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

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    FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Clear Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    BASIS¿ SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    ABGII MODULAR STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWY·January 7, 2013

    SUPER POLIGRIP (FREE AND ORIGINAL)

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·November 2, 2010

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 3, 2014

    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