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TPLC
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show TPLC since
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Device
sterilizer, chemical
Product Code
MLR
Regulation Number
880.6860
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED STERILIZATION PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
2
PLASMAPP CO,.LTD
SUBSTANTIALLY EQUIVALENT
1
PLASMAPP CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
STERILUCENT, INC.
SUBSTANTIALLY EQUIVALENT
1
STERIS
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
6
MDR Year
MDR Reports
MDR Events
2018
289
289
2019
222
222
2020
174
174
2021
202
202
2022
188
188
2023
117
117
Device Problems
MDRs with this Device Problem
Events in those MDRs
Environmental Particulates
591
591
Device Emits Odor
407
407
Smoking
70
70
Adverse Event Without Identified Device or Use Problem
60
60
Use of Device Problem
29
29
Fluid/Blood Leak
23
23
Device Handling Problem
20
20
Appropriate Term/Code Not Available
17
17
Improper or Incorrect Procedure or Method
11
11
Chemical Problem
10
10
Fire
9
9
Leak/Splash
8
8
Gas/Air Leak
7
7
Insufficient Information
7
7
Patient-Device Incompatibility
5
5
Pressure Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Moisture or Humidity Problem
2
2
Chemical Spillage
2
2
Expiration Date Error
2
2
Fumes or Vapors
2
2
Fogging
2
2
Break
2
2
Thermal Decomposition of Device
2
2
Failure to Cycle
2
2
Degraded
2
2
Material Discolored
1
1
Device Reprocessing Problem
1
1
Mechanical Problem
1
1
Defective Component
1
1
Residue After Decontamination
1
1
Failure to Align
1
1
Overheating of Device
1
1
Increase in Pressure
1
1
Shipping Damage or Problem
1
1
Device Displays Incorrect Message
1
1
Inadequate or Insufficient Training
1
1
Device Operates Differently Than Expected
1
1
Electrical Power Problem
1
1
Temperature Problem
1
1
Output Problem
1
1
Material Integrity Problem
1
1
No Apparent Adverse Event
1
1
Noise, Audible
1
1
Ejection Problem
1
1
Excessive Heating
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
552
552
No Clinical Signs, Symptoms or Conditions
387
387
Burn, Thermal
49
49
Burning Sensation
31
31
Skin Irritation
28
28
Burn(s)
27
27
Headache
27
27
Insufficient Information
27
27
No Code Available
23
23
No Known Impact Or Consequence To Patient
18
18
Irritation
16
16
Itching Sensation
14
14
Skin Burning Sensation
10
10
Skin Discoloration
8
8
Nausea
7
7
Dizziness
6
6
Caustic/Chemical Burns
6
6
Superficial (First Degree) Burn
5
5
Eye Burn
4
4
Red Eye(s)
4
4
Dyspnea
4
4
Unspecified Respiratory Problem
3
3
Eye Pain
3
3
Cough
2
2
Chemical Exposure
2
2
Injury
2
2
Sore Throat
1
1
Reaction
1
1
Chest Tightness/Pressure
1
1
Discomfort
1
1
Unspecified Eye / Vision Problem
1
1
Skin Inflammation/ Irritation
1
1
Reaction to Medicinal Component of Device
1
1
Fever
1
1
High Blood Pressure/ Hypertension
1
1
Pneumonia
1
1
Rash
1
1
Swelling
1
1
Tachycardia
1
1
Blurred Vision
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Steris Corporation
II
Aug-31-2018
2
Steris Corporation
II
Feb-13-2018
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