7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LIGHT BEAM COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
The Panthera Anti-Snoring Device
FDA 510(k)
FDA Class 2
·Dental
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·March 14, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FSA·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