|
Device |
eye tray |
Definition |
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Product Code | OJK |
Regulation Number |
886.4790
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
American Contract Systems, Inc. |
II |
Aug-07-2024 |
2 |
American Contract Systems, Inc. |
II |
Jan-26-2024 |
3 |
American Contract Systems, Inc. |
II |
Sep-08-2022 |
4 |
Avid Medical, Inc. |
II |
Mar-19-2020 |
5 |
Beaver Visitec International, Inc. |
II |
Nov-16-2021 |
6 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Oct-23-2024 |
7 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-11-2024 |
8 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
9 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-28-2024 |
10 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Feb-25-2024 |
11 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-03-2023 |
12 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jul-20-2023 |
13 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Feb-06-2023 |
14 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Nov-01-2022 |
15 |
ROi CPS LLC |
II |
Nov-23-2022 |
16 |
ROi CPS LLC |
II |
Nov-18-2021 |
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