Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 96 96
Incorrect, Inadequate or Imprecise Result or Readings 83 83
Incorrect Measurement 53 53
Patient Device Interaction Problem 39 39
Failure to Analyze Signal 27 27
High Readings 21 21
Patient-Device Incompatibility 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Erratic or Intermittent Display 12 12
Device Alarm System 10 10
Contamination /Decontamination Problem 10 10
Image Display Error/Artifact 9 9
Display or Visual Feedback Problem 7 7
Sensing Intermittently 7 7
Use of Device Problem 7 7
Loss of or Failure to Bond 6 6
Appropriate Term/Code Not Available 6 6
Temperature Problem 5 5
Device Damaged Prior to Use 5 5
Data Problem 4 4
Output 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
Communication or Transmission Problem 2 2
Connection Problem 1 1
Ambient Noise Problem 1 1
Battery Problem 1 1
Device Displays Incorrect Message 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Problem: Parameter Calculation Error 1 1
Mechanical Problem 1 1
Unable to Obtain Readings 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 138 138
No Consequences Or Impact To Patient 113 113
Pressure Sores 38 38
Insufficient Information 20 20
No Patient Involvement 13 13
Burn(s) 13 13
Unspecified Tissue Injury 12 12
No Known Impact Or Consequence To Patient 9 9
No Information 9 9
Injury 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Death 3 3
Inflammation 3 3
Rash 2 2
Skin Irritation 2 2
Low Oxygen Saturation 2 2
Skin Tears 2 2
Burn, Thermal 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Diaphoresis 1 1
Bruise/Contusion 1 1
Skin Discoloration 1 1
Ecchymosis 1 1
Edema 1 1
Hemorrhage, Cerebral 1 1
Blister 1 1
Localized Skin Lesion 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
-
-