BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    ECHELON ENDOPATH Staple Line Reinforcement

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

    ISOSEEDS I-125

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODULAP LOOP

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 31, 2024

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    FDA Adverse Event
    Malfunction ·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GDW·October 26, 2008

    PHILIPS INFORMATION CENTER

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·August 17, 2011

    AML SM STATURE 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 11, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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