FDA 510(k) Applications Received During July, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K132236 07/18/2013 .DECIMAL PROTON APERTURE .DECIMAL, INC. KIMBERLY RUPP
K132125 07/10/2013 A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM A.B. DENTAL DEVICES, LTD. DANIELA LEVY
K132366 07/30/2013 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS ACCEL SPINE AEKTA PATEL
K132365 07/30/2013 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION ACCEL SPINE AEKTA PATEL
K132086 07/05/2013 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K132206 07/16/2013 MELYS ATRIAL FIBRILLATION SCREENING MONITOR ADVANCED FLUIDICS, LLC E J SMITH
K132354 07/29/2013 POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE ADVANCED HEALTH PRODUCTS, LOT 60 & 61 FRANCIS V
K132059 07/03/2013 DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K132077 07/05/2013 PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K132243 07/18/2013 BARLE TISSUE ADHESIVE 2 ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD KAY MCGRATH
K132005 07/01/2013 RETROGRADE FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K132011 07/01/2013 APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET AEA SRL MICHELE MENGONI
K132082 07/05/2013 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK AESKU.DIAGNOSTICS SASCHA PFEIFFER
K132021 07/02/2013 AHP 300, EMERGENCY PORTABLE VENTILATOR ALLIED HEALTHCARE PRODUCTS, INC. STEPHEN MUNDWILLER
K132280 07/23/2013 ALTUS SPINE PEDICLE SCREW SYSTEM ALTUS PARTNERS CLAUDIA HILL
K132003 07/01/2013 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
K132300 07/24/2013 EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE APPLIED MEDICAL RESOURCES CORP. JESSICA CHO
K132342 07/26/2013 XVWEB APTERYX, INC. KEVIN CRUCS
K132133 07/11/2013 CG+ ARROW JACC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K132263 07/22/2013 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K132217 07/17/2013 ARTHREX COMPRESSION FT SCREWS ARTHREX, INC. COURTNEY SMITH
K132043 07/02/2013 ARTHREX SPEEDCINCH ARTHREX, INC. LEON BROWN II, PH.D.
K132099 07/08/2013 ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND ARTHROCARE CORPORATION SHIRLEY HYINK
K132031 07/18/2013 AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL AXIS-SHIELD POC AS KARI SKINNEMOEN
K132335 07/26/2013 ULTRASOUND SCANNER FLEX FOCUS 1202 B-K MEDICAL APS RANDI HAUERBERG
K132346 07/29/2013 ULTRASOUND SCANNER PRO FOCUS 2202 B-K MEDICAL APS RANDI HAUERBERG
K132310 07/25/2013 ASCOT BACKROADS CONSULTING, INC. KAREN E WARDEN, PHD
K132183 07/15/2013 DICOM VIDEO BAR CODE COMPUTER LTD DAN LAOR
K132216 07/17/2013 BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION BAUSCH & LOMB INCORPORATED SAMANTHA DUFFY
K132374 07/30/2013 BAYLIS MEDICAL RF PERFORATION PROBE V2.0 BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K132256 07/19/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company GREGORY P PAYNE, RAC
K132259 07/19/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company GREGORY P PAYNE, RAC
K132102 07/08/2013 BECE CAD ZIRKON HT+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K132120 07/09/2013 WTF SECURA SYRINGE AND NEEDLE BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. RAYMOND SUN
K132097 07/08/2013 BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY BEST MEDICAL INTERNATIONAL, INC. DHARMENDRA THAKUR
K132227 07/17/2013 LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY Bio-Rad Laboratories SUZANNE PARSONS
K132377 07/31/2013 OSTEOSPAN MORPHEUS BIOGENNIX, LLC ELAINE DUNCAN
K132010 07/01/2013 VIDAS C DIFFICILE GDH BIOMERIEUX SA CAROLINE KOCH-MATHIAN
K132058 07/03/2013 VIDAS FT4 BIOMERIEUX SA AURELIE PERMEZEL
K132239 07/18/2013 COMPREHENSIVE REVERSE SHOULDER SCREWS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K132373 07/30/2013 BIOMET ACCESS SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY, MS, RAC
K132096 07/08/2013 RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K132071 07/03/2013 BIOACTIVE BONE GRAFT PUTTY BIOSTRUCTURES, LLC PATSY J TRISLER, JD, RAC
K132167 07/12/2013 I-CHROMA IFOB WITH I-CHROMA READER Boditech Med Inc. SANG YEOL PARK
K132253 07/19/2013 REMOVABLE PATIENT LEADS ECG CABLE BOSTON SCIENTIFIC MELISSA KLAMERUS
