FDA applicant
Tdm Co., Ltd.
FDA records 14 decisions for Tdm Co., Ltd. (Gwangju, KR) from 2018 to 2026: 14 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 187 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tdm Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Tdm 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