FDA 510(k) Applications Received During November, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K133436 11/08/2013 FLASH AR; FLASH AR QUICK 3M DEUTSCHLAND GMBH DESI SOEGIARTO
K133400 11/06/2013 FLASH BITE 3M ESPE AG RUEDIGER FRANKE
K133675 11/29/2013 AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K133469 11/12/2013 ACUMED SUTURE ANCHOR SYSTEM ACUMED, LLC LINO TSAI
K133443 11/12/2013 MARATHON NO STING LIQUID SKIN PROTECTANT ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD ROSE GUANG
K133360 11/01/2013 AERONEB SOLO; AERONEB SOLO ADAPTER AEROGEN LTD MARTIN CREHAN
K133394 11/05/2013 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K133450 11/11/2013 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K133411 11/07/2013 ALERE BINAXNOW INFLUENZA A & B CARD ALERE SCARBOROUGH, INC D/B/A BINAX, INC. Angela Drysdale
K133637 11/07/2013 ALERE INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC. Angela Drysdale
K133561 11/20/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH ANGIODYNAMICS, INC. Lorraine M Hanley
K133393 11/05/2013 GELPOINT PATH TRANSANAL ACCESS PLATFORM APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K133606 11/25/2013 N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL ARTHROCARE CORPORATION MITCHELL DHORITY
K133462 11/12/2013 DUOCENTRIC REVERSED SHOULDER PROSTHESIS ASTON MEDICAL CATHERINE GLOSTER
K133521 11/15/2013 AZE PHOENIX SOFTWARE AZE, LTD. KARL DIEDRICH, AZE
K133632 11/26/2013 PERICAN ULTRA B.BRAUN MEDICAL, INC LISA GIAQUINTO
K133375 11/04/2013 BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR BANYAN MEDICAL, LLC. TAMMY HEALEY
K133663 11/29/2013 NIO COLOR 2MP BARCO N.V.
K133569 11/20/2013 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM BARD PERIPHERAL VASCULAR, INC. TIFFINI DIAGE
K133486 11/13/2013 STELLARIS PC VISION ENHANCEMENT SYSTEM BAUSCH & LOMB TIMOTHY W CAPEHART
K133608 11/25/2013 TRINIA BICON, LLC RICHARD WU
K133441 11/12/2013 ONESTEP CPR II MULTI-FUNCTION ELECTRODE BIO-DETEK, INC. SHANNON DUHAMEL
K133520 11/15/2013 HAMMERLOCK 2 BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K133518 11/15/2013 MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE (AKA EBI, LLC) KIMBERLY MCCOY
K133522 11/15/2013 RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM BIONIME COPORATION Feng-Yu Lee
K133642 11/27/2013 RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K133509 11/14/2013 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO Biotest Medical Corp. ROBERT NAWY
K133413 11/07/2013 IDSS SLC BLACK DIAMOND VIDEO RAGUNATH MUNIANDY
K133566 11/20/2013 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. MAYLIN TRUESDELL
K133385 11/05/2013 LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE BRONCUS MEDICAL INC ROBIN BUSH
K133470 11/12/2013 BARD RITECATH INTERMITTENT CATHETER C.R. BARD, INC. MICHELE DAVIS
K133456 11/12/2013 POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. BARD, INC. ELIZABETH PETERSON
K133508 11/14/2013 RESOLUTIONMD MOBILE CALGARY SCIENTIFIC, INC. KYLE PETERSON
K133529 11/15/2013 CAMBER SPINE COVERIS CERVICAL CAGE CAMBER SPINE DANIEL A PONTECORVO