K132192 07/15/2013 BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K132134 07/11/2013 OPTIFIX ABSORBABLE FIXATION SYSTEM C.R. BARD, INC. RADHIKA PONDICHERRY
K132069 07/03/2013 DESARA MESH, DESARA BLUE CALDERA MEDICAL, INC. VICKI GAIL
K132064 07/03/2013 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K132060 07/03/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K132198 07/16/2013 ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI CEREMED, INC. CHELSEA MITCHELL
K132049 07/02/2013 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS CHOICE SPINE KIM FINCH
K132363 07/30/2013 DOLPHIX EXTERNAL FIXATION SYSTEM CITIEFFE S.R.L. Claude Berthoin
K132381 07/31/2013 CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT CLEARMRI SOLUTIONS, INC. MARY ANN FERGUSON
K132085 07/05/2013 ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM CO-INNOVATION BIOTECH CO., LTD. HONG FENG
K132278 07/23/2013 COCHLEAR BAHA 4 SOUND PROCESSOR COCHLEAR AMERICAS SEAN BUNDY
K132281 07/23/2013 REVASC THROMBECTOMY DEVICE Codman & Shurtleff, Inc. Amarilys Machado
K132061 07/03/2013 RESTORELLE M, RESTORELLE XL COLOPLAST CORP. TIM CRABTREE
K132307 07/24/2013 VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPORATION RYAN HUNG
K132020 07/01/2013 ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. STEVEN LAWRIE
K132334 07/26/2013 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK, INC. SEAN SPENCE
K132360 07/30/2013 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN ASHLEY GONCALO
K132242 07/18/2013 INNO SLA SUBMERGED IMPLANT SYSTEM COWELLMEDI CO., LTD SUSAN PARK
K132004 07/01/2013 NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE CREO QUALITY, LLC. JON SPEER
K132337 07/26/2013 ESOFLIP BALLOON DILATION CATHETER CROSPON, LTD. PAUL DRYDEN
K132105 07/08/2013 PERCLOT TOPICAL CRYOLIFE, INC. KIMBERLY DICONO
K132185 07/15/2013 FAMILY OF COOLGLIDE AESTHETIC LASERS CUTERA, INC. SANDRA HANSEN
K132378 07/31/2013 X-MIND UNITY DE GOTZEN S.R.L. MAURIZIO DE GOTZEN
K132338 07/26/2013 DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION ERICA LI
K132139 07/11/2013 DELTEX MEDICAL CARDIOQ-EDM+ DELTEX MEDICAL LIMITED RONALD S WARREN
K132145 07/11/2013 MTM(R) CLEAR ALIGNER DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K132241 07/18/2013 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYORI FUJIMAKI
K132199 07/16/2013 DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST DEROYAL INDUSTRIES, INC. COURTNEY RINEHART
K132252 07/19/2013 EXTRICARE 100CC/ 250CC/ 400CC CANISTERS DEVON MEDICAL RUTH WU
K132225 07/17/2013 EXTRICARE DEVON MEDICAL INC. RUTH WU
K132234 07/18/2013 LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II DIASORIN, INC. JOHN ESKDALE
K132308 07/25/2013 CLIQ DV-300 ASPIRATOR DING HWA CO., LTD. ROBERT O DEAN
K132284 07/23/2013 VECTRA NEO CLINICAL THERAPY SYSTEM DJO, LLC MARIA PRONINA
K132076 07/03/2013 REAGENT, RUSSEL VIPER VENOM - LA CONFIRM DSRV, INC. LAWANDA WASHINGTON
K132130 07/10/2013 REAGENT, RUSSEL VIPER VENOM - LA SCREEN DSRV, INC. LAWANDA WASHINGTON
K132140 07/11/2013 DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER DUTECK INDUSTRIAL CO., LTD. JOSEPH CHEN
K132057 07/03/2013 DYNATRON PELTIER THERMOSTIM PROBE DYNATRONICS CORP. DOUGLAS SAMPSON
K132175 07/15/2013 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K132313 07/25/2013 PESSARY EIS CORPORATION YANG HO DONG
K132065 07/03/2013 INJECTION NEEDLE ENDOCHOICE, INC. THERON GOBER
K132384 07/31/2013 U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA ENDOSEC CORPORATION PIN YU
K132202 07/16/2013 DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET ENTHERMICS MEDICAL SYSTEMS, INC. ADAM VAN ESSEN
K132340 07/26/2013 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 ERBE USA, INC. JOHN TARTAL
K132315 07/25/2013 ERGONOMIC PRODUCTS WORKSTATION ERGONOMIC PRODUCTS, INC. RENEE GOULD
K132231 07/18/2013 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. Allison Scott
K132054 07/03/2013 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC. SUSAN LIN
K132379 07/31/2013 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US MICHAEL LOCKE
K132195 07/15/2013 EUROIMMUN ANTI-PLA2R ELISA (IGG) EUROIMMUN US INC MICHAEL LOCKE
K132161 07/12/2013 OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC. PATRICK HUGHES
K132017 07/01/2013 HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT FISHER & PAYKEL HEALTHCARE, LTD. ELIZABETH GOLDSTEIN
