Coapt LLC
Coapt LLC appears in FDA public data with 2 recalls, 5 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0203-2024, Class II) was initiated on October 2, 2023. Its most recent 510(k) clearance was granted on January 11, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0203-2024 | Class II | Coapt Dome Electrode, Gen2 system, cutaneous electrode | October 2, 2023 |
| Z-0204-2024 | Class II | Coapt ControlSeal Electrode, cutaneous EMG Electrode | October 2, 2023 |