FDA applicant

Surgidev Corp.

Mchenry, IL4 decisions1983–19850 recalls

FDA records 4 decisions for Surgidev Corp. (Mchenry, IL) from 1983 to 1985: 4 510(k) clearances. Most are in product codes HLR (Keratoscope, Battery-Powered) and FRN (Pump, Infusion). 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 Surgidev Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgidev Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgidev Corp.’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

Surgidev Corp.

Which product codes does it file in?

What has FDA decided for it lately?