BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    iCare IC200

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Premature Babies Micro Vascular Clamp #2

    FDA UDI
    Geister Medizintechnik GmbH·04057034058015·Premature Babies Micro Vascular Clamp #2

    POLY-CHEM GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZIRCONIA BLANKS (ZIRCOSTAR)

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 30, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 23, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 11, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 23, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2023

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 9, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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