FDA applicant
Bmr Ent., Inc.
FDA records 2 decisions for Bmr Ent., Inc. (Ireland, IR) in 1993: 2 510(k) clearances. All are in product code IPF (Stimulator, Muscle, Powered). 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 Bmr Ent., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bmr Ent., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bmr Ent., 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