FDA 510(k) Applications Received During December, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K133903 12/20/2013 BIO-PROBE TRANSDUCER (ADULT) MEDTRONIC INC. RAHUL SHAH
K133769 12/11/2013 3B RESMART BPAP 25A, BMC RESMART BPAP 25A 3B MEDICAL, INC ALEX LUCIO
K133776 12/12/2013 A-DEC/W&H ELECTRIC HANDPIECE MOTOR A-DEC, INC. BONNIE DUNDAS
K133963 12/24/2013 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC Caridad Smith
K133898 12/20/2013 NIOX VERO AIRWAY INFLAMMATION MONITOR AEROCRINE AB Susanne Parks
K133802 12/13/2013 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K133890 12/30/2013 AESCULAP OPTILENE NONABSORBABLE SUTURE AESCULAP, INC. KATHY A RACOSKY
DEN130018 12/18/2013 CYTOSCAN(R) DX Affymetrix, Inc. ERIC FUNG
K133851 12/19/2013 ALERE PBP2A SA/CONS CULTURE COLONY TEST ALERE SCARBOROUGH, INC DANIELLE A BRIGGEMAN
K133991 12/26/2013 ISY ALTATEC GMBH LINDA SCHULZ
K133783 12/23/2013 AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION AMERIWATER BRIAN R BOWMAN
K133685 12/02/2013 0.9% SODIUM CHLORIDE FLUSH SYRINGE AMUSA ALEX FERRI
K133770 12/11/2013 A.I.M. KNOTLESS MENISCAL REPAIR DEVICE ANCHOR INNOVATION MEDICAL (A.I.M.) KAREN M BECKER, PH.D.
K133790 12/09/2013 IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM ANDON HEALTH CO., LTD YI LIU
K133998 12/26/2013 ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING ANGIOSCORE, INC. KIMBERLEY KLINE
K133854 12/19/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. LEON BROWN, II
K133727 12/06/2013 Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU ARTHROCARE CORPORATION MITCHELL DHORITY
K133835 12/18/2013 ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K133865 12/19/2013 ASAHI GAIA FIRST, SECOND, THIRD ASAHI INTECC CO., LTD. CANDACE CEDERMAN
K133742 12/16/2013 XQ-1 INCUBATOR AT MEDICAL UAB THOMAS PEDERSEN
K133967 12/24/2013 INTERBODY CAGE SYSTEM AURORA SPINE JUSTIN EGGLETON
K133981 12/26/2013 AVACEN 100 AVACEN INC. THOMAS G MUEHLABUER
K133764 12/11/2013 CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL AVERY DENNISON BELGIE, BVBA LISA BARTAKOVICS
K133663 12/04/2013 NIO COLOR 2MP BARCO N.V.
K133984 12/26/2013 CORONIS 5MP BARCO NV LIEVEN DE WANDEL
K133948 12/23/2013 BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT BARD PERIPHERAL VASCULAR, INC. SARAH MCCARTNEY
K133743 12/09/2013 BAXANO SURGICAL MIS SPINAL SYSTEM BAXANO SURGICAL, INC. KRISTEN ALLEN
K133801 12/13/2013 BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY BAXTER HEALTHCARE CORPORATION THOMAS SAMPOGNA
K133975 12/26/2013 MSA100 PEAK FLOW METER BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD MIKE GU
K133915 12/23/2013 GALAXY CO2 LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K133873 12/20/2013 TRIBALL INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORP. PAUL DRYDEN
K133774 12/24/2013 ATOVEN BIO-MED U.S.A., INC. YOUNG CHI
K134013 12/30/2013 LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO BIO-RAD LABORATORIES SUZANNE PARSONS
K133960 12/24/2013 LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES SUZANNE PARSONS
K133884 12/20/2013 BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM BIODENTA SWISS AG DAVID EILER
K133844 12/20/2013 SPEED TRIAD BIOMEDICAL ENT., INC. JOE SOWARD
K133780 12/12/2013 SPEED XL BIOMEDICAL ENT., INC. JOE SOWARD
