Device Directory
Browse 178 FDA-cleared medical devices
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)
Class Class II K221198 NGZ
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404)
Class Class II K230404 PCH
Access PCT (K222996)
Class Class II K222996 PTF
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743)
Class Class I K212743 JSM
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280)
Class Class II K213280 QQY
Panther Fusion AdV/hMPV/RV Assay (K231017)
Class Class II K231017 OCC
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040)
Class Class II DEN210040 QVP
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (DEN210038)
Class Class II DEN210038 QVP
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736)
Class Class II K222736 QOF
ComASP Cefiderocol 0.008-128 (K230479)
Class Class II K230479 JWY
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