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

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    StealthStation S8 Cranial v2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    URISYS 2400 URINE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHO-JET CRYSTAL

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code OAB·April 6, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    HANCOCK II

    FDA Adverse Event
    MEDTRONIC, INC.·Product code LWR·June 25, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    DRX Revolution Mobile X-Ray System

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021