Device Directory
Browse 178 FDA-cleared medical devices
BinaxNOW COVID-19 Ag Card (K250273)
Class Class II K250273 QVF
BD Veritor System for SARS-CoV-2 (K243872)
Class Class II K243872 QVF
Nano-Check Influenza+COVID-19 Dual Test (K243561)
Class Class II K243561 SCA
Alinity i Rubella IgG (K243168)
Class Class II K243168 LFX
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843)
Class Class II K242843 JWY
Ceftobiprole BPR 5 µg Disc (K250885)
Class Class II K250885 JTN
HardyDisk AST Gepotidacin 10µg (GEP10) (K250956)
Class Class II K250956 JTN
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990)
Class Class II K250990 JWY
Alinity m CMV (K243485)
Class Class II K243485 PAB
Innovita Flu A/B Antigen Rapid Test (K250398)
Class Class II K250398 PSZ
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