Merit Medical Ireland, Ltd
Galway Galway, IE
MERIT MEDICAL IRELAND, LTD appears in FDA device records in Galway Galway, IE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 6 510(k) clearances for Merit Medical Ireland, Ltd between 2012 and 2026. The busiest year on record is 2026, with 4. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2025 | 1 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | DQX | Substantially Equivalent | |
| K254137 | InQwire Amplatz Guide Wire | DQX | Substantially Equivalent | |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | DQX | Substantially Equivalent | |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | DQX | Substantially Equivalent | |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | DQX | Substantially Equivalent | |
| K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | MAV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616662 | 3000335778 | MERIT MEDICAL IRELAND, LTD | Parkmore Business Park West, Galway Galway(County) 0000 IE | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- OEQAngiography/Angioplasty Kit
- HRXArthroscope
- HTWBit, Drill
- LODBone Cement
- GEACannula, Surgical, General & Plastic Surgery
- KRACatheter, Continuous Flush
- DXECatheter, Embolectomy
- NDNCement, Bone, Vertebroplasty
- MMXDevice, Percutaneous Retrieval
- KRDDevice, Vascular, For Promoting Embolization
- GCCDilator, Catheter
- DREDilator, Vessel, For Percutaneous Catheterization
- KIHDispenser, Cement
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- QEYMechanical Thrombolysis Catheter
- JDZMixer, Cement, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- DWONeedle, Biopsy, Cardiovascular
- GCBNeedle, Catheter
- LXHOrthopedic Manual Surgical Instrument
- GXIProbe, Radiofrequency Lesion
- FPASet, Administration, Intravascular
- OJVSingle Use Instrument Tray
- DRBStylet, Catheter
- GAHStylet, Surgical, General & Plastic Surgery
- MAVSyringe, Balloon Inflation
- PTMSyringe, Balloon Inflation, Exempt
- DQXWire, Guide, Catheter
- PTLWire, Guide, Catheter, Exempt
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain