FDA 510(k) Decisions During September, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K142112 09/23/2014 4WEB SPINAL IMPLANT PRODUCTS 4WEB, INC. RICH JANSEN
K141949 09/12/2014 CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K140371 09/30/2014 FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) ABBOTT DIABETES CARE INC. MICHELLE RICAFORT
K142527 09/19/2014 Extension Set with BD Q-Syte Luer Access Split Septum ACACIA, INC. DAN HYUN
K133963 09/09/2014 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC Caridad Smith
K141602 09/12/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K140077 09/22/2014 ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED ALBAAD LTD. ROBERT J STAAB, PH.D.
K141476 09/30/2014 WAVELIGHT FS200 LASER SYSTEM ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. Bob Lundberg
K133851 09/03/2014 ALERE PBP2A SA/CONS CULTURE COLONY TEST ALERE SCARBOROUGH, INC DANIELLE A BRIGGEMAN
K141450 09/17/2014 AXIOM 2.8 ANTHOGYR SAS THERESE CANDAU
K140097 09/24/2014 AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA MEINKE
K141033 09/12/2014 SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV ARGENTUM MEDICAL, LLC C. RICHARD FOSTER
K142336 09/17/2014 GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System ARKRAY FACTORY INC. Kazuya Yorimitsu
K142035 09/05/2014 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. LONNA M DENDOOVEN
K141635 09/03/2014 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. LEON BROWN II
DEN130031 09/05/2014 NEPHROCHECK TEST SYSTEM ASTUTE MEDICAL, INC KARIN HUGHES
K141380 09/26/2014 PROVOX FREEHANDS FLEXIVOICE ATOS MEDICAL AB FERENC DAHNER
K140039 09/15/2014 POLYCRYL AUROLAB KRISHNA KUMAR.R
K142261 09/24/2014 Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. Mario Thomas
K140496 09/16/2014 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents BECKMAN COULTER, INC. NANETTE CANEPA
K140911 09/05/2014 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. BRENT LEMBERG
K141355 09/03/2014 VOLUMETRIC INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORPORATION PAUL DRYDEN
K140837 09/24/2014 LUCID LY BIO-MED USA INC. YOUNG CHI
K141924 09/08/2014 HD BLOOD PRESSURE MONITOR BIOCARE ASIA CORPORATION LTD. Ke-Min Jen
K140390 09/10/2014 TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP. BRIAN KINCAID
K140710 09/04/2014 BIOMET GRAFT DELIVERY SYRINGES BIOMET SPINE (AKA EBI, LLC) DEBRA L BING
K141804 09/25/2014 POLARIS SPINAL SYSTEM - HA COATED BIOMET SPINE LLC, KIMBERLY MCCOY
K142295 09/15/2014 Sirius Femoral Stem, Size 30A Biomet, Inc. Jason Dugger
K141483 09/23/2014 BIOSPACE BODY COMPOSITION ANALYZER BIOSPACE CORPORATION LIMITED DANIEL KAMM
K141439 09/12/2014 ORTHODONTIC ACRYLIC (NOT FINALIZED) BISCO, INC. Michelle Schiltz-Taing
K142259 09/10/2014 Direxion Torqueable Microcatheter BOSTON SCIENTIFIC CORP. Mark Lanz
K141150 09/25/2014 PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. Carol Tiffany
K141831 09/04/2014 HYDRAVIEW GUIDEWIRE BRIVANT LIMITED KENNETH WALSH
K133852 09/19/2014 APOLLO BALLOON DILATATION CATHETER BROSMED MEDICAL STEPHEN LEE
K141025 09/12/2014 ARTIMES BALLOON DILATATION CATHETER BROSMED MEDICAL STEPHEN LEE
K134040 09/10/2014 BTL-9000; BTL-9000 RADIOFREQUENCY MODULE BTL INDUSTRIES LTD MICHAIL M PANKRATOV
K133456 09/24/2014 POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. BARD, INC. ELIZABETH PETERSON
K141985 09/18/2014 TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. BARD, INC. AARON CONOVALOFF
K133223 09/19/2014 XENMATRIX AB SURGICAL GRAFT C.R. BARD, INC. Tony John
K142225 09/12/2014 Pilot Elite Diode Laser CAO Group, Inc. Robert K Larsen
