Data / Medical devices / Table, Surgical With Orthopedic Accessories, Ac-Powered
Table, Surgical With Orthopedic Accessories, Ac-Powered (JEA): 21 FDA-registered makers in 7 countries
21 establishments in 7 countries are registered with the FDA to make Table, Surgical With Orthopedic Accessories, Ac-Powered (product code JEA, Class 1, 21 CFR 878.4960). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on August 8, 1995, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JEA
- Device class
- 1
- Regulation
- 878.4960
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 4 |
| China | 3 |
| India | 3 |
| Taiwan | 2 |
| Estonia | 1 |
| Brazil | 1 |
Makers of Table, Surgical With Orthopedic Accessories, Ac-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| American Surgical Specialties Company | Nashville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems (Suzhou) Co. Ltd | Taicang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | SAALFELD Thuringia, Germany | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Black Forest Medical GmbH | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dexta Corp. | Napa, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galaxy India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gabriel Scientific OU | Parnu linn Parnumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jorg & Sohn GMBH | Ahorn-Schorkendorf Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kanghui Medical Technology (suzhou) Co.,ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet GMBH | RASTATT Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mizuho Orthopedic Systems, Inc. | Union City, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 5 | 0 | api.fda.gov | |
| Nanjing Mindray Bio-Medical Electronics Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steris Corporation | Montgomery, AL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgix Medical LLC | Spring, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares Ltda | Rio Claro Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corp. | Kaohsiung, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corporation | Hsinchu Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Poly Engineering Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 8, 1995. 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.