FDA applicant
Hans Biomed Corporation
FDA records 9 decisions for Hans Biomed Corporation (Daejeon, KR) from 2012 to 2026: 9 510(k) clearances. Most are in product codes NEW (Suture, Surgical, Absorbable, Polydioxanone) and MQV (Filler, Bone Void, Calcium Compound). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Hans Biomed Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hans Biomed Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Hans Biomed Corporation’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 “Hans”
FDA records each applicant name separately; these may or may not be the same firm.