510(k) Report

FDA applicant

Nextec Corp.

Naples, FL3 decisions1992–19920 recalls

FDA records 3 decisions for Nextec Corp. (Naples, FL) in 1992: 3 510(k) clearances. Most are in product codes HBI (Illuminator, Fiberoptic, Surgical Field) and FST (Light, Surgical, Fiberoptic). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Nextec Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nextec 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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