Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
38
38
Defective Device
8
8
Defective Component
5
5
Break
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Failure to Power Up
3
3
Packaging Problem
3
3
Loss of or Failure to Bond
2
2
Material Integrity Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Contamination
1
1
Structural Problem
1
1
Failure to Seal
1
1
Output Problem
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Product Quality Problem
1
1
Material Fragmentation
1
1
Battery Problem
1
1
Material Discolored
1
1
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
Insufficient Heating
1
1
Flaked
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
38
38
No Known Impact Or Consequence To Patient
17
17
Insufficient Information
9
9
No Patient Involvement
7
7
No Consequences Or Impact To Patient
4
4
Foreign Body In Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medline Industries, Inc.
II
Jul-18-2019
2
Sunstar Americas, Inc.
II
Mar-03-2022
-
-