510(k) Report

FDA applicant

X-Tech Medical, LLC

Danville, CA1 decision1999–19990 recalls

FDA records 1 decision for X-Tech Medical, LLC (Danville, CA) in 1999: 1 510(k) clearance. All are in product code HOZ (Sponge, Ophthalmic). 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, ophthalmic panel, where it files most

How often FDA has decided X-Tech Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for X-Tech Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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