7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
CAPTIA(R) SYPHILIS-M
FDA 510(k)
FDA Class 2
·Microbiology
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
FDA 510(k)
FDA Class 2
·Dental
SIGMA PS CEM FEM SZ5 L
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code JWH·June 13, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD / HUNTINGTON·Product code HQL·December 6, 2012
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 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