Panels › Ear, Nose, Throat › Product code FWN · Class 2
Prosthesis, Larynx (Stents And Keels)
Regulation 874.3620
0510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FWN
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Medical Products, Inc. | 4 | 0 |
| Hood Laboratories | 2 | 0 |
| Alveolus, Inc. | 0 | 1 |
| E. Benson Hood Lab, Inc. | 1 | 0 |
| E. Benson Hood Laboratories, Inc. | 1 | 0 |
| Exmoor Plastics , Ltd. | 1 | 0 |
| Walter Lorenz Surgical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2009 | K091135 | RUTTER SUPRA STOMAL STENTS Boston Medical Products, Inc. | FWN |
| Mar 29, 2000 | K000154 | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 E. Benson Hood Lab, Inc. | FWN |
| Aug 9, 1996 | K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL Boston Medical Products, Inc. | FWN |
| Feb 22, 1990 | K896667 | LORENZ STENT Walter Lorenz Surgical, Inc. | FWN |
| May 10, 1989 | K884810 | SILICONE LARYNGEAL STENT Hood Laboratories | FWN |
| Apr 27, 1987 | K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL Exmoor Plastics , Ltd., GB | FWN |
| Mar 12, 1986 | K853726 | LARYNGEAL Hood Laboratories | FWN |
| Aug 2, 1984 | K842800 | MONTG. LARYNGEAL KEEL Boston Medical Products, Inc. | FWN |
| Jun 27, 1984 | K842287 | MONTGOMERY LARYNGEAL STENT Boston Medical Products, Inc. | FWN |
| May 2, 1984 | K841347 | LARYNGEAL STENT E. Benson Hood Laboratories, Inc. | FWN |
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