BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ATS OPEN PIVOT HEART VALVE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·3F AORTIC BIOPROSTHESIS, MODEL 1000

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONATATI100 IMPLANT

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Attain Ability Model 4196

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADAPTA/RELIA/SENSIA/VERSA

    Electrosurgical, Radio Frequency, Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON NEOSPHINTER

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

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCEND HIP ARTICULATION SYSTEM

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·FRONTIER II BIVENTRICULAR PACING SYSTEMS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF

    Light Source System, Diagnostic Endoscopic

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·AFP PACING SYSTEM

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Artificial Heart

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

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·Raindrop® Near Vision Inlay

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator