FDA 510(k) Applications Received During November, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K113235 11/02/2011 PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS MEDTRONIC INC. AMRA RACIC
K113380 11/16/2011 PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR MEDTRONIC INC. THOMAS REICHEL
K113464 11/22/2011 NC TREK OTW CORONARY DILATATION CATHETER ABBOTT VASCULAR SUZANNE REDMAN
K113332 11/30/2011 ON CALL CHOSEN LANCING DEVICE ACON LABORATORIES, INC. AARON FRIDAY
K113315 11/09/2011 RUMBLE TUFF ACUTE IDEAS CO. LTD. MATTHEW KHO
K113318 11/10/2011 ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM ACUTE INNOVATIONS LLC MARIAH KNIGHT
K113365 11/15/2011 INFANT ARRAY ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS RAVI SPRINIVASAN
K113371 11/17/2011 STAPHYLOCOCCUS QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K113436 11/21/2011 ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN HYMAN KATZ
K113382 11/16/2011 ACE ALT REAGENT ALFA WASSERMANN HYMAN KATZ
K113435 11/21/2011 ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN HYMAN KATZ
K113374 11/16/2011 ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113253 11/04/2011 ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113262 11/04/2011 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113389 11/16/2011 ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113438 11/21/2011 ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113437 11/21/2011 ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113511 11/28/2011 ECHOSTAR SPICA 1.5T MR SYSTEM ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K113501 11/25/2011 AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) AMEDITECH, INC. BRETT CASEY
K113400 11/17/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K113208 11/01/2011 GAL-1A BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K113268 11/18/2011 ALEXIS O WOUND PROTECTOR/RETRACTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K113263 11/04/2011 ARGES IMAGING CONTRAST SPRAY ARGES IMAGING, INC REBECCA K PINE
K113508 11/28/2011 DACRYOCATH ARMADILLO BIOMEDICAL, LLC ROBYN SCOPIS
K113277 11/07/2011 ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS ARROW INTERNATIONAL, INC. TRACY MADDOCK
K113452 11/21/2011 ACU-CUT VERTEBRAL AUGMENTATION SYSTEM ASCENDX SPINE, INC. JANICE M HOGAN
K113489 11/23/2011 ORION ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K113424 11/21/2011 LOFRIC SINGLE USE URINARY CATHETER ASTRA TECH AB FLOYD G LARSON
K113420 11/18/2011 RNARETAIN ASURAGEN, INC. LUC VAN HOVE
K113533 11/30/2011 NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. EDWARD SINCLAIR
K113227 11/08/2011 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K113241 11/02/2011 BD EMERALD SINGLE USE, HYPODERMIC SYRINGE BECTON DICKINSON KARA MCKEE
K113431 11/21/2011 CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA BETTINI S.P.A. CLAUDE BERTHOIN
K113311 11/09/2011 TIO2MESH TM BIOCER ENTWICKLUNGS GMBH CHERYL FISHER
K113200 11/17/2011 VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM BIOMERIEUX, INC. SANDRA PERREAND
K113271 11/04/2011 METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS BIOMET MANUFACTURING, INC. GARY BAKER
K113512 11/28/2011 BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM BIOMET MICROFIXATION SHERYL MALMBERG
K113306 11/09/2011 CARDIO 7 BIONET CO., LTD. MARC GOODMAN
K113213 11/07/2011 LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 BIOSENSE WEBSTER, INC. JOHN JIMENEZ
K113401 11/17/2011 ORTHO-1(NOT FINALIZED) BISCO, INC. MICHELLE SCHILTZ-TAING
K113493 11/25/2011 TCX-I REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. MICHEAL MATHUR
K113220 11/01/2011 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) BOSTON SCIENTIFIC CORPORATION VICKY L HAGENS
K113308 11/09/2011 BRUNO ELAN STAIRWAY ELEVATOR BRUNO INDEPENDENT LIVING AIDS, INC. TERRENCE O'BRIEN
K113310 11/08/2011 ENDOGATER AVANTAGE CO2 INSUFFLATOR BYRNE MEDICAL, INC. BRENT GEIGER
K113276 11/07/2011 CATALYST C-RAD POSITIONING AB JANINA OSTLING
K113229 11/02/2011 VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING C.R. BARD, INC. STEPHANIE BAKER
K113472 11/22/2011 PRECISE SHP DIODE LASER CAO GROUP, INC. ROB K LARSEN
