7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NORTHWESTERN VOICE RESTORATION KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Clyra Wound Irrigation Solution
FDA 510(k)
FDA Unclassified
·Unknown
TRICERAM
FDA 510(k)
FDA Class 2
·Dental
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 17, 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