FDA applicant
M.K. Meditech Co., Ltd.
FDA records 6 decisions for M.K. Meditech Co., Ltd. (North Attleboro, MA) from 2002 to 2021: 6 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 13 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Mk Meditech, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided M.K. Meditech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like M.K. Meditech Co., Ltd.’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