BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMIT MCA PROGRAM TAPE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Infrared Ear Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 13, 2026

    D-TRON PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·April 30, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 25, 2007

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025