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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Perfect EMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Synthes GmbH·10886982141439·1.3MM CORTEX SCREW SELF-TAPPING 14MM

    QAB2A IGM ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN COOL TIP ELECTRODE

    FDA Adverse Event
    Death ·COVIDIEN LP·Product code GEI·September 23, 2013

    UNKNOWN COOL TIP ELECTRODE

    FDA Adverse Event
    Death ·COVIDIEN LP·Product code GEI·September 23, 2013

    UNKNOWN COOL TIP ELECTROD

    FDA Adverse Event
    Death ·COVIDIEN LP·Product code GEI·September 23, 2013

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·October 24, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014