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Merit Medical Ireland , Ltd. FDA Approvals
0 new drug approvals and 5 device clearances on file. Matched by name to MMSI.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Merit MAK Nitinol/Gold-Tungsten Guide Wire510(k)Jul 13, 2026Cardiovascular |
| InQwire Amplatz Guide Wire510(k)May 22, 2026Cardiovascular |
| Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)510(k)Jan 31, 2026Cardiovascular |
| 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)510(k)Jan 21, 2026Cardiovascular |
| 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)510(k)Aug 29, 2025Cardiovascular |