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

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    KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYTOSAFE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    3F ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 25, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2010

    OCTRODE

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

    145-DEG PE 36MM HUM LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·December 17, 2024

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

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