FDA applicant

Gc Medtech, LLC

Hialeah, FL2 decisions2014–20150 recalls

FDA records 2 decisions for Gc Medtech, LLC (Hialeah, FL) from 2014 to 2015: 2 510(k) clearances. All are in product code JAQ (System, Applicator, Radionuclide…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Gc Medtech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Gc Medtech, LLC’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

Gc Medtech, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?