510(k) Report

FDA applicant

Med USA

Waltham, MA5 decisions1985–19900 recalls

FDA records 5 decisions for Med USA (Waltham, MA) from 1985 to 1990: 5 510(k) clearances. Most are in product codes KQG (Instrument, Coagulation) and GKL (Counter, Cell, Automated (Particle Counter)). 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, hematology panel, where it files most

How often FDA has decided Med USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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