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

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    EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111014833·SKLARLITEXD ALLIS FCP 4X5 6

    Tri-Staple 2.0 Reloads

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CERALAS D 810 DIODE LASER SYSTEM, MODEL D15

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 19, 2011

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 6, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013

    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