BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EXERCISE BICYCLE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KODAK SURECELL HCG URINE TEST, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 7, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 4, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024