FDA applicant

Vortex Surgical, Inc.

Chesterfield, MO2 decisions2019–20223 recalls

FDA records 2 decisions for Vortex Surgical, Inc. (Chesterfield, MO) from 2019 to 2022: 2 510(k) clearances. All are in product code HQB (Photocoagulator And Accessories). Its devices cite 2 predicates, 1 of them its own earlier devices. 3 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, ophthalmic panel, where it files most

How often FDA has decided Vortex Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2025

2019high 3 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Vortex Surgical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vortex Surgical, 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 “Vortex”

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

Vortex Medical, Inc. 3

Vortex Surgical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vortex”