10 results
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22ms
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Sources: EU EUDAMED, US FDA
Atlan A350 XL
FDA UDI
Drägerwerk AG & Co. KGaA·04048675556183·Available with either electronically or mechani...
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·May 17, 2019
Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 2026
Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·May 7, 2026
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Recall
Open, Classified
·Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee·Product code BSZ·November 17, 2023
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code BSZ·October 15, 2024
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 Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·September 9, 2025
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