FDA applicant
Endomagnetics Ltd.,
FDA records 6 decisions for Endomagnetics Ltd., (Cambridge, GB) from 2016 to 2024: 5 510(k) clearances and 1 original PMA approval. Most are in product codes NEU (Marker, Radiographic, Implantable) and PBY (Temporary Tissue Marker). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Endomagnetics Ltd.,’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Endomagnetics 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