BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    INTERPLANT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Telepack X LED

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DERMICEL, MONTGOMERY STRAP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FLAIR ENDOVASCULAR STENT GRAFT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·June 16, 2014

    ETHICON

    FDA Adverse Event
    Malfunction ·ETHICON·Product code GAM·February 21, 2013

    LIMELIGHT

    FDA Adverse Event
    Injury ·CUTERA·Product code GEX·February 3, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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