FDA applicant

Olsen Medical

Louisville, KY5 decisions2005–20134 recalls

FDA records 5 decisions for Olsen Medical (Louisville, KY) from 2005 to 2013: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 12 predicates, 0 of them its own earlier devices. 4 recalls are 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 Olsen Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2018

2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Olsen Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Electro-Surgical Instruments, Inc. 3 Olsen Industria E Comercio S.A. 2

Olsen Medical

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?

What has been recalled?

Other applicant names beginning “Olsen”