Data / Medical devices / Resectoscope / United States
FDA-registered makers of Resectoscope in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Resectoscope (product code FJL). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Resectoscope
- Product code
- FJL
- Country
- United States
Makers of Resectoscope in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aulea Medical, Inc. | Pleasanton, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | February 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | April 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| National Advanced Endoscopy Devices, Inc. | Canoga Park, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 30, 2010 | 0 | 0 | 0 | api.fda.gov |
| All Quality & Services, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinity Medical International LLC | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RG Medical USA | Mount Juliet, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 1 | 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.