FDA 510(k) Applications Received During February, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K140392 02/14/2014 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER 3M COMPANY SUZANNE LEUNG
K140330 02/10/2014 3M STERI-DRAPE FABRIC SURGICAL DRAPES 3M HEALTH CARE MARK BURVILLE
K143573 12/17/2014 Audit MicroControls Linearity FD Tumor Markers II AALTO SCIENTIFIC LTD. Robert Burda
K143571 12/17/2014 Audit MicroControls Linearity LQ Cystatin-C AALTO SCIENTIFIC, LTD. ROBERT BURDA
K140371 02/14/2014 FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) ABBOTT DIABETES CARE INC. MICHELLE RICAFORT
K143434 12/01/2014 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series ABBOTT MEDICAL OPTICS INC Nooshin Azizi
K140354 02/12/2014 ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG ABBOTT MOLECULAR, INC. STACY FERGUSON
K140483 02/26/2014 ASAP OTC WOUND DRESSING GEL ABL MEDICAL, LLC CALLEY HERZOG
K143613 12/19/2014 PaxWire Occlusion Balloon System ACCESSCLOSURE, INC. Kelly Jabbal
K143541 12/15/2014 Relieva SpinPlus Balloon Sinuplasty System ACCLARENT, INC. Pavan Sethi
K143450 12/02/2014 Ackermann Intervertebral Body Fusion Device ACKERMANN INSTRUMENTE GMBH Rolf Ackermann
K143449 12/02/2014 ADH 200 Analyzer Software ADAMS MEDITECH LLC CECILIA L. YU
K140517 02/28/2014 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC RICHARD JONES
K140293 02/05/2014 TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEMS LTD. NISSIM SHAKED
K143719 12/29/2014 Aeroneb USB Contoller System Aerogen Limited Martin Crehan
K140452 02/24/2014 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEMS JULIE TOM WING
K143443 12/02/2014 VEGA Knee System, Columbus Total Knee System Aesculap Implants Systems, LLC Julie Tom Wing
K140343 02/14/2014 AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP AESCULAP, INC. KATHY A RACOSKY
K143729 12/29/2014 SterilContainer S AESCULAP, INC. Denise R Adams
K140303 02/06/2014 ALAMO T ALLIANCE PARTNERS, LLC. KELLEN HILLS
K143740 12/30/2014 Battalion Universal Spacer System ALPHATEC SPINE, INC. Nadine Smith
K143604 12/18/2014 Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S BASAK DEMIRCI
K143518 12/12/2014 Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. William D. Jordan
K140435 02/21/2014 MEDLEY GOLD AMERICAN DENTAL SLEEP MEDICINE, IP, LLC PAUL DRYDEN
K143580 12/18/2014 PeriCoach ANALYTICA LTD GEOFF DALY
K143757 12/31/2014 ANUTRA Feedback Aspiration Syringe ANUTRA MEDICAL, INC. CAMERON PERKINS
K143750 12/31/2014 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System APEX BIO TECHNOLOGY CORP Hsue-Mei Lee
K143536 12/15/2014 Voyant Fine Fusion Device APPLIED MEDICAL RESOURCES JESSICA CHO
K143517 12/12/2014 Voyant Open Sealer-Divider Device APPLIED MEDICAL RESOURCES Jessica Cho
K140287 02/05/2014 AXERA RX ACCESS SYSTEM ARSTASIS, INC. GRACE LI
K143702 12/24/2014 Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc. David L Roger
K143745 12/31/2014 Arthrex Corkscrew and SwiveLock Suture Anchors Arthrex, Inc. David L Rogers
K143749 12/31/2014 Arthrex Distal Radius System Arthrex, Inc. Laura Medlin
K140476 02/26/2014 ARTHREX FIBERTAK SUTURE ANCHOR ARTHREX, INC. COURTNEY SMITH
K143614 12/19/2014 Arthrex Low Profile Screws ARTHREX, INC. David L Rogers
K140328 02/10/2014 CMC MINI TIGHTROPE ARTHREX, INC. NANCY HOFT
K140463 02/24/2014 INTEGRA EXTERNAL FIXATION SYSTEM ASCENSION ORTHOPEDIC STEVE BROWN
K143519 12/12/2014 The MeDioStar NeXT Family ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K140428 02/26/2014 ULTRASOUND SCANNER SYSTEM BK2300 B-K MEDICAL APS RANDI HAUERBERG