K133366 11/01/2013 ORTHROS POSTERIOR STABILIZATION SYSTEM CAMBER SPINE DANIEL A PONTECORVO
K133399 11/06/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATED BLAIR BUTH
K133532 11/18/2013 ALARIS SYSTEM WITH GUARDRAILS SUITE MX CAREFUSION 303, INC. CHRISTINE CATON
K133442 11/12/2013 BONE SUPPRESSION SOFTWARE CARESTREAM HEALTH, INC. CAROLYN WAGNER
K133476 11/12/2013 SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION CARL ZEISS MEDITEC AG SARAH HARRINGTON
K133519 11/15/2013 CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR CAROLINA LIQUID CHEMISTRIES CORP. Melissa F Thompson
K133412 11/07/2013 S200, S300 CEFLA S.C. BERTHOIN CLAUDE
K133447 11/12/2013 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K133525 11/15/2013 LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD Diana Hong
K133625 11/26/2013 AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & Codman & Shurtleff, Inc. HANNAH FOLEY
K133600 11/25/2013 COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR COEUR, INC. DEBRA F MANNING
K133464 11/12/2013 MODIFIED TREVO PROVUE RETRIEVER CONCENTRIC MEDICAL, INC. SARAH MEYER
K133560 11/20/2013 ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K133465 11/12/2013 CONSURE STOOL MANAGEMENT SYSTEM CONSURE MEDICAL PVT LTD. ALAN DONALD
K133597 11/22/2013 CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY COOK, INC. SEAN SPENCE
K133634 11/26/2013 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET COOK, INC. SEAN SPENCE
K133627 11/26/2013 AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS COOPERVISION, INC. ANNETTE NELSON
K133369 11/01/2013 TIGER SPINE SYSTEM CORELINK LLC J D WEBB
K133599 11/25/2013 CORGRIP CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K133372 11/01/2013 CROSSTREES PVA POD CROSSTREES MEDICAL, INC. JANICE HOGAN
K133367 11/01/2013 ORTHOVIS PREOPERATIVE PLAN CUSTOM ORTHOPAEDIC SOLUTIONS JUSTIN BAKER
K133473 11/12/2013 ILUMINAGE SKIN SMOOTHING LASER CYNOSURE, INC. KEVIN O'CONNELL
K133364 11/01/2013 PICOSURE WORKSTATION CYNOSURE, INC. Connie Hoy
K133448 11/15/2013 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K133410 11/07/2013 DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K133434 11/08/2013 GENESIS II DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K133661 11/29/2013 CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K133517 11/15/2013 NEMUS 2 SYSTEM EB NEURO, S.P.A. ALLISON SCOTT, RAC
K133565 11/20/2013 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB MATILDA FORSBERG
K133405 11/06/2013 MINNIE ELETTRONICA VALSERIANA SRL SERGIO GHERSINI
K133536 11/18/2013 EMERGE MEDICAL BONE PLATE SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K133541 11/18/2013 EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K133452 11/12/2013 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K133425 11/08/2013 SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT ENGINEERED MEDICAL SOLUTIONS CO. LLC. RYAN SAVAGE
K133563 11/20/2013 PATHASSIST LIGHT SEEKER Entellus Medical, Inc. GARRETT P AHLBORG
K133584 11/21/2013 IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM EOSHEALTH, INC. Carrie Hetrick
