FDA applicant

Hancock/Jaffe Laboratories

Irvine, CA1 decision2005–20050 recalls

FDA records 1 decision for Hancock/Jaffe Laboratories (Irvine, CA) in 2005: 1 510(k) clearance. All are in product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Hancock/Jaffe Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hancock/Jaffe Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hancock/Jaffe Laboratories’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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Other applicant names beginning “Hancock/Jaffe”

FDA records each applicant name separately; these may or may not be the same firm.

Hancock Laboratories, Inc. 5 Hancock Medical, Inc. 1

Hancock/Jaffe Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hancock/Jaffe”