BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    GLYC-AFFIN(TM)-GA

    FDA 510(k)
    FDA Class 2 ·Hematology

    NIDEK RT-1200S (MARCO TRS-1200)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CHALLENGE 6010 POWERED MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 28, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 19, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 9, 2013

    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