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

    ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Light Source System, Diagnostic Endoscopic

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN, PROGENY ICD AND NG ICD MODELS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS PC-43,44,45 NB UV ABSORBING IOL

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

    FDA Pre-Market Approval
    FDA Class 3 ·COGNIS, PROGENY CRT-D AND NG CRT-D MODELS

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G

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

    FDA Pre-Market Approval
    FDA Class 3 ·LCS Total Knee System

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·ALLEGRETTO WAVE EXCIMER LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·ALLEGRETTO WAVE EXCIMER LASER SYSTEMS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Progel Pleural Air Leak Sealant

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASCENSION ORTHOPEDICS MCP

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Coseal Surgical Sealant