FDA applicant
Foosin Medical Supplies Inc., Ltd.
FDA records 10 decisions for Foosin Medical Supplies Inc., Ltd. (Weihai, CN) from 2008 to 2020: 10 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Foosin Medical Supplies, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Foosin Medical Supplies Inc., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Foosin Medical Supplies Inc., 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