BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    AUTO-ENZYMATIC GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rhythm View Workstation (non-streaming)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 21, 2014

    ACCU-CHEK ACTIVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 23, 2007

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012

    ACCOLADE DR EL MRI (Model L331)

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021