FDA applicant
Meta Biomed Co., Ltd.
FDA records 25 decisions for Meta Biomed Co., Ltd. (Cheongju-Si, KR) from 2003 to 2024: 25 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 57 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Meta Biomed, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Meta Biomed Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Meta Biomed 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) ReportOther applicant names beginning “Meta”
FDA records each applicant name separately; these may or may not be the same firm.