BEUDAMED
    947 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·CraniSeal Dural Sealant

    Pulmonary Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip™ G4 System

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·WRAPSODY Cell-Impermeable Endoprosthesis

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify Cervical Artificial Disc

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·TactiFlex™ Ablation Catheter, Sensor Enabled™

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Solia S Leads

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·Sphere-9 Catheter and Affera Ablation System

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr

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

    FDA Pre-Market Approval
    FDA Class 3 ·R3 Delta Ceramic Hip System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Thoraflex™ Hybrid

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Zenith Dissection Endovascular System

    Acute Coronary Syndrome Event Detector

    FDA Pre-Market Approval
    FDA Class 3 ·Guardian System

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

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MemoryGel Enhance Breast Implants

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System