Cement, Ear, Nose And Throat
Regulation 872.3275
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Corinthian Medical , Ltd. | 1 | 0 |
| Envoy Medical Corporation | 1 | 0 |
| Ototech, Inc. | 1 | 0 |
| Ototronix, LLC | 1 | 0 |
| Stryker Cmf | 1 | 0 |
| Walter Lorenz Surgical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 2014 | K140644 | PROCEM Ototronix, LLC | NEA |
| Feb 28, 2008 | K080032 | ENVOYCEM, MODEL 1640 Envoy Medical Corporation | NEA |
| Apr 19, 2006 | K060750 | STRYKER INJECTABLE CEMENT Stryker Cmf | NEA |
| Nov 8, 2004 | K042516 | OTOMIMIX Walter Lorenz Surgical, Inc. | NEA |
| Sep 13, 2001 | K011338 | OTO-CEM Ototech, Inc. | NEA |
| Feb 12, 2001 | K003567 | SERENOCEM, MODEL BC 010 Corinthian Medical , Ltd., NL | NEA |
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