HNJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Punch, Corneo-Scleral
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 1 · 1997: 4 · 1998: 1 · 1999: 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 |
|---|---|---|
| TANNE CORNEAL CUTTING BLOCK (K871646) | Ocular Instruments, Inc. | 1987-05-18 |
| DORC CORNEAL PUNCH BLOCK (K830335) | Jedmed Instrument Co. | 1983-03-09 |
| REPL. PISTON FOR TROUTMAN CORNEAL PUNCH (K791988) | Edward Weck, Inc. | 1979-10-30 |
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Every clearance here is in the API, with alerts when new ones post.