542 results
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66ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE MEDICAL SYSTEMS SCS
FDA registration
GE MEDICAL SYSTEMS SCS·18 products·🇫🇷 France
Innova 2000, manufactured by GE Medical Systems, SCS
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MQB·June 10, 2010
ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·August 18, 2011
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code BYD·April 29, 2011
INNOVA 3100-IQ
FDA Adverse Event
Death
·GE MEDICAL SYSTEMS SCS·Product code OWB·July 29, 2015
INNOVA 2100-IQ
FDA Adverse Event
Death
·GE MEDICAL SYSTEMS SCS·Product code OWB·July 23, 2015
ADVANTX
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code IZI·February 16, 2009
INNOVA 4100
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code MQB·January 15, 2009
INNOVA 2000
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code IZI·January 13, 2009
INNOVA 3100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code MQB·February 3, 2009
INNOVA 2100 IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code MQB·March 11, 2009
ADVANTX LCA
FDA Adverse Event
Other
·GE MEDICAL SYSTEMS SCS·Product code IZI·February 18, 2009
INNOVA 2000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code IZI·March 17, 2009
INNOVA 4100-IQ
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code OWB·April 16, 2014
INNOVA 2100IQ
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code OWB·April 29, 2014
INNOVA 3131-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 14, 2014
INNOVA 2121-IQ
FDA Adverse Event
Death
·GE MEDICAL SYSTEMS SCS·Product code JAA·May 14, 2014
IGS 530
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code IZI·April 29, 2014
ADVANTX AFM
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code IZI·February 18, 2010
INNOVA 2000
FDA Adverse Event
Death
·GE MEDICAL SYSTEMS SCS·Product code MQB·February 8, 2010