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

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    LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO OUTBACK CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Other ·INSULET CORPORATION·Product code LZG·November 24, 2010

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 3, 2014

    LUMAX 540 DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO KG·Product code MRM·December 7, 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