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

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    CORDLESS ELECTRIC MASSAGER EV315

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 14, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·November 24, 2010

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    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