BEUDAMED
    1,785 results · 22ms · Sources: EU EUDAMED, US FDA

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    EV1000 CLINICAL PLATFORM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K131982

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

    HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITREAVIEW SOFTWARE 6.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 19, 2008

    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

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 29, 2025