FDA applicant
Remedi Co., Ltd.
FDA records 5 decisions for Remedi Co., Ltd. (Seoul, KR) from 2020 to 2026: 5 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Remedi, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Remedi Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Remedi 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