BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PALL HEAT MOISTURE EXCHANGING FILTER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDI-TECH DILATATION CATHETERS

    FDA 510(k)
    FDA Class 1 ·Dental

    LEAD MODEL 303

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 10, 2014

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 7, 2010

    SCREW LOCKING

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 10, 2012

    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