NEC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bandage, Liquid, Skin Protectant
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 2005: 2 · 2011: 30
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 |
|---|---|---|
| SUPERSKIN (K972081) | Medlogic Global Corp. | 1997-12-17 |
| APLICARE SKIN PROTECTANT PREP PAD (K861557) | Aplicare, Inc. | 1986-07-11 |
| APLICARE SKIN PROTECTANT SWABSTICK (K861558) | Aplicare, Inc. | 1986-06-04 |
Track NEC automatically
Every clearance here is in the API, with alerts when new ones post.