BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·OSTEOTIM BGS

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOMET BHS- MINI

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOMET BHS-MINI

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon

    Warmer, Blood, Electromagnetic Radiation

    FDA classification
    FDA Class 3 ·Warmer, Blood, Electromagnetic Radiation

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM