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TPLC
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Device
anti fog solution and accessories, endoscopy
Definition
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Product Code
OCT
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED MEDICAL DESIGN CO., LTD
SUBSTANTIALLY EQUIVALENT
1
BATRIK MEDICAL MANUFACTURING INC.
SUBSTANTIALLY EQUIVALENT
1
JDI SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MINIMALLY INVASIVE DEVICES LLC
SUBSTANTIALLY EQUIVALENT
1
MISDER, LLC
SUBSTANTIALLY EQUIVALENT
1
SIO2 NANOTECH, LLC
SUBSTANTIALLY EQUIVALENT
1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER
SUBSTANTIALLY EQUIVALENT
1
UNIMAX MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
13
13
2016
27
27
2017
18
18
2018
20
20
2019
20
20
2020
14
14
2021
16
16
2022
10
10
2023
13
13
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Packaging Problem
39
39
Unsealed Device Packaging
37
37
Defective Device
10
10
Device Packaging Compromised
9
9
Detachment of Device or Device Component
8
8
Defective Component
6
6
Break
6
6
Device Contamination with Chemical or Other Material
6
6
Failure to Power Up
5
5
Detachment Of Device Component
4
4
Device Operates Differently Than Expected
4
4
Device Disinfection Or Sterilization Issue
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Integrity Problem
2
2
Product Quality Problem
2
2
Loss of or Failure to Bond
2
2
Delivered as Unsterile Product
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
1
1
Material Separation
1
1
Component Falling
1
1
Contamination
1
1
Material Discolored
1
1
Flaked
1
1
Fluid/Blood Leak
1
1
Material Fragmentation
1
1
Insufficient Heating
1
1
Loose or Intermittent Connection
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
Failure to Seal
1
1
Device Or Device Fragments Location Unknown
1
1
Battery Problem
1
1
Component Missing
1
1
Out-Of-Box Failure
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Failure to Form Staple
1
1
Incorrect Device Or Component Shipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
48
48
No Patient Involvement
34
34
No Clinical Signs, Symptoms or Conditions
34
34
No Information
11
11
Insufficient Information
9
9
No Consequences Or Impact To Patient
8
8
Foreign Body In Patient
3
3
No Code Available
2
2
Radiation Exposure, Unintended
1
1
Not Applicable
1
1
Burn(s)
1
1
Death
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medline Industries, Inc.
II
Jul-18-2019
2
Sunstar Americas, Inc.
II
Mar-03-2022
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