HNW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dilator, Lachrymal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2001: 1 · 2003: 3 · 2006: 14 · 2007: 2 · 2008: 3 · 2010: 6
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 |
|---|---|---|
| INTER-SHARP (K862070) | Intermedics Intraocular, Inc. | 1986-06-17 |
| LACHRYMAL PROBES-VARIOUS (K841002) | Premier Dental Products Co. | 1984-05-09 |
| KOI LACREMAL HOOK & DILATOR (K812097) | Koi, Inc. | 1981-08-18 |
Track HNW automatically
Every clearance here is in the API, with alerts when new ones post.