BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    BIOTRONIK DFH UNIPOLAR PE-60/4-DFH

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM