57 results
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25ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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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
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
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·October 16, 2013
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·February 10, 2016
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·December 23, 2015
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·December 30, 2015
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·March 2, 2016
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·February 10, 2016
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 16, 2018