FDA applicant

Monarch Products, Inc.

Jacksonville, TX2 decisions1985–19910 recalls

FDA records 2 decisions for Monarch Products, Inc. (Jacksonville, TX) from 1985 to 1991: 2 510(k) clearances. All are in product code FRG (Wrap, Sterilization). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Monarch Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Monarch”

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

Monarch Medical Technologies, LLC 6 Monarch Labs, LLC 2 The Monarch Company 1 Monarch Bioimplants GmbH 1 Monarch Medical 1

Monarch Products, Inc.

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?

Other applicant names beginning “Monarch”