510(k) Report

FDA applicant

Hdc Corp.

San Jose, CA33 decisions1983–20090 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Hdc Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22009: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hdc Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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