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

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    VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    URIDROP SPECIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PLANMECA PROSENSOR

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE

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

    CLARITY DDDR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·February 15, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 22, 2018

    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