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

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    Normandy VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DE BAKEY SLIM NEEDLEHOLDER 23 CM TOP DUR

    FDA Adverse Event
    Malfunction ·DUFNER INSTRUMENTE GMBH·Product code FHQ·June 18, 2020

    INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2013

    LTXF SYM CONVP 2CLVE W 0.2 AEF

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 5, 2011

    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23

    FDA Enforcement
    Class II ·Terminated·Dufner Instrumente GmbH·July 15, 2020

    Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

    FDA Enforcement
    Class I ·Terminated·Quidel Corporation·July 7, 2021