4 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 2026
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Enforcement
Class II
·Ongoing·Draegerwerk Ag & Co. Kgaa·February 7, 2024
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·November 20, 2024
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·October 8, 2025