K133537 11/18/2013 EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K133389 11/05/2013 EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K133647 11/27/2013 EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
DEN130047 11/18/2013 PROLONG ERGON MEDICAL LTD. BARRY PEARCE
K133490 11/13/2013 G-SCAN BRIO ESAOTE S.P.A. ALLISON S COTT
K133446 11/12/2013 HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation JOHN LINFANTE
K133636 11/26/2013 EXTREMITY MEDICAL HAMMERTOE DEVICE EXTREMITY MEDICAL, LLC. BRIAN SMEKAL
K133573 11/20/2013 FIAGON NAVIGATION SYSTEM FIAGON GMBH DIRK MUCHA
K133403 11/06/2013 FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS FIRESTONE OPTICS, INC. MARTIN DALSING
K133638 11/27/2013 GEKO FIRSTKIND LIMITED SHEILA HEMEON-HEYER
K133666 11/29/2013 RT016 INSPIRATORY FILTER FISHER & PAYKEL HEALTHCARE LTD. ELIZABETH GOLDSTEIN
K133516 11/15/2013 CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER FLEXICARE CHRISTOPHER WATKINS
K133621 11/25/2013 SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS SHARON YOUNG
DEN130049 11/25/2013 SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS SHARON YOUNG
K133588 11/21/2013 FORA CARE BLOOD PRESSURE MONITORING SYSTEM FORA CARE INC. Sharon Peng
K133454 11/12/2013 SONOSITE EDGE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. PATRICIA LIAU
K133533 11/18/2013 LOGIQ E GE HEALTHCARE BRYAN BEHN
K133431 11/08/2013 VENUE 50 GE HEALTHCARE BRYAN BEHN
K133576 11/20/2013 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K133649 11/27/2013 HEPATIC VCAR GE MEDICAL SYSTEMS SCS HUY DOAN
K133664 11/29/2013 ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN CHRIS PAULIK
K133640 11/27/2013 ASIR-V GE MEDICAL SYSTEMS, LLC HUY DOAN
K133657 11/27/2013 DISCOVERY PET/CT 710 GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K133605 11/25/2013 BD MAX MRSA XT, BD MAX INSTRUMENT GENEOHM SCIENCES CANADA, INC. PATRICIA DIONNE
K133482 11/13/2013 SILC FIXATION SYSTEM GLOBE MEDICAL, INC. CHRISTINA KICHULA
K133567 11/20/2013 UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. CHRISTINA KICHULA
K133678 11/29/2013 CONFIRM BIOACTIVE GLOBUS MEDICAL, INC. CHRISTINA KICHULA
K133655 11/27/2013 RADIANCE V2 GMV SOLUCIONES GLOBALES INTERNET S.A.U. ALBERT KOSTER
K133619 11/25/2013 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K133618 11/25/2013 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K133528 11/15/2013 H&H EMERGENCY CRICOTHYROTOMY KIT H&H MEDICAL CORPORATION J. Lawrence Stevens
K133552 11/19/2013 MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT Hansen Medical HASSAN LABAY
DEN130045 11/04/2013 HEARTFLOW FFRCT HEARTFLOW Dustin Michaels
K133676 11/29/2013 ABX PENTRA MICRO ALB CONTROL L/H HORIBA ABX SAS CAROLINE FERRER
K133602 11/25/2013 ADD-VANTAGE ADDAPTOR HOSPIRA, INC. KAREN KEENER
K133620 11/25/2013 CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM IMAGING SCIENCES INTERNATIONAL RUTH PUI
K133669 11/29/2013 MEDINAUT KYPHOPLASTY SYSTEM IMEDICOM Priscilla Chung
K133617 11/25/2013 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K133459 11/12/2013 ELITE IBF INNOVA SPINAL TECHNOLOGIES, LLC RICH JANSEN, PHARM. D.
