BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    WAKO TOTAL BILIRUBIN V

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Urbanek Device

    FDA 510(k)
    FDA Unclassified ·Unknown

    AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·June 30, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 6, 2011

    Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

    FDA Recall
    Terminated ·Contamac Solutions, Inc.·Product code MRC·July 27, 2021

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026