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
K130185 01/25/2013 4WEB OSTEOTOMY BONE WEDGE 4-WEB, INC. RICH JANSEN, PHARM, D.
K130157 01/23/2013 AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K133675 11/29/2013 AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K130113 01/16/2013 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 11/12/2013 MARATHON NO STING LIQUID SKIN PROTECTANT ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD ROSE GUANG
K130165 01/23/2013 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
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
K130097 01/15/2013 MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED MIKE HOFTMAN
K130152 01/22/2013 HYDRASOLVE LIPOPLASTY SYSTEM ANDREW TECHNOLOGIES, LLC HERBERT CRANE
K133561 11/20/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH ANGIODYNAMICS, INC. Lorraine M Hanley
K130150 01/22/2013 TCM MASSAGER ANHUI JINJIANQIAO MED-TECH CO,. LTD. FIELD FU
K133393 11/05/2013 GELPOINT PATH TRANSANAL ACCESS PLATFORM APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K130192 01/25/2013 NEXTSTEP RETROGRADE ARROW INTERNATIONAL, INC. GWEN TASCHNER
K130129 01/17/2013 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 01/09/2013 TITAN REVERSE SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
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
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
K130103 01/15/2013 CORONIS FUSION 6MP BARCO N.V. LIEVEN DE WANDEL
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
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 01/17/2013 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
K130172 01/24/2013 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
K124067 01/02/2013 VITEK MS BIOMERIEUX, INC. NANCY WEAVER
DEN130013 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 11/15/2013 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
K130065 01/10/2013 BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE BIOSONIC TECHNOLOGIES, LLC SHEPARD G BENTLEY
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
K130161 01/23/2013 PASSEO-35 BIOTRONIK, INC. Jon Brumbaugh
K133413 11/07/2013 IDSS SLC BLACK DIAMOND VIDEO RAGUNATH MUNIANDY
K130243 01/31/2013 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. LORI R SMITH
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 01/02/2013 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation JANIS TARANTO
K130037 01/07/2013 BREATHE CPAP SYSTEM BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
K133385 11/05/2013 LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE BRONCUS MEDICAL INC ROBIN BUSH
K130101 01/15/2013 BYTECH BYTECH DONGTAI CO., LTD. CHU XIAOAN
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
K130036 01/07/2013 COSENSE CO MONITOR Capnia, Inc. Julie Blacklock
K130061 01/10/2013 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K130208 01/28/2013 BERNOULLI ENTERPRISE SOFTWARE CARDIOPULMONARY CORP. UREY KANG
K133399 11/06/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATED BLAIR BUTH
K130124 01/17/2013 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 11/12/2013 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
K130027 01/03/2013 DISPOSABLE NEUTRAL ELECTRODE GP202 CATHAY MANUFACTURING CORP. ZHANG HUI
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
K130180 01/25/2013 CLEANSER ROOT CANAL CERKAMED WOJCIECH PAWLOWSKI KINGA WIERUCKA
K133525 11/15/2013 LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD Diana Hong
K130046 01/08/2013 CLEARSPEC SINGLE USE VAGINAL SPECULUM CLEARSPEC LLC IRA DUESLER
K130194 01/28/2013 ACCULIF XL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
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
K130137 01/18/2013 BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER COLTENE/WHALEDENT EDWARD A KROLL
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 11/20/2013 ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K133465 11/12/2013 CONSURE STOOL MANAGEMENT SYSTEM CONSURE MEDICAL PVT LTD. ALAN DONALD
K130006 01/02/2013 BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS COOK BIOTECH INCORPORATED NICK X WANG
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
K130128 01/17/2013 TRINITY ACETABULAR SYSTEM CORIN MEDICAL LUCINDA GERBER
