EXE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Protector, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2021: 1,144 · 2022: 547 · 2023: 360 · 2024: 295 · 2025: 321 · 2026: 177
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 |
|---|---|---|
| CONVATEC ABSORBENT BANDAGE (K904233) | Convatec, A Division of E.R. Squibb & Sons | 1991-03-06 |
| UNITED SKIN BARRIER (K770982) | Howmedica Corp. | 1977-07-15 |
| STOMA SHIELD ADAPTER (K760927) | Rudolfo T. Sanchez | 1977-01-26 |
Track EXE automatically
Every clearance here is in the API, with alerts when new ones post.