BEUDAMED
    56 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    K091319

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

    REMSTAR AUTO A-FLEX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REMSTAR AUTO A-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

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

    FDA Adverse Event
    Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

    REMSTAR PRO C-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

    REMSTAR

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

    BIPAP PRO BIFLEX

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

    REMSTAR

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 28, 2024

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·April 10, 2025

    REMSTAR PRO C-FLEX+

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 7, 2026

    REMSTAR PLUS C-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·July 17, 2024

    REMSTAR PLUS C-FLEX

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

    REMSTAR PRO C-FLEX+

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

    REMSTAR AUTO A-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 23, 2022

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·December 16, 2024

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 14, 2025

    REMSTAR

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

    BIPAP AUTO BIFLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·June 15, 2022

    REMSTAR W/SD CARD

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·June 22, 2022

    REMSTAR PRO C-FLEX+

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 19, 2022