FDA applicant

Emcyte Corporation

Fort Meyers, FL2 decisions2019–20190 recalls

FDA records 2 decisions for Emcyte Corporation (Fort Meyers, FL) in 2019: 2 510(k) clearances. Most are in product codes MUU (System, Suction, Lipoplasty) and JQC (Centrifuges (Micro, Ultra, Refrigerated) For…). 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 Emcyte Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Emcyte Corporation by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Emcyte Corporation’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

Emcyte Corporation

Which product codes does it file in?

What has FDA decided for it lately?