6 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DIABETES RISK DETECTOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CYSTINE TRYPTIC AGAR W/MALTOSE
FDA 510(k)
FDA Class 1
·Microbiology
RAICHEM CO2 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 10, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·October 4, 2010
NOVA MAX PLUS GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·December 6, 2012