HND
6 FDA 510(k) clearances · Product code
28 daysmedian time to decision
38 days90th percentile
6clearances measured
FDA profile
- Official device name
- Spatula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1997: 7 · 1998: 6 · 1999: 1 · 2025: 23
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 |
|---|---|---|
| THORNTON TITANIUM SILVER SPATULA (K863990) | Keeler Instruments, Inc. | 1986-10-31 |
| ANIS IRRIGATING SPATULA (K810937) | American V. Mueller | 1981-05-15 |
| MADDOX LENS SPATULA CAT. #7245 (K801609) | Edward Weck, Inc. | 1980-08-13 |
| MCCULLEY CONTINUOUS SUTURE TIGHTNER (K801608) | Edward Weck, Inc. | 1980-08-12 |
| SPATULA'S #'S 7618,7248,7240,7242,5108 (K791983) | Edward Weck, Inc. | 1979-10-04 |
| CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM (K761253) | Edward Weck, Inc. | 1976-12-16 |
Track HND automatically
Every clearance here is in the API, with alerts when new ones post.