Panels › Ear, Nose, Throat › Product code EWL · Class 2
Prosthesis, Laryngeal (Taub)
Regulation 874.3730
0510(k)s in 12 months (40 all time)
2recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EWL
| Company | 510(k)s | Recalls |
|---|---|---|
| Helix Medical, Inc. | 12 | 2 |
| Atos Medical AB | 8 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Freudenberg Medical, LLC | 1 | 2 |
| American V. Mueller | 2 | 0 |
| Hood Laboratories | 2 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Dacomed Corp. | 1 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 1 | 0 |
| E. Benson Hood Lab, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LF Open, Classified |
EWL | K932120 |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LEF Open, Classified |
EWL | K932120 |
| Nov 1, 2013 | Helix Medical LLC Blom-Singer Adjustable Tracheostoma Valve II
Models: BE8025H and BE8025H-R3 Terminated |
EWL | K821568 |
| Sep 7, 2012 | Helix Medical LLC BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO
The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenan Terminated |
EWL | None listed |
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