BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    AquaA

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

    COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH

    FDA 510(k)
    FDA Class 2 ·Neurology

    KENT CAMERA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·October 27, 2008

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023