Home › Device types › EWL
Prosthesis, Laryngeal (Taub)
FDA product code EWL · Class 2 · Ear, Nose, Throat
348
Registered devices
174
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
Provox FreeHands FlexiVoice Set Plus — Atos Medical ABInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer; Dual Valve — Freudenberg Medical, LLCProvox Vega XtraSeal 17Fr 8mm — Atos Medical ABProvox FreeHands FlexiVoice Arch (5 pcs) — Atos Medical ABProvox Vega 17Fr 8mm — Atos Medical ABProvox ActiValve Light 8 mm — Atos Medical ABInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox Vega Puncture Set 17Fr 10mm — Atos Medical ABProvox® Vega™ XtraSeal™ — Atos Medical ABInHealth Technologies; Blom-Singer; Dual Valve — Freudenberg Medical, LLCProvox Vega XtraSeal 17Fr 4mm — Atos Medical ABInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer; Classic — Freudenberg Medical, LLCProvox ActiValve XtraStrong 4.5 mm — 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. |
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