FDA 510(k) Decisions During February, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132649 02/14/2014 REVEAL LINQ INSERTABLE CARDIAC MONITOR MEDTRONIC INC. ERIC KALMES
K130864 02/06/2014 C-MAX+ (PLUS) AAT ALBER ANTRIEBSTECHNIK GMBH STEFANIE D BANKSTON
K130255 02/28/2014 HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS ABBOTT LABORATORIES JUDITH R WALLACH
K133115 02/27/2014 COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK ABBOTT MEDICAL OPTICS INC ROSANNE YETEMIAN
K140160 02/20/2014 RELIEVA SCOUT SINUS DILATION SYSTEM ACCLARENT, INC. JAMES P GARVEY, II
K131146 02/10/2014 ARTASSIST AND VENASSIST ACI MEDICAL, LLC ED ARKANS
K132832 02/13/2014 ACTIVAPATCH ET IONTOPHORESIS PATCH ACTIVATEK INC. JAMAL YANAKI
K142686 12/18/2014 StimPad OTC AEMED, INC. John K Burke
K142707 12/19/2014 AIS Odontoid Fracture Fixation System AESCULAP IMPLANT SYSTEM, INC. Lisa M Boyle
K130890 02/06/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) AIR PLASTIC CO., LTD. CHU XIAOAN
K133394 02/06/2014 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K133450 02/14/2014 AIRSTRIP REMOTE PATIENT MONITORING AIRSTRIP TECHNOLOGIES, LP ROBERT A MILLER
K130401 02/07/2014 ALERTWATCH: OR ALERTWATCH LLC DONNA-BEA TILLMAN
K142672 12/03/2014 AliveCor Heart Monitor ALIVECOR, INC. Albert Boniske
K130921 02/06/2014 ALIVECOR HEART MONITOR OTC ALIVECOR, INC. MICHAEL RIGHTER
K133296 02/14/2014 XCATH ALSEAL YOLANDA SMITH
K132925 02/11/2014 SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK AMENDIA, INC. JOHN KAPITAN
K142607 12/11/2014 AngioVac Circuit ANGIODYNAMICS Gary Barrett
K131066 02/21/2014 AXIOM REG ANTHOGYR SAS THERESE CANDAU
K140036 02/06/2014 APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH APTUS ENDOSYSTEMS, INC. BURT GOODSON
K133119 02/28/2014 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS ARJOHUNTLEIGH POLSKA SP Z.O.O. DAVID MOYNHAM
K133854 02/27/2014 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. LEON BROWN, II
K142944 12/16/2014 ArthroPlan Digital Templating Software Arthromeda, Inc Elsa Abruzzo
K142942 12/19/2014 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System ARTHROSURFACE INC. Dawn J. Wilson
K132496 02/26/2014 ARTHROSURFACE TOEMOTION ARTHROSURFACE, INC. DAWN J WILSON
K142619 12/18/2014 Snap Insulin Pump System ASANTE SOLUTIONS, INC EDWARD SINCLAIR
K133462 02/07/2014 DUOCENTRIC REVERSED SHOULDER PROSTHESIS ASTON MEDICAL CATHERINE GLOSTER
K132422 02/13/2014 PALS PLATINUM NEUROSTIMULATION ELECTRODES AXELGAARD MFG. CO., LTD. DAN P JEFFERY
K133948 02/21/2014 BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT BARD PERIPHERAL VASCULAR, INC. SARAH MCCARTNEY
K143067 12/22/2014 Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC. JON P. HUNT
K133242 02/14/2014 STELLARIS VISION ENHANCEMENT SYSTEM BAUSCH & LOMB TIMOTHY W CAPEHART
K132909 02/14/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) BECTON, DICKINSON AND COMPANY KATIE COYLE
K133158 02/28/2014 ND: YAG LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K132457 02/21/2014 FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER BIOCARE ASIA CORPORATION LTD. SHUCHI CHANG
K143188 12/30/2014 3.Omm Biomet Cannulated Screw System BIOMET MANUFACTURING CORP. VICTORIA SCHEITLIN
K142746 12/29/2014 G7 Finned Acetabular Shell BIOMET MANUFACTUTING CORP. TRACY JOHNSON
K142933 12/23/2014 Biomet Tibial trays BIOMET, INC. JASON HECKAMAN
K143009 12/18/2014 Echo Bi-Metric Microplasty Hip System BIOMET, INC. Julie Gantenberg, M.S.,RAC
K132958 02/19/2014 MEDICINAL LEECHES BIOPHARM (UK) LTD. BETHANY SAWYER
K130616 02/07/2014 MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES BIOPSYBELL S.R.L. WILLER GHELFI
