CardioTek BV
CardioTek BV appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1283-2022, Class II) was initiated on April 25, 2022.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1283-2022 | Class II | CardioTek EP-TRACER Software V2.x. | April 25, 2022 |
| Z-2657-2017 | Class II | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measureme | April 13, 2017 |