K133599 11/25/2013 CORGRIP CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
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
K130168 01/24/2013 CL10009 IR LASER CURAE'LASE INC. M. JOYCE HEINRICH
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
K130135 01/18/2013 DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC. HARRY BALA
K130244 01/31/2013 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION NICKY PAN
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 01/29/2013 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT DENTSPLY IMPLANT LINDA K SCHULZ
K130169 01/24/2013 FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
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
K130163 01/23/2013 D-LUX DIADENT GROUP INTERNATIONAL GIL JUN, HONG
K133448 11/15/2013 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K130090 01/14/2013 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
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
K130070 01/11/2013 4MP COLOR LCD MONITOR, RADIFORCE RX440 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K133565 11/20/2013 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB MATILDA FORSBERG
K133405 11/06/2013 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 11/12/2013 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K130048 01/08/2013 REVERSE SHOULDER PROSTHESIS MONOBLOCK ENCORE MEDICAL, L.P. TEFFANY HUTTO
K130099 01/15/2013 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 ENCORE MEDICAL, L.P. WILLIAM GARZON
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
K130068 01/11/2013 DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M KEN SEISE
K130178 01/25/2013 INSPIRATION VENTILATOR SYSTEM 5I/7I EVENT MEDICAL LTD RICK WATERS
K133446 11/12/2013 HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation JOHN LINFANTE
K130120 01/17/2013 EXTREMITY MEDICAL IP FUSION SYSTEM EXTREMITY MEDICAL, LLC BRIAN SMEKAL
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
K130171 01/24/2013 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. SHOSHANA FRIEDMAN
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
K130001 01/02/2013 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 01/24/2013 SONOSITE MAXX SERIES ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K130039 01/07/2013 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K130190 01/28/2013 PIXEL 3 SYSTEM GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
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 11/20/2013 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K130155 01/22/2013 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
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
K130115 01/16/2013 DISCOVERY MR750W 3.0T GE MEDICAL SYSTEMS, LLC MICHELLE HUETTNER
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
K130088 01/14/2013 PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM GENORAY CO., LTD. JAE KIM
K130082 01/14/2013 GENPRIME DRUGS OF ABUSE READER SYSTEM GENPRIME, INC Maureen Garner
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
K130055 01/09/2013 ACON BUP ONE STEP BUPRENORPHINE TEST STRIP Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K133528 11/15/2013 H&H EMERGENCY CRICOTHYROTOMY KIT H&H MEDICAL CORPORATION J. Lawrence Stevens
K130235 01/30/2013 SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY HANS BIOMED CORP. PATSY J TRISLER, JD, RAC
K130191 01/25/2013 MINT HANSBIOMED CORPORATION APRIL LEE
K133552 11/19/2013 MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT Hansen Medical HASSAN LABAY
K130034 01/07/2013 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 01/07/2013 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
K130008 01/02/2013 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
K133617 11/25/2013 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K130224 01/29/2013 ICT IMRIS, INC. Daniel Biank
K130181 01/25/2013 GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
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
K130140 01/22/2013 INTRA-LOCK OP DENTAL IMPLANT INTRA-LOCK INTERNATIONAL DIANA TAYLOR
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
K130232 01/29/2013 ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM JINXINBAO ELECTRONIC CO.,LTD HELEN NAN
