FDA 510(k) Applications Received During January, 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
K130113 01/22/2013 PICCOLO LACTATE TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K130200 01/28/2013 PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE, PHD
K130094 01/10/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE DAVID G LAMBERT
K133469 11/12/2013 ACUMED SUTURE ANCHOR SYSTEM ACUMED, LLC LINO TSAI
K130013 01/02/2013 X4 SYSTEM ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K130007 01/02/2013 SLEEP PROFILER ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K133443 11/22/2013 MARATHON NO STING LIQUID SKIN PROTECTANT ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD ROSE GUANG
K130165 01/30/2013 PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 ADVANCED PLANIMETRIC SERVICES, LLC MARTIN WENDELKEN
K133360 11/01/2013 AERONEB SOLO; AERONEB SOLO ADAPTER AEROGEN LTD MARTIN CREHAN
K123861 01/08/2013 AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC CHEN TIAN
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 11/27/2013 ALERE INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC. ANGELA DRYSDALE
K132933 11/14/2013 THE MOSES ELITE APPLIANCE ALLEN J. MOSES, DDS, LTD. ALLEN J MOSES, DDS
K130097 01/15/2013 MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED MIKE HOFTMAN
K130152 01/24/2013 HYDRASOLVE LIPOPLASTY SYSTEM ANDREW TECHNOLOGIES, LLC HERBERT CRANE
K133561 11/26/2013 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
K124021 01/08/2013 ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. LONNA M DENDOOVEN
K133342 11/18/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. MARIELA CABARCAS
K130129 01/22/2013 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM ARTHREX, INC. COURTNEY SMITH
K130196 01/28/2013 SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR ARTHROCARE CORP. LAURA KASPEROWICZ
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
K130050 01/11/2013 TITAN REVERSE SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
K133297 11/21/2013 QUADROSTARPROGREEN, QUADROSTARPROYELLOW ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K133462 11/12/2013 DUOCENTRIC REVERSED SHOULDER PROSTHESIS ASTON MEDICAL CATHERINE GLOSTER
K130131 01/18/2013 EDRAIN CHEST DRAINAGE SYSTEM ATRIUM MEDICAL CORP. CHRISTINA CALDERWOOD
K130142 01/22/2013 FLIXENE IFG VASCULAR GRAFT ATRIUM MEDICAL CORPORATION MEGAN MCCAGH, RAC, CTBS
K123474 01/28/2013 AVANT LASER AVANT WELLNESS SYSTEMS, LLC ANDY HEWITSON
K133521 11/21/2013 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
K130103 01/18/2013 CORONIS FUSION 6MP BARCO N.V. LIEVEN DE WANDEL
K133569 11/25/2013 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
K133146 11/07/2013 BAUSCH + LUMB, VIS100 INJECTOR SYSTEM BAUSCH & LOMB SHIVANI K CHITALIA
K133486 11/14/2013 STELLARIS PC VISION ENHANCEMENT SYSTEM BAUSCH & LOMB TIMOTHY W CAPEHART
K130245 01/31/2013 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K130122 01/25/2013 BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER BECKMAN COULTER, INC AMANDA BROWN
K130020 01/03/2013 ACCESS TOTAL BHCG (5TH IS) BECKMAN COULTER, INC. GERALDINE L BAGLIEN
K130197 01/28/2013 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 BECTON, DICKINSON AND COMPANY JOHN ROBERTS
K133158 11/04/2013 ND: YAG LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K130172 01/29/2013 BELIMED STEAM STERILIZER MST-V BELIMED, INC. JAY UPCHURCH
K133608 11/25/2013 TRINIA BICON, LLC RICHARD WU
K133441 11/12/2013 ONESTEP CPR II MULTI-FUNCTION ELECTRODE BIO-DETEK, INC. SHANNON DUHAMEL
K130162 01/23/2013 LIQUID ASSAYED MULTIQUAL PREMIUM BIO-RAD LABORATORIES SUZANNE PARSONS
K130053 01/15/2013 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI BIO-RAD LABORATORIES, INC. JUANG WANG
K130158 01/23/2013 M-SCAN BIO-RESEARCH ASSOCIATES, INC. JOHN RADKE
K133520 11/15/2013 HAMMERLOCK 2 BIOMEDICAL ENTERPRISES, INC JOE SOWARD
DEN130013 01/02/2013 VITEK MS BIOMERIEUX, INC. Nancy Weaver
K124067 01/02/2013 VITEK MS BIOMERIEUX, INC. NANCY WEAVER
K130033 01/04/2013 TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K133518 11/15/2013 MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE (AKA EBI, LLC) KIMBERLY MCCOY
K130063 01/10/2013 ARCOS TROCHANTER BUTTON BIOMET, INC. BECKY EARL
K130126 01/17/2013 SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM BIOMET, INC. TRACY B JOHNSON
K130067 01/10/2013 MRNA APPLIANCE BIOMODELING SOLUTIONS, LLS COLETTE COZEAN, PH.D.
