FDA applicant

Tusker Medical, Inc.

Menlo Park, CA3 decisions2017–20260 recalls

FDA records 3 decisions for Tusker Medical, Inc. (Menlo Park, CA) from 2017 to 2026: 2 510(k) clearances and 1 original PMA approval. Most are in product codes ETD (Tube, Tympanostomy) and QJA (Tympanostomy Tube Delivery Product With Drug). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tusker Medical”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2019

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Tusker Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tusker Medical, 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

Tusker Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?