MUD

Masimo O3 Regional Oximeter System

Advisory panel: Cardiovascular
Total cleared: 73

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MUD

K243324 — Masimo O3 Regional Oximeter Masimo Corporation · 2025-07-17
K250519 — Lap.Ox Laparoscopic Tissue Oximeter Vioptix, Inc. · 2025-06-26
K240596 — Cerebral Autoregulation Index (CAI) Algorithm Edwards Lifesciences · 2024-10-16
K241393 — ODI-Tech Odi Medical AS · 2024-08-30
K240601 — SnapshotNIR model KD205 Kent Imaging, Inc. · 2024-04-02
K232385 — OxiplexTS200 Iss Medical, Inc. · 2024-03-01
K233488 — Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. · 2024-02-28
K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin Edwards Lifesciences, LLC · 2023-11-17
K223651 — Cerebral Adaptive Index (CAI) Algorithm Edwards Lifesciences, LLC · 2023-05-26
K214072 — Masimo O3 Regional Oximeter System Masimo Corporation · 2022-05-06
K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. · 2022-05-03
K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) Covidien, LLC · 2021-12-05
K203490 — FORE-SIGHT ELITE Absolute Tissue Oximeter Edwards Lifesciences, LLC · 2021-02-10
K201976 — SnapshotNIR Kent Imaging · 2020-11-10
K201432 — Masimo O3 Regional Oximeter System Masimo Corporation · 2020-08-29
K190334 — MIMOSA Imager Mimosa Diagnostics, Inc. · 2019-11-01
K190270 — FORE-SIGHT ELITE Tissue Oximeter Module Cas Medical Systems, Inc. · 2019-10-21
K192322 — T-Stat 2.0 Microvascular Tissue Oximeter Spectros Corporation · 2019-09-23
K191676 — Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. · 2019-09-16
K182429 — Masimo O3 Regional Oximeter System Masimo Corporation · 2019-06-07
K190560 — SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Nonin Medical, Inc. · 2019-05-02
K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien, LLC · 2019-01-08
K171245 — Presygen/si-1 Christie Medical Holdings, Inc. · 2018-08-09
K181623 — Clarifi Imaging System Modulated Imaging, Inc. · 2018-07-19
K180003 — FORE-SIGHT ELITE Module Tissue Oximeter Cas Medical Systems, Inc. · 2018-05-10
K163472 — Intra.Ox Handheld Tissue Oximeter Vioptix, Inc. · 2017-11-16
K162603 — Masimo O3 Regional Oximeter System Masimo Corporation · 2017-05-26
K163070 — Kent Camera Kent Imaging, Inc. · 2017-05-05
K153426 — Ox-Imager CS Modulated Imaging, Inc. · 2016-12-21
K161237 — HyperView Hyperspectral Tissue Oxygenation Measurement System Hypermed Imaging, Inc. · 2016-12-16
K162117 — NIRO-200NX DP Hamamatsu Photonics K.K. · 2016-10-25
K160526 — Masimo O3 Regional Oximeter System Masimo Corporation · 2016-06-09
K151305 — SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) Nonin Medical, Inc. · 2015-08-27
K143219 — NIRO-200NX Hamamatsu Photonics K.K. · 2015-07-31
K143675 — FORE-SIGHT Elite Absolute Tissue Oximeter Cas Medical Systems, Inc. · 2015-04-10
K133983 — INTRA. OX HANDHELD TISSUE OXIMETER Vioptix, Inc. · 2014-09-12
K141496 — MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER Reflectance Medical, Inc. · 2014-08-04
K141234 — ODISSEY TISSUE OXIMETER Vioptix, Inc. · 2014-07-01
K133879 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. · 2014-04-29
K133923 — MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET Reflectance Medical, Inc. · 2014-04-11
K130079 — MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER Reflectance Medical, Inc. · 2013-07-19
K123700 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. · 2013-04-11
K122645 — MOBILE CAREGUIDE 2100 OXIMETER Reflectance Medical, Inc. · 2012-12-05
K112826 — NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR Moor Instruments, Ltd. · 2012-10-10
K113507 — KENT CAMERA Kent Imaging, Inc. · 2012-08-08
K113656 — CAREGUIDE OXIMETER Reflectance Medical, Inc. · 2012-07-26
K113215 — MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY Nonin Medical, Inc. · 2012-05-14
K112820 — FORE-SIGHT ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. · 2012-01-26
K103613 — INPECTRA STO2 SPOT CHECK Hutchinson Technology, Inc. · 2011-03-02
K100875 — CEROX, MODEL 321OF Or-Nim Medical , Ltd. · 2011-01-25
K094030 — FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 Cas Medical Systems, Inc. · 2010-12-23
K102715 — REGIONAL OXIMETER Nonin Medical, Inc. · 2010-12-17
K100915 — INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 Hutchinson Technology, Inc. · 2010-04-30
K093923 — CEROX MODEL 3210 Or-Nim Medical , Ltd. · 2010-01-19
K091452 — FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) Cas Medical Systems, Inc. · 2009-08-21
K091224 — OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S Somanetics Corp. · 2009-07-09
K090807 — REGIONAL OXIMETER SYSTEM, MODEL 7600 Nonin Medical, Inc. · 2009-06-30
K082327 — INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C Somanetics Corp. · 2009-04-03
K081233 — T-STAT 303 ISCHEMIA MONITORING SYSTEM Spectros Corporation · 2008-07-28
K080769 — INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C Somanetics Corp. · 2008-05-14
K073407 — PACIFICA Or-Nim Medical , Ltd. · 2008-02-28
K073656 — OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM Hypermed, Inc. · 2008-01-25
K061848 — HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 Hypermed, Inc. · 2006-11-08
K061960 — FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 Cas Medical Systems, Inc. · 2006-09-05
K061619 — INSPECTRA STO2 TISSUE OXYGENATION MONITOR Hutchinson Technology, Inc. · 2006-07-12
K053618 — INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 Hutchinson Technology, Inc. · 2006-02-08
K051274 — INVOS SYSTEM Somanetics Corp. · 2005-11-04
K042657 — VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 Vioptix, Inc. · 2005-01-10
K040684 — T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 Spectros Corporation · 2004-11-05
K042020 — SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) Hutchinson Technology, Inc. · 2004-09-15
K023938 — MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 Hutchinson Technology, Inc. · 2002-12-13
K012759 — INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 Hutchinson Technology, Inc. · 2002-01-17
K963903 — BIOSPECTROMETER-NB OXIMETER IIII Hutchinson Technology, Inc. · 1998-01-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.