BEUDAMED
    91 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS (IPP)

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Prosthesis, Penis, Inflatable

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

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·DBS System 4CH Lead / DBS System 8CH Directional Lead

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·ESTEEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·PLASMAFLO

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·GAMBRO PLASMAFILTER, PF2000N

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·GAMBRO PRISMAFLEX TPE 2000 SET

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·PRISMAFLEX TPE2000 SET