7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
FDA 510(k)
FDA Class 1
·Microbiology
TRAUMAFUSE RAPID INFUSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDIVERSE PARENTERAL NUTRITION BAG
FDA 510(k)
FDA Class 2
·General Hospital
ACTIVITY CARRIAGE
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·June 4, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 4, 2013
UNICEL DXC 800 PRO SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 7, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021