BEUDAMED
    47 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class I × Status: Terminated × Clear all

    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

    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

    Fabius Tiro M, anesthesia machine, catalog no. 8608400 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).

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 16, 2018

    Fabius GS Premium, anesthesia machine, catalog no. 8607000 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).

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 16, 2018

    Fabius Tiro, anesthesia machine, catalog no. 8606000 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).

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 16, 2018

    VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·January 30, 2019

    VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·January 30, 2019

    VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·January 30, 2019