BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GEM INSET PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    StitchKit COMBO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CR TIBIAL INSERT SZ4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 31, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    PYXIS ANESTHESIA SYSTEM (PAS)

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code BRY·July 22, 2011

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 18, 2013

    EPOC READER

    FDA Adverse Event
    Death ·EPOCAL INC.·Product code CHL·April 21, 2023

    EPOC READER

    FDA Adverse Event
    Death ·EPOCAL INC.·Product code CHL·April 21, 2023

    ACCOLADE DR SL MRI (Model L311)

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