Checkpoint Surgical Inc
Medical device manufacturer in Cleveland, OH.
1510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative…ETN · Special | 08/26/2021SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1467-2025 Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button… | 02/24/2025Open, Classified |
| Z-1466-2025 Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button… | 02/24/2025Open, Classified |