Miami, FL, US · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | Class II | General Hospital | 2 | 2026-03-24 |
| QAX | — | — | — | 1 | 2026-07-28 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology, Urology | 1 | 2026-03-19 |
| FMF | — | — | — | 1 | 2022-04-15 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-27 | Class II | Ongoing | Z-0912-2026 | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | — | Screw may loosen or fallout of Hemodialysis system |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-28 | K261399 | ELISIO-HX | QAX | — | — |
| 2026-03-24 | K253047 | PRESSONE | FMI | Class II | General Hospital |
| 2026-03-19 | K260533 | ELISIO-H | KDI | Class II | Gastroenterology, Urology |
| 2023-05-25 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | FMI | Class II | General Hospital |
| 2022-04-15 | K212677 | aboNT SYRINGE | FMF | — | — |