FDA applicant

Heyer Schulte Corp.

Mchenry, IL9 decisions1976–19791 recall

FDA records 9 decisions for Heyer Schulte Corp. (Mchenry, IL) from 1976 to 1979: 9 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and LCJ (Tissue Expander And Accessories). 1 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Heyer Schulte Corp. since 2007.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Heyer Schulte 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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Other applicant names beginning “Heyer”

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

Heyer America, Inc. 4

Heyer Schulte Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Heyer”