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

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    RAPIDEX BIOLOGICAL SURFACTANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CardioChek Plus Test System, CardioChek Home Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·October 8, 2010

    HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·December 5, 2012

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021