Device Directory
Browse 178 FDA-cleared medical devices
Lyme-ID IgG Test; Bio-ID800 (K252627)
Class Class II K252627 LSR
Access Rubella IgG (K250588)
Class Class II K250588 LFX
IntelliSep Test (K250912)
Class Class II K250912 QUT
cobas liat Bordetella panel nucleic acid test (K243753)
Class Class II K243753 OZZ
HardyDisk AST Cefiderocol 30µg (FDC30) (K253105)
Class Class II K253105 JTN
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (K242976)
Class Class I K242976 JSM
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697)
Class Class I K251697 GTY
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (K251337)
Class Class II K251337 JTN
iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (K251092)
Class Class II K251092 SCA
iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (K251085)
Class Class II K251085 SCA
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