FDA applicant

Arjo Wiggins Medical, Inc.

Appollo Beach, FL3 decisions1993–20120 recalls

FDA records 3 decisions for Arjo Wiggins Medical, Inc. (Appollo Beach, FL) from 1993 to 2012: 3 510(k) clearances. All are in product code FRG (Wrap, Sterilization). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Arjo Wiggins 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 “Arjo”

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

Arjo-Century, Inc. 6 Arjo, Inc. 1 Arjo Hospital Equipment AB 1

Arjo Wiggins 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 “Arjo”