Masimo Corporation
FDA 510(k) & PMA Approved Devices — 41 products
Total Devices41
Categories13
Latest Approval2025-07-17
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243324 | Masimo O3 Regional Oximeter | MUD | 2025-07-17 | View |
| 510(k) | K250757 | Radius VSM and Accessories | MHX | 2025-05-29 | View |
| 510(k) | K243305 | Masimo W1 | DPS | 2025-04-03 | View |
| 510(k) | K240229 | Masimo W1 | DPS | 2024-08-08 | View |
| 510(k) | K234021 | Masimo Stork | QYU | 2024-05-03 | View |
| 510(k) | K214115 | MightySat -OTC | OLK | 2024-01-31 | View |
| 510(k) | K223721 | Masimo Stork | DQA | 2023-12-15 | View |
| 510(k) | K232512 | Masimo W1 | DPS | 2023-11-17 | View |
| 510(k) | DEN200076 | ORi | QWE | 2023-10-12 | View |
| 510(k) | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | DQA | 2023-09-07 | View |
| 510(k) | K223498 | Radius VSM and Accessories | MHX | 2023-06-01 | View |
| 510(k) | K213676 | Masimo Rad-G with Temperature | DQA | 2023-04-16 | View |
| 510(k) | DEN200011 | Masimo SafetyNet | QVT | 2023-03-31 | View |
| 510(k) | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | MWI | 2023-03-06 | View |
| 510(k) | K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb | DQA | 2022-08-04 | View |
| 510(k) | K214072 | Masimo O3 Regional Oximeter System | MUD | 2022-05-06 | View |
| 510(k) | K203113 | Masimo SedLine Sedation Monitor and Accessories | OLW | 2022-02-25 | View |
| 510(k) | K212876 | Carescape SpO2 - Masimo | DQA | 2021-10-08 | View |
| 510(k) | K203215 | Radius T wearable thermometer | FLL | 2021-06-11 | View |
| 510(k) | K201590 | EMMA Capnograph | CCK | 2021-03-29 | View |
No matching devices.
Page 1 of 3