FDA applicant

Syntheon, LLC

Miami, FL3 decisions2008–20230 recalls

FDA records 3 decisions for Syntheon, LLC (Miami, FL) from 2008 to 2023: 3 510(k) clearances. Most are in product codes PZX (Left Atrial Appendage Clip, Implantable) and FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Syntheon”.

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 Syntheon, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Syntheon, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Syntheon, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?