K130231 01/29/2013 NON-CONTACT INFRARED THERMOMETER JINXINBAO ELECTRONIC CO.,LTD 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
K130056 01/09/2013 PATIENT MONITOR LD TECHNOLOGY LLC ALBERT MAAREK
K133363 11/01/2013 INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM LDR SPINE, USA, INC. MEREDITH MAY
K130016 01/01/2013 LIFESPAN EPTFE VASCULAR GRAFT LEMAITRE VASCULAR, INC. XIANG ZHANG
K130202 01/28/2013 IRIS ANTERIOR CERVICAL PLATE LIFE SPINE, INC RANDY LEWIS
K133564 11/20/2013 MODIFICATION TO NAUTILUS SPINAL SYSTEM LIFE SPINE, LLC. RANDY LEWIS
K130164 01/23/2013 FIBERLASE ENDURE CO2 FIBER LUMENIS LTD. YORAM LEVY
K130195 01/28/2013 SCANNING LASERLINK LUMENIS, INC. JACE R MCLANE
K130028 01/03/2013 RESURFX 1565NM LASER MODULE LUMENIS, LTD. YORAM LEVY
K130189 01/25/2013 XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
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K130213 01/29/2013 QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE LUMIQUICK DIAGNOSTICS, INC. Feng-Yu Lee
K130199 01/28/2013 CLARITY LPC LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
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
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K130210 01/29/2013 MEDELA THOPAZ MEDELA AG MARKUS BUETLER
K130080 01/14/2013 EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL MEDICA CORPORATION Photios Makris
K133428 11/08/2013 MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO MEDIKRO OY MIKKO ELORANTA
K130221 01/29/2013 HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM MEDIMECCA CO., LTD. Priscilla Chung
K130179 01/25/2013 MP VIAL ADAPTER 13MM MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K130132 01/18/2013 BABYLANCE HEEL INCISION DEVICE MEDIPURPOSE PTE. LTD. JULIE STEPHENS
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
K130177 01/25/2013 ANATOMIC PEEK CERVICAL FUSION 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
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K130229 01/29/2013 PALM BLADDER SCANNER MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. HELEN NAN
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
K130073 01/11/2013 MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS MIKRON MAKINA SANAYI VE TICARET LTD STI OMAR DIKER
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K130003 01/02/2013 XIRALITE FLOURESCENCE IMAGING SYSTEM X4 MIVENION GMBH MALTE BAHNER
K130040 01/07/2013 MEPITEL AG MOLNLYCKE HEALTH CARE ANGELA L BUNN
K133515 11/15/2013 PEEK FUSION IMPLANT MTP SOLUTIONS LLC ROBERT HOY
K133453 11/12/2013 IOVERA MYOSCIENCE INC BIJESH CHANDRAN
K130010 01/03/2013 PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES SYLVA KRIZAN, PHD
K133609 11/25/2013 THE DOME S6C NDS SURGICAL IMAGING JIM LENG
K130198 01/28/2013 NEO DENTA ZIRCONIA NEO GROUP LIMITED MIKE ADAMS
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
K130228 01/29/2013 SUITEHEART NEOSOFT, LLC JACKIE SCHWABE
K130117 01/16/2013 NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS NETWORK MEDICAL PRODUCTS, LTD. ALISON MARCH
K130233 01/30/2013 NEUROSTAR TMS THERAPY SYSTEM NEURONETICS JUDY P WAYS, PH.D.
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
K130114 01/16/2013 PAINMASTER MCT PATCH NEWMARK, INC. CHERITA JAMES
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K133507 11/14/2013 GUIDOSS NIBEC CO LTD DANIEL NAM
K130238 01/31/2013 NIHON KOHDEN AE-918P NEURO UNIT NIHON KOHDEN CORP. NATALIE KENNEL
K130049 01/08/2013 MONOJECT 12ML SYRINGE NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K130057 01/09/2013 ESPIN NLT SPINE LTD JOHN J SMITH
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
K130023 01/03/2013 K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR NP MEDICAL, INC. ROBERT J BARD, JD, RAC, CQE
K130242 01/31/2013 MAVEN PRO NSEQUENCE RHONDA ALEXANDER, MS, MPA
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K130058 01/09/2013 ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 OLYMPUS MEDICAL SYSTEMS CORP. DAPHNEY GERMAIN-KOLAWOLE
K133381 11/04/2013 OMNI ARC MONOBLOCK HIP STEM OMNILIFE SCIENCE CHRISTINA FLORES
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K130217 01/29/2013 ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K130104 01/15/2013 GUIDEWIRE, PURSUER SERIES Oscor Inc. MILA DOSKOCIL
