FDA applicant
Bortec Biomedical, Ltd.
FDA records 1 decision for Bortec Biomedical, Ltd. (Seattle, WA) in 2002: 1 510(k) clearance. All are in product code IKN (Electromyograph, Diagnostic). 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 Bortec Biomedical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bortec Biomedical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bortec Biomedical, 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