K133542 11/18/2013 PURACYN PLUS SKIN AND WOUND INNOVACYN, INC. FRED L MA
K133390 11/05/2013 NDX DORSAL APPLIANCE INSTITUTE FOR QUALITY RESOURCE MANAGEMENT LEAH AMIR, MS, MHA
K133523 11/15/2013 STAPIX SUPERELASTIC IMPLANT BONE STAPLES INSTRATEK, INC. Jeff Seavey
K133582 11/21/2013 HEMOSIL D-DIMER HS 500 CONTROL INSTRUMENTATION LABORATORY CAROL MARBLE
K133407 11/06/2013 GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K133607 11/25/2013 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC JULIE BODMER
K133583 11/21/2013 OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 INTERVENTIONAL SPINE, INC. JANE METCALF
K133613 11/25/2013 INTRA-LOCK DENTAL IMPLANTS INTRA-LOCK INTERNATIONAL, INC. MARY L JEAN
K133493 11/14/2013 SINGLE USE STERILE SYRINGE WITH NEEDLE JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT HELEN NAN
K133510 11/14/2013 NEODENT IMPLANT SYSTEM JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA KEVIN A THOMAS
K133511 11/14/2013 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133614 11/25/2013 ALEUTIAN IBF SYSTEM K2M, INC. NANCY GIEZEN
K133494 11/14/2013 CHESAPEAKE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K133402 11/06/2013 K2M MODULAR HOOKS K2M, INC. KAREN E WARDEN
K133363 11/01/2013 INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM LDR SPINE, USA, INC. MEREDITH MAY
K133564 11/20/2013 MODIFICATION TO NAUTILUS SPINAL SYSTEM LIFE SPINE, LLC. RANDY LEWIS
K133550 11/19/2013 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT MAINE STANDARDS COMPANY LLC JAMES W CHAMPLIN
K133598 11/22/2013 CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG HELDER A SOUSA
K133466 11/12/2013 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) MAUNA KEA TECHNOLOGIES MICHAEL A DANIEL
K133540 11/18/2013 FLOCAP MAXTEC, INC. PAUL DRYDEN
K133534 11/18/2013 MCKESSON CARDIOLOGY ECG MOBILE MCKESSON ISRAEL LTD. PAUL SUMNER
K133630 11/26/2013 GMK SHORT STEM MEDACTA INTERNATIONAL ADAM GROSS
K133460 11/12/2013 APTUS CANNULATED COMPRESSION SCREWS MEDARTIS AG ALLISON KOMIYAMA
K133428 11/08/2013 MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO MEDIKRO OY MIKKO ELORANTA
K133665 11/29/2013 MALLEABLE SUCTION INSTRUMENTS MEDTRONIC NAVIGATION, INC. CHARLES M COPPERBERG
K133444 11/12/2013 STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM MEDTRONIC NAVIGATION, INC. KAYE WAITE
K133577 11/21/2013 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC LEE GRANT
K133653 11/27/2013 ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K133650 11/27/2013 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. GREGORY MASCHEK
K133645 11/27/2013 PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K133539 11/18/2013 TOTAL ACROSS MEDTRONIC VASCULAR DIANA JOHNSON
K133673 11/29/2013 ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA MERIDIAN BIOSCIENCE, INC. Michelle L Smith
K133554 11/19/2013 SURGICAL LIGHT HANDLE COVER MICROTEK MEDICAL, INC. AN ECOLAB COMPANY ANDY ROLLER
K133626 11/26/2013 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MICROVENTION, INC. LARAINE PANGELINA
K133624 11/26/2013 COMPASS CT, COMPASS CT PORT MIRADOR BIOMEDICAL JUSTIN HULVERSHORN
K133515 11/15/2013 PEEK FUSION IMPLANT MTP SOLUTIONS LLC ROBERT HOY
K133453 11/12/2013 IOVERA MYOSCIENCE INC BIJESH CHANDRAN
K133609 11/25/2013 THE DOME S6C NDS SURGICAL IMAGING JIM LENG
K133422 11/08/2013 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE NEOCOIL, LLC KATIE GONZALEZ
K133670 11/29/2013 HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE NEOCOIL, LLC MICHEAL LEIGH
K133592 11/22/2013 NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM NEODENT USA, INC. CHRISTOPHER KLACZYK
K133408 11/06/2013 NEUROSTAR TMS THERAPY SYSTEM NEURONETICS JUDY P WAYS, PH.D.