K142223 09/12/2014 Pilot Pro Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K142226 09/12/2014 Pilot Ultra Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K141552 09/05/2014 ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS CAREFUSION JOY GREIDANUS
K141068 09/09/2014 ZEISS CATARACT SUITE MARKERLESS CARL ZEISS MEDITEC AG SARAH HARRINGTON
K141829 09/24/2014 GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. Hak-Sung Kim
K134011 09/03/2014 GENERAL SPINAL SYSTEM CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD Diana Hong
K141806 09/19/2014 CLEAR GUIDE ONE CLEAR GUIDE MEDICAL JACK KENT
K142325 09/18/2014 Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands b.v. Gert Jan Klok
K142134 09/12/2014 C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES CONMED CORPORATION, LARGO JOY LOVETT
K140416 09/17/2014 TREKKER, TREKKER TRANSIT CONVAID PRODUCTS, INC. DONALD GRIGGS
K133889 09/04/2014 PREMIUM COUSIN BIOTECH S.A.S. FRANCK PELLETIER
K142048 09/17/2014 EMPRINT PROCEDURE PLANNING APPLICATION Covidien LLC HEATHER V NIGRO
K140429 09/11/2014 CRANE ACRYLIC HERBST APPLIANCE CRANE DENTAL LABORATORY, INC. KATE YOUNG
K142000 09/25/2014 ESOFLIP ES CROSPON, LTD. PAUL DRYDEN
K133739 09/05/2014 TRUSCULPT CUTERA, INC. BRADLEY RENTON
K141425 09/11/2014 ELITE + LASER SYSTEM CYNOSURE, INC. KELLI MCMILLAN
K142376 09/24/2014 Palomar Icon Aesthetic System CYNOSURE, INC. Allyson Connor
K140719 09/22/2014 PICOSURE WORKSTATION CYNOSURE, INC. KEVIN O'CONNELL
K130742 09/10/2014 POWEDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DAHOON PLASTIC CO., LTD. CHU XIAOAN
K141007 09/25/2014 DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE DEMETECH CORP. ANTHONY DIMERCURIO
K140634 09/19/2014 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit Devon Medical, Inc. Steve XU
K141144 09/03/2014 STA LIATEST D-DI DIAGNOSTICA STAGO CARLO D'ALESSANDRO
K142076 09/30/2014 CLAVEGUARD FREEDOM SURGICAL LIGHT DICKSON & DICKSON HEALTHCARE (US), INC RAGUNATH MUNIANDY
K141565 09/10/2014 GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. GALE WINARSKY
K140399 09/18/2014 EBM IDO VIEWER EBM TECHNOLOGIES USA, LLC JOHN SU
K141590 09/03/2014 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD SURESH KUMAR
K141696 09/18/2014 EDWARDS ESHEATH INTRODUCER SET EDWARDS LIFESCIENCES NEIL DELANEY
K141495 09/03/2014 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER EDWARDS LIFESCIENCES, LLC. ANDREW S MAZURKIEWICZ, JR
K133895 09/05/2014 DEKA SMARTXIDE LASER SYSTEM EL.EN. S.P.A GEORGE CHO
K140670 09/25/2014 ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ ELLIPSE A/S OLE KOFOD
K140613 09/18/2014 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES INC. John McIntyre
K141598 09/30/2014 FUSE COLONOSCOPY SYSTEM ENDOCHOICE, INC. TAMAR FUERST
K142113 09/30/2014 ESOPHYX2 HD ENDOGASTRIC SOLUTIONS, INC. MICHAEL A DANIEL
K141137 09/15/2014 STEREOS WORKSTATION EOS IMAGING JOHN J SMITH
K133584 09/08/2014 IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM EOSHEALTH, INC. Carrie Hetrick
K142008 09/12/2014 MYLABSEVEN, MYLABALPHA ESAOTE S.P.A. Allison Scott
K142077 09/12/2014 MYLABGAMMA ESAOTE, S.P.A. Allison Scott
K141122 09/15/2014 HARMONIC SCALLOP BLADE, GENERATOR G11 ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K142306 09/15/2014 Flower Upper Extremity Plating Set Flower Orthopedics Corporation Gary Barnett
K133976 09/09/2014 FUJIFILM ENDOSCOPIC CO2 REGULATOR FUJIFILM MEDICAL SYSTEM U.S.A., INC. GINA WALLJASPER
K141514 09/03/2014 SYNAPSE 3D TENSOR ANALYSIS FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. JYH-SHYAN LIN
K141562 09/05/2014 MSN-006 GC AMERICA, INC. MARK HEISS
K141074 09/18/2014 CORTEX ID SUITE GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K141477 09/18/2014 DISCOVERY IQ GE MEDICAL SYSTEMS, LLC HUY DOAN
