Masimo Corporation - FDA 510(k) Cleared Devices
Recent clearances: Masimo Root Monitoring System, SedLine Sedation Monitor, Radius VSM and Accessories
87
Total
85
Cleared
2
Denied
FDA 510(k) Regulatory Record - Masimo Corporation Anesthesiology ✕
64 devices
Cleared
Aug 12, 2026
Masimo Root Monitoring System
Anesthesiology
315d
Cleared
Jul 10, 2026
SedLine Sedation Monitor
Anesthesiology
115d
Cleared
Jan 31, 2024
MightySat -OTC
Anesthesiology
762d
Cleared
Dec 15, 2023
Masimo Stork
Anesthesiology
368d
Not Cleared
Oct 12, 2023
ORi
Anesthesiology
1025d
Cleared
Sep 07, 2023
Carescape SpO2 - Masimo
Anesthesiology
29d
Cleared
Apr 16, 2023
Masimo Rad-G with Temperature
Anesthesiology
510d
Not Cleared
Mar 31, 2023
Masimo SafetyNet
Anesthesiology
1136d
Cleared
Mar 06, 2023
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
Anesthesiology
602d
Cleared
Aug 04, 2022
Masimo CARESCAPE SpO2 – Masimo with SpHb
Anesthesiology
30d
Cleared
Feb 25, 2022
Masimo SedLine Sedation Monitor and Accessories
Anesthesiology
498d
Cleared
Mar 29, 2021
EMMA Capnograph
Anesthesiology
290d
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