7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
TM-5 INTRACRANIAL PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Neurology
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 8, 2010
EVO 3 MODULE CORE WITH ISE600
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·December 7, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012