BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    UNI-FAST LACTATE DEHYDROGENASE (LDH-L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311824·Low Profile Screw, 2.0 x 30mm, Cortical

    IMPLANT CENTER

    FDA 510(k)
    FDA Class 2 ·Dental

    Devon 51

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 13, 2014

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 8, 2010

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·December 11, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015