BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018

    ROSA One 3.1 Brain Application

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020