K140311 02/07/2014 CARESITE LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. KIMBERLY SMITH
K143632 12/22/2014 Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens Bausch & Lomb Incorporated Jessica Burger
K143538 12/15/2014 MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit BAYER MEDICAL CARE INC. LISA A. EWING
K140496 02/27/2014 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
K143610 12/19/2014 BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems Inc. John Roberts
K140446 02/21/2014 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SHERMA WINSTON
K140448 02/21/2014 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SHERMA WINSTON
K143648 12/22/2014 BD MAX Enteric Parasite Panel, BD MAX Instrument BECTON, DICKINSON AND COMPANY PAUL SWIFT
K140468 02/25/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) BECTON, DICKINSON AND COMPANY MONICA E GIGUERE
K140447 02/21/2014 BD VIPER LT SYSTEM BECTON, DICKINSON AND COMPANY SHERMA WINSTON
K143462 12/04/2014 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) BENQ MATERIALS CORPORATION Kenix Chang
K140370 02/14/2014 DISPOSABLE PRESSURE MANOMETER BESMED HEALTH BUSINESS CORP. PAUL DRYDEN
K143715 12/29/2014 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Better Plastic Co., Ltd. Du Wei
K143524 12/12/2014 Fiber Disks and Blocks (TRINIA) Bicon, LLC Richard Wu
K143492 12/08/2014 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA Judith Clerc
K140407 02/18/2014 FILMARRAY GASTROINTESTINAL (GI) PANEL BIOFIRE DIAGNOSTICS BETH LINGENFELTER
K143543 12/15/2014 Prelude PF Patellae BIOMET INC. JARED COOPER
K143697 12/24/2014 Biomet Proximal Humerus Plating System Biomet Manufacturing Julie Largent
K140390 02/14/2014 TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP. BRIAN KINCAID
K140509 02/28/2014 BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE BIOMET MANUFACTURING LLC TRACY BICKEL JOHNSON, RAC
K140318 02/10/2014 SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER BIOSENSE WEBSTER MARINA GUEVREKIAN
K143503 12/10/2014 BioMonitor BIOTRONIK, INC. JON BRUMBAUGH
K143705 12/29/2014 NeedleCam HD Visualization System BIOVISION TECHNOLOGIES, LLC DAVID SANSO
K143668 12/24/2014 Navio BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K140323 02/10/2014 NAVIGATOR HD URETERAL ACCESS SHEATH SETS BOSTON SCIENTIFIC NICHOLE RIEK
K140329 02/10/2014 RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT BOSTON SCIENTIFIC MARK MURPHY
K140273 02/03/2014 EQUALIZER OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP. DIANE NELSON
K140495 02/27/2014 LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. MATT BEAUCHANE
K140288 02/05/2014 TRUEPATH CTO DEVICE BOSTON SCIENTIFIC CORP. CAROL TIFFANY
K143587 12/18/2014 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire BOSTON SCIENTIFIC CORPORATION NIKKI M WAHLBERG
K143643 12/22/2014 Brainscope Ahead 200 BRAINSCOPE COMPANY, INC. Michael E Singer
K143559 12/16/2014 XP1000 RF BTL INDUSTRIES, INC Jan Zarsky
K140501 02/27/2014 XENMATRIX SURGICAL GRAFT C.R. BARD GINA CASSIDY
K143743 12/31/2014 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH C.R. Bard Inc. FELICIA RULEY
K143522 12/12/2014 Presto Inflation Device C.R. BARD, INC. TIMOTHY WADE
K140345 02/14/2014 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. BARD, INC. JAMES R DAVIS
K143490 12/08/2014 VERTA Corpectomy Cage CAMBER SPINE Daniel A. Pontecorvo
K143718 12/29/2014 Mammography Color Display DP-M3010 CANON INC. MASAKI TAMURA
K143496 12/09/2014 Piccolo Composite Plate System CarboFix Orthopedics Ltd. Yael Rubin
K143714 12/29/2014 Powerheart G5 AED CARDIAC SCIENCE CORPORATION Kathleen Roberts
K143432 12/01/2014 Cardio-TriTest CARDIO-PHOENIX INC. MARC BISNAIRE
K140497 02/27/2014 ECVUE MAPPING SYSTEM CARDIOINSIGHT TECHNOLOGIES, INC CHRISTINA V VACCA
K140271 02/05/2014 TABLET VIEWER SOFTWARE FOR IMAGE SUITE CARESTREAM HEALTH, INC. ALEXANDRA CHAMBERLAIN
K140430 02/19/2014 740 SELECT CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K143675 12/24/2014 FORE-SIGHT Elite Absolute Tissue Oximeter CAS MEDICAL SYSTEMS, INC. Ron Jeffrey
K143473 12/05/2014 Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles CAYENNE MEDICAL, INC Shima Hashemian
K140426 02/25/2014 ANTHRACIS REAL-TIME PCR ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) HYE-JOO KIM
K143599 12/18/2014 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 Chemtron Biotech, Inc. Jane Zhang
K140364 02/12/2014 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K140321 02/18/2014 INITARY BETTER BLADDER-PEDIATRIC CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K140490 02/27/2014 CIVA SHEET PD-103 CIVATECH ONCOLOGY, INC. BLIX WINSTON
K143758 12/31/2014 PerioType Rapid CLINICAL HOUSE EUROPE GMBH Judi Weissinger
K140313 02/10/2014 STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM COAG MEDICAL LLC BERNARD HORWATH
K140307 02/07/2014 ENVOY GUIDING CATHETER CODMAN & SHURTLEFF, INC. HANNAH FOLEY
K140469 02/25/2014 MR SYRINGE DUAL PACK COEUR, INC. ERIN RHEINSCHELD
K140423 02/18/2014 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K140459 02/24/2014 ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM CONMED CORPORATION LISA ANDERSON
K143725 12/29/2014 Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc Matthew M Hills
K140416 02/18/2014 TREKKER, TREKKER TRANSIT CONVAID PRODUCTS, INC. DONALD GRIGGS
K143650 12/23/2014 CooperSurgical Advincula Delineator Uterine Manipulator Cooper Surgical Inc. James Keller
K140438 02/21/2014 MICRO GUIDE CATHETER ELITE CORDIS CORP., A JOHNSON & JOHNSON CO. Michelle Ragozzine Rodgers
K140286 02/05/2014 OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER CORDIS, A JOHNSON & JOHNSON CO. SHAMSA KARIMI
K140306 02/07/2014 CORMATRIX PROTECT ECM ENVELOPE CORMATRIX CARDIOVASCULAR, INC. BRYAN BROSSEAU
K143506 12/10/2014 BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL COVIDIEN TIMOTHY HOLWICK
K143644 12/22/2014 Premium Surgiclip?; Endo Clip?; AcuClip? COVIDIEN Michael Koczocik
K140339 02/10/2014 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN BRIANNA REYNOLDS
K143598 12/18/2014 Lapro-Clip Auto Suture Reusable Long Clip Applier Covidien LLC Rebecca Magnanimo
K143654 12/23/2014 Valleylab LS10 Generator COVIDIEN LLC DONALD HENTON
K140429 02/19/2014 CRANE ACRYLIC HERBST APPLIANCE CRANE DENTAL LABORATORY, INC. KATE YOUNG
K140338 02/10/2014 CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) CREGANNA-TACTX MEDICAL NIALL FOX
K143520 12/12/2014 SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) CROSSTEX Michael G Nolan
K143625 12/22/2014 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K140358 02/12/2014 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K143530 12/12/2014 Aespire View Datex-Ohmeda, Inc. Michelle Huettner
K140206 02/07/2014 SCINTILLATION GAMMA CAMERA DDD-DIAGNOSTIC A/S NEERGAARDS VEJ 5E
K143679 12/24/2014 Nuance FLOW Den-Mat Holdings, LLC Helen Ragus
