Graphic Controls Acquisition Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0936-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US | March 15, 2022 |
| Z-0937-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US | March 15, 2022 |
| Z-0939-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US | March 15, 2022 |
| Z-0940-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US | March 15, 2022 |
| Z-0938-2022 | Class II | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US | March 15, 2022 |
| Z-0935-2022 | Class II | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US | March 15, 2022 |