BEUDAMED
    10,000 results · 43ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Femtosecond Laser System For Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VisuMax Femtosecond Laser

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ClearView™ 3

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Ventricular Assist (HVAD) System

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF CRT-ICD'S

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID BRAF KIT

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GENVISC 850

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Nuvisc, Anikavisc, Ophthalin

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCHROMED INFUSION SYSTEMS, SYNCHROMED, SYNCHROMED II, SYNCHROMED EL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·PERCEVAL SUTURELESS HEART VALVE