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Data / Medical devices / Ireland / Integra Lifesciences (ireland) Limited

Integra Lifesciences (ireland) Limited: FDA-registered device maker in SRAGH TULLAMORE Offaly, Ireland, 15 510(k) clearances

Integra Lifesciences (ireland) Limited is registered with the FDA (registration 3006697299) in SRAGH TULLAMORE Offaly, Ireland. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 4, 2024. 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 Integra Lifesciences (ireland) Limited
FDA registration number
3006697299
Address
IDA BUSINESS and TECHNOLOGY PARK, SRAGH TULLAMORE Offaly, Ireland, --
Owner or operator
Integra LifeSciences Corporation (9004007)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 15, 2003
Registered through
2026
Brand names listed
Acclarent, CODMAN CERTAS Plus Electronic Tool Kit, CUSA Clarity 23 kHz Single-Sided Bone Tip, CUSA Clarity 23kHz CEM Nosecone, CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA, CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA, CUSA EXCEL Ultrasonic Surgical Aspirator System, CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 and more

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
Camera, Television, Surgical, With AudioFWC1Manufactureraccessdata.fda.gov
Device, Monitoring, Intracranial PressureGWM2Manufactureraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUManufacturer, Specification developeraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Manufactureraccessdata.fda.gov
Light, Headband, SurgicalFSR2Manufactureraccessdata.fda.gov
Light, Surgical, FiberopticFST2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Neurosurgical Ultrasonic InstrumentsLBKUManufacturer, Specification developeraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.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
February 4, 2024K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWMSubstantially EquivalentIntegra Lifesciences Production Corporationaccessdata.fda.gov
July 11, 2023K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
August 22, 2022K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
July 15, 2022K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
April 30, 2021K210993CereLink ICP MonitorGWMSubstantially EquivalentIntegra Lifesciences Production Corporationaccessdata.fda.gov
April 1, 2019K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
December 7, 2018K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
October 25, 2018K181902Codman Certas Plus Electronic Tool KitJXGSubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
October 14, 2016K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
November 6, 2014K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFLSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
August 30, 2013K131184INTEGRA LICOX PTO2 MONITORGWMSubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
September 10, 2012K121573INTEGRA CAMINO ICP MONITORGWMSubstantially EquivalentIntrgra Lifesciences Corporationaccessdata.fda.gov
May 11, 2011K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMFSRSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
July 6, 1998K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFLSubstantially EquivalentValleylab, Inc.accessdata.fda.gov
November 19, 1986K864380LUTEX HEADLIGHT SYSTEMSFSTSubstantially EquivalentLuxtec Corp.accessdata.fda.gov

Compare with other makers

Updated February 4, 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.