BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    The Optilite IgG3 kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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