FDA applicant

Sentient Manufacturing, LLC

Park City, UT1 decision2022–20220 recalls

FDA records 1 decision for Sentient Manufacturing, LLC (Park City, UT) in 2022: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). No recall is 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 Sentient Manufacturing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Sentient Manufacturing, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sentient Manufacturing, LLC

Which product codes does it file in?

What has FDA decided for it lately?