BEUDAMED
    2,762 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·On-X Ascending Aortic Prosthesis

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME ENDOPROSTHESIS

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·CPR Stat-Padz Electrode and CPR-D Padz Electrode

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP with SmartAssist

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BioGlue Surgical Adhesive

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF (Heart Failure) System

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOSTE(TM) BETA-CATH SYSTEM

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·LOTUS Edge Valve System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System