K133373 11/01/2013 CLEARVIEW NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K133475 11/12/2013 STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS NEXXT SPINE LLC ERIC LINTULA
K133507 11/14/2013 GUIDOSS NIBEC CO LTD DANIEL NAM
K133377 11/04/2013 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE NOBEL BIOCARE AB PHUONG NGUYEN
K133506 11/14/2013 NORAS OR HEAD HOLDER FLEXIBILITY NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K133530 11/15/2013 NUVASIVE EMG ENDOTRACHEAL TUBE NUVASIVE, INCORPORATED JEREMY MARKOVICH
K133547 11/19/2013 NXSTAGE SYSTEM ONE WITH NXVIEW NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K133562 11/20/2013 CATARHEX 3 OERTLI INSTRUMENTE AG KARIN ROHR
K133538 11/18/2013 VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE OLYMPUS CORPORATION OF THE AMERICAS SHERI L MUSGNUNG
K133381 11/04/2013 OMNI ARC MONOBLOCK HIP STEM OMNILIFE SCIENCE CHRISTINA FLORES
K133379 11/04/2013 HEM-7311 OMRON HEALTHCARE, INC. PAUL DRYDEN
K133383 11/04/2013 HEM-7320 OMRON HEALTHCARE, INC. PAUL DRYDEN
K133387 11/05/2013 ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED ORIGIO A/S TOVE KJAER
K133449 11/12/2013 KASM KNEE ARTICULATING SPACER MOLDS ORTHO DEVELOPMENT CORP. MIKE ENSIGN
K133386 11/05/2013 OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM ORTHO DEVELOPMENT CORP. MIKE ENSIGN
K133527 11/15/2013 SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT OSSTEM GERMANY GMBH PATRICK LIM
K133437 11/07/2013 1ST MTP PLATE OSTEOMED BLESSON ABRAHAM
K133514 11/15/2013 XCAGE INTERBODY FUSION SYSTEM OUROBOROS MEDICAL JOHN TO
K133397 11/06/2013 P-POD P-POD LINDA BRADDON
K133544 11/18/2013 OP300 PALODEX GROUP OY TERHO TURKUMAKI
K133432 11/05/2013 SHERPA PAK CARDIAC TRANSPORT SYSTEM PARAGONIX TECHNOLOGIES, INC. LEO BASTA
K133404 11/06/2013 IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH PHADIA AB MARTIN R MANN
K133674 11/29/2013 PHILIPS IQON SPECTRAL CT PHILIPS HEALTHCARE (CLEVELAND) CATHERINE M CONNELL
K133659 11/27/2013 HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING PHILIPS MEDICAL SYSTEMS JOHN PARDO
K133603 11/25/2013 PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION PHILIPS MEDICAL SYSTEMS SUSAN QUICK
K133526 11/15/2013 MDIXON-QUANT PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SUSAN QUICK
K133623 11/26/2013 C-PLUS PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K133455 11/12/2013 CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC PIONEER SURGICAL TECHNOLOGY, INC EMILY DOWNS
K133374 11/01/2013 STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I SARAH MCINTYRE
K133579 11/21/2013 MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS PONTIS ORTHOPAEDICS, LLC LEONARD GORDON
K133483 11/13/2013 PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE PORTABLE THERAPEUTIX Sharyn Orton, Ph.D.
K133524 11/15/2013 PVMED DDR 2430T PORTAVISION MEDICAL LLC TERRY ANCAR
K133629 11/26/2013 ANGIOJET ULTRA AVX THROMBECTOMY SET POSSIS MEDICAL, INC. GEORGE LUCAS
K133474 11/12/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
K133502 11/14/2013 5000Z FIREFLY SYSTEM PRIZM MEDICAL, INC. CARL BEAURLINE
K133546 11/19/2013 STARLITE-OM, LIGHT EFFECTS, THIBIANT PS ADVANCED ENGINEERING CD FEAK
K133382 11/04/2013 QB TEST QBTECH AB HANS BOSTROM
K133503 11/14/2013 AMPLIVUE GBS ASSAY QUIDEL CORPORATION Ronald H Lollar
K133423 11/08/2013 REST ASSURED EXTRA COMFORT NITE PROTECTOR RANIR LLC PAULA BOJSEN
K133409 11/07/2013 DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA RAYENCE CO., LTD DAVE KIM
