7 results
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17ms
·
Sources: EU EUDAMED, US FDA
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Aurora
FDA 510(k)
FDA Class 2
·Dental
PEEK-OPTIMA ALIF SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 18, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·July 1, 2015
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·December 20, 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