Home › Device types › ETA
Replacement, Ossicular Prosthesis, Total
FDA product code ETA · Class 2 · Ear, Nose, Throat
804
Registered devices
93
Adverse events
2
Recalls
39
510(k) clearances
Devices with this code
Schwaber — MEDTRONIC XOMED, INC.MICRON II — Gyrus ACMI, LLCMortez — MEDTRONIC XOMED, INC.MICRON II — Gyrus ACMI, LLCMICRON II — Gyrus ACMI, LLCVincent Flex H/A® — MEDTRONIC XOMED, INC.MICRON II — Gyrus ACMI, LLCTTP-Tuebingen Type AERIAL Total Titanium — Heinz Kurz GmbHFlex H/A — MEDTRONIC XOMED, INC.MNP Total Prosthesis Titanium — Heinz Kurz GmbHCausse/Vincent — MEDTRONIC XOMED, INC.MICRON — Gyrus ACMI, LLCMORETZ ALTO HA, RIGHT — Grace Medical, Inc.Causse — MEDTRONIC XOMED, INC.GYRUS ACMI, INC — Gyrus ACMI, LLCMNP Total Prosthesis Titanium — Heinz Kurz GmbHPRECISE HA LITE TOTAL — Grace Medical, Inc.Gyrus ACMI — Gyrus ACMI, LLCN/A — MEDTRONIC XOMED, INC.Duesseldorf Type AERIAL Total Titanium — Heinz Kurz GmbHCausse — MEDTRONIC XOMED, INC.HABERMAN ALTO TOTAL ROUND HEAD — Grace Medical, Inc.MICRON II — Gyrus ACMI, LLCN/A — MEDTRONIC XOMED, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-23 | Medtronic Xomed, Inc. | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. |
| 2011-04-27 | Heinz Kurz GmbH Medizintechnik | Outer package labels product .75 mm longer than actual size. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.