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K130174 01/24/2013 DVTCARE CA5 OSSUR AMERICAS INC JOHN LINDAHL
K133437 11/07/2013 1ST MTP PLATE OSTEOMED BLESSON ABRAHAM
K130201 01/28/2013 NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM OTOTRONIX, LLC BERNARD HORWATH
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K130206 01/28/2013 PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS PENTAX OF AMERICA, INC. KRISHNA GOVINDARAJAN
K133404 11/06/2013 IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH PHADIA AB MARTIN R MANN
K130091 01/15/2013 PULMOSAL PHARMACARIBE PAUL DRYDEN
K130159 01/23/2013 QLAB QUANTIFICATION SOFTWARE HEART MODEL PHILIPS HEALTHCARE PENNY GRECO
K133674 11/29/2013 PHILIPS IQON SPECTRAL CT PHILIPS HEALTHCARE (CLEVELAND) CATHERINE M CONNELL
K130153 01/22/2013 HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST PHILIPS MEDICAL SYSTEMS MARK PUOPOLO
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
K130021 01/03/2013 PHILIPS HERCEPTEST DIGITAL SCORE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. DIRK VOSSEN
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
K130223 01/29/2013 RMGI FILL PULPDENT CORPORATION KENNETH J BERK
K133382 11/04/2013 QB TEST QBTECH AB HANS BOSTROM
K133503 11/14/2013 AMPLIVUE GBS ASSAY QUIDEL CORPORATION Ronald H Lollar
K130144 01/22/2013 ABL90 FLEX RADIOMETER MEDICAL APS Martin Gabler
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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
K130079 01/14/2013 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER REFLECTANCE MEDICAL INC Nandini Murthy
K130237 01/31/2013 PONTIC PAINT RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K130002 01/02/2013 SURECALL LABOR MONITOR REPRODUCTIVE RESEARCH TECHNOLOGIES, LP J. HARVEY KNAUSS
K124065 01/02/2013 FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY LTD GREG HOLLAND
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K130170 01/24/2013 EXSPIRON 1XI RESPIRATORY MOTION, INC. JENNY FREEMAN, MD
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K130218 01/30/2013 XSTAT REVMEDX, INC. JOHN J SMITH
DEN130016 01/30/2013 XSTAT REVMEDX, INC. JOHN J SMITH
K130220 01/29/2013 MR CONDITIONAL PRESSON ELECTRODE RHYTHMLINK INTERNATIONAL, LLC JAMES M MEWBORNE
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K130138 01/18/2013 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM ROCHE DIAGNOSTICS CORP. Justin Davis
K133496 11/14/2013 X TWIN SYSTEM ROESYS GMBH JOCHEN DYSZBALIS
K130125 01/17/2013 MTA CEMENTS S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN CHRISTIAN BOETTCHER
K130014 01/02/2013 A1C GEAR SYSTEM Sakae Corporation ERICA B AMMIRATI
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
K130130 01/17/2013 ATG/SM-OSA APPLIANCES SELANE PRODUCTS, INC. CAROLYN PRIMUS
K133362 11/01/2013 SGS DENTAL IMPLANT SGS INTERNATIONAL LTD DANIELA LEVY
K130015 01/03/2013 SHASER V-MINI HAIR REMOVAL SYSTEM SHASER, INC. SARAH HACKETT
K130041 01/08/2013 SHEATHES STERILE ULTRASOUND GEL SHEATHING TECHNOLOGIES, INC. JENNIFER DOWNING
K133478 11/12/2013 POWDER FREE POLYETHYLENE EXAMINATION GLOVES SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD KATHY LIU
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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
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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
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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
K130225 01/29/2013 QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE SILVERBAY LLC, D/B/A QUASAR BIO-TECH ROBERT WAGNER
K130147 01/22/2013 ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) SMALL BONE INNOVATIONS, INC. JOHN MINIER
K133662 11/29/2013 SMITH & NEPHEW CANNULATED CAPTURED SCREW SMITH & NEPHEW, INC. KATHERINE MARCACCIO
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DEN130046 11/14/2013 REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE SOMNA THERAPEUTICS, LLC James S. Miller
K130025 01/03/2013 SONENDO ENDOTHERAPY SYSTEM SONENDO, INC. DAN W MILLER
K130119 01/16/2013 PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED TOKI WU
K130209 01/29/2013 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED SORIN GROUP ITALIA S.R.L. SCOTT LIGHT
