FDA applicant
Shandong Haidike Medical Products Co., Ltd.
FDA records 3 decisions for Shandong Haidike Medical Products Co., Ltd. (Heze, CN) from 2021 to 2023: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). Its devices cite 3 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 Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Shandong Haidike Medical Products Co.…’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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