BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·LATITUDE G2 COMMUNICATOR

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·GENESYS HTA SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL SILICONE INTRAOCULAR LENSES

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS and Micra TPS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

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

    FDA Pre-Market Approval
    FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Total PSA, Total PSA CalSet ll

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Zilver Vascular Stent

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) plus generator (PG) devices

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Vistakon (etafilcon A) Brand Contact Lenses

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IOL LENS MODEL GR1A