K113407 11/18/2011 SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS CAREFUSION 2200, INC. KATE FULLER
K113480 11/23/2011 SPECTRA OPTIA APHERESIS SYSTEM CARIDIANBCT, INC. TINA O'BRIEN
K113497 11/25/2011 HYPERION CEFLA S.C. CEFLA DENTAL GROUP MARISA TESTA
K113336 11/14/2011 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K113440 11/21/2011 HIGH FIVE CENTRAL MEDICARE SDN BHD NICK WANG
K113212 11/01/2011 DENTAL LASER THERAPY SYSTEM CHINA DAHENG GROUP, INC. DIANA HONG
K113359 11/14/2011 CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K113387 11/16/2011 CITIEFFE TITANIUM NAILING SYSTEM CITIEFFE CLAUDE BERTHOIN
K113388 11/16/2011 CITIEFFE-TITANIUM CANNULATED SCREW CITIEFFE CLAUDE BERTHOIN
K113384 11/16/2011 EXTERNAL FIXATOR ST.A R 90 F4 CITIEFFE CLAUDE BERTHOIN
K113465 11/22/2011 ACCULIF TL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K113498 11/25/2011 DISPOSABLE TORQUE DEVICE COEUR, INC. DEBRA F MANNING
K113496 11/25/2011 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT COLOPLAST A/S JANELL COLLEY
K113260 11/04/2011 MODIFIED CONCENTIRC MICROCATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K113378 11/18/2011 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K113510 11/28/2011 EVOLUTION COLONIC STENT SYSTEM COOK IRELAND LTD JACINTA KILMARTIN
K113300 11/09/2011 ATB ADVANCE PTA DILATATION CATHETER COOK, INC. ELYSIA POOR
K113245 11/02/2011 AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL COOPERVISION, INC. GWEN SHARP
K113267 11/04/2011 BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC COOPERVISION, INC. GWEN SHARP
K113351 11/14/2011 CORTRAK ENTERAL ACCESS DEVICE CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K113372 11/16/2011 NUVANT, MOBILC CARDIAC TELEMETRY CORVENTIS, INC. KATHLEEN LUNDBERG
K113468 11/22/2011 ELM PTA BALLON DILATATION CATHETER CREAGH MEDICAL LTD MAUREEN O'CONNELL
K113361 11/14/2011 SECURIS SPINAL FIXATION CUMTOM SPINE DAVID BRUMFIELD
K113255 11/03/2011 PUREGRAFT 850/PURE SYSTEM CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K113316 11/14/2011 DCS LACRIMAL STENT DCS SURGICAL INC HARRY ROSS
K113343 11/14/2011 DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION NICKY PAN
K113301 11/08/2011 CONCENPIECE,HIGH-SPEED HANDPIECE SERIES DENTALEZ, INC. JIM WATKINS
K113406 11/18/2011 AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K113534 11/30/2011 HEALIX KNOTLESS ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K113324 11/10/2011 REXIOUS HOOK FIXATION SYSTEMS DIO MEDICAL CO., LTD. APRIL LEE
K113206 11/01/2011 NANOBLUTM 500 DRAEGER MEDICAL SYSTEMS, INC. BRYAN OVERTON
K113250 11/03/2011 DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE DYNATRONICS CORP. DOUGLAS SAMPSON
K113459 11/22/2011 ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K113411 11/18/2011 EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K113182 11/07/2011 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K113478 11/23/2011 PLIF CAGE EISERTECH, LLC LUKAS EISERMANN
K113240 11/07/2011 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113226 11/01/2011 8MP COLOR LCD MONITOR,RADIFORCE RX840 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113504 11/28/2011 DEKA SMARTXIDE AND DELIVERY ACCESSORIES EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K113269 11/04/2011 ELITTECH CLINICAL SYSTEMS ALP IFCC SL ELITECHGROUP DEBRA K HUTSON
K113219 11/01/2011 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCLNTYRE
K113475 11/23/2011 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K113522 11/29/2011 PATHASSIST LIGHT SEEKER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K113344 11/14/2011 STEREOS WORKSTATION EOS IMAGING JOHN J SMITH
K113243 11/10/2011 EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K113439 11/21/2011 EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) EUROIMMUN US KATHRYN KOHL
K113309 11/08/2011 EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC. PATRICK HUGHES
K113320 11/10/2011 NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 EXACTECH, INC. VLADISLAVA ZAITSEVA
K113383 11/16/2011 XTRAFIX EXTERNAL FIXATION SYSTEM EXTRAORTHO, INC. MARCOS VELEZ-DURAN
K113516 11/29/2011 THERASOM-CAST FAMILY DENTAL SERVICES, P.C. DEANNA L BAXAM
