510(k) Report

FDA applicant

Bioplexus Corp.

Las Vegas, NV3 decisions1993–19950 recalls

FDA records 3 decisions for Bioplexus Corp. (Las Vegas, NV) from 1993 to 1995: 3 510(k) clearances. Most are in product codes MIB (Elastomer, Silicone Block) and FTL (Mesh, Surgical, Polymeric). 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 Bioplexus Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioplexus Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bioplexus Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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