FDA applicant
Vericom Co., Ltd.
FDA records 20 decisions for Vericom Co., Ltd. (Chuncheon-Si, KR) from 2004 to 2026: 20 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and ELW (Material, Impression). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 0 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 Vericom 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 2007.
Planning a device like Vericom 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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