A sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g.,
| Company | Devices | Share |
|---|---|---|
| Boston Medical Products, Inc. | 40 | 62% |
| Biomet Microfixation, Inc | 25 | 38% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FWN | Prosthesis, Larynx (Stents And Keels) | 40 |
| FWN | PROSTHESIS, LARYNX (STENTS AND KEELS) | 32 |
Use these as the dimensions to specify in a tender line.
65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric laryngeal stent", from 2 companies. The largest labeler is Boston Medical Products, Inc. with 62% of records.
FWN (Prosthesis, Larynx (Stents And Keels)), FWN (PROSTHESIS, LARYNX (STENTS AND KEELS))
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.