510(k) Report

FDA applicant

Stemcell Technologies Canada, Inc.

Vancouver, CA1 decision2023–20230 recalls

FDA records 1 decision for Stemcell Technologies Canada, Inc. (Vancouver, CA) in 2023: 1 De Novo grant. All are in product code QYO (Hematopoietic Cell Enrichment Kit). 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, immunology panel, where it files most

How often FDA has decided Stemcell Technologies Canada, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Stemcell Technologies Canada, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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