Device Directory
Browse 178 FDA-cleared medical devices
BD CTGCTV2 (K243343)
Class Class II K243343 QEP
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400)
Class Class II K243400 QOF
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (K243406)
Class Class II K243406 QOF
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274)
Class Class II K250274 JWY
Xpert Xpress CoV-2/Flu/RSV plus (K250995)
Class Class II K250995 QOF
Xpert Xpress CoV-2/Flu/RSV plus (K250996)
Class Class II K250996 QOF
Teal Wand (DEN240045)
Class Class II DEN240045 SEP
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294)
Class Class II K242294 PTF
Flowflex Plus COVID-19 + Flu A/B Home Test (K250377)
Class Class II K250377 SCA
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (K250454)
Class Class II K250454 JTN
Loading more devices…