510(k) Report

FDA applicant

Medisil Corporation

Ventura, CA1 decision2004–20040 recalls

FDA records 1 decision for Medisil Corporation (Ventura, CA) in 2004: 1 510(k) clearance. All are in product code MIB (Elastomer, Silicone Block). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Medisil Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MIBElastomer, Silicone Block1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040042Medisil Silicone SheetingMedisil Corporation · 20041cites it

What has FDA decided for it lately?

  • K040042Medisil Silicone SheetingMedisil Corporation · 2004

The one decision as Medisil Corporation →