Device Directory
Browse 322 FDA-cleared medical devices
Ceribell Status Epilepticus Monitor (K223504)
Class Class II K223504 OMB
SomniCheck (K223676)
Class Class II K223676 GWL
TMINI Miniature Robotic System (TMINI 1.1) (K241031)
Class Class II K241031 OLO
allay Nerve Cap (DEN230061)
Class Class II DEN230061 SBG
B4C System – Addition of new sensor model (BcSs-PICNIW-2000) (K240821)
Class Class II K240821 GWM
CEFALY Connected – OTC, CEFALY Connected – Rx (K234029)
Class Class II K234029 PCC
Wireless TENS & EMS (Model SM9110,SM9113,SM9116) (K233067)
Class Class II K233067 NUH
Transcutaneous Electrical Nerve Stimulator (K6106) (K241119)
Class Class II K241119 NUH
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130)
Class Class II K241130 OLO
Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171)
Class Class II K241171 OLO
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