K133635 11/26/2013 EASYPOINT NEEDLE RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K133330 11/01/2013 C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN Roche Diagnostics Susan Hollandbeck
K133496 11/14/2013 X TWIN SYSTEM ROESYS GMBH JOCHEN DYSZBALIS
K133505 11/14/2013 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K133418 11/07/2013 INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM SEASPINE, INC. JEFF BRITTAN
K133362 11/01/2013 SGS DENTAL IMPLANT SGS INTERNATIONAL LTD DANIELA LEVY
K133478 11/12/2013 POWDER FREE POLYETHYLENE EXAMINATION GLOVES SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD KATHY LIU
K133668 11/29/2013 AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL SHOULDER OPTIONS, INC. JOHN KAPITAN
K133512 11/15/2013 LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) SIEMENS HEALTHCARE DIAGNOSTICS ANNA MARIE K ENNIS
K133601 11/25/2013 ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics Inc. PHILIP LIU
K133491 11/13/2013 ADVIA CENTAUR TESTOSTERONE (TSTO) Siemens Healthcare Diagnostics Inc. MATTHEW GEE
K133580 11/21/2013 ARTIS ONE SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K133435 11/08/2013 MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K133654 11/27/2013 SCENIUM SIEMENS MEDICAL SOLUTIONS USA, INC. MARIA EBIO
K133424 11/08/2013 SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K133589 11/22/2013 SOMATOM FORCE SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K133590 11/22/2013 SOMATOM PERSPECTIVE SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K133677 11/29/2013 SYNGO CT SINGLE SOURCE DUAL ENERGY SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K133648 11/27/2013 SYNGO, CT DUAL ENERGY SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K133644 11/27/2013 SYNGO.VIA MI WORKFLOWS SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO, RAC
K133401 11/06/2013 SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K133643 11/27/2013 SYNGO, CT LIVER ANALYSIS SIEMENS MEDICAL SOLUTIONS, INC. KIMBERLY MANGUM
K133646 11/27/2013 ADMIRE SIEMENS MEDICAL SYSTEMS, INC. KIMBERLY MANGUM
K133370 11/04/2013 REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE SIGNATURE ORTHOPAEDICS PTY LIMITED DECLAN BRAZIL
K133662 11/29/2013 SMITH & NEPHEW CANNULATED CAPTURED SCREW SMITH & NEPHEW, INC. KATHERINE MARCACCIO
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K133586 11/21/2013 VISI MOBILE MONITIORING SYSTEM SOTERA WIRELESS, INC EBEN GORDON
K133472 11/12/2013 SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) SOUFLON PHARMACEUTICALS LTD CHRISTOPHER SMEJKAL
K133631 11/26/2013 LEXIPLIANT DILATOR SHEATH SET SPECTRANETICS CORPORATION STACEY A STRAND
K133557 11/19/2013 JULIET LL LATERAL LUMBAR CAGE SPINEART FRANCK PENNESI
K133371 11/01/2013 RAMPART-L SPINEOLOGY, INC. BRYAN BECKER
K133575 11/20/2013 SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM SPINEVISION, S.A. J.D. WEBB
K133587 11/21/2013 PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 ST. JUDE MEDICAL SYSTEMS AB ERDULFO DE PERALTA
K133481 11/13/2013 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) ST. JUDE MEDICAL, INC. Michael McSweeney
K133152 11/22/2013 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT STANMORE IMPLANTS WORLDWIDE LTD. GERARD J PRUD'HOMME
K133396 11/06/2013 VDRIVE WITH V-SONO STEREOTAXIS, INC. DIANE HORWITZ, PH.D. RAC
K133414 11/07/2013 REPROCESSED CLOSURE SYSTEM STERILMED, INC. JASON SKRAMSTED
K133549 11/19/2013 STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR STERITEC PRODUCTS MFG., CO., INC. JONATHAN RUTIGLIANO
K133421 11/08/2013 STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW STRAUMANN USA, LLC CHARLOTTE RINGLEB
