Omnicell, Inc.
Medical device manufacturer in Cranberry Township, PA.
1510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K212530 | IVX Fluid Transfer SetLHI · Traditional | 04/24/2022SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2047-2026 Class I | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028…Potential for mislabeled syringe produced by the i.v.STATION device. | 03/25/2026Open, Classified |
| Z-1532-2025 Class II | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per…IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended… | 02/20/2025Open, Classified |
| Z-1617-2023 Class II | Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures…IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation… | 03/27/2023Open, Classified |