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

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    Opus Bulk Fill APS, Opus Bulk Fill Flow APS

    FDA 510(k)
    FDA Class 2 ·Dental

    KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NITRILE POWDER FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 7, 2008

    SYNERGY

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 26, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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