FDA applicant

Hayes Medical, Inc.

El Dorado Hills, CA12 decisions1995–20070 recalls

FDA records 12 decisions for Hayes Medical, Inc. (El Dorado Hills, CA) from 1995 to 2007: 12 510(k) clearances. Most are in product codes LWJ (Prosthesis, Hip, Semi-Constrained…) and LPH (Prosthesis, Hip, Semi-Constrained…). Its devices cite 14 predicates, 2 of them its own earlier devices. 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, orthopedic panel, where it files most

How often FDA has decided Hayes Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hayes Medical, Inc.’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

Other applicant names beginning “Hayes”

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

Hayes Products, Inc. 5

Hayes Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hayes”