FDA applicant

Tedan Surgical Innovations, LLC

Sugar Land, TX4 decisions2014–20260 recalls

FDA records 4 decisions for Tedan Surgical Innovations, LLC (Sugar Land, TX) from 2014 to 2026: 4 510(k) clearances. Most are in product codes PDQ (Neurosurgical Nerve Locator) and GXZ (Electrode, Needle). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “TeDan Surgical Innovations, Inc.”, “Tedan Surgical Innovations”.

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

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

How often FDA has decided Tedan Surgical Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Tedan Surgical Innovations, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tedan Surgical Innovations, LLC’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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Tedan Surgical Innovations, LLC

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?