7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
UNICATCH
FDA 510(k)
FDA Class 1
·Pathology
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CATHETER, CAVA (CAVAFIX)
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 14, 2010
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 18, 2014
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 1, 2012
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