Home › Device types › EWL
Prosthesis, Laryngeal (Taub)
FDA product code EWL · Class 2 · Ear, Nose, Throat
348
Registered devices
178
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
InHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox® Vega™ XtraSeal™ — Atos Medical ABProvox® FreeHands HME® Replacement Device — Atos Medical ABInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox2 Voice Prosthesis 4.5mm — Atos Medical ABProvox® Vega™ XtraSeal™ — Atos Medical ABProvox NID 17, 12 mm — Atos Medical ABProvox FreeHands FlexiVoice XtraStrong — Atos Medical ABProvox ActiValve Light 4.5 mm — Atos Medical ABInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox Vega XtraSeal 17Fr 15mm — Atos Medical ABInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCProvox Vega 20Fr 12.5mm — Atos Medical ABInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox Vega 22.5Fr 15mm — Atos Medical ABProvox Vega 20Fr 15mm — Atos Medical ABProvox NID 20, 12 mm — Atos Medical ABInHealth Technologies — Freudenberg Medical, LLCProvox® FreeHands HME® Adjustment Kit — Atos Medical ABProvox® Vega™ — Atos Medical ABProvox Vega Puncture Set 20Fr 8mm — Atos Medical ABProvox Vega 20Fr 8mm — Atos Medical AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Freudenberg Medical, LLC | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophagea |
| 2026-06-17 | Freudenberg Medical, LLC | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophagea |
| 2013-10-01 | Helix Medical LLC | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the |
| 2012-03-08 | Helix Medical LLC | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.