K113536 11/30/2011 MASTERKA 40 MASTERKA 35 MASTERKA 30 FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) BARBARA FRANT
K113433 11/21/2011 SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT FOCUS DIAGNOSTICS, INC. SHARON YOUNG
K113236 11/02/2011 FORYOU NPWT DEVICE FORYOU MEDICAL ELECTRONICS CO, LTD SCOTT WRIGHT
K113427 11/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K113284 11/07/2011 BIOPSY POSITIONER FUJI FILM MEDICAL SYSTEMS KIMERLY A SHARP
K113244 11/02/2011 SYNAPSE MPR FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOOK
K113313 11/09/2011 MOLECULAR ADSORBENT RECIRCULATING(MARS) GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K113350 11/14/2011 BRIVO NM 615 GE HEALTHCARE ELI WERNER
K113456 11/21/2011 READY VIEW GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) ELIZABETH MATHEW
K113286 11/09/2011 ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS LUNAR TRISHIA DWYER
K113403 11/17/2011 GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE MEDICAL SYSTEMS SCS MICHEL GENUER
K113394 11/17/2011 MAVRIC SL GE MEDICAL SYSTEMS, LLC YUAN MA
K113490 11/25/2011 OPTIMA MR450W GE MEDICAL SYSTEMS, LLC ROBIN MARTIN
K113408 11/28/2011 Q. FREEZE (MOTION VUE2) GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K113265 11/04/2011 GENII GI 4000 ELECTROSUGICAL GENERATOR GENII, INC. JULIE POWELL
K113395 11/17/2011 REVERE 4.5 STABILIZATION SYSTEM GLOBUS MEDICAL INC. SARAH M FITZGERALD
K113447 11/21/2011 RISE SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K113358 11/14/2011 PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC LARRY REA
K113505 11/28/2011 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K113377 11/16/2011 GLIADIN IGA AND GLIADIN LGA GRIFOLS USA, LLC CATHERINE L WONG
K113238 11/02/2011 FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K113239 11/02/2011 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) HEALTH & LIFE CO., LTD. SARAH SU
K113341 11/14/2011 GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K113307 11/08/2011 GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM HMD BIOMEDICAL, INC. JESSICA TUNG
K113314 11/09/2011 PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM HMD BIOMEDICAL, INC. WANG YUNHAN
K113356 11/14/2011 HOLOGIC VISCERAL FAT SOFTWARE HOLOGIC, INC. EILEEN M BOYLE
K113409 11/18/2011 S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL HOWMEDICA OSTEONICS CORP. JUMA HOSHINO
K113360 11/14/2011 MEDICAL IMAGE PROCESSING UNIT HUMANRAY CO,LTD DAVE KIM
K113506 11/28/2011 IND ONE STEP OCCULT BLOOD (FOB) TEST IND DIAGNOSTICS INC. KAI LOU
K113272 11/04/2011 INOMAX DS(DELIVERY SYSTEMS INO THERAPEUTICS LLC/DBA IKARIA LARRY LEPLEY
K113317 11/10/2011 LIFECHOICE OXYGEN CONCENTRATOR INOVA LABS, INC. DAVID SHOCKLEY
K113399 11/17/2011 IFS SUBTALAR IMPLANT INTERNAL FIXATION SYSTEMS, INC. CHRIS ENDARA
K113527 11/30/2011 OPTICAGE INTERBODY FUSION DEVICE INTERVENTIONAL SPINE, INC. JANE METCALF
K113210 11/01/2011 ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT ISOAID, L.L.C. BENJAMIN ROEDELL
K113348 11/14/2011 COUGAR SYSTEM JOHNSON & JOHNSON KEVIN G STEVENS
K113273 11/07/2011 SPOTLIGHT ACCESS SYSTEM JOHNSON & JOHNSON LAURA BLEYENDAAL
K113329 11/15/2011 K2M, PYRENEES CERVICAL PLATE SYSTEM K2M, INC. NANCY GIEZEN
K113507 11/28/2011 KENT CAMERA KENT IMAGING INC. DARRELL BARNHART
K113279 11/07/2011 IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT KETTENBACH GMBH & CO KG SIMONE MATUSCHKA
K113247 11/02/2011 ANESTHESIA INJECTION TOOL SET KI WORKS CO., LTD. EILEEN YANG
K113340 11/14/2011 KIMBERLY-CLARK CHILD'S FACEMASK KIMBERLY-CLARK ANN WATERHOUSE
K113423 11/21/2011 KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE KIMBERLY-CLARK CORP. LESTER F PADILLA
K113333 11/14/2011 KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS KIMBERLY-CLARK CORPORATION MARCIA JOHNSON
K113248 11/03/2011 AERODR SYSTEM WITH P-21 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K113509 11/28/2011 LEXUS ANTERIOR CERVICAL PLATE SYSTEM L&K BIOMED CO., LTD HEE KYEONG JOO
K113434 11/25/2011 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, INC. MICHAEL FUNK
K113264 11/04/2011 ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) LD TECHNOLOGY LLC ABBERT MAAREK
K113285 11/07/2011 LDR SPINE USA AVENUE L INTERBODY FUSION LDR SPINE USA INC. MARITZA ELIAS
