BEUDAMED
    494 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut R Transcatheter Aortic Valve System, Evolut PRO Transcatheter Aortic Valve System, Evolut PRO+ Transcatheter Aort

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SALINE FILLED BREST IMPLANTS

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut PRO+ System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED Pro Device

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Pro

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Pro

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System