Device Directory
Browse 209 FDA-cleared medical devices
BTL-199 (K250309)
Class Class II K250309 QPL
BD Phoenix Automated Microbiology System – GN Eravacycline (0.125-2 µg/mL) (K251713)
Class Class II K251713 LON
Bone Screw (K251569)
Class Class II K251569 DZL
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (K243544)
Class Class II K243544 QOF
Brainomix 360 Triage Stroke (K251983)
Class Class II K251983 QAS
BruxZir® NOW (K252446)
Class Class II K252446 EIH
Ball Joint Guide Array (66295) (K250893)
Class Class II K250893 HAW
BioTraceIO Vision (V1.7) (K251931)
Class Class II K251931 QTZ
Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (K252180)
Class Class II K252180 KPO
BONX805 (K243864)
Class Class II K243864 IZL
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