BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Progressive Orthopaedic Total Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV

    MANZI CLEANER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    POWERHEART G5 AUTOMATIC AED

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC. CRMD·Product code DTB·January 13, 2014

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code FTL·May 23, 2013

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 29, 2011

    SURETEK?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·November 19, 2025

    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