FDA applicant

Silimed, LLC

Crofton, MD10 decisions1998–20050 recalls

FDA records 10 decisions for Silimed, LLC (Crofton, MD) from 1998 to 2005: 10 510(k) clearances. Most are in product codes MIB (Elastomer, Silicone Block) and KXP (Stent, Vaginal). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Silimed, Inc.”.

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 Silimed, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Silimed, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Silimed, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?