Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
1 total · filtered by GEI
Showing 1–1
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K250065 | DENSITY; DENZA; DENSITY Noir | GEI | Class 2 | 2025-07-08 |
Companies whose devices this company cited as predicates
3 manufacturers
Companies that cited this company's devices as predicates