FDA applicant

Equipmed North America, Inc.

Verona, WI1 decision2015–20150 recalls

FDA records 1 decision for Equipmed North America, Inc. (Verona, WI) in 2015: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 0 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 and plastic surgery panel, where it files most

How often FDA has decided Equipmed North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Equipmed North America, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Equipmed”

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

Equipmed USA, LLC 1

Equipmed North America, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Equipmed”