K133398 11/06/2013 STRYKER PEDIATRIC MANDIBLE DISTRACTOR Stryker Manish Patel
K133461 11/12/2013 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker JULIE SCHOELL
K133671 11/29/2013 ICONIX ALL SUTURE ANCHORS STRYKER CORP. KELLY KUCHARCZYK
K133672 11/29/2013 REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY STRYKER SUSTAINABILITY SOLUTIONS SCOTT ENGLISH
K133578 11/21/2013 REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER STRYKER SUSTAINABILITY SOLUTIONS JILL CLARK
K133440 11/12/2013 AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION Stryker Trauma AG Elijah Wreh
K133451 11/12/2013 FIXOS SCREW SYSTEM Stryker Trauma AG ESTELA CELI
K133420 11/08/2013 TRANQUILL BARBED DEVICE SURGICAL SPECIALTIES CORP. DBA ANGIOTECH KIRSTEN STOWELL
K133499 11/14/2013 SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. ROBERT SEIPLE, RAC
K133477 11/12/2013 TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS SYNCHRO MEDICAL MARK F SCHENK
K133616 11/25/2013 MATRIXRIB FIXATION SYSTEM SYNTHES (USA) PRODUCTS LLC Damon Lees
K133593 11/22/2013 T:SLIM INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. JOHN SHERIDAN
K133439 11/12/2013 PILLING ESOPHAGEAL BOUGIES Teleflex Medical, Inc. HOLLY KORNEGAY
K133658 11/27/2013 CDI BLOOD PARAMETER MONITORING SYSTEM 500 TERUMO CARDIOVASCULAR SYSTEMS CORP. Kevin Kong
K133604 11/25/2013 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS THE ANSPACH EFFORT, INC. JEANNETTE G DAILEY
K133667 11/29/2013 SLIT LAMP SL-D701 TOPCON CORP. MAUREEN O'CONNELL
K133376 11/04/2013 AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT TORNIER, INC. JANELL A COLLEY
K133553 11/19/2013 KALARE TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K133497 11/14/2013 AQUILION ONE VISION TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K133535 11/18/2013 INFX-8000V, V5.30 TOSHIBA MEDICAL SYSTEMS CORPORATION CHARLEMAGNE CHUA
K133633 11/26/2013 CHOCOLATE PTCA BOLLOON CATHETER TRIREME MEDICAL INC SHIVA ARDAKANI
K133419 11/07/2013 BABYMEG BIOMAGNETOMETER SYSTEM TRISTAN TECHNOLOGIES INC EUGENE HIRSCHKOFF
K133406 11/06/2013 CS 8100 3D TROPHY MARIE PIERRE
K133513 11/12/2013 MULTI-STAGE SNARE UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
K133572 11/20/2013 ARIA RADIATION THERAPY MANAGEMENT VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133501 11/14/2013 LEADLINER CS LEAD DELIVERY SYSTEM VASCULAR SOLUTIONS, INC. MIA HUNT
K133568 11/20/2013 G-TL VITROLIFE, INC. MARK LARMAN
K133641 11/27/2013 CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE VOLCANO CORPORATION MARCUS GARCIA
K133445 11/12/2013 ANGIOVAC CANNULA VORTEX MEDICAL INC Lorraine M Hanley
K133488 11/13/2013 PIEZOMED W & H DENTALWERK BUERMOOS GMBH ANJA LINDNER
K133652 11/27/2013 GSP NEONATAL TOTAL GALACTOSE KIT WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. JEANETTE SCHIER-PUGSLEY
K133615 11/25/2013 WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER WELL LEAD MEDICAL CO. LTD JOHN OBRIEN
K133622 11/22/2013 MAC 2000 ECG ANALYSIS SYSTEM WIPRO GE HEALTHCARE DOUGLAS KENTZ
K133585 11/21/2013 INBONE TOTAL ANKLE WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K133551 11/19/2013 ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM ZIMMER DENTAL INC. MELISSA BURBAGE
K133556 11/19/2013 VIRAGE OCT SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. HOLLY SEPPANEN
K133378 11/04/2013 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM ZIMMER, INC. DAN WILLIMAN
K133484 11/13/2013 ZOLL X SERIES ZOLL MEDICAL CORP. TANMAY SHUKLA


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