Data / Medical devices / United States / Bahadir Usa LLC
Bahadir Usa LLC: FDA-registered device maker in Carneys Point, NJ, United States, 4 510(k) clearances
Bahadir Usa LLC is registered with the FDA (registration 3005741909) in Carneys Point, NJ, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005741909
- Address
- 431 S Pennsville Auburn Rd, Carneys Point, NJ, United States, 08069
- Owner or operator
- BAHADIR USA LLC (9087223)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 30, 2010
- Registered through
- 2026
- Brand names listed
- BAHADIR STERILIZATION CONTAINERS, Bahadir Rigid Lite Sterile Container Systems, Bahadir Wire Basket Trays
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 22, 2024 | K233578 | BAHADIR STERILIZATION CONTAINERS | KCT | Substantially Equivalent | Bahadir USA, LLC | accessdata.fda.gov |
| August 12, 2014 | K131407 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| June 7, 2012 | K112090 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| November 18, 2010 | K102146 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Tray, Surgical, Instrument
Updated March 22, 2024. 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.