103 results
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Sources: EU EUDAMED, US FDA
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Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·December 25, 2024
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·December 25, 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 A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·November 20, 2024
Ventstar Coax 180, MP03374
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Circuit Kit Coax HEPA, MP17102
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Set Coax 180, MP03384
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
VentStar Watertrap (N) 180, MP00363
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
VentStar Bag Set (N) 110, MP00383
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Dr¿ger Perseus A500 Anesthesia Workstation
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·April 24, 2024
Drager SafeStar 55, Catalog No. MP01790
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·June 22, 2022
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·November 20, 2013
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·August 10, 2016
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·August 26, 2015
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·March 17, 2021
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·March 17, 2021
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·March 17, 2021
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·March 17, 2021
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 9, 2021
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 9, 2021