Home › Device types › MUD
Oximeter, Tissue Saturation
FDA product code MUD · Class 2 · Cardiovascular
221
Registered devices
706
Adverse events
6
Recalls
74
510(k) clearances
Devices with this code
HemoSphere Vita — Edwards Lifesciences LLCO3 — MASIMO CORPORATIONCARESCAPE B850 — GE Healthcare Finland OyIntra.Ox Smart Sensor — VIOPTIX, INC.INVOS — Covidien LPHyperView — Hypermed Imaging, Inc.Component Neuromonitoring System — MOBERG RESEARCH INCINVOS — Covidien LPINVOS — Covidien LPINVOS — Covidien LPO3 — MASIMO CORPORATIONINVOS — Covidien LPComponent Neuromonitoring System — MOBERG RESEARCH INCINVOS — Covidien LPINVOS — Covidien LPSmart Pressure Controller — Edwards Lifesciences LLCrSO2 Accessory kit (Adult/Ped) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Component Monitoring System — MOBERG RESEARCH INCNonin — NONIN MEDICAL, INC.moorVMS-TREND PC Software — MOOR INSTRUMENTS LIMITEDSpectros T-Stat — SPECTROS CORPORATIONNonin — NONIN MEDICAL, INC.Spectros T-Stat — SPECTROS CORPORATIONFORESIGHT OXIMETER CABLE — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-09 | Covidien | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2024-01-09 | Covidien | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2023-10-30 | KENT IMAGING, INC. | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. |
| 2022-03-01 | Edwards Lifesciences, LLC | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor w |
| 2022-03-01 | Edwards Lifesciences, LLC | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor w |
| 2009-10-23 | Nonin Medical, Inc | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikel |
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