434 results
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20ms
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Sources: EU EUDAMED, US FDA
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 5, 2012
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 5, 2012
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 5, 2012
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 25, 2012
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 6, 2013
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2013
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2012
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2012
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2012
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2012
GE Healthcare, Discovery MR750w
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 13, 2016
GE Healthcare, Aisys Carestation.
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·April 20, 2016
GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare·July 8, 2015