K133817 12/16/2013 VITEK 2 AST - YEAST FLUCONAZOLE BIOMERIEUX, INC. JOCELYN JENNINGS
K133952 12/23/2013 VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE BIOMERIEUX, INC. CHARLENE FERRAND
K133939 12/23/2013 MODIFIED DISTAL RADIUS PLATING SYSTEM BIOMET SUZANA OTANO
K133746 12/12/2013 POLARIS SPINAL SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY, MS, RAC
K133940 12/23/2013 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) BIOMET UK LTD. JASON HECKAMAN
K133950 12/23/2013 ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) BIORETEC LTD. MINNA RASANEN
K133916 12/27/2013 CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K134037 12/31/2013 PREMVIA BIOTIME, INC. DAVID C FURR
K133684 12/02/2013 ULTRABLOX BLOXR CORPORATION RAI CHOWDHARY
K133700 12/03/2013 ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS BOSTON SCIENTIFIC CORPORATION ELENA NIEVES
K133987 12/26/2013 CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORPORATION JANIS F TARANTO
K133933 12/23/2013 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER BOSTON SCIENTIFIC CORPORATION ASHLEY SANTOS
K133750 12/12/2013 OCCLUDER OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORPORATION CHRISTINE SHOEMAKER
K134031 12/31/2013 THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER Boston Scientific Corporation VICKY L HAGENS
K133852 12/19/2013 APOLLO BALLOON DILATATION CATHETER BROSMED MEDICAL STEPHEN LEE
K134040 12/31/2013 BTL-9000; BTL-9000 RADIOFREQUENCY MODULE BTL INDUSTRIES LTD MICHAIL M PANKRATOV
K133856 12/19/2013 POWERGLIDE MIDLINE CATHETER C.R. BARD, INC. CASEY COOMBS
K134010 12/30/2013 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN F BRIAN, PH.D.
K134038 12/31/2013 CAMBER SPINE DIAGON OBLIQUE CAGE CAMBER SPINE DANIEL A PONTECORVO
K133693 12/03/2013 DIGITAL RADIOGRAPHY CXDI-401C WIRELESS CANON, INC. DIANE RUTHERFORD
K133999 12/27/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. BLAIR BUTH
K133925 12/23/2013 VYNTUS/ SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K133823 12/17/2013 NUFACE MINI DEVICE CAROL COLE COMPANY RAND DAOUD
K133879 12/26/2013 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K134004 12/27/2013 VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS LOLITA D FORBES
K133869 12/20/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) HYE-JOO KIM
K133758 12/31/2013 CENTERVUE MACULAR INTEGRITY ASSESSMENT CENTERVUE SPA ROGER GRAY
K134011 12/30/2013 GENERAL SPINAL SYSTEM CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD Diana Hong
K133625 12/04/2013 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
K133870 12/20/2013 FLUID LEVEL MONITOR COLEMAN LABORATORIES LE-JUN YIN
K133703 12/03/2013 PHYSIOGLOVE ET SYSTEM COMMWELL R&D LTD. JONATHON KAHAN
K133919 12/23/2013 CONSENSUS VITALITE TIBIAL INSERT CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K133843 12/20/2013 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER CORDIS CORPORATION KIM FONDA
K133599 12/03/2013 CORGRIP CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K133701 12/03/2013 NUVANT MCT SYSTEM CORVENTIS, INC. CHERYL SWANSON
K133889 12/20/2013 PREMIUM COUSIN BIOTECH S.A.S. FRANCK PELLETIER
K133938 12/23/2013 ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN JOSE MARQUEZ
K133821 12/18/2013 EMPRINT ABLATION SYSTEM COVIDIEN LLC HEATHER V NIGRO
K133762 12/11/2013 ENDO GIA(TM) EXTRA LONG ADAPTER COVIDIEN LLC DEBRA PEACOCK
