Natus Manufacturing Limited
GORT, Co. Galway, IE
Natus Manufacturing Limited appears in FDA device records in GORT, Co. Galway, IE. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Natus Manufacturing Limited between 2015 and 2024. The busiest year on record is 2015, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242346 | Grass® MR Conditional/CT Cup Electrodes | GXY | Substantially Equivalent | |
| K173815 | Allergan Botox Needle Electrode | IKT | Substantially Equivalent | |
| K161430 | Myoject Luer Lock Needle Electrode | IKT | Substantially Equivalent | |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm | IKT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005581270 | 3005581270 | Natus Manufacturing Limited | IDA BUSINESS PARK, GORT, Co. Galway(County) -- IE | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GWLAmplifier, Physiological Signal
- OMAAmplitude-Integrated Electroencephalograph
- LXVApparatus, Vestibular Analysis
- EWOAudiometer
- ORTBurst Suppression Detection Software For Electroencephalograph
- IKDCable, Electrode
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems
- ETTCushion, Earphone (For Audiometric Testing)
- JXEDevice, Nerve Conduction Velocity Measurement
- GXYElectrode, Cutaneous
- GZLElectrode, Depth
- GXZElectrode, Needle
- IKTElectrode, Needle, Diagnostic Electromyograph
- IKNElectromyograph, Diagnostic
- ESDHearing Aid, Air-Conduction, Prescription
- GXPMethyl Methacrylate For Cranioplasty
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- GWNNystagmograph
- ERAOtoscope
- GWJStimulator, Auditory, Evoked Response
- KHHStimulator, Caloric-Air
- GWFStimulator, Electrical, Evoked Response
- GZPStimulator, Mechanical, Evoked Response
- BXNStimulator, Nerve, Battery-Powered
- GWEStimulator, Photic, Evoked Response
- ETYTester, Auditory Impedance
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1143-2021 | 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 reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. | The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. | Class II | Terminated | |
| Z-0951-2017 | 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 designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items | The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain