BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    WAKO(TM) IGG-HA DIRECT

    FDA 510(k)
    FDA Class 2 ·Immunology

    WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 25, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025