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

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    AliveCor Heart Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 10, 2023

    14F DUAL FLOATING DIALYSIS CATHETER/TRAY

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

    TARGET DETACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 28, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·October 6, 2014

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022