
CELL-DYN 22 PLUS CONTROL |
Streck |
Deborah Kipp |
| K113109 |
12/23/2011 |
STRYKER RESORBABLE FIXATION SYSTEM |
Stryker |
Manish Patel |
| K112926 |
12/19/2011 |
AXSOS LOCKING PLATE SYSTEM |
STRYKER CORP. |
KELLY KUCHARCZYK |
| K113598 |
12/20/2011 |
POWER-LOAD COT FASTENER SYSTEM |
STRYKER MEDICAL |
RENATA SILA |
| K113412 |
12/13/2011 |
TARGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
RHODA SANTOS |
| K113043 |
12/20/2011 |
DIRECT ANTIBIOTIC INFUSION KIT |
SUMMIT MEDICAL PRODUCTS, INC |
MARKO V AMEN |
| K113193 |
12/16/2011 |
PATIENT EXAMINATION GLOVE |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K112923 |
12/27/2011 |
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
CURTIS RAYMOND |
| K113404 |
12/06/2011 |
DENTAL 3D PLANNING SOFTWARE |
SYMBYO DENTAL, LLC |
PARUL CHANSORIA |
| K110924 |
12/07/2011 |
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS |
SYNERGETICS, INC |
GARY OLIVEROS |
| K110604 |
12/13/2011 |
VBB SYSTEM |
SYNTHES |
JASON LIPMAN |
| K111667 |
12/05/2011 |
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS |
SYNTHES (USA) |
CHRISTOPHER HACK |
| K112583 |
12/05/2011 |
SYNTHES CORTICAL SCREWS |
SYNTHES (USA) PRODUCTS LLC |
REBECCA BLANK |
| K113079 |
12/13/2011 |
SYNTHES HEMOSTATIC BONE PUTTY |
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION |
JEFFREY L DOW |
| K113251 |
12/21/2011 |
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES |
SYNTHES INC |
ALAN HALEY |
| K113044 |
12/21/2011 |
SYNTHES MIRS |
SYNTHES SPINE |
HEATHER GUERIN |
| K112459 |
12/12/2011 |
SYNTHES ZERO-P |
SYNTHES SPINE CO.LP |
STACEY BONNELL |
| K112296 |
12/01/2011 |
LATERAL BUTTON |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
GEORGE J HATTUB |
| K101926 |
12/20/2011 |
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K112275 |
12/15/2011 |
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K112216 |
12/22/2011 |
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K112274 |
12/21/2011 |
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K102456 |
12/15/2011 |
INTRAORAL BELSENSOR GOLD |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
| K112704 |
12/19/2011 |
LIPIFLOW THERMAL PULSATION SYSTEM |
TEARSCIENCE, INC. |
CHRISTY STEVENS |
| K112983 |
12/12/2011 |
SPACER-S |
TECRES SPA |
CHRISTINE BRAUER |
| K110698 |
12/07/2011 |
NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K112229 |
12/09/2011 |
SARN CENTRIFUGAL PUMP |
TERUMO CARDIOVASCULAR SYSTEMS |
REBECCA ANDERSEN |
| K112587 |
12/19/2011 |
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
REBECCA ANDERSEN |
| K112382 |
12/14/2011 |
TERUMO ASPRIATION CATHETER |
Terumo Medical Corporation |
DANIEL R PLONSKI |
| K113476 |
12/16/2011 |
ANSPACH DISSECTION TOOLS |
THE ANSPACH EFFORT, INC. |
JEANNETTE G DAILEY |
| K103531 |
12/01/2011 |
PRESTIGE 24I; BIOLIS 24I; MGC 240 |
TOKYO BOEKI MEDISYS INC. |
James M Clinton |
| K112776 |
12/22/2011 |
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER |
TOMOTHERAPY INCORPORATED |
GREG BANGE |
| K112003 |
12/02/2011 |
VANTAGE TITAN HSR |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K111335 |
12/01/2011 |
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 |
Tosoh BioScience, Inc. |
JUDITH K OGDEN |
| K113136 |
12/20/2011 |
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
| K113443 |
12/23/2011 |
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) |
TOTOKU ELECTRIC CO., LTD. |
TSUKASA TASHIRO |
| K112657 |
12/21/2011 |
AUREFLO MONITORING SYSTEM |
TRANSONIC SYSTEMS, INC. |
DAVID KLEMENTOWSKI |
| K111834 |
12/06/2011 |
DISCO SUBTALAR IMPLANT |
TRILLIANT SURGICAL LTD |
J D WEBB |
| K111738 |
12/14/2011 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) |
TRIREME MEDICAL, INC. |
SHIVA ARDAKAMI |
| K111736 |
12/08/2011 |
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES |
TUTTNAUER CO. LTD. |
THEODORE SULLIVAN |
| K103508 |
12/20/2011 |
UNMIAX LAPAROSCOPIC INSTRUMENT |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K113075 |
12/21/2011 |
EMBRYO VIEWER SOFTWARE |
UNISENSE FERTILITECH A/S |
METTE MUNCH |
| K113500 |
12/09/2011 |
CANADY VIEIRA HYBRID PLASMA SCALPEL |
US MEDICAL INNOVATIONS LLC |
JEROME CANADY |
| K112778 |
12/29/2011 |
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K112082 |
12/01/2011 |
GUIDELINER V2 CATHETER |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| 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 |
| DEN100013 |
12/20/2011 |
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 |
VIOGUARD |
CRAIG RANTA |
| K111922 |
12/02/2011 |
VOCARE MYHEALTH TABLET |
VOCARE, INC |
STEVE PEABODY |
| K113563 |
12/21/2011 |
N-HYBRIDE-COMPOSITE LC |
VOCO GMBH |
M.TH. PLAUMANN |
| K113444 |
12/21/2011 |
N-HYBRIDE-COMPOSITE LC FLOW |
VOCO GMBH |
T. GERKENSMEIER |
| K111123 |
12/08/2011 |
VARILIFT CERVICAL INTERBODY FUSION SYSTEM |
WENZEL SPINE |
SOURABH MISHRA |
| K113325 |
12/09/2011 |
EVOLUTION MP ADAPTIVE CS INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
| K113339 |
12/12/2011 |
ORTHOLOC 3DSI LOCKING SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PEGGY S RIVERS |
| K112080 |
12/28/2011 |
PRESERVE HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K110360 |
12/16/2011 |
PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K112592 |
12/05/2011 |
AXLE PEEK INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K112819 |
12/16/2011 |
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW |
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD |
Diana Hong |
| 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 |
| K112160 |
12/14/2011 |
TAPERED SCREW-VENT X IMPLANT |
ZIMMER DENTAL INC. |
JEREMY MARKOVICH |
| K111889 |
12/06/2011 |
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K113270 |
12/16/2011 |
INSTINCT JAVA SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K112885 |
12/19/2011 |
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
