EIB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Syringe, Irrigating (Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1992: 1 · 1993: 1 · 1995: 3 · 2000: 1 · 2001: 1
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 |
|---|---|---|
| DTF-1000LL,DTF-1000 (K911118) | Cp Medical | 1991-11-20 |
| MODEL OPO-32 IRRIGATION SLEEVE (K874543) | Allergan, Inc. | 1988-01-14 |
| SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (K822411) | Western Advanced Technology, Inc. | 1983-07-12 |
| ROBINSON MIDDLE EAR PROSTHESIS (K760570) | Xomed, Inc. | 1976-09-21 |
Track EIB automatically
Every clearance here is in the API, with alerts when new ones post.