Data / Medical devices / Camera, Still, Endoscopic
Camera, Still, Endoscopic (FXM): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Camera, Still, Endoscopic (product code FXM, 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 1 510(k) clearance under this code, the latest on August 20, 1982, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FXM
- Device class
- 1
- Regulation
- 878.4160
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 2 |
| India | 1 |
| Taiwan | 1 |
| Mexico | 1 |
Makers of Camera, Still, Endoscopic
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 |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 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 | |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hukui Biotechnology Co., Ltd. | Zhubei City Hsinchu(County), Taiwan | 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 | |
| Linvatec Corporation | Largo, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 20, 1982. 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.