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

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    SOFIA DISTAL ACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131482·TiBase NR NP .3G NE

    K131982

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 23, 2024

    CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE

    FDA 510(k)
    FDA Class 2 ·Neurology

    EM-9000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIPAP PRO BIFLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 2, 2026

    DREAMSTATION BIPAP AUTOSV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

    REMSTAR SYSTEM ONE 60 SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 31, 2024

    REMSTAR SYSTEM ONE 60 SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 19, 2026

    REMSTAR AUTO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

    REMSTAR PRO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

    DREAMSTATION BIPAP AUTOSV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 30, 2022

    OMNILAB ADVANCED PLUS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code MNS·March 31, 2022

    REMSTAR PLUS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

    REMSTAR AUTOA-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 20, 2022

    REMSTAR AUTO A-FLEX W/HUMID

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code BZD·August 10, 2021

    REMSTAR PLUS C-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

    DREAMSTATION BIPAP AUTOSV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·May 8, 2024

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER

    FDA Adverse Event
    Injury ·RESPIRONICS INC·Product code BZD·August 30, 2021