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
K130112 01/16/2013 CAPNO MODULE, 92517 SPACELABS HEALTHCARE THOMAS KROENKE
K130207 01/28/2013 SPACELABS HEALTHCARE CARDIOEXPRESS SPACELABS HEALTHCARE LTD. THOMAS KROENKE
K133631 11/26/2013 LEXIPLIANT DILATOR SHEATH SET SPECTRANETICS CORPORATION STACEY A STRAND
K130066 01/10/2013 SPECTRUM SPINE SPINOUS PROCESS DEVICE SPECTRUM SPINE IP HOLDINGS, LLC RICH JANSEN
K133557 11/19/2013 JULIET LL LATERAL LUMBAR CAGE SPINEART FRANCK PENNESI
K133371 11/01/2013 RAMPART-L SPINEOLOGY, INC. BRYAN BECKER
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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
K130160 01/23/2013 VERIFY PROCESS INDICATOR FOR RELIANCE EPS STERIS Corporation MARCIA L BENEDICT
K133549 11/19/2013 STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR STERITEC PRODUCTS MFG., CO., INC. JONATHAN RUTIGLIANO
K130183 01/25/2013 SFI BAR ABUTMENTS STERNGOLD DENTAL LLC MARIA RAO
K130222 01/29/2013 STRAUMANN DENTAL IMPLANT SYSTEM STRAUMANN USA, LLC JENNIFER M JACKSON, MS
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
K130116 01/16/2013 SUPERIOR LATERAL VARIAX CLAVICLE PLATE Stryker Trauma AG ESTELA CELI
K130009 01/02/2013 VARIAX 2 COMPRESSION PLATING SYSTEM Stryker Trauma AG ESTELA CELI
K130078 01/14/2013 QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANGIOTECH KIRSTEN STOWELL
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
K130146 01/22/2013 SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM SYNTHES (USA) LLC STACEY BONNELL
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
K130136 01/18/2013 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, TECHNOMED EUROPE PIERRE VREULS
K133439 11/12/2013 PILLING ESOPHAGEAL BOUGIES Teleflex Medical, Inc. HOLLY KORNEGAY
K130043 01/08/2013 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
K130084 01/14/2013 MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM TGM MEDICAL, INC. PRAKASH PAI
K133604 11/25/2013 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS THE ANSPACH EFFORT, INC. JEANNETTE G DAILEY
K130052 01/09/2013 TONE-A-MATIC TONE-A-MATIC INTERNATIONAL, INC. ANNIA KORDIUK
K133667 11/29/2013 SLIT LAMP SL-D701 TOPCON CORP. MAUREEN O'CONNELL
K130051 01/09/2013 611 ANKLE FUSION NAIL Tornier SAS DAMIEN GUILLAUD
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
K130012 01/02/2013 WET PLATINUM PERSONAL LUBRICANT TRIGG LABORATORIES, INC. ERNIE JOHNSON
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
K130149 01/22/2013 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
K130017 01/02/2013 VALENTINE STEEL WHEELCHAIR VALENTINE INTL. LTD. JEN KE-MIN
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
K130109 01/16/2013 ENDOGRAPH DC VILLA SISTEMI MEDICALI S.P.A. PAOLO CASAGRANDE SANTIN
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
K130215 01/29/2013 GORE ACUSEAL VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC Michael Ivey
K133652 11/27/2013 GSP NEONATAL TOTAL GALACTOSE KIT WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. JEANETTE SCHIER-PUGSLEY
K130074 01/14/2013 GYMFORM ABS-A-ROUND WELL BRAIN INTERNATIONAL, LTD. VICTOR K WAI
K133615 11/25/2013 WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER WELL LEAD MEDICAL CO. LTD JOHN OBRIEN
K130184 01/25/2013 ZENOLUX WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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 01/23/2013 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
K130212 01/29/2013 SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE WUXI YUSHOU MEDICAL APPLICANCES CO., LTD GARFIELD WANG
K130230 01/29/2013 STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES WUXI YUSHOU MEDICAL APPLICANCES CO., LTD GARFIELD WANG
K130108 01/16/2013 DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD DA ZENG
K130030 01/04/2013 ZAVATION CERVICAL PLATE SYSTEM ZAVATION LLC JOHN WALKER
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
K130143 01/22/2013 PERSONA NATURAL TIBIA BASEPLATES ZIMMER, INC. NICOLE J MEREDITH
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
K130092 01/15/2013 SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. Diane Brinza


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