510(k) Report

FDA applicant

Alphamedix, Inc.

Mchenry, IL7 decisions1982–19850 recalls

FDA records 7 decisions for Alphamedix, Inc. (Mchenry, IL) from 1982 to 1985: 7 510(k) clearances. Most are in product codes HNN (Knife, Ophthalmic) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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 Alphamedix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alphamedix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report