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

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    PAD, BED LINEN PROTECTIVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPROVED THAYER-MARTIN MEDIUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 7, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 12, 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