Ceribell, Inc. - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
FDA 510(k) cleared devices by Ceribell, Inc. Neurology ✕
12 devices
Cleared
Feb 09, 2026
Ceribell Instant EEG Headset
Neurology
55d
Cleared
Dec 08, 2025
Ceribell Delirium Monitor System
Neurology
167d
Cleared
Nov 21, 2025
Ceribell Infant Seizure Detection Software
Neurology
143d
Cleared
Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
Neurology
182d
Cleared
Apr 09, 2025
Ceribell Seizure Detection Software
Neurology
310d
Cleared
Aug 08, 2023
Ceribell Instant EEG Headband
Neurology
29d
Cleared
May 23, 2023
Ceribell Status Epilepticus Monitor
Neurology
182d
Cleared
Mar 22, 2023
Ceribell Instant EEG Headcap
Neurology
173d
Cleared
Aug 30, 2021
Ceribell Instant EEG Headband
Neurology
166d
Cleared
Sep 11, 2019
Ceribell Pocket EEG Device
Neurology
120d
Cleared
Aug 21, 2017
Ceribell Instant EEG Headband
Neurology
95d
Cleared
May 08, 2017
Ceribell Pocket EEG Device
Neurology
91d