BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    LOGIQ S8

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·December 5, 2013

    BD SYRINGE LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 29, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 14, 2013

    INSYNC ICD

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·June 16, 2011

    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