Device Directory
Browse 178 FDA-cleared medical devices
Access anti-HAV (K243846)
Class Class II K243846 LOL
Babio® Virus Transport Kit (Non-inactivating) (K250205)
Class Class I K250205 JSM
Panther Fusion GI Expanded Bacterial Assay (K251993)
Class Class II K251993 PCH
Panther Fusion GI Bacterial Assay (K251868)
Class Class II K251868 PCH
Alinity m HCV (K252102)
Class Class II K252102 MZP
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062)
Class Class II K252062 JWY
miDiagnostics HSV-1&2 CSF Test (K250050)
Class Class II K250050 PGH
Visby Medical Men’s Sexual Health Test (K251501)
Class Class II K251501 QEP
MTS Aztreonam-Avibactam 0.016/4 – 256/4 µg/mL (K252114)
Class Class II K252114 JWY
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249)
Class Class II K250249 GMQ
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