FDA applicant
Customed, Inc.
FDA records 37 decisions for Customed, Inc. (Fajardo, PR) from 1990 to 2026: 37 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and LRO (General Surgery Tray). Its devices cite 2 predicates, 0 of them its own earlier devices. 107 recalls are linked to its devices.
FDA’s records also spell it “CustoMED , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Customed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
42in 2016
Class I Class II/III not classified
Planning a device like Customed, Inc.’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