FDA applicant
Therex Corp.
FDA records 26 decisions for Therex Corp. (Walpole, MA) from 1988 to 1995: 26 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and FMI (Needle, Hypodermic, Single Lumen). 20 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Therex Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Therex Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Therex 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