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Masimo Corporation FDA Approvals
0 new drug approvals and 23 device clearances on file. Matched by name to MASI.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Masimo Root Monitoring System510(k)Aug 12, 2026Cardiovascular |
| SedLine Sedation Monitor510(k)Jul 10, 2026Neurology |
| Radius VSM and Accessories510(k)Jun 4, 2026Cardiovascular |
| Masimo O3 Regional Oximeter510(k)Jul 17, 2025Cardiovascular |
| Radius VSM and Accessories510(k)May 29, 2025Cardiovascular |
| Masimo W1510(k)Apr 3, 2025Cardiovascular |
| Masimo W1510(k)Aug 8, 2024Cardiovascular |
| Masimo Stork510(k)May 3, 2024Cardiovascular |
| MightySat -OTC510(k)Jan 31, 2024Cardiovascular |
| Masimo Stork510(k)Dec 15, 2023Cardiovascular |
| Masimo W1510(k)Nov 17, 2023Cardiovascular |
| ORi510(k)Oct 12, 2023Anesthesiology |
| Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue510(k)Sep 7, 2023Cardiovascular |
| Radius VSM and Accessories510(k)Jun 1, 2023Cardiovascular |
| Masimo Rad-G with Temperature510(k)Apr 16, 2023Cardiovascular |
| Masimo SafetyNet510(k)Mar 31, 2023Anesthesiology |
| Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories510(k)Mar 6, 2023Cardiovascular |
| Masimo CARESCAPE SpO2 Masimo with SpHb510(k)Aug 4, 2022Cardiovascular |
| Masimo O3 Regional Oximeter System510(k)May 6, 2022Cardiovascular |
| Masimo SedLine Sedation Monitor and Accessories510(k)Feb 25, 2022Neurology |
| Carescape SpO2 - Masimo510(k)Oct 8, 2021Cardiovascular |
| Radius T wearable thermometer510(k)Jun 11, 2021General Hospital |
| EMMA Capnograph510(k)Mar 29, 2021Anesthesiology |