Device Directory
Browse 104 FDA-cleared medical devices
i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984)
Class Class II K240984 MMI
Safecare Urinary Tract Infection Test (K242767)
Class Class I K242767 JMT
ABL90 FLEX PLUS System (K241037)
Class Class II K241037 CEM
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (K243573)
Class Class II K243573 LCX
Alere NT-proBNP for Alinity i Reagent Kit (K241176)
Class Class II K241176 NBC
TeleRPM Gen2 Blood Glucose Monitoring System (K243060)
Class Class II K243060 NBW
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135)
Class Class II K242135 LCX
Elecsys sFlt-1 and Elecsys PlGF (K241453)
Class Class II K241453 QWH
Calcium2 (K244042)
Class Class II K244042 CJY
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117)
Class Class II K250117 LCX
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