K132613 02/05/2014 SONILASE LIGHT THERAPY DEVICE BIORENEW LABS, LLC SUSAN ANTHONEY
K133509 02/21/2014 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO BIOTEST MEDICAL CORP. ROBERT NAWY
K140104 02/13/2014 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL REBECCA K PINE
K132810 02/28/2014 GLADIATOR ELITE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. BETH TOROK
K142973 12/01/2014 Resolution Clip Boston Scientific Corporation Elena Nieves
K142975 12/12/2014 Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation Moshe Citronowicz
K132192 02/14/2014 BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K132763 02/28/2014 ADVANCED VIEWER BRAINLAB, AG ALEXANDER SCHWIERSCH
K133385 02/26/2014 LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE BRONCUS MEDICAL INC ROBIN BUSH
K143208 12/09/2014 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc Laurie Sang
K133335 02/14/2014 POWERPORT IMPLANTABLE PORT C.R. BARD, INC. AMY HONEY
K132064 02/28/2014 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K122758 02/12/2014 POWERHEART G5 AED CARDIAC SCIENCE CORPORATION KATHLEEN ROBERTS
K133293 02/12/2014 15 FR. TANDEMHEART ARTERIAL CANNULA CARDIACASSIST INC. GREG JOHNSON
K140118 02/25/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE CARDICA, INC. VEE ARYA
K140170 02/19/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE CARDICA, INC. VEE ARYA
K122632 02/11/2014 GUAVA II CARDIOCOMM SOLUTIONS, INC. JONATHAN WARD
K140015 02/05/2014 CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER CARDIOSOLUTIONS INC CHRISTINE SANTAGATE
K133999 02/28/2014 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. BLAIR BUTH
K132824 02/06/2014 CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION CARESTREAM HEALTH,INC. DAVID C FURR
K133476 02/12/2014 SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION CARL ZEISS MEDITEC AG SARAH HARRINGTON
K134004 02/14/2014 VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS LOLITA D FORBES
K133447 02/24/2014 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K131727 02/28/2014 CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. HAKSUNG KIM
K142580 12/01/2014 Chemtrue Multi-Panel DOA DIP Card Tests CHEMTRON BIOTECH, INC. Jane Zhang
K142800 12/11/2014 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard Co-Innovation Biotech Co., Ltd. Hong Feng
K133625 02/24/2014 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
K140116 02/12/2014 RESTORELLE Y CONTOUR MESH COLOPLAST A/S TIM CRABTREE
K133177 02/25/2014 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. RHODA SANTOS
K131552 02/12/2014 CONVENTUS DRS CONVENTUS ORTHOPAEDICS KENT LIND
K140033 02/27/2014 TARGET3D FUSION CONVERGENT LIFE SCIENCES, INC. DINESH KUMAR
K142688 12/19/2014 Echotip Procore HD Ultrasound Biopsy Needle COOK IRELAND LTD Nora O'Connor
K131772 02/20/2014 CANTATA(R) 2.9 MICROCATHETER COOK, INC. JENNIFER A RICHARDSON
K133701 02/06/2014 NUVANT MCT SYSTEM CORVENTIS, INC. CHERYL SWANSON
K130320 02/04/2014 BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW COVIDIEN ELIZABETH MALO
K142547 12/09/2014 Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm COVIDIEN MARY MELLOWS
K143161 12/19/2014 Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) COVIDIEN Sharon McDermott
K131252 02/24/2014 PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM COVIDIEN MICHAEL AYMAMI
K142643 12/15/2014 Stabilynx PEEK Suture Anchor D3 DC, LLC /Stabilynx, Inc Mike Rosenthal
K133858 02/28/2014 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K131909 02/24/2014 DALTON LIFT CHAIR DALTON INSTRUMENT CORP. MEI LEIN
