BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    CORDIS ELECTROPHYSIOLOGY STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUER LOCKING ADAPTER(MATERIAL CHANGE)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPTIMATE IGA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 15, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 26, 2012

    ENDO GIA II 60-3.5 SULU

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·September 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021