Panels › Ear, Nose, Throat › Product code LXB · Class 2
Hearing Aid, Bone Conduction
Regulation 874.3302
4510(k)s in 12 months (53 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in LXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cochlear Americas | 12 | 2 |
| Oticon Medical AB | 8 | 0 |
| Sonitus Medical, Inc. | 2 | 5 |
| Xomed, Inc. | 6 | 0 |
| Entific Medical Systems, Inc. | 5 | 0 |
| Sophono, Inc. | 5 | 0 |
| Audifon-USA, Inc. | 1 | 0 |
| Bhm-Tech Produktionsgesellschaft Mbh | 1 | 0 |
| Cochlear | 1 | 0 |
| Cochlear Bone Anchored Systems AB | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 1987 | K872168 | XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. Xomed, Inc. | LXB |
| May 30, 1986 | K861971 | XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL Xomed, Inc. | LXB |
| Apr 3, 1986 | K855059 | AUDIANT BONE CONDUCTOR OR A.B.C. Xomed, Inc. | LXB |
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