7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Agiliti Health - Ellis
FDA registration
Agiliti Health - Ellis·5 products·🇺🇸 United States
BIOMERIEUX HEMOLAB AT III
FDA 510(k)
FDA Class 2
·Hematology
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
FDA 510(k)
FDA Class 2
·Orthopedic
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code JJE·July 23, 2014
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 30, 2015