BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    HYDRODERM BREATHABLE TRANSPARENT DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    BACTEC 9240 SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DOSE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION INC·Product code DRM·January 2, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 3, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 15, 2014

    BD BACTEC FX, INSTRUMENT TOP, PACKAGED

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 22, 2021

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021