BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    WHOLE BLOOD PLATELET COUNTER -2510

    FDA 510(k)
    FDA Class 2 ·Hematology

    Gemini NOVA 810+980 Soft Tissue Laser

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

    HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADJ PIN COLLET 2.0-3.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·April 21, 2014

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·September 26, 2012

    SYMBIQ PUMP

    FDA Adverse Event
    Malfunction ·SYMBIQ·Product code FRN·July 13, 2010

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·March 14, 2019

    Model Number U228, VISIONIST CRT-P EL MRI

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

    ACCOLADE DR EL MRI (Model L331)

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