K142085 09/26/2014 DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T GE MEDICAL SYSTEMS, LLC JENNY WONG
K142383 09/25/2014 Optima XR200amx, Optima XR220amx GE Medical Systems, LLC Chris Paulik
K141437 09/19/2014 XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING, GOH
K140380 09/26/2014 OPERA SWING GENERAL MEDICAL MERATE S.P.A. BERTHOIN CLAUDE
K133911 09/03/2014 GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM GENESYS SPINE BRIAN J BERGERON
K141286 09/30/2014 AER-O-SCOPE COLONOSCOPE SYSTEM GI VIEW LTD. MARK HELLER
K140195 09/10/2014 SURGICAL DRAPE GRIFFITH-LUCAS LLC MIKE GU
K142423 09/10/2014 EyeSuite Imaging HAAG-STREIT AG Oscar Banz
K140367 09/12/2014 ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX HARBOR MEDTECH, INC. JERRY MEZGER
K140050 09/12/2014 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE HARTALEGA SDN BHD NURUL AISHYAH KONG
K142157 09/05/2014 PALACOS R+G PRO HERAEUS MEDICAL GMBH ASTRID MARX
K131173 09/18/2014 FIA Blood Glucose Monitoring System (G2) HMD BIOMEDICAL, INC. AXEL LIN
K140841 09/11/2014 TABLO CARTRIDGE HOME DIALYSIS PLUS NANCY GALLO
K140866 09/10/2014 TABLO CONSOLE HOME DIALYSIS PLUS NANCY GALLO
K142300 09/17/2014 Arrow GPSCath Balloon Dialation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., ERICK ANKERUD
K140928 09/15/2014 ABPM7100 I.E.M. GMBH ARNE BRIEST
K142418 09/26/2014 I.T.S. Hand Locking Plates System - HLS I.T.S. GmbH Al Lippincott
K141343 09/05/2014 AXXENT CERVICAL APPLICATOR ICAD, INC. John DeLucia
K142054 09/29/2014 IMACOR ZURA EVO IMAGING SYSTEM IMACOR INC. JAMES W MONROE
K141069 09/17/2014 Lung Density Analysis IMBIO LLC JASON SHEARD
K141572 09/05/2014 MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K141950 09/04/2014 HFD100 ROCKER ARM ACCESSORY IMRIS, INC. KARISSA HOLCOMB
K133753 09/19/2014 MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR INFOBIONIC, INC. CARRIE NEUBERGER
K141591 09/24/2014 SMARTGRAFT 30 SYSTEM INGENERON, INC. ANITA KADALA
K130312 09/18/2014 IROOT FM INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K141075 09/26/2014 SINGLE-SITE WRISTED NEEDLE DRIVER INTUITIVE SURGICAL EINAV YEMINI
K123329 09/17/2014 DA VINVI SURGICAL SYSTEM INTUITIVE SURGICAL, INC. CINDY DOMECUS
K141670 09/18/2014 ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA JOHNSON & JOHNSON VISION CARE, INC. SCOTT DURLAND
K141873 09/08/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. NANCY GLEZEN
K140964 09/04/2014 CALCULASE II KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K140362 09/15/2014 KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES KATALYST SURGICAL, LLC MERYL KOCH
K142179 09/17/2014 D-KAT Z-YPE KEELER LTD. EUGENE R VAN ARSDALE
K141271 09/26/2014 AERODR SYSTEM 2 KONICA MINOLTA, INC. RUSSELL D MUNVES
K142397 09/19/2014 Predicate III Guidewire Lake Region Medical Mathew Pexa
K133717 09/19/2014 LONGBOW SPACER SYSTEM LIFE SPINE RANDY LEWIS
K141905 09/26/2014 PRO-LINK WEDGE SYSTEM LIFE SPINE RANDY LEWIS
K141453 09/19/2014 ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K142386 09/29/2014 Operating Room Light Handle Adapter Litex Manufacturing, Inc. Noel Gharibian
K131968 09/05/2014 LONGFIAN OXYGEN CONCENTRATOR LONGFIAN SCITECH CO., LTD. JUN PENG
K140377 09/16/2014 XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MOLECULAR DIAGNOSTICS, INC. Tina Ip
K140488 09/10/2014 CONTACT LENS CASE MACA PLASTICS, INC. CORRINA CULBERTSON
K131340 09/09/2014 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES MADE PLASTIC CO., LTD. CHU XIAOAN
K141358 09/25/2014 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL A DANIEL
