Masimo Corporation - FDA 510(k) Cleared Devices
84
Total
82
Cleared
2
Denied
FDA 510(k) cleared devices by Masimo Corporation Cardiovascular ✕
16 devices
Cleared
May 29, 2025
Radius VSM and Accessories
Cardiovascular
78d
Cleared
Apr 03, 2025
Masimo W1
Cardiovascular
164d
Cleared
Aug 08, 2024
Masimo W1
Cardiovascular
192d
Cleared
May 03, 2024
Masimo Stork
Cardiovascular
135d
Cleared
Nov 17, 2023
Masimo W1
Cardiovascular
91d
Cleared
Jun 01, 2023
Radius VSM and Accessories
Cardiovascular
192d
Cleared
Oct 08, 2021
Carescape SpO2 - Masimo
Cardiovascular
29d
Cleared
Nov 17, 2017
Masimo Root Monitoring System and Accessories
Cardiovascular
214d
Cleared
Sep 14, 2017
Masimo Rad-97 and Accessories
Cardiovascular
238d
Cleared
May 26, 2017
Masimo O3 Regional Oximeter System
Cardiovascular
249d
Cleared
Jun 21, 2016
Masimo Root Monitoring System and Accessories
Cardiovascular
228d
Cleared
Jun 09, 2016
Masimo O3 Regional Oximeter System
Cardiovascular
105d
Cleared
Feb 12, 2016
Masimo Root Vital Signs Monitoring System and Accessories
Cardiovascular
239d
Cleared
Nov 25, 2014
Masimo Root Monitoring System and Accesories
Cardiovascular
90d
Cleared
Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
Cardiovascular
152d
Cleared
Jun 08, 2007
MASIMO PATIENT SAFETY NET
Cardiovascular
56d