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

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    Healing cap

    Device
    EU MDR · Eu Md Class 1 ·Oticon Medical AB·On the market·16 countries

    Soft healing cap

    Device
    EU MDR · Eu Md Class 1 ·Oticon Medical AB·On the market·16 countries

    Healing Cap Multi-Unit Titanium

    FDA 510(k)
    FDA Class 2 ·Dental

    Healing Cap

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Oticon Medical AB·2 devices

    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·August 29, 2018

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018