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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, tissue saturation
Product CodeMUD
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ISS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING INC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MIMOSA DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTROS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 104 104
2020 50 50
2021 27 27
2022 52 52
2023 73 73
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 91 91
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Incorrect Measurement 52 52
Patient Device Interaction Problem 37 37
Failure to Analyze Signal 21 21
High Readings 21 21
Adverse Event Without Identified Device or Use Problem 14 14
Patient-Device Incompatibility 14 14
Contamination /Decontamination Problem 10 10
Image Display Error/Artifact 9 9
Device Alarm System 9 9
Display or Visual Feedback Problem 7 7
Use of Device Problem 7 7
Sensing Intermittently 7 7
Loss of or Failure to Bond 6 6
Appropriate Term/Code Not Available 6 6
Temperature Problem 5 5
Erratic or Intermittent Display 5 5
Device Damaged Prior to Use 5 5
Output Problem 4 4
Data Problem 4 4
Insufficient Information 4 4
Detachment of Device or Device Component 3 3
Failure to Power Up 3 3
Defective Component 2 2
Thermal Decomposition of Device 2 2
Device Emits Odor 2 2
Defective Device 2 2
Device Displays Incorrect Message 1 1
Ambient Noise Problem 1 1
Battery Problem 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Problem: Parameter Calculation Error 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 113 113
Pressure Sores 38 38
Insufficient Information 18 18
No Patient Involvement 13 13
Burn(s) 13 13
Unspecified Tissue Injury 11 11
No Known Impact Or Consequence To Patient 9 9
No Information 9 9
Injury 7 7
Death 3 3
Inflammation 3 3
Skin Irritation 2 2
Low Oxygen Saturation 2 2
Skin Tears 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blister 1 1
Localized Skin Lesion 1 1
Burn, Thermal 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Diaphoresis 1 1
Bruise/Contusion 1 1
Rash 1 1
Skin Discoloration 1 1
Ecchymosis 1 1
Edema 1 1
Hemorrhage, Cerebral 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Mar-30-2022
2 KENT IMAGING, INC. II Jan-25-2024
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