BEUDAMED
    36 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·VIBRANT SOUNDBRIDGE

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCYTE

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT HBE (RDNA) EIA

    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    FDA Pre-Market Approval
    FDA Class 3 ·LCS UNI KNEE SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM