7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SYMBIOS DISPOSABLE INFUSION PUMP KIT
FDA 510(k)
FDA Class 2
·General Hospital
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 5, 2014
CUSTOM DEFINED PRODUCT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·November 29, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021