FDA applicant
Stemcell Technologies Canada, Inc.
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
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
2023high 1 (2023) · low 0 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Stemcell Technologies Canada, Inc.’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