9 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
FDA Enforcement
Class I
·Terminated·Getinge Usa Sales Inc·June 29, 2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
FDA Enforcement
Class I
·Terminated·Getinge Usa Sales Inc·June 29, 2022
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 18, 2012
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·May 8, 2013
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·June 17, 2015
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 2, 2016
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 5, 2018
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 5, 2018
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·April 3, 2019