FDA applicant
Shandong Haidike Medical Product Co., Ltd.
FDA records 2 decisions for Shandong Haidike Medical Product Co., Ltd. (Heze, CN) from 2021 to 2024: 2 510(k) clearances. Most are in product codes GAR (Suture, Nonabsorbable, Synthetic, Polyamide) and GAP (Suture, Nonabsorbable, Silk). Its devices cite 2 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 Shandong Haidike Medical Product 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 2021.
Planning a device like Shandong Haidike Medical Product Co.…’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