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

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    ES Series V2

    FDA 510(k)
    FDA Class 2 ·Radiology

    TINA-QUANT CRP (LATEX)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011

    QUANTA SYSTEM

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 18, 2012

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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