FDA applicant

Soundbite Medical Solutions, Inc.

Montreal, CA2 decisions2021–20230 recalls

FDA records 2 decisions for Soundbite Medical Solutions, Inc. (Montreal, CA) from 2021 to 2023: 2 510(k) clearances. All are in product code PDU (Catheter For Crossing Total Occlusions). Its devices cite 2 predicates, 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Soundbite Medical Solutions, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Soundbite”

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

Soundbite Medical Solution, Inc. 1

Soundbite Medical Solutions, 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?

Other applicant names beginning “Soundbite”