510(k) Report

FDA applicant

Lorons International Corp.

Secaucus, NJ6 decisions1994–19950 recalls

FDA records 6 decisions for Lorons International Corp. (Secaucus, NJ) from 1994 to 1995: 6 510(k) clearances. All are in product code EFQ (Gauze/Sponge, Internal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Lorons International Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lorons International Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lorons International Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lorons International 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