7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EBV TEST
FDA 510(k)
FDA Class 1
·Microbiology
BP5S Wireless Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
HISTO-TEK W/ AUTOMATIC COVERSLIPPER
FDA 510(k)
FDA Class 1
·Pathology
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LEH·April 24, 2014
MAVERICK²¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 3, 2012
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014