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 15, 2026, FDA's public records list Bryan Medical with 4 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Sep 3, 2026: Tenax® Laser Resistant Endotracheal Tube.
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 3, 2026 | Tenax® Laser Resistant Endotracheal TubeK251794 · BTR | 510(k) clearances |
| May 16, 2023 | Aeris Balloon Dilation CatheterClass II · Devices were mislabeled. | Device recalls |
| Oct 21, 2021 | Tenax Laser Resistant Endotracheal TubeK213028 · BTR | 510(k) clearances |
| Nov 25, 2020 | Tenax Laser Resistant Endotracheal TubeK200761 · BTR | 510(k) clearances |
| Jun 25, 2015 | aeris Balloon Dialation CatheterK150951 · KTI | 510(k) clearances |
| Apr 17, 2013 | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.Class I · The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | Device recalls |
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
