Device Directory
Browse 158 FDA-cleared medical devices
HiRise (1040-230) (K241713)
Class Class II K241713 JAK
Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285)
Class Class II K240285 MNR
HardyDisk AST Cefiderocol 30µg (FDC30) (K241060)
Class Class II K241060 JTN
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969)
Class Class II K241969 NGL
HeartKey® Rhythm (K233755)
Class Class II K233755 DQK
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239)
Class Class II K242239 NQQ
Human Lubricant (K240081)
Class Class II K240081 NUC
Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275)
Class Class II K241275 OWN
HealthCCSng (K241440)
Class Class II K241440 JAK
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200)
Class Class II K240200 PZP
Loading more devices…