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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
Regulation Description Oximeter.
Product CodeMUD
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  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
ODI MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 50 50
2021 27 27
2022 52 52
2023 73 79
2024 140 140
2025 130 130

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 93 93
Low Readings 85 85
Incorrect Measurement 79 79
Failure to Analyze Signal 68 68
Patient Device Interaction Problem 48 53
Communication or Transmission Problem 45 45
Manufacturing, Packaging or Shipping Problem 39 39
Erratic or Intermittent Display 39 39
High Readings 37 37
Image Display Error/Artifact 28 28
Defective Device 28 28
Device Alarm System 25 25
Patient-Device Incompatibility 14 14
Adverse Event Without Identified Device or Use Problem 13 14
Use of Device Problem 11 11
Temperature Problem 10 10
Display or Visual Feedback Problem 8 8
Insufficient Information 7 7
Failure to Power Up 7 7
Material Split, Cut or Torn 6 6
Loss of or Failure to Bond 6 6
Device Damaged Prior to Use 4 4
Data Problem 4 4
Output Problem 3 3
Detachment of Device or Device Component 3 3
Appropriate Term/Code Not Available 3 3
Defective Component 2 2
Therapeutic or Diagnostic Output Failure 2 2
Ambient Noise Problem 2 2
Device Slipped 1 1
Failure to Shut Off 1 1
Mechanical Problem 1 1
Device Fell 1 1
Contamination /Decontamination Problem 1 1
Unable to Obtain Readings 1 1
No Apparent Adverse Event 1 1
Human-Device Interface Problem 1 1
Loose or Intermittent Connection 1 1
Failure to Run on Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 313 313
Insufficient Information 49 49
Pressure Sores 44 49
No Consequences Or Impact To Patient 36 36
Unspecified Tissue Injury 13 14
Burn(s) 10 10
No Known Impact Or Consequence To Patient 8 8
No Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Patient Involvement 4 4
Inflammation 3 3
Low Oxygen Saturation 3 3
Localized Skin Lesion 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 1 1
Death 1 1
Stroke/CVA 1 1
Skin Irritation 1 1
Blister 1 2
Skin Discoloration 1 1
Rash 1 1
Ecchymosis 1 1
Tissue Breakdown 1 1
Bruise/Contusion 1 1

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