FDA applicant
Bio-Medical Research, Ltd.
FDA records 37 decisions for Bio-Medical Research, Ltd. (Galway, IE) from 1984 to 2021: 36 510(k) clearances and 1 De Novo grant. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 240 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 33 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bio-Medical Research Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bio-Medical Research, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bio-Medical Research, 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