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

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    GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6

    FDA 510(k)
    FDA Class 1 ·Hematology

    DURAGEN II DURAL REGENERATION MATRIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    QuickSleeper 5

    FDA 510(k)
    FDA Class 2 ·Dental

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 14, 2014

    EON MINI

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

    AUTOSUTURE

    FDA Adverse Event
    Malfunction ·COVIDIEN SURGICAL DEVICES·Product code GDW·September 21, 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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018