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Bryan Medical Inc

FDA Regulatory Profile

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