LFB
12 FDA 510(k) clearances · Product code
42 daysmedian time to decision
96 days90th percentile
12clearances measured
FDA profile
- Official device name
- Button, Nasal Septal
- Device class
- Unclassified
- Medical specialty
- Unknown
- Flags
- Implant
- Adverse events (MAUDE)
- 1996: 1 · 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 |
|---|---|---|
| BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (K131745) | Helix Medical, LLC | 2013-09-17 |
| SILMED NASAL SEPTAL BUTTON (K013696) | Silmed, Inc. | 2001-11-28 |
| MICROMEDICS NASAL SEPTAL BUTTON (K982667) | Micromedics, Inc. | 1998-11-24 |
| NASAL SEPTAL BUTTON (K972060) | Boston Medical Products, Inc. | 1997-07-03 |
| HOOD NASAL SEPTAL BUTTON (K920994) | Hood Laboratories | 1992-05-15 |
| INVOTEC SEPTAL BUTTON (K901366) | Invotec International, Inc. | 1990-06-14 |
| OMEGA NASAL SEPTAL BUTTON (K871072) | Omega Silicone, Inc. | 1987-06-08 |
| CUI NASAL SEPTUM BUTTON (K871200) | Cox-Uphuff Intl. | 1987-04-15 |
| MICROTEK SEPTAL BUTTON (K862497) | Microtek Medical, Inc. | 1986-07-14 |
| NASAL SEPTAL BUTTON (K850492) | Santa Barbara Medco, Inc. | 1985-03-07 |
| NASAL SEPTAL BUTTONS (K822637) | Abco Dealers, Inc. | 1982-09-28 |
| SEPTAL BUTTON (K781529) | Xomed, Inc. | 1978-10-17 |
Track LFB automatically
Every clearance here is in the API, with alerts when new ones post.