510(k) Report

FDA applicant

Meditec of America

Walker, MI2 decisions1984–19870 recalls

FDA records 2 decisions for Meditec of America (Walker, MI) from 1984 to 1987: 2 510(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 Meditec of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meditec of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Meditec”

FDA records each applicant name separately; these may or may not be the same firm.