Data / Medical devices / Larynx, Artificial (Battery-Powered)
Larynx, Artificial (Battery-Powered) (ESE): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Larynx, Artificial (Battery-Powered) (product code ESE, Class 1, 21 CFR 874.3375). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on March 16, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ESE
- Device class
- 1
- Regulation
- 874.3375
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Sweden | 2 |
| Australia | 1 |
| Germany | 1 |
| China | 1 |
Makers of Larynx, Artificial (Battery-Powered)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atos Medical AB | HORBY Skane, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elogio Speech Technologies LLC | San Antonio, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fountain Head Marketing Inc | San Antonio, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laronix Pty Ltd | Brisbane City Queensland, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LaunchPort LLC | Baltimore, MD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Montex AB | Jamjoe Blekinge, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orbisana Healthcare GmbH | TROISDORF North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultravoice, LLC. | Newtown Sq, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 16, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.