Data / Medical devices / Biopsy Needle Guide Kit / United States
FDA-registered makers of Biopsy Needle Guide Kit in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Biopsy Needle Guide Kit (product code OIJ). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Biopsy Needle Guide Kit
- Product code
- OIJ
- Country
- United States
Makers of Biopsy Needle Guide Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Sonosite,inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheathing Technologies, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Medical Solutions Usa, Inc. | Issaquah, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Medical Solutions USA, Inc. | Plymouth Meeting, PA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transducerworks | Centre Hall, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.