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TPLC
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show TPLC since
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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
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unsealed Device Packaging
42
42
Packaging Problem
39
39
Defective Device
10
10
Device Packaging Compromised
9
9
Detachment of Device or Device Component
8
8
Break
6
6
Defective Component
6
6
Device Contamination with Chemical or Other Material
6
6
Failure to Power Up
5
5
Device Operates Differently Than Expected
4
4
Detachment Of Device Component
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Device Disinfection Or Sterilization Issue
3
3
Material Integrity Problem
2
2
Delivered as Unsterile Product
2
2
Product Quality Problem
2
2
Loss of or Failure to Bond
2
2
Improper or Incorrect Procedure or Method
2
2
Appropriate Term/Code Not Available
1
1
Protective Measures Problem
1
1
Incorrect Device Or Component Shipped
1
1
Component Missing
1
1
Material Discolored
1
1
Contamination
1
1
Component Falling
1
1
Fluid/Blood Leak
1
1
Failure to Seal
1
1
Loose or Intermittent Connection
1
1
Flaked
1
1
Device Or Device Fragments Location Unknown
1
1
Failure to Form Staple
1
1
Insufficient Heating
1
1
Material Separation
1
1
Tear, Rip or Hole in Device Packaging
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Structural Problem
1
1
Out-Of-Box Failure
1
1
Battery Problem
1
1
Material Fragmentation
1
1
Device Damaged Prior to Use
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
48
48
No Clinical Signs, Symptoms or Conditions
38
38
No Patient Involvement
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
Not Applicable
1
1
Radiation Exposure, Unintended
1
1
Burn(s)
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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