BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    ESOPHAGEAL DILATOR SET

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

    IR VIEWER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARESCAPE R860

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 21, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·May 19, 2014

    EON MINI IPG

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 3, 2010

    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