FDA applicant

Profound Medical, Inc.

Mississauga, CA5 decisions2019–20240 recalls

FDA records 5 decisions for Profound Medical, Inc. (Mississauga, CA) from 2019 to 2024: 5 510(k) clearances. All are in product code PLP (High Intensity Ultrasound System For Prostate…). Its devices cite 4 predicates, 3 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Profound Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Profound Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Profound Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?