Bryan Medical Inc
Cincinnati, OH, US
BRYAN MEDICAL INC. appears in FDA device records in Cincinnati, OH. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Bryan Medical Inc between 2015 and 2021. The busiest year on record is 2015, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213028 | Tenax Laser Resistant Endotracheal Tube | BTR | Substantially Equivalent | |
| K200761 | Tenax Laser Resistant Endotracheal Tube | BTR | Substantially Equivalent | |
| K150951 | aeris Balloon Dialation Catheter | KTI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005803389 | 3005803389 | BRYAN MEDICAL INC. | 6100 Wooster Pike, Cincinnati, OH 45227 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2148-2023 | Aeris Balloon Dilation Catheter | Devices were mislabeled. | Class II | Open, Classified | |
| Z-1667-2013 | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain