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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 CORPARATION
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
6
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
26
26
2022
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unexpected Color
20
20
Material Discolored
6
6
Product Quality Problem
4
4
Problem with Sterilization
4
4
Output Problem
4
4
Chemical Problem
4
4
Contamination /Decontamination Problem
3
3
Detachment of Device or Device Component
3
3
Use of Device Problem
3
3
Delivered as Unsterile Product
3
3
Device Reprocessing Problem
2
2
Shelf Life Exceeded
2
2
Improper or Incorrect Procedure or Method
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Operates Differently Than Expected
2
2
Expiration Date Error
2
2
Defective Device
2
2
Packaging Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Non Reproducible Results
1
1
Missing Information
1
1
Protective Measures Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Optical Discoloration
1
1
Material Rupture
1
1
Material Separation
1
1
Nonstandard Device
1
1
Loss of or Failure to Bond
1
1
Burst Container or Vessel
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
37
37
Insufficient Information
13
13
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
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
2
Resource Optimization & Innovation LLC
II
Jul-24-2020
3
Steris Corporation Hopkins Facility
III
Sep-10-2022
4
Young Dental Mfg Co I LLC
II
Feb-02-2022
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