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TPLC
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Device
indicator, physical/chemical sterilization process
Product Code
JOJ
Regulation Number
880.2800
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M COMPANY
SUBSTANTIALLY EQUIVALENT
13
ANDERSEN STERILIZERS, INC.
SUBSTANTIALLY EQUIVALENT
1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
SUBSTANTIALLY EQUIVALENT
1
INTERTAPE POLYMER INC.
SUBSTANTIALLY EQUIVALENT
1
KEM MEDICAL PRODUCTS CORP.
SUBSTANTIALLY EQUIVALENT
1
PROPPER MANUFACTURING CO., INC.
SUBSTANTIALLY EQUIVALENT
4
SERIM RESEARCH CORPORATION
SUBSTANTIALLY EQUIVALENT
2
STERILUCENT, INC.
SUBSTANTIALLY EQUIVALENT
1
STERIS
SUBSTANTIALLY EQUIVALENT
3
STERIS CORPARATION
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
7
STERIS CORPORATIONS
SUBSTANTIALLY EQUIVALENT
1
STERITEC PRODUCTS MFG CO INC
SUBSTANTIALLY EQUIVALENT
1
TERRAGENE SA
SUBSTANTIALLY EQUIVALENT
1
TRUE INDICATING LLC
SUBSTANTIALLY EQUIVALENT
1
U&U MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
12
12
2019
8
8
2020
6
6
2021
29
29
2022
23
23
2023
39
39
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unexpected Color
23
23
Fluid/Blood Leak
13
13
Material Integrity Problem
11
11
Appropriate Term/Code Not Available
10
10
Material Discolored
8
8
Contamination /Decontamination Problem
7
7
Leak/Splash
5
5
Product Quality Problem
5
5
Problem with Sterilization
5
5
Output Problem
4
4
Chemical Problem
4
4
Explosion
4
4
No Apparent Adverse Event
3
3
Defective Component
3
3
Detachment of Device or Device Component
3
3
Use of Device Problem
3
3
Delivered as Unsterile Product
3
3
Burst Container or Vessel
3
3
Device Reprocessing Problem
3
3
Improper or Incorrect Procedure or Method
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Separation
2
2
Shelf Life Exceeded
2
2
Device Operates Differently Than Expected
2
2
Expiration Date Error
2
2
Defective Device
2
2
Therapeutic or Diagnostic Output Failure
2
2
Packaging Problem
2
2
Improper Chemical Reaction
2
2
Insufficient Information
2
2
Device Handling Problem
2
2
Material Split, Cut or Torn
1
1
Non Reproducible Results
1
1
Illegible Information
1
1
Missing Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Optical Discoloration
1
1
Protective Measures Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Device Ingredient or Reagent Problem
1
1
Device Slipped
1
1
Material Rupture
1
1
Device Damaged Prior to Use
1
1
Contamination
1
1
Loss of or Failure to Bond
1
1
Peeled/Delaminated
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
78
78
Insufficient Information
23
23
No Known Impact Or Consequence To Patient
13
13
No Consequences Or Impact To Patient
7
7
No Patient Involvement
2
2
Foreign Body In Patient
1
1
Not Applicable
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
May-18-2023
2
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
3
Resource Optimization & Innovation LLC
II
Jul-24-2020
4
Steris Corporation Hopkins Facility
III
Sep-10-2022
5
TERRAGENE S.A.
II
Jan-26-2024
6
Young Dental Mfg Co I LLC
II
Feb-02-2022
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