Device Directory
Browse 178 FDA-cleared medical devices
HardyDisk AST Rezafungin 5µg (RZF5) (K230827)
Class Class II K230827 JTN
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306)
Class Class II K231306 QQX
Cue COVID-19 Molecular Test (DEN220028)
Class Class II DEN220028 QWB
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (DEN230092)
Class Class II DEN230092 SBT
Avantik VTM (K233449)
Class Class I K233449 JSM
HardyDisk AST Cefiderocol 30µg (FDC30) (K241060)
Class Class II K241060 JTN
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K241240)
Class Class II K241240 QOF
Aptima HCV Quant Dx Assay (K233352)
Class Class II K233352 MZP
Nano-Check™ RSV Test (K240280)
Class Class I K240280 GQG
iDart Lyme IgG ImmunoBlot Kit (K233367)
Class Class II K233367 LSR
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