Handle, Instrument, Dental
Regulation 872.4565
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Aukland Medical Plastics, Inc. | 1 | 0 |
| Biomet 3i, Inc. | 0 | 1 |
| Centrix, Inc. | 1 | 0 |
| E&D Dental Products, Inc. | 1 | 0 |
| Joel Lander D.D.S. | 1 | 0 |
| Lone Star Technologies | 1 | 0 |
| Military Engineering, Inc. | 1 | 0 |
| Neks Technologies | 1 | 0 |
| Treace Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Biomet 3i, Inc. Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery. Terminated |
EJB | None listed |
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