FZM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stool, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2014: 58 · 2015: 59 · 2017: 14 · 2018: 17 · 2020: 13 · 2021: 13
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 |
|---|---|---|
| MALIS SURGICAL STOOL (K890309) | Valley Forge Scientific Corp. | 1989-02-14 |
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