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

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    BIODERM MEDICAL COMPOSITE WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BABYLOG 8000 INFANT VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code NFA·February 6, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014

    CATH 5F INFINITI TL PIG145 110

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQO·January 4, 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