Data / Medical devices / Calibrator, Hearing Aid / Earphone And Analysis Systems
Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW): 14 FDA-registered makers in 8 countries
14 establishments in 8 countries are registered with the FDA to make Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW, Class 2, 21 CFR 874.3310). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on October 23, 2012, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETW
- Device class
- 2
- Regulation
- 874.3310
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Denmark | 3 |
| United States | 3 |
| Poland | 2 |
| Ireland | 2 |
| Canada | 1 |
| Germany | 1 |
| Italy | 1 |
| Sweden | 1 |
Makers of Calibrator, Hearing Aid / Earphone And Analysis Systems
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 |
|---|---|---|---|---|---|---|---|---|
| Interacoustics A/S | Middelfart Syddanmark, Denmark | Manufacturer | 2 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Natus Medical Denmark ApS | TAASTRUP Hovedstaden, Denmark | Complaint file establishment, Manufacturer, Specification developer | 2 | October 23, 2012 | 0 | 0 | 0 | api.fda.gov |
| Etymonic Design, Inc. | DORCHESTER Ontario, Canada | Manufacturer | 1 | September 21, 2001 | 0 | 0 | 0 | api.fda.gov |
| Sivantos GmbH | Erlangen Bavaria, Germany | Specification developer | 1 | June 5, 2007 | 0 | 0 | 0 | api.fda.gov |
| Auditdata A/S | Copenhagen Hovedstaden, Denmark | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DGS Diagnostics Sp. z o.o | Kolbaskowo Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frye Electronics, Inc. | Beaverton, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventis SRL | Padova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inission Syd AB (Malmo AB) | Malmo Skane, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medrx, Inc. | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Sensory Ireland Ltd | Gort Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nordes Sp. z o.o. | Wroclaw Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 23, 2012. 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.