Data / Medical devices / Replacement, Ossicular Prosthesis, Total
Replacement, Ossicular Prosthesis, Total (ETA): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Replacement, Ossicular Prosthesis, Total (product code ETA, Class 2, 21 CFR 874.3495). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on October 14, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETA
- Device class
- 2
- Regulation
- 874.3495
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| United States | 3 |
| Austria | 1 |
| Italy | 1 |
| Dominican Republic | 1 |
| United Kingdom | 1 |
Makers of Replacement, Ossicular Prosthesis, Total
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 6 | June 21, 1991 | 0 | 1 | 0 | api.fda.gov |
| Heinz Kurz GMBH Medizintechnik | DUSSLINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | October 1, 2004 | 0 | 1 | 0 | api.fda.gov |
| Med-El Elektromedizinische Geraete, GMBH | INNSBRUCK Tirol, Austria | Manufacturer | 2 | April 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | January 24, 2005 | 0 | 0 | 0 | api.fda.gov |
| Spiggle & Theis Medizintechnik GMBH | OVERATH North Rhine-Westphalia, Germany | Manufacturer, Specification developer | 1 | March 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Audio Technologies S.R.L. | GOSSOLENGO Piacenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wesley Coe (cambridge) Ltd | ELY, CAMBS Cambridgeshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 14, 2026. 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.