BEUDAMED
    55 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Light Source System, Diagnostic Endoscopic

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM

    System, Imaging, Fluorescence

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·R Series MCU 20.01 software release

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Heart

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·OCS Heart System

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart System

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart System

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart System

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System™ (OCS™) Heart

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·EPi-Sense®, EPi-Sense ST™ Guided Coagulation System

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM