FDA applicant

Universiti Malaya

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Universiti Malaya (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code ECG (Sterilizer, Boiling Water). 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Universiti Malaya since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Universiti Malaya’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

Universiti Malaya

Which product codes does it file in?

What has FDA decided for it lately?