9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN FP FOR CANNABINOIDS (15-50)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756356725·MINOR PACK
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 2014
AQUA WATER TREATMENT FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3.7MM/5.0MM DYNAMIC LOCKING SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·December 3, 2012
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-CLONMEL·Product code NIQ·November 30, 2010
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 2, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021