FDA applicant

Ivalon

San Diego, CA3 decisions1994–19950 recalls

FDA records 3 decisions for Ivalon (San Diego, CA) from 1994 to 1995: 3 510(k) clearances. Most are in product codes HCG (Device, Neurovascular Embolization) and NAB (Gauze / Sponge,Nonresorbable For External Use). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Ivalon since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ivalon

Which product codes does it file in?

What has FDA decided for it lately?