ImaCor Inc.
ImaCor Inc. appears in FDA public data with 2 recalls, 4 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0038-2026, Class II) was initiated on August 29, 2025. Its most recent 510(k) clearance was granted on April 8, 2022.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0038-2026 | Class II | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for u | August 29, 2025 |
| Z-0231-2025 | Class II | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagn | September 16, 2024 |