NAC
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dressing, Wound, Hydrophilic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4018
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 57 · 2022: 71 · 2023: 115 · 2024: 35 · 2025: 84 · 2026: 161
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 |
|---|---|---|
| DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208) | Scivolutions, Inc. | 2008-12-01 |
| HYDRASORB JOYCE SPONGE (K925841) | Avitar, Inc. | 1993-05-12 |
| SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (K914575) | Dow B. Hickam, Inc. | 1991-12-04 |
| ALGINATE FIBER (K914779) | Adri/Technam | 1991-12-04 |
Track NAC automatically
Every clearance here is in the API, with alerts when new ones post.