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

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    FPP ARMBOARD STRAP

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

    T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLINPRO PROPHY POWDER

    FDA 510(k)
    FDA Class 2 ·Dental

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·November 20, 2012

    UNKNOWN ZIMMER TRABECULAR METAL STEM

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HSD·September 17, 2010

    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    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