FDA applicant
Titane SL Co.
FDA records 1 decision for Titane SL Co. (Minneapolis, MN) in 1987: 1 510(k) clearance. All are in product code ECM (Band, Preformed, Orthodontic). 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 Titane SL Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Titane SL Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Titane SL Co.’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