FDA applicant
Axis-Shield, Ltd.
FDA records 3 decisions for Axis-Shield, Ltd. (Dundee, GB) from 2000 to 2005: 3 510(k) clearances. Most are in product codes MID (System, Test, Anticardiolipin Immunological) and NRP (Sirolimus Test System). Its devices cite 1 predicate, 0 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Axis-Shield”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Axis-Shield, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Axis-Shield, Ltd. since 2007.
Recalls per year
2in 2016
Class I Class II/III not classified
Planning a device like Axis-Shield, 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) ReportOther applicant names beginning “Axis-Shield”
FDA records each applicant name separately; these may or may not be the same firm.