BEUDAMED
    32 results · 20ms · 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

    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

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT

    Device, Hemostasis, Vascular

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

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

    Stimulator, Electrical, Implantable, For Incontinence

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

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    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

    Automated External Defibrillators (Non-Wearable)

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

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·Barricaid® Annular Closure Device

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·Barricaid Annular Closure Device

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·Barricaid® Annular Closure Device

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·Barricaid Anular Closure Device