BEUDAMED
    17 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Classification × Regulation: Us FDA × Clear all

    Fluorescent Immunoassay, Primidone

    FDA classification
    FDA Class 2 ·Fluorescent Immunoassay, Primidone

    Antigen, Cf, T. Cruzi

    FDA classification
    FDA Class 1 ·Antigen, Cf, T. Cruzi

    Radioimmunoassay, Prolactin (Lactogen)

    FDA classification
    FDA Class 1 ·Radioimmunoassay, Prolactin (Lactogen)

    Igm, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Antigen, Antiserum, Control

    Ldt, Approved By Nys Clep

    FDA classification
    FDA Not Classified ·Ldt, Approved By Nys Clep

    Left Atrial Appendage Clip, Implantable

    FDA classification
    FDA Class 2 ·Left Atrial Appendage Clip, Implantable

    System, Appendage Closure, Left Atrial

    FDA classification
    FDA Class 3 ·System, Appendage Closure, Left Atrial

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Left Ventricular Ejection Fraction Screening Tool

    FDA classification
    FDA Not Classified ·Left Ventricular Ejection Fraction Screening Tool

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ldt, Unmet Need Within An Integrated Healthcare System

    FDA classification
    FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA classification
    FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA classification
    FDA Class 3 ·Temporary Non-Roller Type Left Heart Support Blood Pump

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    Temporary Non-Roller Type Left Or Right Heart Support Blood Pump

    FDA classification
    FDA Not Classified ·Temporary Non-Roller Type Left Or Right Heart Support Blood Pump

    Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    FDA classification
    FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule