FXR
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Holder, Camera, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2020: 14 · 2022: 37 · 2023: 43 · 2024: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONI-LOK SCOPE STABILIZER (K850122) | Med Surg Designs, Inc. | 1985-02-21 |
| TELEVISION CAMERA HOLDER FOR SURGERY (K810303) | The Anspach Effort, Inc. | 1981-02-26 |
Track FXR automatically
Every clearance here is in the API, with alerts when new ones post.