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BRYAN MEDICAL INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Tenax Laser Resistant Endotracheal Tube	TG0050	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG0730	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG1240	FDA UDI	Class II	Active
Tenax Laser Resistant Endotracheal Tube	TG0055	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG1030	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG1840	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG1640	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG0830	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG0530	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG0630	FDA UDI	Class II	Active
Tenax Laser Resistant Endotracheal Tube	TG0070	FDA UDI	Class II	Active
Tenax Laser Resistant Endotracheal Tube	TG0065	FDA UDI	Class II	Active
Aeris Balloon Dilation Catheter	KG0930	FDA UDI	Class II	Active
Tenax Laser Resistant Endotracheal Tube	TG0060	FDA UDI	Class II	Active
Tenax Laser Resistant Endotracheal Tube	TG0075	FDA UDI	Class II	Active
aeris Balloon Dialation Catheter	K150951	FDA 510(k)	Class II	Active
Tenax Laser Resistant Endotracheal Tube	K200761	FDA 510(k)	Class II	Active
Tenax Laser Resistant Endotracheal Tube	K213028	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 16, 2023	Z-2148-2023	—	open, classified	Devices were mislabeled.
Apr 17, 2013	Z-1667-2013	—	terminated	The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.