Bryan Medical Inc

FDA Regulatory Profile

Bryan Medical Inc appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2148-2023, Class II) was initiated on May 16, 2023. Its most recent 510(k) clearance was granted on October 21, 2021.

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2148-2023Class IIAeris Balloon Dilation CatheterMay 16, 2023
Z-1667-2013Class ITracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airwaApril 17, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K213028Tenax Laser Resistant Endotracheal TubeOctober 21, 2021
K200761Tenax Laser Resistant Endotracheal TubeNovember 25, 2020
K150951aeris Balloon Dialation CatheterJune 25, 2015