HNM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Needle, Ophthalmic Suturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1993: 1 · 1997: 3 · 1998: 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 |
|---|---|---|
| OMS/GONVERS RETINAL PERFORATOR (K844448) | Optical Micro Systems, Inc. | 1985-08-21 |
| NEEDLEHOLDER, MICROVASULAR 5 1/2 (K780154) | Edward Weck, Inc. | 1978-03-17 |
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Every clearance here is in the API, with alerts when new ones post.