BEUDAMED
    44 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

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

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip Delivery System

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Epi proColon

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Cardiva VASCADE VCS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY LEAD

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY SPIRAL LEAD, ACUITY X4 LEAD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Defibrillator

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE 4-SITE Leads

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM