510(k) Report

FDA applicant

Vioguard

Bothell, WA1 decision2011–20110 recalls

FDA records 1 decision for Vioguard (Bothell, WA) in 2011: 1 De Novo grant. All are in product code OSZ (Antimicrobial Keyboard). 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 hospital panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Vioguard by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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