8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
FDA 510(k)
FDA Class 2
·Radiology
URIC ACID REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code KNK·April 15, 2011
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
ST Internal Implant System
FDA 510(k)
FDA Class 2
·Dental
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·March 6, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·February 15, 2011
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·August 8, 2014
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