10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Arthrex
FDA UDI
Provision·B504OMAR8737500·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867127272·3.2MM DRILL BIT, CMP FT, CALIBRATED
CLEANING AGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Prelude IDeal Hydrophilic Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arthrex®
FDA UDI
ARTHREX, INC.·00888867264014·3.2MM DRILL BIT,CMP FT,CALIBRATED, REUSE
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
HOOK
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·December 14, 2012
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 27, 2010
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