Natus Manufacturing Limited
Medical device manufacturer in Gort, IE.
4510(k) clearances
0PMA approvals
2recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242346 | Grass® MR Conditional/CT Cup ElectrodesGXY · Traditional | 08/29/2024SE |
| K173815 | Allergan Botox Needle ElectrodeIKT · Traditional | 06/29/2018SE |
| K161430 | Myoject Luer Lock Needle ElectrodeIKT · Traditional | 03/02/2017SE |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional | 08/28/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1143-2021 Class II | Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for…The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal… | 01/12/2021Terminated |
| Z-0951-2017 Class II | Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket…The fuse blows during initial power up or after a period of time. This results in a complete loss of power… | 10/15/2016Terminated |