Data / Medical devices / Confocal Optical Imaging / United States
FDA-registered makers of Confocal Optical Imaging in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Confocal Optical Imaging (product code OWN). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Confocal Optical Imaging
- Product code
- OWN
- Country
- United States
Makers of Confocal Optical Imaging in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 9 | February 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 8 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Activ Surgical Inc | Boston, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 1 | September 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Life Science Logistics, LLC | Brownsburg, IN, United States | Manufacturer, Repackager or relabeler | 1 | July 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex California Technology, Incorporated | Santa Barbara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc. | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract 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.