FDA applicant
Medicon, Inc.
FDA records 15 decisions for Medicon, Inc. (Norwalk, CT) from 1981 to 2012: 15 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and BZQ (Monitor, Breathing Frequency). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medicon Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medicon, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medicon, 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) ReportOther applicant names beginning “Medicon”
FDA records each applicant name separately; these may or may not be the same firm.