BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    FLOW-DIRECTED PEDIATRIC THERMODIL- CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    simpli-COLLECT STI Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EPIPHYSIS SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    28MM MOD HD STD NECK TP1 TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 23, 2018

    SMARTLIFE LARGE BATTERY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 2, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 15, 2015

    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