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

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    CEMENT-IT ALL PURPOSE, MODEL N97

    FDA 510(k)
    FDA Class 2 ·Dental

    AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

    FDA 510(k)
    FDA Class 2 ·Neurology

    MASTERSCREEN CPX AND OXYCON CPX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 19, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013

    ARTHREX PUSHLOCK 4.5 MM X 18.5 MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·June 10, 2008

    UNKNOWN DEPUY CURVED POLY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 6, 2011

    CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·November 16, 2018

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 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