K140347 02/11/2014 ANKYLOS C/X IMPLANT SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K143475 12/05/2014 VAPR Tripolar Suction Electrode Depuy Mitek Susan Kagan
K143660 12/23/2014 Milagro / Milagro Advance Interference Screw DEPUY MITEK, A JOHNSON & JOHNSON COMPANY Yayoi Fujimaki
K140324 02/10/2014 RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY YAYOI FUJIMAKI
K143677 12/24/2014 DeVilbiss Intellipap2/DeVilbiss BLUE DeVilbiss Healthcare, LLC Betty Miller
DEN140038 12/15/2014 Dexcom Share Direct Secondary Displays DEXCOM, INC. Andrew K Balo
K143586 12/18/2014 FACT Medical Imaging Sysytem Dexin Medical Imaging Technology Co., Ltd. Wang Yu
DEN140004 02/21/2014 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC. Ronald H Lollar
K140458 02/24/2014 DIOTECH LASER FIBER DIOTECH CO PETER CHUNG
K143551 12/15/2014 Compex Wireless USA DJO, LLC GINA FLORES
K140384 02/14/2014 FMWAND HANDPIECE SE DOMAIN SURGICAL, INC. CURTIS JENSEN
K143430 12/01/2014 SmartTENS EASYMED INSTRUMENT CO., LTD. Jeffery Wu(Tingjie Wu)
K140399 02/18/2014 EBM IDO VIEWER EBM TECHNOLOGIES USA, LLC JOHN SU
K143695 12/24/2014 CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC QUEENA CHEN
K140398 02/18/2014 EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K140312 02/12/2014 EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM EDWARDS LIFESCIENCES, LLC. RENATE A MACLAREN
K140208 02/03/2014 FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII EDWARDS LIFESCIENCES, LLC. LINDSAY MARTIN
K140381 02/14/2014 SENSILIGHT/ SENSILIGHT PLUS EL GLOBAL TRADE LTD. SHLOMIT SEGMAN
K140467 02/24/2014 FLEX-MT + EMSI CHERITA JAMES
K140472 02/25/2014 BONASTENT TRACHEAL / BRONCHIAL ENDOCHOICE, INC. Bosmat Friedman
K143645 12/22/2014 EsophyX« Z Fastener Delivery Device ENDOGASTRIC SOLUTIONS, INC. DARREN CROW
K140389 02/14/2014 CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 ENTROTECH LIFE SCIENCES INC. VALERIE DEFIESTA-NG
K140281 02/04/2014 FLEXI-LUME LED SYSTEM EPIC MEDICAL CONCEPTS & INNOVATIONS ALEX WALLER
K143557 12/15/2014 SupaScoota Motorized vehicle EUROGREEN INTERNATIONAL INC DAVID HSIEH
K143659 12/23/2014 Equinoxe Mega Prosthesis EXACTECH, INC. Thomas McNamara
K143576 12/17/2014 Exactech Ambassador EXACTECH, INC. DAWN DAVISSON
K140302 02/06/2014 OPTETRAK LOGIC POROUS FEMORAL COMPONENTS EXACTECH, INC. PATRICK HUGHES
K140254 02/05/2014 EZONO 4000 EZONO AG GRAHAM COX
K143666 12/23/2014 Noblex Long Pulse Alexandrite Laser FINEMEC CO.,LTD. GHUN HEE LEE
K143646 12/22/2014 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit Fisher & Paykel Healthcare Ltd Elizabeth Goldstein
K140473 02/25/2014 DUALGUARD FLEXICARE MEDICAL LTD. CHRISTOPHER WATKINS
K143484 12/08/2014 BioZorb Marker FOCAL THERAPEUTICS George Hermann
K143651 12/23/2014 Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack FOCUS DIAGNOSTICS, INC. Sharon Young
K143723 12/29/2014 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro FOTONA D.D. STOJAN TROST
K143556 12/15/2014 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T FUJIFILM MEDICAL SYSTEMS U.S.A., INC. MARY MOORE
K143732 12/29/2014 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc. Mary Moore
K143721 12/29/2014 PRCT2 FX SOLUTIONS JEAN JACQUES MARTIN
K143564 12/16/2014 Visual-ICE Cryoablation System, Software Revision 1.3.1 GALIL MEDICAL INC. AMY MCKINNEY
K143570 12/17/2014 WIRION GARDIA MEDICAL OHAD HAAS
K133922 02/18/2014 GENTLECARE AR APPLICATOR GC MEDTECH, LLC GREGORY MATHISON
K143667 12/23/2014 GC KommonBase GC Orthodontics America Inc. Tom Macari
