Company · IE
Natus Manufacturing Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2024. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2024 | K242346 | Grass® MR Conditional/CT Cup Electrodes Natus Manufacturing Limited, IE | GXY |
| Jun 29, 2018 | K173815 | Allergan Botox Needle Electrode Natus Manufacturing Limited, IE | IKT |
| Mar 2, 2017 | K161430 | Myoject Luer Lock Needle Electrode Natus Manufacturing Limited, IE | IKT |
| Aug 28, 2015 | K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec Natus Manufacturing Limited, IE | IKT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2021 | Natus Manufacturing Limited Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of Terminated |
JXG | K162437 |
| Oct 15, 2016 | Natus Manufacturing Limited Natus Warmette Blanket Cabinet and Warmette Dual Cabinet
The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is design Terminated |
LGZ | K132110 |