FDA applicant
Mirada Medical, Ltd.
FDA records 8 decisions for Mirada Medical, Ltd. (Oxford, GB) from 2010 to 2022: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 of them its own earlier devices. 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 Mirada Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Mirada Medical, 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 “Mirada”
FDA records each applicant name separately; these may or may not be the same firm.