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

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    ISOLIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    LOCON VLS DISTAL RADIUS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Osstell IDx

    FDA 510(k)
    FDA Class 1 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 1, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2012

    HUDSON AQUAPAK WITH ADAPTOR

    FDA Adverse Event
    Malfunction ·TELEFELX MEDICAL·Product code BTT·August 30, 2010

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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