Data / Medical devices / Biopsy Needle Guide Kit
Biopsy Needle Guide Kit (OIJ): 22 FDA-registered makers in 9 countries
22 establishments in 9 countries are registered with the FDA to make Biopsy Needle Guide Kit (product code OIJ, Class 2, 21 CFR 892.1560). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OIJ
- Device class
- 2
- Regulation
- 892.1560
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| South Korea | 4 |
| China | 4 |
| Canada | 2 |
| Singapore | 1 |
| Mexico | 1 |
| Malaysia | 1 |
| Italy | 1 |
| Slovakia | 1 |
Makers of Biopsy Needle Guide Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Biobot Surgical Pte. Ltd. | Singapore South West, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exact Imaging, Inc. | Markham Ontario, Canada | Manufacturer, Specification developer | 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 | |
| Global Tech Plastic Industry Sdn Bhd | ULU TIRAM Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Humanscan Co., Ltd | Siheung-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingfang Precision Medical Device(shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medax S.R.L. Unipersonale | San Possidonio Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RF Medical Co., Ltd | Seoul, South Korea | Manufacturer | 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 | |
| Sonele Inc. | Markham Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonoscape Medical Corp. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonoscape Medical Corp. | SHENZHEN Guangdong, China | Manufacturer | 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 Healthcare s.r.o. | Kosice-Barca Kosicky, Slovakia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | Manufacturer, 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 | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | 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.