FDA applicant

Stefanovsky & Assoc.

Walker, MI3 decisions1983–19970 recalls

FDA records 3 decisions for Stefanovsky & Assoc. (Walker, MI) from 1983 to 1997: 3 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and GEX (Powered Laser Surgical Instrument). 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 Stefanovsky & Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stefanovsky & Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stefanovsky & Assoc.’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

Stefanovsky & Assoc.

Which product codes does it file in?

What has FDA decided for it lately?