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

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    SUTURELESS SKIN CLOSURE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763498084·MIS Cannulated Screw M, Ø10.5 x 65mm, Ø6.0mm Rod

    MODIFICATION TO: SAVI APPLICATOR KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEAK NS033CF, PEAK NS017CF

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 10, 2012

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2007

    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023