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

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    UNITY VCS (8065000296); UNITY CS (8065000297)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Spineology Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 6, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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