K133522 11/22/2013 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
K130065 01/16/2013 BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE BIOSONIC TECHNOLOGIES, LLC SHEPARD G BENTLEY
K133509 11/18/2013 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO BIOTEST MEDICAL CORP. ROBERT NAWY
K130161 01/23/2013 PASSEO-35 BIOTRONIK, INC. JON BRUMBAUGH
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
K130121 01/17/2013 SHORT PORT BLUNT TIP TROCAR BOSTON SCIENTIFIC CORPORATION MARK DINGER
K130004 01/04/2013 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION JANIS TARANTO
K130037 01/08/2013 BREATHE CPAP SYSTEM BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
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. AMY HONEY
K133073 11/22/2013 CAIR DRIVE, NEUTRACLEAR CAIR LGL IRVING WIESEN
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 11/04/2013 ORTHROS POSTERIOR STABILIZATION SYSTEM CAMBER SPINE DANIEL A PONTECORVO
K130036 01/08/2013 COSENSE CO MONITOR CAPNIA, INC. JULIE BLACKLOCK
K130061 01/15/2013 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K133148 11/19/2013 BIOMARC COAXIAL NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K130208 01/30/2013 BERNOULLI ENTERPRISE SOFTWARE CARDIOPULMONARY CORP. UREY KANG
K133399 11/06/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATED BLAIR BUTH
K130124 01/24/2013 CATALYST II AND III CARDIVA MEDICAL, INC. MICHAEL A DANIEL
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 11/14/2013 SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION CARL ZEISS MEDITEC AG SARAH HARRINGTON
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
K133357 11/01/2013 CHARRUAPACS SYSTEM CHARRUASOFT SA CARL ALLETTO
K130194 01/30/2013 ACCULIF XL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K133600 11/27/2013 COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR COEUR, INC. DEBRA F MANNING
K130019 01/03/2013 J-SCREW COMPRESSION SCREW COMPETITIVE ENGINEERING INC. DAVID M DAVIS
K133464 11/12/2013 MODIFIED TREVO PROVUE RETRIEVER CONCENTRIC MEDICAL, INC. SARAH MEYER
K133560 11/25/2013 ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K133256 11/12/2013 ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. ANITA SHAH
K133465 11/12/2013 CONSURE STOOL MANAGEMENT SYSTEM CONSURE MEDICAL PVT LTD. ALAN DONALD
K130006 01/08/2013 BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS COOK BIOTECH INCORPORATED NICK X WANG
K133597 11/26/2013 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
K130128 01/22/2013 TRINITY ACETABULAR SYSTEM CORIN MEDICAL LUCINDA GERBER
K133204 11/26/2013 AIRVIEW MINI OWIE DICK TEST PACK CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K130089 01/14/2013 CROSSTREES PVA POD CROSSTREES MEDICAL, INC. JANICE M HOGAN
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
K130083 01/14/2013 DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE DEMETECH CORP. ANTHONY J DIMERCURIO
K130186 01/25/2013 DENTEK EASY BRUSH WITH FLUORIDE DENTEK ORAL CARE, INC. LINDA GILES
K130216 01/31/2013 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT DENTSPLY IMPLANT LINDA K SCHULZ
K130105 01/15/2013 RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K133448 11/15/2013 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K130090 01/18/2013 STA COMPACT MAX DIAGNOSTICA STAGO, INCORPORATED CARLO D'ALESSANDRO
K133410 11/07/2013 DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET DIAZYME LABORATORIES ABHIJIT DATTA
K123785 01/17/2013 DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET DIAZYME LABORATORIES ABHIJIT DATTA
K133434 11/08/2013 GENESIS II DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K133517 11/15/2013 NEMUS 2 SYSTEM EB NEURO, S.P.A. ALLISON SCOTT, RAC
K130070 01/18/2013 4MP COLOR LCD MONITOR, RADIFORCE RX 440 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K133565 11/20/2013 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB MATILDA FORSBERG
K133405 11/12/2013 MINNIE ELETTRONICA VALSERIANA SRL SERGIO GHERSINI
K130110 01/16/2013 MEDDUSA BIPOLAR SYSTEM ELLIQUENCE LLC OSCAR R PAREDES
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 11/14/2013 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K130048 01/10/2013 REVERSE SHOULDER PROSTHESIS MONOBLOCK ENCORE MEDICAL, L.P. TEFFANY HUTTO
K130099 01/16/2013 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 ENCORE MEDICAL, L.P. WILLIAM GARZON
