7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TSH (RIA) KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOGENESIS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
AMPLATZER CRIBRIFORM OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·May 20, 2014
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·Product code JDI·November 6, 2012
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 24, 2010
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