78 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 2026
Atlan A350. Model Number: 8211500. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 2026
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 31, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 31, 2025
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·April 9, 2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 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
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