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Medical Device Safety | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/medical-device-safety
    Medical Device Safety | FDA Medical Device Safety The FDA monitors reports of adverse events and other problems with medical devices and alerts health …

Safety information - International Medical Device …

    https://www.imdrf.org/safety-information
    Safety information | International Medical Device Regulators Forum Safety information The following table provides links to device safety information as published by IMDRF …

Recalls, Corrections and Removals (Devices) | FDA

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

    Alerts, recalls and safety information: drugs and medical …

      https://www.gov.uk/drug-device-alerts
      Alert type: Field safety notice Medical specialism: General practice and 2 others Issued: 26 January 2023 EyeCee One preloaded and EyeCee One Crystal preloaded intraocular …

    GE HealthCare Recalls Nuclear Medicine 600/800 …

      https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients
      See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; Date …

    Effective field safety notices (FSNs): guidance for …

      https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices
      The medical devices regulations state that manufacturers must tell users about corrective actions involving their device as soon as possible using a Field Safety …

    Safety monitoring: Medical devices - Therapeutic Goods …

      https://www.tga.gov.au/safety/safety/safety-monitoring-medical-devices
      The TGA's medical device Incident Reporting and Investigation Scheme (IRIS) is responsible for the management of all reports of adverse events or problems associated …

    Notifications Related to Safety Measures (Medical …

      https://www.pmda.go.jp/english/safety/info-services/devices/0007.html
      Sep 13, 2022

    Medical Devices Safety Bulletin (MDSB/2020/01) - GOV.UK

      https://www.gov.uk/drug-device-alerts/medical-devices-safety-bulletin-mdsb-2020-01
      A field safety notice (FSN) is an important communication about the safety of a medical device that a manufacturer, or their representative, sends to customers. For …



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