7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BURTON LENSMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
MEWISSEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BLOOD ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·June 23, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
SHILEY CUFFLESS
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·December 8, 2010
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