BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    EsoCheck Cell Collection Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CLINICAL ALERT NOTIFICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAUTERY TIP CLEANER, MODEL-TC-100

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

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 1, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 21, 2014

    AFN Ø12 LE L380 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HSB·July 16, 2013

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023