BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    LIPIFLOW THERMAL PULSATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·May 19, 1999

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOMATOM DEFINITION AS

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 19, 2011

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 22, 2008

    VITROS 250 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·September 16, 2014

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014