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

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    Headway 27 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DOLPHIN INFLATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·July 23, 2019

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·July 23, 2019

    VERIFY

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·June 3, 2013

    3.7MM CANNULATED CONICAL SCREW

    FDA Adverse Event
    Death ·SYNTHES MONUMENT·Product code HWC·June 17, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    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