FDA applicant

Supermax Healthcare Canada-Supermax Medical

Saint-Bruno-De-Montarville, CA2 decisions2023–20240 recalls

FDA records 2 decisions for Supermax Healthcare Canada-Supermax Medical (Saint-Bruno-De-Montarville, CA) from 2023 to 2024: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Supermax Healthcare Canada – Supermax Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Supermax Healthcare Canada-Supermax Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Supermax Healthcare Canada-Supermax Medical by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Supermax Healthcare Canada-Supermax…’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

Other applicant names beginning “Supermax”

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

Supermax Sdn Bhd 9 Supermax Glove Manufacturing Sdn Bhd 6 Supermax Plastic Products Co., Ltd. 3 Supermax Latex Products Sdn. Bhd. 1

Supermax Healthcare Canada-Supermax Medical

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Supermax”