FDA applicant
Taeyeon Medical Co., Ltd.
FDA records 3 decisions for Taeyeon Medical Co., Ltd. (Wonju-Si, KR) from 2007 to 2022: 3 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 5 predicates, 1 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 Taeyeon Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Taeyeon Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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