7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FETALERT ADR FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERFACE CARDIOTOMY BLOOD FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
FDA 510(k)
FDA Class 2
·Dental
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·June 13, 2014
HALF DAY INFUSOR, 5ML/HR 12PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 15, 2010
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 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