7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRUM M2 MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ClearCheck
FDA 510(k)
FDA Class 2
·Radiology
INSYNC III
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWP·June 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 10, 2012
TRANSGASTRIC JEJUNAL, 22F.
FDA Adverse Event
Malfunction
·HALYARD HEALTH·Product code KNT·June 23, 2015
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