FDA applicant
Obus Forme, Ltd.
FDA records 1 decision for Obus Forme, Ltd. (Walker, MI) in 1982: 1 510(k) clearance. All are in product code IQE (Orthosis, Lumbar). 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 Obus Forme, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Obus Forme, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Obus Forme, Ltd.’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