K132248 07/19/2013 FLOWER BONE SCREW SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K132247 07/19/2013 ULTRASONIC MESH NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K132188 07/15/2013 MAMMOGRAPHY VIEWER SMV658 FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K132210 07/16/2013 FUJIFILM 600 SERIES ENDOSCOPES FUJIFILM MEDICAL SYSTEMS U.S.A., INC. GINA WALLJASPER
K132376 07/30/2013 DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K132045 07/02/2013 ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS GE HUNGARY KFT STEPHEN SLAVENS
K132261 07/19/2013 DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K132027 07/01/2013 OEC 9800 PLUS GE OEC MEDICAL SYSTEMS, INC JEFF WAGNER
K132289 07/23/2013 GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM GEMSS MEDICAL SYSTEMS CO. LTD HARVEY KNAUSS
K132200 07/16/2013 PRO HMPV+ ASSAY GEN-PROBE PRODESSE, INC EMILY ZIEGLER
K132159 07/12/2013 PROADENO+ ASSAY GEN-PROBE PRODESSE, INC EMILY ZIEGLER
K132237 07/18/2013 PRODESSE PROFAST+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K132129 07/10/2013 PRODESSE PROFLU+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K132238 07/18/2013 PROPARAFLU+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K132375 07/30/2013 GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG GENICON KATLYN TISSUE
K132191 07/15/2013 SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBE MEDICAL, INC. CHRISTINA KICHULA
K132272 07/22/2013 GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION GLOOKO, INC. SHILPA MYDUR
K132240 07/18/2013 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K132383 07/31/2013 GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER GYRUS ACMI, INC. NEIL KELLY
K132214 07/16/2013 ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE HAGER & MEISINGER GMBH WIEBKE STOLTEN
K132212 07/16/2013 DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL HAGER & MEISINGER GMBH WIEBKE STOLTEN
K132184 07/15/2013 ACESSA GUIDANCE HANDPIECE HALT MEDICAL INC CLARISA TATE
K132369 07/30/2013 MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR HANSEN MEDICAL, INC. HASSAN LABAY
K132006 07/01/2013 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) HARTALEGA SDN BHD NURUL AISYAH KONG
K132067 07/03/2013 MULTI ANGLED ABUTMENT SYSTEM HIOSSEN INC. PATRICK LIM
K132287 07/23/2013 JAZZ SYSTEM HOGAN LOVELLS US LLP JANICE M HOGAN
K132251 07/19/2013 APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) HOLOGIC / GEN-PROBE INCORPORATED
K132316 07/25/2013 MULTIVIEW HOLOGIC, INC. EILEEN M BOYLE
K132276 07/22/2013 STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML HOSPIRA, INC. ABIGAIL FERGUSON
K132288 07/23/2013 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER i-SENS, Inc. CHAE YUN LIM
K132180 07/15/2013 IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM IDEAL LIFE INC. DAINE HORWITZ
K132303 07/24/2013 IMPLANET SPINE SYSTEM IMPLANET S.A. JANICE M HOGAN
K132353 07/29/2013 SUCTION LIPOPLASTY ACCESSORIES INEX RAYMOND PATEL
K132229 07/18/2013 OMNI PATENT MONITORS INFINIUM MEDICAL JOHN O'BRIEN
K132244 07/18/2013 N-FORCE FIXATION SYSTEM INNOVISION, INC. MICHELLE MCDONOUGH
K132205 07/16/2013 ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM INOVA LABS, INC. PAMELA M BUCKMAN
K132250 07/19/2013 INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM INTEGRA LIFE SCIENCES CORPORATION FREDERIC TESTA
K132235 07/18/2013 IMDX C.DIFFICILE FOR ABBOTT M2000 Intelligent Medical Devices, Inc. FRAN WHITE
K132347 07/29/2013 MULTICAM 3000 ECO INTER MEDICAL MEDIZINTECHNIK GMBH WILLIAM CARROLL
K132143 07/11/2013 EXHALATION VALVE INTERSURGICAL INCORPORATED MICHAEL ZALEWSKI
K132359 07/30/2013 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION RUSTY KELLY
K132179 07/15/2013 ARASYS ION GENIUS INC XANYA SOFRA-WEISS, PH.D
K132209 07/16/2013 IPS E.MAX CAD ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG DONNA HARTNETT
K132039 07/02/2013 ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM JEDMED INSTRUMENT CO. CRAIG PARKS
K132321 07/25/2013 JMS SYRINGE JMS NORTH AMERICA CORPORATION SHO HOSOKI
K132361 07/30/2013 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K132104 07/08/2013 ELIBRA SOFT-TISSUE FORCE SENSOR Kamm & Associates DANIEL KAMM, P.E.
