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
Total Middle Ear Implant — Spiggle & Theis Medizintechnik GmbHWILDCAT FIXED LENGTH TOTAL — Grace Medical, Inc.WILDCAT PRO, 3.00MM L — Grace Medical, Inc.Gyrus ACMI — Gyrus ACMI, LLCGYRUS ACMI, INC — Gyrus ACMI, LLCGYRUS ACMI, INC — Gyrus ACMI, LLCFlex H/A® — MEDTRONIC XOMED, INC.GYRUS ACMI, INC — Gyrus ACMI, LLCOFFSET ALTO TOTAL — Grace Medical, Inc.TOTAL TILT TOP HEAD CENTERED — Grace Medical, Inc.MNP Total Prosthesis Titanium — Heinz Kurz GmbHNA — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.HA WILDCAT FIXED LENGTH TOTAL — Grace Medical, Inc.Lippy — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.Duesseldorf Type AERIAL Total Titanium — Heinz Kurz GmbHGyrus ACMI — Gyrus ACMI, LLCMICRON — Gyrus ACMI, LLCDuesseldorf Type AERIAL Total Titanium — Heinz Kurz GmbHNA — MEDTRONIC XOMED, INC.Schuknecht — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.Big Easy® Piston — 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. |
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