BEUDAMED
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    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025