Data / Medical devices / Camera, Television, Surgical, With Audio
Camera, Television, Surgical, With Audio (FWC): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Camera, Television, Surgical, With Audio (product code FWC, Class 1, 21 CFR 878.4160). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 24, 1989, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FWC
- Device class
- 1
- Regulation
- 878.4160
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 3 |
| India | 1 |
| Ireland | 1 |
| Mexico | 1 |
| China | 1 |
| South Korea | 1 |
Makers of Camera, Television, Surgical, With Audio
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 |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentlight Inc. | Plano, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eclipse Prism Medical Devices Pvt. Ltd | RABALE, NAVI MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happersberger Otopront GMBH | Hohenstein Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Lifesciences (ireland) Limited | SRAGH TULLAMORE Offaly, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jam-Labs Corp | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Fly Medical Devices Co., Ltd. | Minhang District Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenosys Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 24, 1989. 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.