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

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    Centurion™ Vision System (Active Sentry™) (8065753057)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONTRAK TESTCUP II AND ONSITE CUPKIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 7, 2014

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 18, 2013

    UNKNOWN C-TAPER HEAD

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·November 18, 2015

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025