BEUDAMED
    4 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Cirq Arm System 2.0

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·April 5, 2023

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 16, 2022

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 22, 2023

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 26, 2025