Device Directory
Browse 178 FDA-cleared medical devices
BD Phoenix™ Automated Microbiology System – GN Imipenem-relebactam (0.0625/4 – 16/4 µg/mL) (K250447)
Class Class II K250447 LON
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659)
Class Class II K242659 JWY
Puritan PurSafe Plus Collection and Transport System (K242820)
Class Class II K242820 QBD
OHC COVID-19 Antigen Self Test (K241313)
Class Class II K241313 QYT
NG-Test® CTX-M MULTI (K243499)
Class Class II K243499 PTJ
LIAISON PLEX Gram-Positive Blood Culture Assay (K243490)
Class Class II K243490 PAM
Elecsys Anti-SARS-CoV-2 (K250768)
Class Class II K250768 QVP
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)
Class Class II K250856 JWY
iDart Lyme IgM ImmunoBlot Kit (K242872)
Class Class II K242872 LSR
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (K250789)
Class Class II K250789 JTN
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