FDA applicant
Taewoong Medical Co., Ltd.
FDA records 17 decisions for Taewoong Medical Co., Ltd. (Gimpo-Si, KR) from 2005 to 2026: 17 510(k) clearances. Most are in product codes ESW (Prosthesis, Esophageal) and FGE (Stents, Drains And Dilators For The Biliary…). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 19 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Taewoong Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Taewoong Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Taewoong 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.
See the 510(k) Report