K133945 12/23/2013 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC. BRADLEY RENTON
K133739 12/09/2013 TRUSCULPT CUTERA, INC. BRADLEY RENTON
K133858 12/19/2013 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K133834 12/17/2013 DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND) KELLIE MYERS
K133794 12/13/2013 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TATYANA KORSUNSKY
K134055 12/31/2013 ADX4000W DEXCOWIN CO., LTD CLAUDE BERTHOIN
K133007 12/06/2013 DX3000-L DEXCOWIN CO., LTD CLAUDE BERTHOIN
K133751 12/09/2013 DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K133803 12/16/2013 DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K133786 12/16/2013 DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID DORNOCH MEDICAL SYSTEMS, INC. LARRY SMITH
K133661 12/03/2013 CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K133895 12/20/2013 DEKA SMARTXIDE LASER SYSTEM EL.EN. S.P.A GEORGE CHO
K133194 12/19/2013 DIAMOND RATTLESNAKE SYSTEM EMINENT SPINE LINDA BRADDON
K133747 12/09/2013 ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K133734 12/10/2013 SEAL SINGLE-USE BIOPSY VALVE ENDOCHOICE, INC. JANNA BABSON
K133389 12/16/2013 EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K133718 12/04/2013 ZERONA ERCHONIA CORPORATION KEVIN WALLS
K133722 12/11/2013 ASTHMA MONITOR AM3 ERESEARCH TECHNOLOGY RICHARD A MILLER
K133905 12/23/2013 6200 / 6250 ULTRASOUND SYSTEM ESAOTE S.P.A. ALLISON SCOTT
K133864 12/19/2013 DERMABOND PRINEO SKIN CLOSURE SYSTEM ETHICON, INC. DONNA MARSHALL
K133775 12/16/2013 EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING EXCITON TECHNOLOGIES INC. MELANIE USSYK
K133813 12/16/2013 FLXFIT INTERVERTEBRAL BODY FUSION DEVICE EXPANDING ORTHOPEDICS, INC. MEREDITH MAY
K133636 12/04/2013 EXTREMITY MEDICAL HAMMERTOE DEVICE EXTREMITY MEDICAL, LLC. BRIAN SMEKAL
K134001 12/27/2013 FIREFLY FIRSTKIND LIMITED SHEILA HEMEON-HEYER
K133872 12/23/2013 ARIA WIFI SMART SCALE FITBIT, INC. DIANE HORWITZ
K133976 12/26/2013 FUJIFILM ENDOSCOPIC CO2 REGULATOR FUJIFILM MEDICAL SYSTEM U.S.A., INC. GINA WALLJASPER
K133972 12/26/2013 ASPIRE CRISTALLE FUJIFILM MEDICAL SYSTEMS, USA INC. PETER ALTMAN
K133197 12/18/2013 FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT
K133957 12/23/2013 DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE GALEMED CORP. PAUL DRYDEN
K133807 12/19/2013 MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K133836 12/18/2013 OPTIGLAZE COLOR GC AMERICA INC. MARK HEISS
K133824 12/17/2013 CERASMART GC AMERICA, INC. MARK HEISS
K133664 12/05/2013 ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC CHRIS PAULIK
K133657 12/05/2013 DISCOVERY PET/CT 710 GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K133705 12/03/2013 REVOLUTION CT GE MEDICAL SYSTEMS, LLC HELEN PENG
K133695 12/03/2013 TITAN 11 GEMSS MEDICAL SYSTEMS CO., LTD DAVE KIM
K133911 12/23/2013 GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM GENESYS SPINE BRIAN J BERGERON
K133655 12/04/2013 RADIANCE V2 GMV SOLUCIONES GLOBALES INTERNET S.A.U. ALBERT KOSTER
K133766 12/11/2013 HUMICARE D900 GRUENDLER GMBH JIM CASSI
K133968 12/26/2013 WONDFO MULTI-DRUG URINE TEST CUP, PANEL GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K133966 12/24/2013 MODEL-BASED RSA SOFTWARE HALIFAX BIOMEDICAL, INC. DANIEL KAMM
