BEUDAMED
    45 results · 17ms · 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

    Automated External Defibrillators (Non-Wearable)

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

    System, Imaging, Fluorescence

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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    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

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Phakic Toric Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

    Intracranial Coil-Assist Stent

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

    Intracranial Coil-Assist Stent

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

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Intracranial Coil-Assist Stent

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

    Intracranial Coil-Assist Stent

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

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas Stent System

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse