Data / Medical devices / Integrated Operating Table-Electromechanical Surgical System
Integrated Operating Table-Electromechanical Surgical System (SIR): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Integrated Operating Table-Electromechanical Surgical System (product code SIR, Class 2, 21 CFR 878.4966). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 21, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SIR
- Device class
- 2
- Regulation
- 878.4966
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Dominican Republic | 1 |
| Germany | 1 |
Makers of Integrated Operating Table-Electromechanical Surgical System
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 |
|---|---|---|---|---|---|---|---|---|
| Auris Health, Inc | Santa Clara, CA, United States | Manufacturer, Specification developer | 1 | July 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Das Medical International, SRL | La Romana, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nolato GW Tucson | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Neenah, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schoelly Fiberoptic, GMBH | DENZLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 21, 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.