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

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    VISC X-VITREOUS ASPIRATING & CUT. INSTR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Atteris No-Sting Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADPER PROMPT, ADPER PROMPT L-POP

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2014

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 26, 2012

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 14, 2010

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025