FWH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Camera, Cine, Surgical, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 1 · 2003: 1 · 2004: 2 · 2006: 2
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 |
|---|---|---|
| MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 (K884039) | Medical Dynamics, Inc. | 1988-10-13 |
| ESA CAMERA (K823516) | Concept, Inc. | 1982-12-30 |
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