K133719 12/05/2013 PDE-NEO HAMAMATSU PHOTONICS, K.K. JEFFREY K SHAPIRO
K133956 12/23/2013 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN HARTALEGA SDN BHD NURUL AISYAH KONG
K133848 12/31/2013 RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK HEARTVISTA, INC. JAMES J ROGERS
K134016 12/30/2013 ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL AMERICA) ANGELA VANARSDALE
K133881 12/20/2013 MACY CATHETER HOSPI CORPORATION IGAL LADABAUM
K133692 12/05/2013 IMRI 1.5T AND IMRI 3T S IMRIS, INC. SANJAY SHAH
K133826 12/17/2013 INTONEMV INCONTROL MEDICAL, LLC JESSICA ANDRESHAK
K134020 12/30/2013 INTONEMV INCONTROL MEDICAL, LLC JESSICA ANDRESHAK
K133753 12/09/2013 MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR INFOBIONIC, INC. CARRIE NEUBERGER
K133897 12/27/2013 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER INFRAREDX, INC. STEVEN J CHARTIER
K133810 12/16/2013 VC150 VITAL SIGNS MONITOR INNOKAS YHTYMA TIINA VETELAINEN
K133690 12/04/2013 TRUE SPINAL FUSSION SYSTEM INNOVATIVE SURGICAL DESIGNS ED MORRIS
K133754 12/09/2013 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER INTEGRA LIFESCIENCES CORPORATION ELIZABETH MCMENIMAN
K134047 12/31/2013 JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS INTEGRA LIFESCIENCES CORPORATION RUTHANNE VENDY
K133759 12/11/2013 INTELLIJOINT HIP INTELLIJOINT SURGICAL INC. BRANDON GINGRICH
K134005 12/27/2013 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD JINYOUNG LEE
K133845 12/18/2013 8MM TROCAR KIT INTUITIVE SURGICAL BRANDON HANSEN
K133942 12/23/2013 ENDOSCOPE STERILIZATION TRAY INTUITIVE SURGICAL BRANDON HANSEN
K133853 12/19/2013 VIEWFLEX XTRA ICE CATHETER IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY JENNIFER CORREA
K133859 12/19/2013 WATCH-PAT200U (WP200U) ITAMAR MEDICAL LTD JONATHAN KAHAN, ESQ
K133696 12/03/2013 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S KEVIN A THOMAS
K133686 12/04/2013 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS3512 (ML21035) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133944 12/23/2013 RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K133815 12/16/2013 INTESS CERVICAL CAGE SYSTEM KALITEC DIRECT, LLC J.D. WEBB
K133716 12/05/2013 TRC-PASTE KM CORPORATION PRISCILLA CHUNG
K133730 12/06/2013 CO PILOT/REGIUS UNITEA KONICA MINOLTA INC. RUSSELL MUNVES
K133755 12/09/2013 KOWA SL-17 KOWA CO. LTD. HIROYUKI KOIDE
K133997 12/27/2013 LG SMARTHEALTH LG ELECTRONICS DIANE SUDDUTH
K133717 12/05/2013 LONGBOW SPACER SYSTEM LIFE SPINE RANDY LEWIS
K133710 12/04/2013 LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K133934 12/26/2013 MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) LINKS MEDICAL PRODUCTS, INC. JAMES SMITH
K133849 12/19/2013 VANTERA CLINICAL ANALYZER LIPOSCIENCE SUZETTE WARNER
K133811 12/16/2013 RESTORIS POROUS PARTIAL KNEE SYSTEM MAKO SURGICAL CORP. TERRY POWELL
K133149 12/12/2013 BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM MAR COR PURIFICATION, INC. KINNARI SHAH
K133796 12/13/2013 NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), MARVAO MEDICAL DEVICES, LTD. CHRISTINE NICHOLS, RAC
K133534 12/03/2013 MCKESSON CARDIOLOGY ECG MOBILE MCKESSON ISRAEL LTD. PAUL SUMNER
K133763 12/11/2013 SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM MEDI-GLOBE CORPORATION SCOTT KARLER
K133907 12/23/2013 VSP SYSTEM MEDICAL MODELING INC. JONATHAN S KAHAN
