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

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    AMER. MEDICAL OPTICS DIGITAL KERATO-

    FDA 510(k)
    FDA Class 3 ·Ophthalmic

    SpineFrontier Lumbar Interbody Fusion Device System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    10 LEAD ECG TRUNK AAMI/IEC 2M

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSA·February 20, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·November 21, 2012

    TERUMO CDI 101 MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·August 31, 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