HOC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clip, Iris Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2013: 10 · 2014: 31 · 2015: 20 · 2018: 11 · 2025: 77 · 2026: 91
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 |
|---|---|---|
| PART #860070 ULTRAPAK & #860075 ULTRAPAK (K871474) | Medical Technical Products | 1987-08-10 |
| PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (K830871) | Phakosystems, Inc. | 1983-06-02 |
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Every clearance here is in the API, with alerts when new ones post.