K133906 12/23/2013 C-JAWS CERVICAL COMPRESSIVE STAPLE MEDICREA INTERNATIONAL JOHN J SMITH
K133428 12/16/2013 MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO MEDIKRO OY MIKKO ELORANTA
K133724 12/06/2013 MINNCARE HD MEDIVATORS, INC. KINNARI SHAH
K133941 12/30/2013 MITEK ARTHROSCOPES MEDOS INTERNATIONAL SARL SUSAN KAGAN
K134009 12/30/2013 UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL MEDTEK LIGHTING SUSAN ANTHONEY-DE WET
K133904 12/20/2013 CD HORIZON SPINAL SYSTEM GROWTH ROD SET MEDTRONIC SOFAMOR DANEK USA LEE GRANT
K133726 12/10/2013 MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE MEGADYNE MEDICAL PRODUCTS, INC. RONDA MAGNESON
K133673 12/03/2013 ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K133714 12/05/2013 TRU FLU MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K134015 12/27/2013 M-PM-DISC MERZ DENTAL GMBH RICHARD G HUNTER
K134008 12/30/2013 MD-FLEX HEAVY BODY META BIOMED, INC. BLIX WINSTON
K133683 12/02/2013 MICR02 OSA DEVICE MICRODENTAL, INC. LAURA SHEPPARD
K133170 12/04/2013 QUICK JET M MICRON CORP. TAKASHI TERUI
K133725 12/06/2013 TRAXCESS 14 GUIDEWIRE MICROVENTION, INC. Naomi Gong
K133779 12/16/2013 CP RELIEF WAND MID-AMERICA MEDICAL INNOVATIONS, LLC. NORM SCHROEDER
K134033 12/31/2013 MIROMATRIX BIOLOGICAL MESH MIROMATRIX MEDICAL INC. STEPHEN RHODES
K134006 12/27/2013 DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED THOMAS CHAN TSZ FUNG
K133806 12/16/2013 M1 CAPNOGRAPHY MASK MONITOR MASK, INC. STUART R GOLDMAN
K133989 12/26/2013 AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM MORTARA INSTRUMENT, INC. AMY YANG
K133609 12/16/2013 THE DOME S6C NDS SURGICAL IMAGING JIM LENG
K133708 12/23/2013 MD302C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR NEC DISPLAY SOLUTIONS, LTD. TONY HSU
K133189 12/09/2013 DUAL SHOT ALPHA 7 NEMOTO KYORINDO CO., LTD. KEN WAKABAYASHI
K133951 12/23/2013 SMARTTOUCH NEXUS6, LTD. GARTH SUTHERLAND
K133731 12/06/2013 NOBELACTIVE WIDE PLATFORM (WP) NOBELBIOCARE AB PHUONG NGUYEN
K133738 12/11/2013 NOVOFINE PLUS 32G 4 MM NOVO NORDISK INC. RICK SPRING
K134019 12/30/2013 MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO NXSTAGE MEDICAL, INC. LAURA F PLATH
K134026 12/30/2013 ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT OLYMPUS MEDICAL SYSTEMS CORP. DAPHNEY GERMAIN-KOLAWOLE
K134039 12/31/2013 DAYTONA ICG (P200TICG) OPTOS PLC RANDY PREBULA
K133892 12/20/2013 IVUE 500 OPTOVUE, INC. MICHAEL J SARRASIN
K133912 12/23/2013 ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO ORIGIO A/S TOVE KJAER
K133707 12/16/2013 SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS ORIGIO A/S TOVE KJAER
K133875 12/20/2013 THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA ORTHO KINEMATICS, INC. JOHN J SMITH
K133827 12/17/2013 A-LINK Z OSTEO VASIVE LLC KEVIN A THOMAS
K133691 12/02/2013 EXTRIMILOCK ANKLE PLATING SYSTEM OSTEOMED LP BLESSON ABRAHAM
K133861 12/19/2013 FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM OSTIAL CORPORATION JAKE WOLENBERG
K133809 12/16/2013 OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE OXFORD PERFORMANCE MATERIALS LEIGH AYRES
K133980 12/27/2013 PANTHEON ELECTROSTIMULATOR PANTHEON RESEARCH YOLANDA SMITH
K133694 12/03/2013 SHERPA PAK TRANSPORTER PARAGONIX TECHNOLOGIES, INC. LEO BASTA
K133757 12/11/2013 GFS II STANDARD, GFS II LARGE, GFS MIMI PARCUS MEDICAL, LLC PAUL VAGTS
