Pompano Beach, FL, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FMF | — | — | — | 2 | 2024-09-04 |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | Class II | General Hospital | 1 | 2020-12-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-09-16 | Class II | Ongoing | Z-0925-2023 | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, St… | — | Blister package had an unsealed edge compromising sterility. |