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 indicator, biological sterilization process
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 8
3M COMPLANY
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS (ASP)
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 2
TRUE INDICATING LLC
  SUBSTANTIALLY EQUIVALENT 1
TSO3 INC., NOW A PART OF STRYKER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 16 16
2021 10 10
2022 9 9
2023 20 20
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 75 75
Leak/Splash 6 6
Chemical Problem 5 5
Use of Device Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Contamination /Decontamination Problem 2 2
Improper Chemical Reaction 1 1
Off-Label Use 1 1
Problem with Sterilization 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Defective Device 1 1
Device Reprocessing Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
No Known Impact Or Consequence To Patient 29 29
No Consequences Or Impact To Patient 18 18
Burn(s) 3 3
Insufficient Information 2 2
Eye Pain 1 1
Eye Injury 1 1
Skin Discoloration 1 1
Discomfort 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-26-2023
2 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
3 Steris Corporation II Jan-03-2023
4 TERRAGENE S.A. II Jan-26-2024
-
-