11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
LASER-GLOBIN
FDA 510(k)
FDA Class 2
·Hematology
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P8500962·Pro Advantage Electrode Foam 2X4 4PK
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169072640·LID 1850096 GENERIC METAL EXTRAS
ASI Measles IgG EIA Test
FDA UDI
ARLINGTON SCIENTIFIC, INC.·00816057020591·Detection of Measles Antibody
ASI Measles IgM EIA Test
FDA UDI
ARLINGTON SCIENTIFIC, INC.·00816057020607·Detection of Measles Antibody
Felix NeuroAI System
FDA 510(k)
FDA Class 2
·Neurology
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code KWA·November 29, 2012
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 28, 2010
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