Data / Medical devices / Prosthesis, Partial Ossicular Replacement
Prosthesis, Partial Ossicular Replacement (ETB): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Prosthesis, Partial Ossicular Replacement (product code ETB, Class 2, 21 CFR 874.3450). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 74 510(k) clearances under this code, the latest on April 3, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETB
- Device class
- 2
- Regulation
- 874.3450
- 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 Prosthesis, Partial Ossicular Replacement
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 |
|---|---|---|---|---|---|---|---|---|
| Heinz Kurz GMBH Medizintechnik | DUSSLINGEN Baden-Wurttemberg, Germany | Manufacturer | 8 | December 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Grace Medical, Inc. | Memphis, TN, United States | Manufacturer | 6 | April 17, 2008 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 5 | October 11, 2000 | 0 | 0 | 0 | api.fda.gov |
| Med-El Elektromedizinische Geraete, GMBH | INNSBRUCK Tirol, Austria | Manufacturer | 4 | April 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Audio Technologies S.R.L. | GOSSOLENGO Piacenza, Italy | Manufacturer | 1 | June 23, 2000 | 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 | |
| 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 | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 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 | |
| Spiggle & Theis Medizintechnik GMBH | OVERATH North Rhine-Westphalia, Germany | Manufacturer, Specification developer | 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 April 3, 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.