FDA applicant

Focus Medical, LLC

Bethel, CT10 decisions1997–20160 recalls

FDA records 10 decisions for Focus Medical, LLC (Bethel, CT) from 1997 to 2016: 10 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and KPS (System, Tomography, Computed, Emission). Its devices cite 24 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Focus Medical SA”.

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

FDA decisions per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Focus Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Focus Medical, 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

Other applicant names beginning “Focus”

FDA records each applicant name separately; these may or may not be the same firm.

Focus Diagnostics, Inc. 18 Focus Technologies, Inc. 5 Focus International, Inc. 1 Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC 1 Focus Surgery, Inc. 1

Focus Medical, 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?

Other applicant names beginning “Focus”