BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    ELECTRONIC UNIT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AIRFIT N10

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PHENOL RED STOCK SOLUTION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 27, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017