BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oh'Care Lite Smart Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOACTYS

    FDA 510(k)
    FDA Class 2 ·Dental

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 18, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 26, 2010

    PERILOC ANKLE FUSION TTC PLATE SCREW

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HRS·December 20, 2012

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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