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

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    IQ CHAMBERS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AGAROSE BARBITAL-EDTA BUFFER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRU FLU, MODEL 751230

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    MIS PRECISION NEURO, 3.0MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·March 7, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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