K143452 12/02/2014 LOGIQ P9, LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K143676 12/24/2014 B40i Patient Monitor GE HEALTHCARE FINLAND OY JOEL KENT
K140518 02/28/2014 GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER GEISTLICH PHARMA AG DANIEL A KRACOV
K143574 12/17/2014 Melodi Prime Breast Pump Genadyne Biotechnologies, Inc. Chien Ming GOH
K143726 12/29/2014 XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING GOH
K140380 02/14/2014 OPERA SWING GENERAL MEDICAL MERATE S.P.A. BERTHOIN CLAUDE
K143591 12/18/2014 Dorsal Appliance GERGENS ORTHODONTIC LAB Chris Morrison
K143438 12/02/2014 Flowtron ACS900 Getinge (Suzhou) Co., Ltd Lenda Hou
K140295 02/06/2014 GIS ENDOSCOPIC OPTICAL LENS GI SCIENTIFIC LLC MICHELE LUCEY
K140411 02/18/2014 ALTERA SPACER GLOBUS MEDICAL INC. CHRISTINA KICHULA
K143633 12/22/2014 CREO Stabilization System GLOBUS MEDICAL INC. Kelly J. Baker
K143527 12/12/2014 IPM Wound Gel Bio, IPM Derm Gel Bio GLYCOBIOSCIENCES, INC Kevin Drizen
K143734 12/30/2014 Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K143735 12/30/2014 Digital Automatic Blood Pressure Monitor MD2300 Grandway Technology (Shenzhen) Limited Patrick Chow
K143733 12/30/2014 Digital Automatic Wrist Blood Pressure Monitor MD2400 Grandway Technology (Shenzhen) Limited Patrick Chow
K143535 12/15/2014 CR3 Keyless Split Sample Cup Secobarbital- Methadone GUANGZHOU WONDFO BIOTECH CO., LTD. Ben Chen
K143656 12/23/2014 StarCeram« Z-Nature, StarCeram« Z-Smile H.C. Starck Ceramics GmbH Alexandra Krausch
K143539 12/15/2014 Dental Implant OKTAGON Bone Level Hager & Meisinger GmbH Wiebke Stolten
K140367 02/14/2014 ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX HARBOR MEDTECH, INC. JERRY MEZGER
K140270 02/03/2014 NEXUS MIDLINE CT CATHETER HEALTH LINE INTERNATIONAL CORPORATION JOHN E LINCOLN
K140269 02/03/2014 HERMES MEDICAL IMAGING SUITE V5.4 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K140422 02/18/2014 HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM HET SYSTEMS, LLC HOWARD L SCHRAYER
K143537 12/15/2014 Sirius Starmobile tiara HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K143737 12/30/2014 EM25 - glute toning device HIVOX BIOTEK, INC. CLYTIE CHIOU
K140316 02/14/2014 EXAMINATION GLOVES HL RUBBER INDUSTRIES SDN BHD NOORZALIZA AHMAD
K140366 02/14/2014 ENDLESSFIBER REUSABLE SURGICAL LASER FIBER HOGUE SURGICAL LLC ROGER S HOGUE, MD
K143594 12/18/2014 VaPro Pocket Hollister Incorporated Jeanne Lee
K140351 02/11/2014 ARROW GPSCATH BALLOON DILATATION CATHETER HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX MEDICAL, INC ERIC ANKERUD, JD
K143437 12/01/2014 Droplet Pen Needles HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska
K143431 12/01/2014 Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) i-codi Co., Ltd Yoo Hwan Park
K140445 02/27/2014 DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC IMAGING SCIENCES INTERNATIONAL, LLC SANJAY AHUJA
K143736 12/30/2014 ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K143500 12/10/2014 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Immunalysis Corporation Joseph Ginete
K143502 12/10/2014 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls IMMUNALYSIS CORPORATION JOSEPH GINETE
K143731 12/29/2014 IMPLANET Spine System (ISS) IMPLANET S.A. Regis Le Couedic
K143759 12/31/2014 JAZZ System IMPLANET S.A. REGIS LE COUEDIC
K143563 12/16/2014 Infusion Aspiration Catheter System Inari Medical, Inc. Eben Gordon
DEN140039 12/15/2014 NOVA View Automated Fluorescense Microscope INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K143754 12/31/2014 QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 INOVA DIAGNOSTICS, INC. Gabriella Lakos
