FDA applicant
Ote Biomedica
FDA records 3 decisions for Ote Biomedica (Walker, MI) in 1982: 3 510(k) clearances. 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 Ote Biomedica’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ote Biomedica since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ote Biomedica’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