9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TISSUE CULTURE BAG
FDA 510(k)
FDA Class 1
·Hematology
KATENA
FDA UDI
NURSE ASSIST, INC.·B150K870650·
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPANDING VASCULAR SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPTIVATOR?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·June 12, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 12, 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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020