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

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    CRYSTALLINE C2 AND CRYSTALLINE L3

    FDA 510(k)
    FDA Class 2 ·Dental

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 4, 2012

    HOOK PROBE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TELL ME TAGS - NONPOWERED COMMUNICATION SYS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    WALLSTENT? RX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·June 25, 2014

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code OEZ·November 8, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·December 20, 2012

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·June 6, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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