FDA applicant
7D Surgical ULC
FDA records 2 decisions for 7D Surgical ULC (Toronto, CA) from 2024 to 2026: 2 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and OLO (Orthopedic Stereotaxic Instrument). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 7D Surgical ULC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like 7D Surgical ULC’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