BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRAIN HEART INFUSION AGAR IV - PRODUCT #P3591

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTHESIS, KNEE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·December 2, 2015

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 5, 2014

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·February 21, 2013

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code JJE·January 28, 2011

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020