8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VARIAN RMS-2000
FDA 510(k)
FDA Class 2
·Radiology
Introcan Safety 3 Closed IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
GERARD MEDICAL ELECTRODE TESTER
FDA 510(k)
FDA Class 2
·Cardiovascular
RATCHETING ADAPTER, CANNULATED
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code LXH·April 1, 2021
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTE·October 9, 2010
PERMANENT CAUTERY SPATULA
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 10, 2012
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021