K113523 11/29/2011 LIMACORPORATE SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. CHERYL HASTINGS
K113254 11/03/2011 SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS LIMACORPORATE S.P.A. CHERYL HASTINGS
K113502 11/25/2011 ADVANTAGE LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K113524 11/29/2011 VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT MAINE STANDARDS CO. HOLLY A CRESSMAN
K113232 11/04/2011 MAXMIXING BLOCK MAXTEC, INC. TAMMY LAVERY
K113228 11/01/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K113515 11/28/2011 HORIZON CARDIOLOGY ECG MANAGEMENT MCKESSON ISRAEL LTD. TOMER LEVY
K113304 11/08/2011 BLADDER SCANNER MEDA CO. LTD. KAI CHEN
K113487 11/29/2011 HEMO-CATH 10F, HEMO-CATH 12.5F MEDICAL COMPONENTS INC JEAN CALLOW
K113525 11/29/2011 ACTIVECARE DVT ACTIVECARE+SFT MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. JONATHAN S KAHAN
K113353 11/14/2011 GEMINI STERILZATION WRAP MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K113526 11/30/2011 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM MEDOS INTERNATIONAL SARL JOCELYN RAPOSO
K113396 11/07/2011 DEPUY PULSE THORACOLUMBAR SCREW SYSTEM MEDOS INTERNATIONAL SARL EUGENE BANG
K113363 11/15/2011 ANGIOJET SOLENT DISTA THROMBECTOMY SET MEDRAD, INC. MIKE BURNSIDE
K113428 11/21/2011 ANGIOJET ULTRA DVX THROMBECTOMY SET MEDRAD, INC. MIKE BURNSIDE
K113529 11/30/2011 CD HORIZON VOYAGER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MIKE SCOTT
K113252 11/03/2011 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK KRISTI FRISCH
K113528 11/30/2011 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K113303 11/09/2011 OSLEOBRIDGE IDSF SPACER CONECTOR MERETE MEDICAL GMBH EMMANUEL ANAPLIOIS
K113390 11/16/2011 LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) MERIDIAN AG KEVIN WALLS
K113337 11/14/2011 VISIA DYNAMIC REVIEW MEVIS MEDICAL SOLUTIONS AG THOMAS E TYNES
K113455 11/21/2011 SOLITAIRE FR REVASCULARIZATION DEVICE MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR LAURA HEATON
K113454 11/21/2011 14 WIRE STANDARD, 14 WIRE LS MICRO THERAPEUTICS, INC. GREGORY J GEISSINGER
K113289 11/07/2011 ORION MICRO CATHETER MICRO THERAPEUTICS, INC. ANALIA NIETO
K113513 11/28/2011 PLANCET MICROPOINT TECHNOLOGIES PTE LTD CHEE Y LIM
K113457 11/22/2011 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K113234 11/02/2011 MOBCARDIO SYSTEM MOBHEALTH INCORPORATION PATRICIA LIN
K113222 11/01/2011 ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. SHINICHI NAKAMURA
K113530 11/30/2011 ULTRASONIC SCALER NAKANISHI, INC. DIANE RUTHERFORD
K113450 11/21/2011 VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) NANOSPHERE, INC MARK DEL VECCHIO
K113474 11/22/2011 1.5T GEM FLEX COIL NEOCOIL, LLC STEVEN NICHOLS
K113376 11/16/2011 NEOSS PROACTIVE TAPERED IMPLANT NEOSS LTD CHERITA JAMES
K113237 11/02/2011 CERTUS 140 2.45GHZ ABLATION SYSTEM NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K113398 11/17/2011 NEXUS TKO-6, LUER-ACTIVATED DEVICE NEXUS MEDICAL, LLC HEATHER TURNER
K113246 11/02/2011 OCS-B NIBEC COMPANY, LIMITED DANIEL NAM
K113451 11/21/2011 NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX NIDEK TECHNOLOGIES SRL ENRICO BISSON
K113471 11/22/2011 NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113469 11/22/2011 NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113470 11/22/2011 NIPRO SAFE TOUCH HUBER INFUSION SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113429 11/21/2011 SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113494 11/25/2011 NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA NOBLES MEDICAL TECHNOLOGIES II, INC. MARIA HATEGAN
K113215 11/01/2011 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY NONIN MEDICAL, INC. BRODIE PEDERSON
K113221 11/02/2011 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K113302 11/08/2011 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K113242 11/02/2011 APEX ARC HIP STEM OMNILIFE SCIENCE INC. CHRISTINE NASSIF
K113334 11/14/2011 AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. DIANE ROGERS
K113479 11/23/2011 OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION ALAN MARQUARDT
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