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Postmarket Safety

Home » Topics » Medical Devices » Postmarket Safety
  • July 1, 2022

    FDA Warns Baby Neck Floats Used in Water Therapy Can Cause Death or Injury

    The agency did not identify any specific products.
  • June 30, 2022

    FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

    If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support, the FDA says.
  • June 29, 2022

    Philips Provides Update on Its CPAP, BiPAP and Ventilator Recall

    Philips issued an update on the status of the June 14, 2021 recall of its Philips Respironics’ continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices, citing ozone cleaning as a possible contributor to the problem.
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  • June 28, 2022

    FDA Provides Update on Baxter’s Recall of Volara System for Respiratory Treatment

  • June 27, 2022

    FDA Provides Update on Illumina’s Recall of Its DNA Analyzer

  • June 27, 2022

    Becton Dickinson Recalls Intraosseous Needle Devices

  • June 24, 2022

    FDA Provides Update on Draeger’s Recall of Its SafeStar 55 Breathing System Filter

  • June 15, 2022

    FDA Provides Update on Dräger’s Recall of Its Breathing System Filter

  • June 13, 2022

    FDA Provides Update on GE Healthcare’s Recall of Ventilator Batteries

  • June 9, 2022

    Medtronic’s Recalled HVAD Pump Implant Kit Killed One, Injured Two, FDA Says

  • June 8, 2022

    One Death, Four Injuries Linked to Recalled Philips Respironics Ventilators

  • June 7, 2022

    FDA Provides Update on Its Safety Notice About Apyx’s Renuvion/J-Plasma

  • June 7, 2022

    FDA Provides Update on Atrium Medical’s Recall of Its iCast Covered Stent

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Products

  • Eric henry blue500

    Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript

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  • Michael m gaba 600red

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does – Webinar Recording/Transcript

    $287.00
  • James pink 600green

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments? – Webinar Recording/Transcript

    $287.00
  • Richard kingston and diane mcenroe 600red

    Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

    $287.00
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Events

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

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