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1,751 devices

FDA PMA Clear all

  • PerQseal® Elite Vascular Closure Device Ref P250015

    Vivasure Medical, Ltd.,Ireland
    Active Regimes: PMA Registry: PMA Class:III

  • TorEx Lung Perfusion System Ref P250025

    Traferox Technologies, Inc.,Canada(FDA applicant)
    Active Regimes: PMA Registry: PMA Class:III

  • RefluxStop® Device and RefluxStop® Deployment Tool Ref P250018

    Implantica Ce Reflux Ltd,Malta
    Active Regimes: PMA Registry: PMA Class:III

  • HepQuant SHUNT® Liver Diagnostic Test Ref P220016

    Hepquant, LLC,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • OncoMate® MSI Dx Analysis System Ref P250046

    Promega Corporation,United States
    Active Regimes: PMA Registry: PMA Class:III

  • VENTANA PTEN (SP218) RxDx Assay Ref P250031

    Ventana Medical Systems, Inc. (Roche Tissue Diagnostics),FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:—

  • Belotero® Intense (+) Lidocaine Ref P250016

    Merz North America, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III

  • AbsorbaSeal 5.6.7F Vascular Closure Device Ref P230038

    Cyndrx, LLC,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • PGDx elio tissue complete CDx Ref P250036

    Personal Genome Diagnostics, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III

  • SimpleScreen™ CRC Ref P250029

    Freenome, LLC,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • AMDS Hybrid Prosthesis Ref P250055

    Artivion, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III

  • Juveena Hydrogel System Ref P250051

    Rejoni, Inc.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens Ref P220015

    Tianjin Mastervision Technology Co., Ltd.,China(FDA applicant)
    Active Regimes: PMA Registry: PMA Class:III

  • Autus Size-Adjustable Valve Ref P260007

    Edwards Lifesciences LLC,United States
    Active Regimes: PMA Registry: PMA Class:III

  • LungFX™ device Ref P240033

    Lung Bioengineering, Inc.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • saypha® ChiQ™ Ref P250021

    Croma-Pharma GmbH,FDA registration: Austria
    Active Regimes: PMA Registry: PMA Class:III

  • BAGUERA®C Cervical Disc Prosthesis Ref P250042

    Spineart USA, Inc.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • SELUTION SLR™ 014 PTCA Drug-Eluting Balloon Ref P250041

    Medalliance, LLC,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III

  • Liverty™ TIPS Stent Graft Ref P250050

    Bard Peripheral Vascular,United States
    Active Regimes: PMA Registry: PMA Class:III

  • Belotero Volume (+) Lidocaine Ref P250020

    Merz North America, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III