Medical device makerLabelled 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 14, 2026, FDA's public records list NeuroSync, Inc. with 1 device recall and 1 warning letter. The most recent is a warning letter dated May 9, 2025: Warning letter: CAPA, MDR reporting, Design controls.
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.
| May 9, 2025 | Warning letter: CAPA, MDR reporting, Design controlsCDRH | Warning letters |
| Sep 19, 2023 | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tabletClass II ยท Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the | Device recalls |
| Jul 31, 2017 | Warning letter: 510(k) requiredCDRH | Warning letters |
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