K140439 02/21/2014 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION ANTONETTE M DELEO, RAC
K143663 12/23/2014 MiroCam Capsule Endoscope System INTROMEDIC CO., LTD Jinyoung Lee
K143738 12/30/2014 DSS Sinusplasty Balloon Catheter Intuit Medical Products, LLC Jack Griffis
K143436 12/01/2014 InvisionECG System InvisionHeart Inc. Michael Wurst
K143513 12/11/2014 ZIO SR ECG Monitoring Service iRhythm Technologies, Inc. Rich Laguna
K143575 12/17/2014 Accu-Dent XD Tray, Accu-Dent XD Syringe IVOCLAR VIVADENT, INC. Donna Marie Hartnett
K143730 12/29/2014 GBR System JEIL MEDICAL CORPORATION HYEROUNG LEE
K140512 02/28/2014 UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE JUNO DENTISTRY LP ROGER MASTRONY
K140420 02/18/2014 VADO STEERABLE SHEATH KALILA MEDICAL, INC. CARRIE NEUBERGER
K143465 12/04/2014 MASTERmatic LUX Kaltenbach & Voigt Gmbh Stefan Trampler
K140308 02/07/2014 MASTERSURG / EXPERTSURG KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K143640 12/22/2014 KSEA CMOS Camera System (C-cam) KARL STORZ ENDOSCOPY-AMERICA, INC. Susie S Chen
K140362 02/12/2014 KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES KATALYST SURGICAL, LLC MONA DEAN
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K143424 12/01/2014 UTAH CVX-RIPE UTAH MEDICAL PRODUCTS, INC. Ben Shirley
K143652 12/23/2014 Vector PTA Balloon Dilatation Catheter Vector Corporation LLC Jay Sturm
K140465 02/24/2014 VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER VENTANA MEDICAL SYSTEMS, INC. MORT MINAEE
K143554 12/15/2014 Venus Legacy CX Venus Concept Ltd. Orit Ron Edoute
K143685 12/24/2014 Hedgehog Cervical Interbody Fusion Device Vertera, Inc. Stephen Laffoon
K140395 02/18/2014 VITREA IMAGE DENOISING SOFTWARE VITAL IMAGES, INC. PARTHIV SHAH
K143549 12/15/2014 Vivorte Trabexus VIVORTE, INC ROBERT BURDEN
K143547 12/15/2014 Vivorte Trabexus EB VIVORTE, INC Robert Burden
K143486 12/08/2014 Ufi Gel hard C VOCO GMBH M.Th. Plaumann
K143701 12/24/2014 EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM VOLCANO CORPORATION MARCUS GARCIA
K140291 02/05/2014 VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS VOLCANO CORPORATION MARCUS GARCIA
K143724 12/29/2014 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit WILLIAM A. COOK AUSTRALIA PTY, LTD. Gordana Pozvek
K143460 12/04/2014 Cannulated Screw System WRIGHT MEDICAL TECHNOLOGY, INC. Tara Conrad
K140408 02/18/2014 SALVATION OSTEOPENIC SCREW WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K140418 02/18/2014 POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP RUBBER PRODUCTS SDN BHD LIM CHIN YIT
K143741 12/31/2014 Lipofina Laser System YOLO MEDICAL, INC. Robert J Krznaric
K140314 02/18/2014 WARTIE WART REMOVER YONMEDICAL BV KATHLEEN JOHNSON
K143528 12/12/2014 Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System ZIMMER DENTAL INC. CHRISTINA BOYDSTON
K143505 12/10/2014 Zimmer Patient-Specific Abutment, Internal Hex, Titanium Zimmer Dental, Inc. Christina Boydston
K143626 12/22/2014 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele Zimmer Spine, Inc. Donna M. Semlak
K143618 12/19/2014 Kirschner Wires, Steinmann Pins ZIMMER, INC. PATRICK MCCULLAGH
K140508 02/28/2014 ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS ZIMMER, INC. STEPHEN H MCKELVEY, MA, RAC
K140502 02/27/2014 ZOLL E SERIES ALS ZOLL MEDICAL CORPORATION TANMAY B SHUKLA


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