HNI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Retractor, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1997: 2 · 2005: 2 · 2013: 7
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 |
|---|---|---|
| KSEA DE LA PLAZA BLEPHAROPLASTY SET (K991592) | KARL STORZ Endoscopy-America, Inc. | 1999-11-02 |
| IRIS RETRACTOR (K770222) | Concept, Inc. | 1977-02-17 |
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Every clearance here is in the API, with alerts when new ones post.