FDA applicant
Tri/Bor Medical, Inc.
FDA records 5 decisions for Tri/Bor Medical, Inc. (Westtown, NY) in 1991: 5 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BYG (Mask, 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 Tri/Bor Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Tri/Bor Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tri/Bor Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report