K133425 11/14/2013 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
K133647 11/27/2013 EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K133490 11/13/2013 G-SCAN BRIO ESAOTE S.P.A. ALLISON S COTT
K130068 01/15/2013 DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF MISSOURI KEN SEISE
K133356 11/14/2013 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, INC. ELLIOTT JANG
K133446 11/12/2013 HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation JOHN LINFANTE
K130120 01/18/2013 EXTREMITY MEDICAL IP FUSION SYSTEM EXTREMITY MEDICAL, LLC BRIAN SMEKAL
K133573 11/20/2013 FIAGON NAVIGATION SYSTEM FIAGON GMBH DIRK MUCHA
K133403 11/08/2013 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 11/20/2013 CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER FLEXICARE CHRISTOPHER WATKINS
K130171 01/24/2013 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. SHOSHANA FRIEDMAN
DEN130049 11/25/2013 SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS SHARON YOUNG
K133621 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
K130001 01/30/2013 CARE SU01A SUCTION ASPIRATOR FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. GANG WU
K133454 11/12/2013 SONOSITE EDGE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. PATRICIA LIAU
K130173 01/28/2013 SONOSITE MAXX SERIES ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K130039 01/11/2013 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K130190 01/28/2013 PIXEL 3 SYSTEM GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
K133182 11/12/2013 HTFX-222 GC AMERICA, INC. MARK HEISS
K130069 01/11/2013 INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 GE HEALTHCARE NING WEN
K133533 11/18/2013 LOGIQ E GE HEALTHCARE BRYAN BEHN
K133431 11/08/2013 VENUE 50 GE HEALTHCARE BRYAN BEHN
K133576 11/26/2013 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K130155 01/25/2013 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K133278 11/06/2013 DISCOVERY IGS 740 GE MEDICAL SYSTEMS SCS MICHEL GENUER
K133649 11/27/2013 HEPATIC VCAR GE MEDICAL SYSTEMS SCS HUY DOAN
K133640 11/27/2013 ASIR-V GE MEDICAL SYSTEMS, LLC HUY DOAN
K130115 01/16/2013 DISCOVERY MR750W 3.0T GE MEDICAL SYSTEMS, LLC MICHELLE HUETTNER
K133605 11/25/2013 BD MAX MRSA XT, BD MAX INSTRUMENT GENEOHM SCIENCES CANADA, INC. PATRICIA DIONNE
K130082 01/18/2013 GENPRIME DRUGS OF ABUSE READER SYSTEM GENPRIME, INC MAUREEN GARNER
K123864 01/04/2013 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD. TIM THOMAS
K133482 11/13/2013 SILC FIXATION SYSTEM GLOBE MEDICAL, INC. CHRISTINA KICHULA
K133567 11/25/2013 UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. CHRISTINA KICHULA
K133678 11/29/2013 CONFIRM BIOACTIVE GLOBUS MEDICAL, INC. CHRISTINA KICHULA
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
K130055 01/11/2013 ACON BUP ONE STEP BUPRENORPHINE TEST STRIP GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K133528 11/26/2013 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
K132937 11/27/2013 HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) HARVEST DENTAL PRODUCTS, LLC ANDREW ROWE
K130034 01/08/2013 UNI-PICC HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
DEN130045 11/04/2013 HEARTFLOW FFRCT HEARTFLOW Dustin Michaels
K130141 01/22/2013 S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA B AMMIRATI, RAC, MT (ASCP)
K130038 01/29/2013 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE HL RUBBER INDUSTRIES SDN BHD NOORZALIZA AHMAD
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
K133352 11/01/2013 HYPERSOUND AUDIO SYSTEM (HSS) HYPERSOUND HEALTH, INC. JAMES A BARNES
K133346 11/21/2013 SMARTLOG DIABETES MANAGEMENT SOFTWARE I-SENS, INC. HYE YOUNG KANG
K130008 01/23/2013 DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING I.T.S. GMBH AL LIPPINCOTT
K130059 01/10/2013 ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. ELISSA BURG
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
K133196 11/01/2013 IMPACT MODEL 323 ASPIRATOR IMPACT INSTRUMENTATION, INC. ALAN GIORDANO
K133617 11/25/2013 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K130224 01/31/2013 ICT IMRIS, INC. DANIEL BIANK
K130181 01/30/2013 GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K133290 11/06/2013 COLLACARE DENTAL INNOCOLL PHARMACEUTICALS AARON WYSE
K133459 11/12/2013 ELITE IBF INNOVA SPINAL TECHNOLOGIES, LLC RICH JANSEN, PHARM. D.