K132025 07/01/2013 MESO BILAYER SURGICAL MESH KENSEY NASH CORPORATION DBA DSM BIOMEDICAL Susan Pileggi
K132343 07/30/2013 MARIGEN WOUND DRESSING KERECIS LIMITED GUDMUNDUR F SIGURJONSSON
K132124 07/10/2013 KLARITY VACUUM BAG, KLARITY MOLD CUSHION KLARITY MEDICAL PRODUCTS, LLC PETER LARSON
K132123 07/10/2013 TRC-PEX, RADIC-SEALER KM CORPORATION Priscilla Chung
K132172 07/15/2013 NEONATALIE RESUSCITATOR LAERDAL MEDICAL A/S MARI KAADA
K132136 07/11/2013 SINGLE USE GROUNDING PAD LCCS PRODUCTS LIMITED
K132190 07/15/2013 EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. Anna Kasseris
K132022 07/01/2013 LEMAITRE 8F OCCLUSION CATHETER LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K132047 07/02/2013 LEMILLS VALVULOTOME LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K132204 07/16/2013 INSUFLOW SYNERGY XL PORT LEXION MEDICAL, LLC. BERNARD HORWATH
K132203 07/16/2013 PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA LEXION MEDICAL, LLC. BERNARD HORWATH
K132220 07/17/2013 PJ'S SERENITY LIMERICK, INC. PATRICIA KELLY
K132135 07/10/2013 LINA GOLD LOOP HC LINA MEDICAL APS
K132144 07/11/2013 KERATOR LK Consulting Group USA, Inc. Priscilla Chung
K132166 07/12/2013 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT MAQUET CARDIOPULMONARY AG INGRID RICHTER
K132293 07/23/2013 SYVEK RADIAL BAND MARINE POLYMER TECHNOLOGIES SERGIO FINKIELSZTEIN
K132290 07/23/2013 SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES MATERIALISE N.V. OLIVER CLEMENS
K132084 07/05/2013 PROTURA COUCH SOFTWARE MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K132177 07/15/2013 MEDCOMP GEN III POWER INJECTABLE PORT MEDCOMP (MEDICAL COMPONENTS) SARAH SHAFFER
K132151 07/11/2013 SRS ENDOSCOPIC STAPLING SYSTEM MEDIGUS, LTD. JONATHAN S KAHAN
K132040 07/02/2013 VIAL CONNECTOR 13MM CLOSED COLLAR MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K132314 07/25/2013 MEDLINE ANTI-REFLUX VALVE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K132332 07/26/2013 MOUNTAINEER OCT SPINAL SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K132324 07/26/2013 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K132333 07/26/2013 BONDILOXS TOPICAL HEMOSTATIC DRESSING MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K132008 07/01/2013 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP MEDTRONIC INC. MICHELE MACHACEK
K132030 07/01/2013 MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING MEDTRONIC INC. CHECHAMMA VARUGHESE
K132111 07/09/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K132328 07/26/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K132297 07/24/2013 EM SINUS DILATION SYSTEM MEDTRONIC XOMED, INC. ROZANNE PACIEJ
K132226 07/17/2013 METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K132155 07/12/2013 ASAPLP ASPIRATION CATHETER MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K132164 07/12/2013 HEARTSPAN STEERABLE INTRODUCER KIT MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K132041 07/02/2013 REXTAR X META BIOMED, INC. BLIX WINSTON
K132137 07/11/2013 MULTISTIM METRON MEDICAL AUSTRALIA PTY LTD DAVID MITCHELL
K132083 07/05/2013 AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MICRO VENTION, INC. LARAINE PANGELINA
K132317 07/25/2013 MICROPLEX COIL SYSTEM (MCS), VFC MICROVENTION, INC. LARAINE PANGELINA
K132026 07/01/2013 V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 MINDRAY DS USA, INC. RUSSELL OLSEN
K132038 07/01/2013 ACCUTORR 7 VITAL SIGNS MONITOR MINDRAY NORTH AMERICA RUSSELL OLSEN
K132075 07/03/2013 PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) MINDRAY NORTH AMERICA RUSSELL OLSEN
K132037 07/01/2013 VITAL SIGNS MONITOR MINDRAY NORTH AMERICA RUSSELL OLSEN
K132232 07/18/2013 MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM MINILAP TECHNOLOGIES ALLAN ALWARD
K132048 07/02/2013 BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET MOLNLYCKE HEALTH CARE US, LLC CURTIS D TRUESDALE
K132163 07/12/2013 MOORLDLS-BI LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. XIABING HUANG
K132178 07/15/2013 MOSTDI DENTAL IMPLANT SYSTEM MOSTDI INNOVATIONS SDN BHD SUSAN PARK
K132264 07/22/2013 PRIMADO2 TOTAL SURGICAL SYSTEM NAKANISHI, INC. DIANE RUTHERFORD
K132110 07/09/2013 NATUS WARMETTE BLANKET AND DUAL CABINETS NATUS NICOLET IRELAND LTD MICHAEL GALVIN
K132044 07/02/2013 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM NEOS SURGERY S.L. CHERITA JAMES
K132323 07/25/2013 RS-3000 ADVANCE NIDEK CO., LTD. LENA SATTLER
K132072 07/03/2013 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM NIPRO DIAGNOSTICS, INC. BETH FOSTER
K132153 07/12/2013 SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K132329 07/26/2013 NIVATOPIC PLUS NIVAGEN PHARMACEUTICALS INC. LARA NOAH
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K132092 07/05/2013 ESTEYA NUCLETRON B.V. LU ANNE JOHNSON
K132107 07/08/2013 MALE LATEX CONDOM NULATEX SDN. BHD. AI SIANG TEO
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K132122 07/10/2013 KESTREL POSTERIOR CERVICAL SPINE SYSTEM OMNI SURGICAL LLC DBA SPINE360 DAVE LAMB
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K132245 07/18/2013 AJAX DENTAL UNIT PRO DENTAL SERVICES LLC. JOHN NEACSU
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K132294 07/23/2013 GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS RADIOLOGY SOLUTIONS LLC DANIEL KAMM
K132090 07/12/2013 BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K132156 07/11/2013 RANDOX CSF CONTROLS LEVELS 2 AND 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K132066 07/03/2013 INFLAMMA DRY RAPID PATHOGEN SCREENING, INC. Douglas Bueschel
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K132371 07/30/2013 EASYCARE ONLINE RESMED LTD. JIM CASSI
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K132228 07/17/2013 UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD KYEONG-MI PARK
K132173 07/15/2013 FAMILY HEALTHWARE SANITAS, INC. ALAN DONALD
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K132119 07/09/2013 MAGNETOM PRISMA, MAGNETOM PRISMA FIT SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
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K132325 07/26/2013 GUIDOR BIORESORBABLE MATRIX BARRIER SUNSTAR AMERICAS, INC. DEBORAH L GRAYESKI
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K132222 07/17/2013 AQUILION ONE VISION, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
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K132218 07/17/2013 PERFIX ILIAC SCREW SYSTEM U & I CORPORATION YOUNG-GEUN KIM
K132028 07/01/2013 ULTHERA SYSTEM ULTHERA, INC. SUZON LOMMEL
K132109 07/08/2013 ENAMELAST ULTRADENT PRODUCTS INC. / ORATECH LLC KAREN KAKUNES
K132255 07/19/2013 ULTRACEM ULTRADENT PRODUCTS INC. / ORATECH LLC DIANE E ROGER
K132224 07/17/2013 UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES UNIMED SURGICAL PRODUCTS, INC. LEE ALEXANDER
K132207 07/16/2013 UTF STEM-REDUCED, ADDITIONAL SIZES UNITED ORTHOPEDIC CORPORATION FANG-YUAN HO
K132142 07/11/2013 NERIA SOFT 90 INFUSION SET UNOMEDICAL A/S DEIRDRE BARROW
K132302 07/24/2013 QXLINK VIEWORKS CO., LTD. Priscilla Chung
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K132070 07/03/2013 VITA SUPRINITY(R) VITA ZAHNFABRIK H. RAUTER GMBH & CO. NEVINE ERIAN
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K132012 07/01/2013 TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC. JONATHAN GILBERT
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