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Data / Medical devices / Ireland / Merit Medical Ireland, Ltd

Merit Medical Ireland, Ltd: FDA-registered device maker in Galway Galway(County), Ireland, 13 510(k) clearances

Merit Medical Ireland, Ltd is registered with the FDA (registration 9616662) in Galway Galway(County), Ireland. It lists 33 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 11, 2010. 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 Merit Medical Ireland, Ltd
FDA registration number
9616662
FEI number
3000335778
Address
Parkmore Business Park West, Galway Galway(County), Ireland, 0000
Owner or operator
Merit Medical Systems, Inc. (1721504)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 14, 1992
Registered through
2026
Brand names listed
10Fore Hemostasis Valve, 10Fore Hemostasis Valve Kit, Access-9, AccessPLUS, Activation Element, ERx bone cement, BIG60, BIG60 ALPHA Inflation Devie, BackStop Plus Closed Waste Basin and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Contract manufacturer, Manufactureraccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Bone CementLOD2Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufactureraccessdata.fda.gov
Catheter, EmbolectomyDXE2Contract manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Percutaneous RetrievalMMX2Contract manufactureraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Contract manufactureraccessdata.fda.gov
Dilator, CatheterGCC1Contract manufactureraccessdata.fda.gov
Dilator, Vessel, For Percutaneous CatheterizationDRE2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, CementKIH1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Contract manufactureraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufactureraccessdata.fda.gov
Mechanical Thrombolysis CatheterQEY2Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufactureraccessdata.fda.gov
Needle, Biopsy, CardiovascularDWO1Contract manufactureraccessdata.fda.gov
Needle, CatheterGCB1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Probe, Radiofrequency LesionGXI2Contract manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeleraccessdata.fda.gov
Single Use Instrument TrayOJV1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Stylet, CatheterDRB2Contract manufactureraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Contract manufactureraccessdata.fda.gov
Syringe, Balloon Inflation, ExemptPTM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Wire, Guide, Catheter, ExemptPTL2Repackager 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
August 11, 2010K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682GEISubstantially EquivalentDfine, Inc.accessdata.fda.gov
December 30, 2009K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)NDNSubstantially EquivalentDfine, Inc.accessdata.fda.gov
November 20, 2007K073035PRELUDE AND PRELUDE PRO SHEATH INTRODUCERSDRESubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
October 5, 2007K072496MODIFICATION TO SPACE CPSXL BONE CEMENTNDNSubstantially EquivalentDfine, Inc.accessdata.fda.gov
June 21, 2007K070159PRELUDE SHEATH INTRODUCERDRESubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
July 23, 1999K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEYSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
June 9, 1999K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEYSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
February 27, 1998K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEYSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
March 31, 1994K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
March 15, 1994K936032TORQUE DEVICEDQXSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
September 21, 1992K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQXSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
July 30, 1992K915678MERIT ADMINISTRATION SETFPASubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
June 26, 1985K850827GUIDE, WIRE, ANGIOGRAPHICDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov

Compare with other makers

Updated August 11, 2010. 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.