BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLYMERASE

    FDA Adverse Event
    Malfunction ·LIFETECHNOLOGIES CORP.·Product code MZI·September 25, 2013

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 14, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·May 25, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 16, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 7, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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