Device Directory
Browse 104 FDA-cleared medical devices
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027)
Class Class II DEN220027 QWH
iLet® ACE Pump (K223846)
Class Class II K223846 QFG
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790)
Class Class II K230790 DHA
iLet® Dosing Decision Software (K220916)
Class Class II K220916 QJI
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (K230408)
Class Class II K230408 JKA
ADVIA Centaur® Anti-Müllerian Hormone (AMH) (K221801)
Class Class II K221801 PQO
Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937)
Class Class II K230937 DHA
VACUETTE® QUICKSHIELD Complete (Plus) (K233979)
Class Class II K233979 JKA
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (K234091)
Class Class II K234091 JLW
Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165)
Class Class II K241165 MMI
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