BEUDAMED
    3 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Enforcement
    Class II ·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020