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

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    CD Horizon Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRS Plate

    FDA UDI
    I.T.S. GmbH·09120034302701·PRS Plate, 8-Hole, Curved, R108

    TETRIC EVOCERAM BULK FILL

    FDA 510(k)
    FDA Class 2 ·Dental

    CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·February 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    PRECISION SPECTRA®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·November 9, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023