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Data / Medical devices / Ireland / Natus Manufacturing Limited

Natus Manufacturing Limited: FDA-registered device maker in GORT, Co. Galway(County), Ireland, 14 510(k) clearances

Natus Manufacturing Limited is registered with the FDA (registration 3005581270) in GORT, Co. Galway(County), Ireland. It lists 27 device types. The FDA files 14 510(k) clearances under its listings, the newest dated December 12, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Natus Manufacturing Limited
FDA registration number
3005581270
Address
Ida Business Park, GORT, Co. Galway(County), Ireland, --
Owner or operator
Natus Medical Incorporated (9004873)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
May 7, 1997
Registered through
2026
Brand names listed
1081, Loudspeaker, 1093, HEADSET HS3, 1096 Diagnostic probe Gen 2 Kit, 1096 Probe, Diagnostic, 1096 Probe, Quick Check, 1096 Quick Check Probe Gen 2 kit, 8-04-15600, 1085 ICS Impulse (Lateral only Head Impulse System), 8-04-15601, 1085 ICS Impulse (Full w/webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) and more

Devices it lists

DeviceProduct codeClassRoleSource
Amplifier, Physiological SignalGWL2Complaint file establishment, Specification developeraccessdata.fda.gov
Amplitude-Integrated ElectroencephalographOMA2Contract manufactureraccessdata.fda.gov
Apparatus, Vestibular AnalysisLXVUContract manufactureraccessdata.fda.gov
AudiometerEWO2Contract manufactureraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Contract manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Specification developeraccessdata.fda.gov
Calibrator, Hearing Aid / Earphone And Analysis SystemsETW2Contract manufactureraccessdata.fda.gov
Cushion, Earphone (For Audiometric Testing)ETT1Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Nerve Conduction Velocity MeasurementJXE2Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Electrode, DepthGZL2Complaint file establishment, Specification developeraccessdata.fda.gov
Electrode, NeedleGXZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, Needle, Diagnostic ElectromyographIKT2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Contract manufacturer, Manufactureraccessdata.fda.gov
Hearing Aid, Air-Conduction, PrescriptionESD1Contract manufactureraccessdata.fda.gov
Methyl Methacrylate For CranioplastyGXP2Contract manufactureraccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Contract manufacturer, Manufactureraccessdata.fda.gov
NystagmographGWN2Contract manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufactureraccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Caloric-AirKHH1Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Mechanical, Evoked ResponseGZP2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Battery-PoweredBXN2Complaint file establishment, Specification developeraccessdata.fda.gov
Stimulator, Photic, Evoked ResponseGWE2Contract manufacturer, Manufactureraccessdata.fda.gov
Tester, Auditory ImpedanceETY2Contract manufactureraccessdata.fda.gov
Ventilatory Effort RecorderMNR2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 12, 2024K243495Natus Ultrapro S100 (982A0594)GWFSubstantially EquivalentNatus Neurology Incorporatedaccessdata.fda.gov
August 29, 2024K242346Grass® MR Conditional/CT Cup ElectrodesGXYSubstantially EquivalentNatus Manufacturing Limitedaccessdata.fda.gov
June 29, 2018K173815Allergan Botox Needle ElectrodeIKTSubstantially EquivalentNatus Manufacturing Limitedaccessdata.fda.gov
March 2, 2017K161430Myoject Luer Lock Needle ElectrodeIKTSubstantially EquivalentNatus Manufacturing Limitedaccessdata.fda.gov
August 28, 2015K143433Dantec 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-75mmIKTSubstantially EquivalentNatus Manufacturing Limitedaccessdata.fda.gov
December 12, 2014K140680LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEMGZLSubstantially EquivalentAlpine Biomed Apsaccessdata.fda.gov
August 12, 2011K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESIKTSubstantially EquivalentCarefusion 209, Inc.accessdata.fda.gov
June 17, 2011K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESIKTSubstantially EquivalentCarefusion 209, Inc.accessdata.fda.gov
February 8, 2007K062478CLAVISBXNSubstantially EquivalentMedtronic A/Saccessdata.fda.gov
December 21, 2004K043132UNIVERSAL XACTTRACEMNRSubstantially EquivalentMedcare Flagaaccessdata.fda.gov
November 20, 1997K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESIKTSubstantially EquivalentMedelec, Inc. D.B.A. Teca Corp.accessdata.fda.gov
September 26, 1994K934580DANTEC 13R45 BAR ELECTRODEGXYSubstantially EquivalentDantec Medical, Inc.accessdata.fda.gov
January 22, 1988K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODEGXYSubstantially EquivalentDantec Electronics, Inc.accessdata.fda.gov
April 11, 1985K850108EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEGGXYSubstantially EquivalentNicolet Biomedical Instrumentsaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 12, 202187175Class IITerminatedRef: 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 intracranialThe external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.accessdata.fda.gov
October 15, 201675846Class IITerminatedNatus 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 warmThe 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.accessdata.fda.gov

Compare with other makers

Updated December 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.