7 results
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26ms
·
Sources: EU EUDAMED, US FDA
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
FDA 510(k)
FDA Class 2
·Cardiovascular
MONET Anterior Cervical Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 13, 2014
WALGREENS BY ACE TEKZONE KNEE OPEN PAT
FDA Adverse Event
Other
·3M COMPANY, 3M CONSUMER HEALTH CARE·Product code IQI·October 12, 2010
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·December 13, 2012
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024