Company · US
Bryan Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 2026 | K251794 | Tenax® Laser Resistant Endotracheal Tube Bryan Medical, Inc. | BTR |
| Oct 21, 2021 | K213028 | Tenax Laser Resistant Endotracheal Tube Bryan Medical, Inc. | BTR |
| Nov 25, 2020 | K200761 | Tenax Laser Resistant Endotracheal Tube Bryan Medical, Inc. | BTR |
| Jun 25, 2015 | K150951 | aeris Balloon Dialation Catheter Bryan Medical, Inc. | KTI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2023 | Bryan Medical Inc Aeris Balloon Dilation Catheter Open, Classified |
KTI | K150951 |
| Jul 8, 2013 | Bryan Medical Inc Tracoe Mini 3.0mm Tube, for pediatric use.
Pediatric tracheostomy tube used to provide safe airway access. Terminated |
BTO | K893866 |