FDA applicant

Intravista Medical Systems, Inc.

Sunnyvale, CA1 decision2009–20090 recalls

FDA records 1 decision for Intravista Medical Systems, Inc. (Sunnyvale, CA) in 2009: 1 510(k) clearance. All are in product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). 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, ophthalmic panel, where it files most

How often FDA has decided Intravista Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

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Intravista Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?