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

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    LYNX EL MICROSCOPY TISSUE PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Pathology

    INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2017

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 23, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021