FDA applicant

Equashield Medical, Ltd.

Migdal, IL5 decisions2010–20230 recalls

FDA records 5 decisions for Equashield Medical, Ltd. (Migdal, IL) from 2010 to 2023: 5 510(k) clearances. Most are in product codes ONB (Closed Antineoplastic And Hazardous Drug…) and LHI (Set, I.V. Fluid Transfer). Its devices cite 7 predicates, 4 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 Equashield Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Equashield Medical, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Equashield Medical, Ltd.

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?