7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
ANATOM SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Mitsar-EEG
FDA 510(k)
FDA Class 2
·Neurology
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 14, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 24, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021