FDA applicant
Aju Pharm Co., Ltd.
FDA records 10 decisions for Aju Pharm Co., Ltd. (Seongnam-Si, KR) from 2017 to 2024: 10 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 228 days from receipt to decision, against 81 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aju Pharm 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
8in 2025
Class I Class II/III not classified
Planning a device like Aju Pharm 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