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Data / Medical devices / Ireland / Stryker Ireland Ltd. Instruments Division, Innovation Centre

Stryker Ireland Ltd. Instruments Division, Innovation Centre: FDA-registered device maker in Carrigtwohill Cork(County), Ireland, 33 510(k) clearances

Stryker Ireland Ltd. Instruments Division, Innovation Centre is registered with the FDA (registration 3040335671) in Carrigtwohill Cork(County), Ireland. It lists 27 device types. The FDA files 33 510(k) clearances under its listings, the newest dated October 8, 2026. Registered through 2027. 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 Stryker Ireland Ltd. Instruments Division, Innovation Centre
FDA registration number
3040335671
Address
Carrigtwohill Business & Technology Park, Carrigtwohill Cork(County), Ireland, T45 PN79
Owner or operator
STRYKER CORP. (1811755)
Roles
Specification developer
First device listed
December 22, 1992
Registered through
2027
Brand names listed
0485-840-000 - XL Round Diamond Bur, 4 mm, 0485-860-000 - XL Round Diamond Bur, 5.5 mm, 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10cm iQ Broad Knife, 11.5MM FLEXIBLE REAMER, 11MM FLEXIBLE REAMER, 11cm iQ Apex Knife and more

Devices it lists

DeviceProduct codeClassRoleSource
Bit, SurgicalGFG1Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Specification developeraccessdata.fda.gov
Blade, Saw, Surgical, CardiovascularDWH1Specification developeraccessdata.fda.gov
Bone CementLOD2Specification developeraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Specification developeraccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Specification developeraccessdata.fda.gov
Bur, DentalEJL1Specification developeraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Specification developeraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Specification developeraccessdata.fda.gov
Catheter, IrrigationGBX1Specification developeraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Specification developeraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Specification developeraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)HBF2Specification developeraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And RevisionSFQ2Specification developeraccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Specification developeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUSpecification developeraccessdata.fda.gov
Motor, Drill, PneumaticHBB2Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Specification developeraccessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, AbsorbableNHB2Specification developeraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Specification developeraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Specification developeraccessdata.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
October 8, 2026K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)LFLSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
September 17, 2026K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)GEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
September 9, 2025K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 11, 2025K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond RHBESubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
July 25, 2024K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
February 16, 2023K223770Sonopet 1Q 3 7cm 1Q LargeLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
February 3, 2022K213824Sonopet iQ Ultrasonic Aspirator SystemLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 30, 2021K210377Stryker iBur hubs and cutting accessoriesHBESubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 25, 2021K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementNDNSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 31, 2020K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPMLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
March 6, 2020K191583PhotonBlade with Smoke EvacuationGEISubstantially EquivalentInvuity, Inc.accessdata.fda.gov
December 14, 2018K182354SafeAir Telescopic Smoke PencilGEISubstantially EquivalentLina Medical Apsaccessdata.fda.gov
January 17, 2017K161514Precision Thin Reciprocating Blade, 0.010in.EQJSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 15, 2016K162053PhotonBladeGEISubstantially EquivalentInvuity, Inc.accessdata.fda.gov
April 13, 2016K160693Neptune E-SEP Smoke Evacuation PencilGEISubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 22, 2016K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEISubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 12, 2015K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDNSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 8, 2015K143399Stryker Footed Attachments and Cutting AccessoriesHBESubstantially EquivalentStryker Corp.accessdata.fda.gov
May 1, 2015K143540Stryker MIS Attachments and Cutting AccessoriesHBESubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 23, 2015K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBESubstantially EquivalentStryker Corp.accessdata.fda.gov
December 4, 2014K143145SafeAir Smoke PencilGEISubstantially EquivalentLina Medical Apsaccessdata.fda.gov
October 23, 2014K141816HEMOPORELYASubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
August 7, 2014K141423NASOPORE-FDLYASubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
July 10, 2012K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEISubstantially EquivalentSynergetics, Inc.accessdata.fda.gov
May 1, 2012K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
December 7, 2011K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEISubstantially EquivalentSynergetics, Inc.accessdata.fda.gov
December 29, 2008K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITHBFSubstantially EquivalentStryker Ireland Ltd., Instruments Divisionaccessdata.fda.gov
August 26, 2008K073633STRYKER ESSX MICRODEBRIDER SYSTEMERLSubstantially EquivalentStryker Ireland Ltd., Instruments Divisionaccessdata.fda.gov
May 7, 2007K070715NASOPORE EARNHBSubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
October 26, 2006K061725STRYKER ARIA PNEUMATIC SYSTEMHBBSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
November 21, 2005K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZLYASubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
January 16, 2004K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMHBESubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 23, 2002K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTELFLSubstantially EquivalentSynergetics, Inc.accessdata.fda.gov

Compare with other makers

Updated October 8, 2026. 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.