Canary Medical, Inc.
FDA Regulatory Profile
Canary Medical, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2099-2025, Class II) was initiated on May 2, 2025. Its most recent 510(k) clearance was granted on August 27, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2099-2025 | Class II | Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030- | May 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | August 27, 2021 |