BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SHEAR FORCE GAUGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867125933·HEADLESS COMPRES SCRW 4.3X30MM

    ALBUMIN REAGENT FOR DEMAND ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 7, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 6, 2012

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIM·June 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021