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

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    MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COAXIAL CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FIXATION DEVICE, TRACH TUBE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·June 4, 2024

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·July 1, 2024

    CHARGER¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·February 28, 2013

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Injury ·COVIDIEN LLC (SHANGHAI)·Product code GEI·February 2, 2011

    3.5MM TI CORTEX SCREW 32MM

    FDA Adverse Event
    Malfunction ·SYNTHES GRENCHEN·Product code HWC·August 6, 2014

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    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