Data / Medical devices / Lacrimal Stents And Intubation Sets
Lacrimal Stents And Intubation Sets (OKS): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Lacrimal Stents And Intubation Sets (product code OKS, Class U). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on March 11, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OKS
- Device class
- U
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Japan | 2 |
| France | 1 |
| Mauritius | 1 |
Makers of Lacrimal Stents And Intubation Sets
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fci SAS | BESANCON Doubs, France | Exporter to the US, Manufacturer | 15 | March 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Exporter to the US, Manufacturer | 15 | March 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 2 | April 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Specification developer | 2 | April 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 2 | October 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Anodyne Surgical | O Fallon, MO, United States | Manufacturer | 1 | May 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Kaneka Medix Corporation Kanagawa Plant | Ashigara-Kami-gun Kanagawa, Japan | Manufacturer | 1 | April 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kaneka Corporation Osaka Plant | Settsu-shi Osaka, Japan | Exporter to the US, Specification developer | 1 | April 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Oasis Medical, Inc. | Glendora, CA, United States | Complaint file establishment, Specification developer | 1 | May 13, 2016 | 0 | 0 | 0 | api.fda.gov |
Updated March 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.