K140167 09/10/2014 RENAISSANCE X SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K142258 09/30/2014 PolyCatch Retrieval Device Medi-Globe Corporation Scott Karler
K141633 09/29/2014 PRO-PICC WITH VALVE TECHNOLOGY MEDICAL COMPONENTS INC JONATHAN SCHELL
K141321 09/15/2014 GLUCOSTABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISION NETWORK JANE KEATHLEY
K140369 09/26/2014 MEDLINE NEURO SPONGE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K141290 09/29/2014 HELICAL RIDGE PEEK INTERFERENCE SCREW MEDSHAPE, INC JACK GRIFFIS
K133577 09/26/2014 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC LEE GRANT
K141824 09/05/2014 MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK, INC. COURTNEY N LONG
K140608 09/12/2014 MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC. SIOBHAN KING
K140758 09/15/2014 M-PM-DISC (PINK) MERZ DENTAL GMBH RICHARD G HUNTER
K133298 09/19/2014 ENDO SMART META BIOMED, INC. BLIX WINSTON
K141235 09/12/2014 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K141272 09/04/2014 FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR MINIMMALLY INVASIVE DEVICES TRUDIE L SEEGER, PH.D.
K141885 09/18/2014 CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY MINXRAY, INC. DANIEL KAMM
K140557 09/18/2014 MIVI 6F GUIDE CATHETER MIVI, LLC MICHELLE STRAIGHT
K141719 09/04/2014 BIOGEL PL MICRO SURGICAL GLOVE MOLNLYCKE HEALTH CARE, US LLC CURTIS TRUESDALE
K142105 09/05/2014 ELI 380 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC AMY YANG
K140349 09/22/2014 STARBRIGHT 5% SODIUM FLUORIDE VARNISH NANOVA BIOMATERIALS, INC. ANDREW RITTS
K140280 09/05/2014 FORTICORE NANOVIS, LLC KAREN E WARDEN PHD
K141669 09/19/2014 SURGIMAP NEMARIS INC KEITH BARRITT
K141103 09/23/2014 INTRAMEDULLARY NAIL AND SCREWS-NEONAIL NEOORTHO PRODUTOS ORTOPEDICOS S/A KEVIN A THOMAS
K140947 09/04/2014 COMPAT ENTERAL DELIVERY PUMP SETS NESTLE HEALTHCARE NUTRITION, INC. M.W.(ANDY) ANDERSON
K141244 09/09/2014 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) NORTH AMERICAN SCIENCE ASSOC., INC. JULIE WHEELER
K132121 09/24/2014 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD, PHD
K134019 09/11/2014 MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO NXSTAGE MEDICAL, INC. LAURA F PLATH
K140378 09/25/2014 FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT OMNIGUIDE, INC. NICOLE RASMUSSEN
K141140 09/30/2014 COMP A-I-R OMRON HEALTHCARE, INC. PAUL DRYDEN
K141079 09/11/2014 OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION STEVE JWANOUSKOS
K142339 09/26/2014 HEMASORB Resorbable Hemostatic Bone Putty ORTHOCON, LLC Howard L Schrayer
K141078 09/02/2014 ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) ORTHOFIX SRL CHERYL WAGONER
K131817 09/26/2014 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. MIKE GU
K133050 09/19/2014 ONE PLUS IMPLANT SYSTEM OSSEOFUSE, INC. Priscilla Chung
K141616 09/23/2014 STERILIZATION CASSETTE OTICON MEDICAL AB CAROL A WESSLING
K141422 09/30/2014 PROFLUORO FLUORIDE VARNISH PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K133603 09/25/2014 PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION PHILIPS MEDICAL SYSTEMS SUSAN QUICK
K141998 09/19/2014 SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS PINGHU SAMA MEDICAL PACKING CO., LTD. CHARLES SHEN
K131983 09/10/2014 ITRAC CERVICAL TRACTION SYSTEM PIVOTAL HEALTH SOLUTIONS AARON TVEDT
K142408 09/25/2014 FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) POLYMED THERAPEUTICS, INC FRANK LUO
K132245 09/05/2014 AJAX DENTAL UNIT PRO DENTAL SERVICES LLC. JOHN NEACSU
K140865 09/03/2014 INFRARED HEATING DEVICE PRO MEDICAL SUPPLIES, INC. DORIS DONG
K141018 09/15/2014 ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT PROCTER & GAMBLE CO. MICHAEL KAMINSKI, PH.D.
