BEUDAMED
    12 results · 35ms · Sources: EU EUDAMED, US FDA

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    KODAK ORTHO M FILM

    FDA 510(k)
    FDA Class 1 ·Radiology

    i-STAT CHEM8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CLEARFLUX DIALYZER REPROCESSING SYSTEM

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 10, 2010

    M2A-MAGNUM MOD HD SZ 46MM 46MM

    FDA Adverse Event
    Injury ·Product code LPH·February 24, 2020

    CARBON TARGET ARM - ANKLE NAIL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·March 26, 2018

    COMPR RVS GLENO 2-PRNG INS/IMP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PHX·January 2, 2026

    CONNECTING BOLT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·March 26, 2018

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 24, 2020

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025