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

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    PathKeeper System

    FDA 510(k)
    FDA Class 2 ·Neurology

    VANISHPOINT BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    STRL TUBE, 1/4X1/16 X 6'

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·August 18, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 12, 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