FDA applicant

Nfocus Neuromedical, Inc.

Palo Alto, CA2 decisions2009–20100 recalls

FDA records 2 decisions for Nfocus Neuromedical, Inc. (Palo Alto, CA) from 2009 to 2010: 2 510(k) clearances. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and DQY (Catheter, Percutaneous). 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, cardiovascular panel, where it files most

How often FDA has decided Nfocus Neuromedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Nfocus Neuromedical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Nfocus Neuromedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?