9 results
·
32ms
·
Sources: EU EUDAMED, US FDA
LARES 757 WORKHORSE HIGHSPEED HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
LASER LAPAROSCOPIC CHOLECYSTECTOMY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFE-TEL CELLULAR TRANSCEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
RHEUMATOID FACTOR
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHR·March 6, 2011
RHEUMATOID FACTOR
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHR·March 6, 2011
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 9, 2013
UNK DEPUY HYLAMER LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 19, 2010
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 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