K133901 12/31/2013 PARI-PATH SURGICAL NAVIGATION SYSTEM PARITIC INC KEVIN BARRETT
K133793 12/16/2013 PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORPORATION DARI DARABBEIGI
K133961 12/31/2013 SURESIGNS VS3, SURESIGNS VS4 PHILIPS MEDICAL SYSTEMS GREG LI
K133819 12/16/2013 VERADIUS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. RUOJUAN ZHANG
K133833 12/17/2013 NUVIS DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. MARK JOB
K133993 12/26/2013 CAAS WORKSTATION PIE MEDICAL IMAGING FLORIE DANIELS
K133721 12/05/2013 INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 PINNACLE SPINE GROUP, LLC REBECCA K PINE
K133785 12/12/2013 TRITIUM STERNAL CABLE PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC EMILY DOWNS
K133629 12/02/2013 ANGIOJET ULTRA AVX THROMBECTOMY SET POSSIS MEDICAL, INC. GEORGE LUCAS
K134017 12/30/2013 GIGALASER POWERMEDIC APS M. JOYCE HEINRICH
K133921 12/23/2013 PRECEPTIS TYMPANOSTOMY TUBE INSERTER PRECEPTIS MEDICAL KEITH LELAND
K133850 12/19/2013 CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K133857 12/20/2013 BRELLA-SPEC(TM) VAGINAL SPECULUM PROA MEDICAL, INC. VICTORIA NADERSHAHI
K134052 12/31/2013 RADIANCE 330 PROTON THERAPY SYSTEM PROTOM INTERNATIONAL, INC. JOHN J SMITH, MD, JD
K133689 12/23/2013 POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K133699 12/03/2013 POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES PT. SMART GLOVE INDONESIA KHON PU FOO
K133883 12/20/2013 LYRA DIRECT STREP ASSAY QUIDEL CORPORATION RONALD H LOLLAR
K133923 12/30/2013 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET REFLECTANCE MEDICAL INC NANDINI MURTHY
K133990 12/27/2013 IEVA REHABILITATIVE POSITIONAL DEVICE REMENDIUM LABS, LLC YOLANDA LORIE
K133973 12/26/2013 TEMPUS PRO WITH ENHANCED FEATURES REMOTE DIAGNOSTIC TECHNOLOGIES LTD LEIGH CORNOCK
K134014 12/30/2013 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) REMOTE DIAGNOSTIC TECHNOLOGIES LTD. LEIGH CORNOCK
K133988 12/26/2013 TEMPUS PRO EXTENDED FEATURES REMOTE DIAGNOSTIC TECHNOLOGIES LTD. LEIGH CORNOCK
K133868 12/20/2013 ASTRAL VENTILATOR RESMED LTD. JIM CASSI
K133635 12/05/2013 EASYPOINT NEEDLE RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K134003 12/27/2013 RHINIX NASAL FILTER RHINIX APS METTE MUNCH
K133741 12/09/2013 ACCU-CHEK Performa Blood Glucose Monitoring System Roche Diagnostics NATHAN CARRINGTON
K133862 12/20/2013 ACCU-CHEK AVIVA PLUS SYSTEM ROCHE DIAGNOSTICS CORPORATION KHONE SAYSANA
K133893 12/20/2013 STERISPINE LC CAGE SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K133740 12/09/2013 SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT SAUFLON PHARMACEUTICALS, LTD. CHRISTOPHER SMEJKAL
K133682 12/02/2013 SCHOELLY ARTHROSCOPE SCHOLLY FIBEROPTIC GMBH PAMELA PAPINEAU, RAC
K133782 12/12/2013 NOVA FA DR SYSTEM SEDECAL SA DANIEL KAMM, P.E.
K134029 12/31/2013 BELTER BLOOD PRESSURE METER SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE PANG MING
K133929 12/23/2013 HEALTH EXPERT ELCTRONIC STIMULATOR SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED LI YANG
K133478 12/09/2013 POWDER FREE POLYETHYLENE EXAMINATION GLOVES SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD KATHY LIU
K133728 12/06/2013 DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS INC. LAURA J DUGGAN, PH.D.
