Data / Medical devices / Netherlands / N.V. Organon
N.V. Organon: FDA-registered device maker in Oss Noord-Brabant, Netherlands, 1 510(k) clearance
N.V. Organon is registered with the FDA (registration 3002806821) in Oss Noord-Brabant, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806821
- Address
- Kloosterstraat 6, Oss Noord-Brabant, Netherlands, 5349 AB
- Owner or operator
- Organon LLC (10082609)
- Roles
- Repackager or relabeler
- First device listed
- October 17, 2023
- Registered through
- 2026
- Brand names listed
- FOLLISTIM PEN & Pen Needles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2016 | K162516 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
Updated December 9, 2016. 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.