FDA applicant
Xre Corp.
FDA records 20 decisions for Xre Corp. (Littleton, MA) from 1977 to 1997: 20 510(k) clearances. Most are in product codes IZI (System, X-Ray, Angiographic) and IXR (Table, Radiographic, Tilting). 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 Xre Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Xre Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Xre Corp.’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