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

    Telescope, Implantable, Miniature

    FDA Pre-Market Approval
    FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MARGINPROBE SYSTEM

    ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,

    Light Source System, Diagnostic Endoscopic

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

    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

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Simplera™ System