K133267 02/11/2014 DANA REUSABLE TEST PACK DANA PRODUCTS, INC. HARRY BALA
K132389 02/25/2014 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED DANIEL & DANIEL CONSULTING MICHAEL A DANIEL
K131033 02/12/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DECENT PLASTIC CO., LTD. CHU XIAOAN
K143378 12/29/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K133090 02/28/2014 OXICARE FINGERTIP PULSE OXIMETER DELBIO INCORPORATION ERICA LI
K133794 02/04/2014 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
K131292 02/03/2014 DEROYAL SPINE SPACER SYSTEM DEROYAL INDUSTRIES, INC. KAREN E WARDEN, PHD
K130511 02/10/2014 CITRISOL ACID CONCENTRATE DIASOL, INC. MONICA ABELES
K130580 02/25/2014 RETRACTION PASTE DMG USA, INC. PAMELA PAPINEAU, RAC
K132842 02/21/2014 FLAATZ 600 SERIES (FLAATZ 600/601) DRTECH CORP. CHOUL-WOO SHIN
K132140 02/04/2014 DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER DUTECK INDUSTRIAL CO., LTD. JOSEPH CHEN
K132480 02/24/2014 AIR-FLOW HANDY 3.0 PERIO E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K133517 02/26/2014 NEMUS 2 SYSTEM EB NEURO, S.P.A. ALLISON SCOTT, RAC
K131503 02/25/2014 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. CHERRY SUN
K131882 02/12/2014 GEODESICEEG SYSTEM 400 SERIES (GES 400) ELECTRICAL GEODESICS, INC. LINDA J BOVARD
K140178 02/27/2014 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCINTYRE
K132949 02/20/2014 PELLEFIRM ELLMAN INTERNATIONAL, INC. ALISON SATHE
K133536 02/26/2014 EMERGE MEDICAL BONE PLATE SYSTEM EMERGE MEDICAL MICHELLE POTVIN
K133359 02/11/2014 ENDORINGS ENDO-AID, INC. JANICE M HOGAN
K132839 02/06/2014 FUSE 1C COLONOSCOPY SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K133647 02/27/2014 EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K143186 12/18/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K131990 02/21/2014 OXYGEN GENERATOR LIQUEFIER - (OGL) ESSEX CRYOGENICS OF MISSOURI, INC. PAUL DRYDEN
K132580 02/28/2014 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC. PETER CECCHINI
K131791 02/26/2014 IFA 40: HEP-20-10 EUROIMMUN US MICHAEL LOCKE
K142571 12/17/2014 Powder Free Vinyl Patient Examination Gloves EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K142570 12/18/2014 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K140063 02/11/2014 EQUINOXE EXTRA SHORT HUMERAL HEAD EXACTECH, INC. PATRICK HUGHES
K132582 02/12/2014 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM EXACTECH, INC. PATRICK HUGHES
K131266 02/14/2014 TREZ_HD EXCEL-TECH LTD. (XLTEK) DANIEL RAMIREZ
K131626 02/26/2014 EXCELERON BACTERIAL FILTERS EXCELERON MEDICAL BERNARD HORWATH
K142620 12/12/2014 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe Excelsior Medical Corporation John Linfante
K140254 02/26/2014 EZONO 4000 EZONO AG GRAHAM COX
K130723 02/07/2014 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL FAMIDOC TECHNOLOGY CO., LTD REANNY WANG
K131196 02/20/2014 INFANT PHOTOTHERAPY BILITRON SKY 5006 FANEM LDA TARA CONRAD
K133666 02/05/2014 RT016 INSPIRATORY FILTER FISHER & PAYKEL HEALTHCARE LTD. ELIZABETH GOLDSTEIN
K130891 02/18/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES FRIEND PLASTIC CO., LTD. CHU XIAOAN
K133533 02/12/2014 LOGIQ E GE HEALTHCARE BRYAN BEHN
K133576 02/21/2014 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K133567 02/20/2014 UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. CHRISTINA KICHULA
K130781 02/14/2014 L.A.M. IPM WOUND GEL, IPM DERM GEL GLYCOBIOSCIENCES, INC OLUFEMI ADEOYE
K132957 02/27/2014 MADSEN ACCUSCREEN TYPE 1077 GN OTOMETRICS DANIEL KAMM, P.E.
K131334 02/28/2014 HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST GOLD STANDARD DIAGNOSTICS NAPLEON MONCE
K131898 02/18/2014 A SERIES AND Q SERIES PATIENT MONITORS GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K142609 12/18/2014 CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K133968 02/25/2014 WONDFO MULTI-DRUG URINE TEST CUP, PANEL GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K142700 12/19/2014 InsufflatOR Needle GYNETECH PTY. LTD. Kevin MacDonald
K132383 02/04/2014 GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER GYRUS ACMI, INC. NEIL KELLY
K132212 02/14/2014 DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL HAGER & MEISINGER GMBH WIEBKE STOLTEN
K133552 02/07/2014 MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT HANSEN MEDICAL HASSAN LABAY
K130517 02/25/2014 EZ TRANSPORT CHAIR HARRIS MEDICAL, LLC JAMES WASON, PH.D.
K142805 12/18/2014 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) HARTALEGA SDB. BHD. KUAN KAM HON
K142588 12/18/2014 Nitrile Powder Free Examination Glove (Blue) HARTALEGA SDN BHD KUAN KAM HON
K142968 12/19/2014 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co.,Ltd. Sarah Su
K142997 12/17/2014 RTHawk, HeartVista Workstation with RTHawk HEARTVISTA, INC. James J Rogers
K142891 12/17/2014 HEPATIQ HEPATIQ LLC Dipu Ghosh
K142631 12/18/2014 Hermes Medical Imaging Suite v5.5 HERMES MEDICAL SOLUTIONS, AB Joakim Arwidson
K130582 02/04/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEZE CITY GREEN FOOD CO., LTD. CHU XIAOAN
K130807 02/07/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HOPE PLASTIC CO., LTD. CHU XIAOAN
K132650 02/07/2014 SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM HUNTLEIGH HEALTHCARE LIMITED LAURA GARCIA DEACON
K131777 02/28/2014 HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM HYPER TECHNOLOGY INC DIANA HONG
K133352 02/12/2014 HYPERSOUND AUDIO SYSTEM (HSS) HYPERSOUND HEALTH, INC. JAMES A BARNES
K131249 02/03/2014 ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-FLOW LLC SHELLY HARRIS
K143339 12/19/2014 Mini me ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) BOBAE KIM
K133617 02/20/2014 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K132539 02/07/2014 RING-LOK MODULAR BIPOLAR SYSTEM IMPLANTS INTERNATIONAL, LTD TRUDIE SEEGAR, PHD
K133692 02/10/2014 IMRI 1.5T AND IMRI 3T S IMRIS, INC. SANJAY SHAH
K134020 02/25/2014 INTONEMV INCONTROL MEDICAL, LLC JESSICA ANDRESHAK
K132229 02/21/2014 OMNI PATENT MONITORS INFINIUM MEDICAL JOHN O'BRIEN
K133274 02/12/2014 VENA PRO INNOVAMED HEALTH, LLC JOE ADKINS
K142638 12/19/2014 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) InnovaQuartz LLC Stephen Griffin
K132991 02/12/2014 C-BOX PEEK CERVICAL IBF INNOVASIS, INC. MARSHALL MCCARTY
K123880 02/07/2014 QUANTA FLASH CENTROMERE INOVA DIAGNOSTICS, INC. ANDREA SEAMAN
K133523 02/06/2014 STAPIX SUPERELASTIC IMPLANT BONE STAPLES INSTRATEK, INC. JEFF SEAVEY
K130249 02/06/2014 INTEGRITY SPINAL CARE SYSTEM 3.0 INTEGRITY LIFE SCIENCES JAMES J GIBSON
K132469 02/28/2014 THE BITE GUARD INTERNATIONAL PROFIT BUILDERS, INC. BRYAN TAPOCIK
K133607 02/11/2014 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC JULIE BODMER
K133583 02/10/2014 OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 INTERVENTIONAL SPINE, INC. JANE METCALF
K133845 02/19/2014 8MM TROCAR KIT INTUITIVE SURGICAL BRANDON HANSEN
K143217 12/03/2014 12 mm & Stapler Bladeless Obturators INTUITIVE SURGICAL, INC. Manish Patel
K142683 12/10/2014 12 mm Endoscopes and Accessories INTUITIVE SURGICAL, INC. Crystal Ong
K133318 02/11/2014 ADHESE UNIVERSAL IVOCLAR VIVADENT AG DONNA HARTNETT
K132039 02/21/2014 ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM JEDMED INSTRUMENT CO. CRAIG PARKS
K130809 02/18/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JEWEL PLASTIC CO., LTD. CHU XIAOAN
K130847 02/28/2014 JINTRONIX REHABILITATION SYSTEM (JRS) JINTRONIX INC. NAVNEET SEKHON
K133510 02/24/2014 NEODENT IMPLANT SYSTEM JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA KEVIN A THOMAS
K133696 02/25/2014 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S KEVIN A THOMAS
K132321 02/20/2014 JMS SYRINGE JMS NORTH AMERICA CORPORATION SHO HOSOKI
K142564 12/23/2014 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation Sho Hosoki
K132472 02/11/2014 JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD JUSTRIGHT SURGICAL, LLC MICHELE LUCEY
K140214 02/19/2014 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K142558 12/22/2014 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M Nancy Giezen
K130800 02/18/2014 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) KAIXUAN PLASTIC CO., LTD. CHU XIAOAN
K133234 02/21/2014 T-TYPE D-KAT, R-TYPE D-KAT KEELER LIMITED EUGENE R VANARSDALE
K143164 12/02/2014 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set KIMBERLY-CLARK CORPORATION MARIA E WAGNER
K142803 12/02/2014 Skintact, various other tradenames Leonhard Lang GmbH Burrhus Lang
K123475 02/03/2014 SHOOCIN INTRODUCER KIT LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD ARTHUR GODDARD
K130982 02/28/2014 LERADO, POWER WHEELCHAIR LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED JEN KE-MIN
K142573 12/01/2014 HairMax LaserComb, HairMax LaserComb LEXINGTON INTERNATIONAL, LLC DAVID MICHAELS
K133564 02/19/2014 MODIFICATION TO NAUTILUS SPINAL SYSTEM LIFE SPINE, LLC. RANDY LEWIS
K133273 02/12/2014 LIGER MEDICAL ESU-110 LIGER MEDICAL, LLC STEVE SMITH
K133710 02/21/2014 LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K131653 02/04/2014 LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K143145 12/04/2014 SafeAir Smoke Pencil LiNA Medical ApS Anne Klitgard
K142682 12/22/2014 The Lipogems System Lipogems International SpA Carlo Russo
K143119 12/18/2014 LT-300 Video Colposcope Lutech Industries, Inc. Ron Vachula
K133550 02/05/2014 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT MAINE STANDARDS COMPANY LLC JAMES W CHAMPLIN
K133162 02/25/2014 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA MATERIALISE N.V. OLIVER CLEMENS
K123697 02/24/2014 MATRICEL DENTAL BARRIER MEMBRANE MATRICEL GMBH DR. INGO HESCHEL
K130385 02/18/2014 COMPRESSIBLE LIMB SLEEVE SYSTEM MAXSTAR INDUSTRIAL CO. LTD. DANIEL NAM
K131481 02/21/2014 FREEDOM PCK COMPONENTS MAXX ORTHOPEDICS, INC. NACH DAVE
K142728 12/04/2014 ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) Medical Compressions System (DBN) Ltd. Eyal Sandach
K142702 12/18/2014 Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad MEDIVANCE, INC. Stacci Cronk
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K131154 02/12/2014 ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; ZEVEX, INC. NILOUFAR SAMIMI
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