EBR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Unit, Suction Operatory
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6640
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1992: 1 · 2002: 1 · 2004: 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 |
|---|---|---|
| A-DEC 7284 CUSPIDOR, CASCADE (K925367) | A-Dec, Inc. | 1994-04-11 |
| DENPAX (K860058) | Nissho Iwai American Corp. | 1986-03-12 |
| OROPHARYNGEAL SUCTION AIRWAY (K770600) | W.H. Wall, D.D.S. | 1977-04-08 |
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Every clearance here is in the API, with alerts when new ones post.