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TPLC
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show TPLC since
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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
GRANTED
1
SUBSTANTIALLY EQUIVALENT
13
ADVANCED STERILIZATION PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
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
KEM MEDICAL PRODUCTS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
PROPPER MANUFACTURING CO., INC.
SUBSTANTIALLY EQUIVALENT
5
SERIM RESEARCH CORPORATION
SUBSTANTIALLY EQUIVALENT
2
STERILUCENT, INC.
SUBSTANTIALLY EQUIVALENT
1
STERIS
SUBSTANTIALLY EQUIVALENT
6
STERIS CORPARATION
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
4
STERIS CORPORATIONS
SUBSTANTIALLY EQUIVALENT
1
STERITEC PRODUCTS MFG CO INC
SUBSTANTIALLY EQUIVALENT
1
STERITEC PRODUCTS MFG. (A GETINGE GROUP COMPANY)
SUBSTANTIALLY EQUIVALENT
1
TERRAGENE SA
SUBSTANTIALLY EQUIVALENT
1
TRUE INDICATING LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
8
8
2020
6
6
2021
29
29
2022
23
23
2023
39
39
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unexpected Color
23
23
Fluid/Blood Leak
13
13
Appropriate Term/Code Not Available
12
12
Material Integrity Problem
11
11
Leak/Splash
7
7
Material Discolored
7
7
Product Quality Problem
5
5
Problem with Sterilization
5
5
Explosion
4
4
Output Problem
4
4
Contamination /Decontamination Problem
4
4
Improper Chemical Reaction
3
3
Device Reprocessing Problem
3
3
No Apparent Adverse Event
3
3
Detachment of Device or Device Component
3
3
Use of Device Problem
3
3
Defective Component
3
3
Insufficient Information
3
3
Burst Container or Vessel
3
3
Therapeutic or Diagnostic Output Failure
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Defective Device
2
2
Packaging Problem
2
2
Material Separation
2
2
Contamination
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Fragmentation
1
1
Expiration Date Error
1
1
Device Damaged by Another Device
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Material Rupture
1
1
Material Deformation
1
1
Device Handling Problem
1
1
Non Reproducible Results
1
1
Device Damaged Prior to Use
1
1
Peeled/Delaminated
1
1
Illegible Information
1
1
Missing Information
1
1
Protective Measures Problem
1
1
Material Split, Cut or Torn
1
1
Device Ingredient or Reagent Problem
1
1
Nonstandard Device
1
1
Optical Discoloration
1
1
Activation, Positioning or Separation Problem
1
1
Loss of or Failure to Bond
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
88
88
Insufficient Information
25
25
No Known Impact Or Consequence To Patient
8
8
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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