FDA applicant

Olsen Industria E Comercio S.A.

Palhoça -, BR2 decisions2020–20220 recalls

FDA records 2 decisions for Olsen Industria E Comercio S.A. (Palhoça -, BR) from 2020 to 2022: 2 510(k) clearances. All are in product code EIA (Unit, Operative Dental). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Olsen Indústria E Comércio S.A.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Olsen Industria E Comercio S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Olsen Industria E Comercio S.A. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Olsen Industria E Comercio S.A.’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 “Olsen”

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

Olsen Electrosurgical, Inc. 11 Olsen Medical 5 Olsen Electro-Surgical Instruments, Inc. 3

Olsen Industria E Comercio S.A.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Olsen”