Device Directory
Browse 104 FDA-cleared medical devices
iLet ACE Pump (K252770)
Class Class II K252770 QFG
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073)
Class Class II K250073 PDJ
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (K250085)
Class Class II K250085 NBW
Glucose2 (K252357)
Class Class II K252357 CFR
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393)
Class Class II K252393 MMI
AllTest Urinary Tract Infection Test (K252607)
Class Class I K252607 JMT
Tandem Mobi insulin pump with interoperable technology (K253074)
Class Class II K253074 QFG
Dexcom Smart Basal (K252818)
Class Class II K252818 QRX
Tru Kidney Health Test Panel; Tru Analyzer (K251058)
Class Class II K251058 CGX
Omnipod 5 algorithm (K251779)
Class Class II K251779 QJI
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