Device Directory
Browse 104 FDA-cleared medical devices
BD Vacutainer® Eclipse™ Blood Collection Needle (K243207)
Class Class II K243207 JKA
Shinetell PlusTM Digital Early Pregnancy Test (K251053)
Class Class II K251053 LCX
Elecsys Cortisol III (K242505)
Class Class II K242505 JFT
Access hsTnI (K243483)
Class Class II K243483 MMI
Origin™ (K243965)
Class Class II K243965 SFO
SmartGuard technology; Predictive Low Glucose technology (K251217)
Class Class II K251217 QJI
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (K251040)
Class Class II K251040 LCX
Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080)
Class Class II DEN240080 SFU
t:slim X2 insulin pump with interoperable technology (K250792)
Class Class II K250792 QFG
Steripath® Flow™ Blood Collection System (K251812)
Class Class II K251812 JKA
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