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

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    SUCTION DEVICE-PHARYNEAL DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERAFORM BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G7 OSSEOTI ACETUBLAR SHELLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 30, 2014

    STERIS SYSTEM 1E

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·November 20, 2012

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 17, 2010

    Colonoscope, Model Number PCF-H190DL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 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