ClearanceBrief
Panels › Cardiovascular › Product code MUD · Class 2

Oximeter, Tissue Saturation

Regulation 870.2700

1510(k)s in 12 months (74 all time)
1recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in MUD

Company510(k)sRecalls
Cas Medical Systems, Inc.90
Hutchinson Technology, Inc.80
ViOptix, Inc.80
Edwards Lifesciences42
Masimo Corporation60
Nonin Medical, Inc.51
Kent Imaging41
Reflectance Medical, Inc.50
Covidien, LLC22
Somanetics Corp.40
DateFirm and productCodeLinked 510(k)
Sep 21, 2026Becton, Dickinson and Company
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxyg
Open, Classified		 MUDK243781
Apr 30, 2024Covidien
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Open, Classified		 MUDK182868
Apr 30, 2024Covidien
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Open, Classified		 MUDK211561
Jan 25, 2024KENT IMAGING, INC.
Snapshot NIR, REF: KD204
Open, Classified		 MUDK201976
Mar 1, 2022Edwards Lifesciences, LLC
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Open, Classified		 MUDK180003
K201446
Mar 1, 2022Edwards Lifesciences, LLC
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Open, Classified		 MUDK143675
K203490
Nov 25, 2009Nonin Medical, Inc
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Pl
Terminated		 MUDK090807

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