K133542 11/21/2013 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 11/25/2013 STAPIX SUPERELASTIC IMPLANT BONE STAPLES INSTRATEK, INC. JEFF SEAVEY
K133582 11/21/2013 HEMOSIL D-DIMER HS 500 CONTROL INSTRUMENTATION LABORATORY CAROL MARBLE
K133407 11/12/2013 GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
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K133616 11/25/2013 MATRIXRIB FIXATION SYSTEM SYNTHES (USA) PRODUCTS LLC DAMON LEES
K123130 01/15/2013 ANSWATCH WRIST MONITOR MODEL TS-0411 TAIWAN SCIENTIFIC CORPORATION DEHCHUAN SUN
K133593 11/22/2013 T:SLIM INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. JOHN SHERIDAN
K130136 01/18/2013 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, TECHNOMED EUROPE PIERRE VREULS
K133202 11/04/2013 HEM-O-LOK LIGATING CLIP TELEFLEX MEDICAL ASHLEA RICCI
K133439 11/12/2013 PILLING ESOPHAGEAL BOUGIES TELEFLEX MEDICAL, INC. HOLLY KORNEGAY
K130043 01/09/2013 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM TELEFLEX MEDICAL, INC. NATALIE SMITH
K133658 11/27/2013 CDI BLOOD PARAMETER MONITORING SYSTEM 500 TERUMO CARDIOVASCULAR SYSTEMS CORP. Kevin Kong
K133151 11/07/2013 SARNS HIGH FLOW AORTIC ARCH CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
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
K130051 01/14/2013 611 ANKLE FUSION NAIL TORNIER SAS DAMIEN GUILLAUD
K133376 11/07/2013 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
K130012 01/24/2013 WET PLATINUM PERSONAL LUBRICANT TRIGG LABORATORIES, INC. ERNIE JOHNSON
K133419 11/07/2013 BABYMEG BIOMAGNETOMETER SYSTEM TRISTAN TECHNOLOGIES INC EUGENE HIRSCHKOFF
K133406 11/13/2013 CS 8100 3D TROPHY MARIE PIERRE
K123162 01/17/2013 U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL U&U MEDICAL TECHNOLOGY CO., LTD GARFIELD WANG
K130149 01/25/2013 U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE UNITED ORTHOPEDIC CORPORATION FANG-YUAN HO
K130148 01/22/2013 FOREIGN BODY HOOD UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
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
K133247 11/04/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133227 11/04/2013 SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133240 11/04/2013 VARIAN MULTILEAF COLLIMATOR VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133501 11/14/2013 LEADLINER CS LEAD DELIVERY SYSTEM VASCULAR SOLUTIONS, INC. MIA HUNT
K130109 01/25/2013 ENDOGRAPH DC VILLA SISTEMI MEDICALI S.P.A. PAOLO CASAGRANDE SANTIN
K133568 11/26/2013 G-TL VITROLIFE, INC. MARK LARMAN
K133139 11/12/2013 VIZION ULTRA VIZTEK LLC DANIEL KAMM, P.E.
K133641 11/29/2013 CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE VOLCANO CORPORATION MARCUS GARCIA
K133445 11/15/2013 ANGIOVAC CANNULA VORTEX MEDICAL INC LORRAINE M HANLEY
K133488 11/13/2013 PIEZOMED W & H DENTALWERK BUERMOOS GMBH ANJA LINDNER
K130215 01/29/2013 GORE ACUSEAL VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC MICHAEL IVEY
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
K130167 01/25/2013 PROFEMUR XM DISTAL CENTRALIZER WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K130044 01/08/2013 SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. RYAN BORMANN
K123958 01/29/2013 JIAJIAN POINTOSELECT DIGITAL WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. DORIS DONG
K130108 01/22/2013 DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD DA ZENG
K130030 01/08/2013 ZAVATION CERVICAL PLATE SYSTEM ZAVATION LLC JOHN WALKER
K133339 11/04/2013 ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED ZIMMER DENTAL INC. JULIE L CORMAN
K133551 11/19/2013 ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM ZIMMER DENTAL INC. MELISSA BURBAGE
K133184 11/07/2013 ARDIS INTERBODY SYSTEM ZIMMER SPINE, INC MICHELLE LENZ
K133556 11/20/2013 VIRAGE OCT SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. HOLLY SEPPANEN
K130143 01/23/2013 PERSONA NATURAL TIBIA BASEPLATES ZIMMER, INC. NICOLE J MEREDITH
K133378 11/12/2013 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM ZIMMER, INC. DAN WILLIMAN
K133484 11/13/2013 ZOLL X SERIES ZOLL MEDICAL CORP. TANMAY SHUKLA
K130092 01/15/2013 SIMMETRY SACROILIAC JOINT FUSION SYSTEM ZYGA TECHNOLOGY, INC. DIANE BRINZA


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