BEUDAMED
    657 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS HBSAG TEST 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

    Aortic Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Minima Stent System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·CentriMag™ Circulatory Support System

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

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

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp Ablation System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

    Intracranial Aneurysm Flow Diverter

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

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM

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

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