BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    Disposable Nitrile Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTUITIVE SURGICAL BIPOLAR FORCEPS

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

    Sequel External Fixation Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VICTORY XL SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code LWP·January 13, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·July 9, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025