K133816 12/16/2013 IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS INC. ERNEST JOSEPH
K133680 12/04/2013 ENCORE SYSTEM SIESTA MEDICAL, INC. MICHAEL KOLBER
K133662 12/03/2013 SMITH & NEPHEW CANNULATED CAPTURED SCREW SMITH & NEPHEW, INC. KATHERINE MARCACCIO
K133752 12/09/2013 SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT SONENDO, INC. DAN MILLER
K133702 12/03/2013 PRESTO BREAST BIOPSY DEVICE SONTINA MEDICAL, LLC ROBERT PELIKS
K133575 12/23/2013 SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM SPINEVISION, S.A. J.D. WEBB
K133791 12/13/2013 ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] STERNGOLD DENTAL LLC MARIA RAO
K133671 12/04/2013 ICONIX ALL SUTURE ANCHORS STRYKER CORP. KELLY KUCHARCZYK
K133974 12/26/2013 VARIAX DISTAL RADIUS PLATING SYSTEM STRYKER LEIBINGER GMBH ELIJAH N WREH
K133672 12/03/2013 REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY STRYKER SUSTAINABILITY SOLUTIONS SCOTT ENGLISH
K133979 12/26/2013 TENS SUNMAS (H.K.) TRADING LIMITED Diana Hong
K133855 12/19/2013 BREEZY ELEGANCE SUNRISE MEDICAL (US) LLC LAURIE H ROBERTS
K133781 12/16/2013 DECLIPSESPECT LAPAROSCOPY SURGICEYE GMBH MORITZ HOYER
K133840 12/18/2013 KANGLI SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD ALICE GONG
K133698 12/05/2013 SYNAPSE SYSTEM SYNTHES USA PRODUCTS LLC LAURA BLEYENDAAL
K133797 12/13/2013 QMASTER-H/REVO TELESYSTEMS CO., LTD. Claude Berthoin
K133894 12/20/2013 SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V. M.J. AERTS
K133867 12/20/2013 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V. M.J. AERTS
K133687 12/02/2013 THD N-ANO ANOSCOPE THD SPA GUIDO BONAPACE
K133799 12/16/2013 THERMEDX FLUID MANAGMENT SYSTEM THERMEDX LLC JEFF WILLIAMS
K133773 12/12/2013 SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K133847 12/18/2013 SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific Cynthia Knapp
K133949 12/23/2013 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS TOP CALIBRE SDN BHD ROSNITA MAODIN
K133777 12/12/2013 TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR TORNIER, INC. MIREILLE LEMERY
K133761 12/11/2013 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION CHARLEMAGNE CHUA
K134025 12/30/2013 AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K133832 12/17/2013 KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS TOTAL JOINT ORTHOPEDICS, INC. BEN CASEY
K134035 12/31/2013 TRANSONIC HCM 103 SYSTEM TRANSONIC SYSTEMS, INC. NAVEEN THURAMALLA
K133633 12/03/2013 CHOCOLATE PTCA BOLLOON CATHETER TRIREME MEDICAL INC SHIVA ARDAKANI
K133896 12/20/2013 REJUVALITE MD TROPHY SKIN, INC. SUSAN ANTHONEY-DEWET
K133842 12/23/2013 TYBER MEDICAL TRAUMA SCREW TYBER MEDICAL LLC JEFF TYBER
K134032 12/31/2013 ULTHERA SYSTEM ULTHERA, INC. ASHLEY FICKETT
K133712 12/05/2013 EMBRYOVIEWER SOFTWARE UNISENSE FERTILITECH A/S Henrik Wahlgren
K133736 12/09/2013 ENDOSCOPIC SUTURE CUTTER UNITED STATES ENDOSCOPY GROUP, INC. ERIC MAYNARD
K133983 12/27/2013 INTRA. OX HANDHELD TISSUE OXIMETER VIOPTIX INC. GREG HOLLAND
K133837 12/23/2013 VIORA V-TOTAL VIORA LTD. YORAM LEVY
K133829 12/19/2013 AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF VIVONIC GMBH ANDREAS HESSBERGER
K133681 12/02/2013 CRUX SNARE FILTER RETRIEVAL SET VOLCANO CORPORATION ELISA HEBB
K133652 12/04/2013 GSP NEONATAL TOTAL GALACTOSE KIT WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. JEANETTE SCHIER-PUGSLEY
K133723 12/06/2013 OTC PATCH WELL-LIFE HEALTHCARE LIMITED CHIN-CHIN HSIEH
K133713 12/06/2013 CHARLOTTE (TM) SNAP-OFF SCREW WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K133715 12/06/2013 CHARLOTTE CLAW PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K133947 12/23/2013 IRIX-A LUMBAR INTEGRATED FUSION SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
K133735 12/09/2013 EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K134045 12/31/2013 ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM ZIMMER DENTAL INC. JULIE LAMOTHE
K133784 12/23/2013 VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION ZIMMER TRABECULAR METAL TECHNOLOGY JUDITH ROSEN
K133737 12/09/2013 ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION ZIMMER, INC. PAULINE A SHAND
K133706 12/03/2013 ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM ZL MICRODENT-ATTACHMENT GMBH & CO. KG SYNNOVE LINDEMAN


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