BEUDAMED
    3 results · 19ms · Sources: EU EUDAMED, US FDA

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    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    FDA Enforcement
    Class II ·Terminated·Rockwell Medical, Inc·May 23, 2018

    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 23, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025