K141638 09/17/2014 PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE PROPPER MANUFACTURING CO.,INC. ANDREW SHARAVARA
K130450 09/30/2014 SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE PURNA BINA SDN BHD ROBERT HILL
K142181 09/18/2014 RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K140991 09/11/2014 RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE RANFAC CORP. CHRISTOPHER P WHELAN
K142123 09/24/2014 REACH ACCESS TELEMEDICINE DOSE CALCULATOR REACH HEALTH, INC. BETH DESTASIO
K141547 09/30/2014 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL Rebecca K Pine
K140780 09/10/2014 KEGEL SMART, KEGELSMART PEARL REGULATORY INSIGHT, INC. Kevin Walls
K141370 09/02/2014 RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton
K134003 09/04/2014 RHINIX NASAL FILTER RHINIX APS METTE MUNCH
K142127 09/05/2014 ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics KELLI TURNER
K141384 09/12/2014 WHISPERJECT AUTOINJECTOR SCANDINAVIAN HEALTH LIMITED James Haynes
K141895 09/18/2014 MOBILEDIAGNOST WDR SEDECAL SA JENNIFER CARTLEDGE
K142241 09/12/2014 LARIAT sulture Delivery Device SENTREHEART INC. Kit Cariquitan
K140874 09/02/2014 GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY RHONDA ALEXANDER, MS, MPA
K141260 09/17/2014 ELECTRONIC PULSE STIMULATOR SHENZHEN JINGKEHUI ELECTRONIC CO., LTD BILL QUANQIN DAI
K140690 09/02/2014 BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K141574 09/05/2014 ARTIS ZEE/ZEEGO SW VC21 SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K141971 09/12/2014 BIOGRAPH TRUE PET/CT FAMILY SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K142395 09/09/2014 SC2000 and ACUSON X300 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
K140912 09/15/2014 SOMATOM SCOPE/SOMATOM SCOPE POWER SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K141405 09/16/2014 MOBIS II ST SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH J.D. WEBB
K141255 09/22/2014 SIMEX SUBGLOTTIC ASPIRATION SYSTEM SIMEX MEDIZINTECHNIK GMBH HAMID KHOSROWSHAHI
K140013 09/05/2014 SOPIX INSIDE, SOPIX2 INSIDE SOPRO - ACTEON GROUP RICK ROSATI
K141156 09/09/2014 SPACELABS HEALTHCARE TELEMETRY RECEIVER SPACELABS HEALTHCARE THOMAS KROENKE
K141113 09/26/2014 SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE SPACELABS HEALTHCARE LTD. AL VAN HOUDT
K142546 09/25/2014 TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath SPECTRANETICS, INC. Christopher McLellan
K141835 09/10/2014 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS SPINE ART FRANCK PENNESI
K141314 09/29/2014 SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION SPINEART Franck Pennesi
K141337 09/08/2014 ARENA-C SPINEFRONTIER, INC. MEREDITH MAY MS, RAC
K142213 09/10/2014 VIA SPINOUS PROCESS FIXATION SYSTEM SPINEOLOGY, INC. TIM CRABTREE
K140804 09/03/2014 VDRIVE WITH V-LOOP/ VDRIVE DUO STEREOTAXIS, INC. DIANE HORWITZ, PH.D., RAC
K141551 09/08/2014 PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) STRYKER CORPORATE BECKY DITTY
K141673 09/04/2014 IVAS 8 GAUGE BONE BIOPSY KIT STRYKER CORPORATION BRITTNEY L LARSEN
K141935 09/26/2014 STRYKER S2 DRILL STRYKER CORPORATION VISHAL KANANI
K141800 09/26/2014 PERFRACTION SUN NUCLEAR CORPORATION JEFF KAPATOES
K142309 09/16/2014 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. Troy Thome
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