8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PROVIAL II #006-010-0201
FDA 510(k)
FDA Class 1
·Pathology
X-TRA BASE
FDA 510(k)
FDA Class 2
·Dental
EMIT-ST URINE COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TOTALCARE BARIATRIC PLUS
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·October 10, 2012
MAQUET CARDIOPULMONARY AG
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 20, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 2, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015