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

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    THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT

    FDA 510(k)
    FDA Unclassified ·Unknown

    TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 21, 2014

    ASPHERE M SPEC 12/14 36 +1.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·February 15, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code MUZ·December 22, 2010

    BIOMET MODULAR TIBIAL I-BEAM STEM 40MM

    FDA Adverse Event
    Injury ·.·Product code JWH·September 5, 2017

    VANGUARD TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 5, 2017

    BIOMET ILOCK TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 5, 2017

    BIOMET VANGUARD FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·September 5, 2017

    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