BEUDAMED
    35 results · 41ms · Sources: EU EUDAMED, US FDA

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    HUMIDAIR STANDARD TUBE

    FDA Adverse Event
    Malfunction ·RESMED CORP.·Product code BZD·October 9, 2025

    S8

    FDA Adverse Event
    Malfunction ·RESMED CORPORATION·Product code BZD·March 30, 2010

    CPAP AIRSENSE 10

    FDA Adverse Event
    Injury ·RESMED CORPORATION·Product code BZD·July 15, 2020

    RESMED S9 AUTOSET

    FDA Adverse Event
    Malfunction ·RESMED CORPORATION·Product code BZD·October 28, 2016

    RESMED

    FDA Adverse Event
    Injury ·RESMED CORPORATION·Product code BZD·December 21, 2007

    VPAP III ST

    FDA Adverse Event
    RESMED CORPORATION·Product code BZD·September 29, 2008

    RESMED AIRSENSE 10 - AUTOSET

    FDA Adverse Event
    Malfunction ·RESMED CORPORATION·Product code BZD·January 5, 2024

    RESMED ASTRAL 150

    FDA Adverse Event
    Death ·RESMED CORPORATION·Product code CBK·March 12, 2020

    Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.

    FDA Recall
    Terminated ·Resmed Corporation·Product code CBK·January 13, 2016

    LIFECHOICE

    FDA Adverse Event
    Malfunction ·INOVA LABS, INC.·Product code CAW·December 16, 2016

    RESMED AIRCURVE 10

    FDA Adverse Event
    Injury ·RESMED CORP.·Product code BZD·April 6, 2022

    ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.

    FDA Recall
    Terminated ·Resmed Corporation·Product code BZD·April 23, 2007

    Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

    FDA Recall
    Terminated ·Resmed Corporation·Product code BZD·July 12, 2016

    ResMed European Operations BV

    Importer
    🇳🇱 Netherlands·4 Manufacturers

    Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.

    FDA Enforcement
    Class II ·Terminated·Resmed Corporation·February 10, 2016

    Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

    FDA Enforcement
    Class II ·Terminated·Resmed Corporation·August 24, 2016

    VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

    FDA Adverse Event
    Injury ·PHILIPS / RESPIRONICS INC.·Product code BZD·May 21, 2024

    PHILIPS DREAMSTATION BIPAP

    FDA Adverse Event
    Injury ·PHILIPS / RESPIRONICS INC.·Product code BZD·May 21, 2024

    Oxigen Salud, S.A.

    Importer
    🇪🇸 Spain·17 Manufacturers

    Besmed Health Business Corporation

    FDA registration
    Besmed Health Business Corporation·47 products·🇹🇼 Taiwan