8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ELECTRIFIED TRANSFER TOILET SEAT
FDA 510(k)
FDA Class 2
·Physical Medicine
Arthrex®
FDA UDI
ARTHREX, INC.·00888867125902·HEADLESS COMPRES SCRW 4.3X24MM
TIGER BAND
FDA 510(k)
FDA Class 1
·Dental
TSA
FDA 510(k)
FDA Class 1
·Microbiology
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 10, 2014
ABTHERA ABDOMINAL THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·October 7, 2010
SUREPATH PRESERVATIVE FLUID COLLECTION VIAL
FDA Adverse Event
Injury
·BD DIAGNOSTIC - TRIPATH·Product code MKQ·December 5, 2012
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