FDA applicant
Hdc Corp.
FDA records 33 decisions for Hdc Corp. (San Jose, CA) from 1983 to 2009: 33 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 22 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Hdc S.R.L.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hdc Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hdc Corp.’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