FDA applicant
Transtracheal Systems
FDA records 8 decisions for Transtracheal Systems (Boulder, CO) from 1986 to 1999: 8 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and NFB (Conserver, Oxygen). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Transtracheal Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Transtracheal Systems since 2007.
Recalls per year
No recall linked to its devices since 2007.
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