Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Ceribell with 16 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 16, 2026: Ceribell EEG Analysis Software.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 16, 2026 | Ceribell EEG Analysis SoftwareK261712 · OLT | 510(k) clearances |
| Jun 30, 2026 | Ceribell MonitorK261101 · OMC | 510(k) clearances |
| Jun 24, 2026 | Ceribell Neurology Review SoftwareK260998 · OMB | 510(k) clearances |
| Apr 3, 2026 | Ceribell Brain Monitor HeadbandK260363 · GXY | 510(k) clearances |
| Feb 9, 2026 | Ceribell Instant EEG HeadsetK254033 · GXY | 510(k) clearances |
| Dec 8, 2025 | Ceribell Delirium Monitor SystemK251936 · NCG | 510(k) clearances |
| Dec 8, 2025 | Ceribell Delirium Monitor SystemK251936 · Neurology | AI-enabled devices |
| Nov 21, 2025 | Ceribell Infant Seizure Detection SoftwareK252070 · OMB | 510(k) clearances |
| Oct 31, 2025 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252)K251381 · GXY | 510(k) clearances |
| May 23, 2023 | Ceribell Status Epilepticus MonitorK223504 · Neurology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
