Home › Device types › ETB
Prosthesis, Partial Ossicular Replacement
FDA product code ETB · Class 2 · Ear, Nose, Throat
1,103
Registered devices
100
Adverse events
3
Recalls
74
510(k) clearances
Devices with this code
HA PARTIAL PROSTHESIS — Grace Medical, Inc.Gyrus ACMI — Gyrus ACMI, LLCECLIPSE PISTON — Grace Medical, Inc.NiTiFLEX Nitinol/Titanium — Heinz Kurz GmbHGRACE MEDICAL FLUOROPLASTIC PISTON — Grace Medical, Inc.N/A — MEDTRONIC XOMED, INC.GYRUS ACMI — Gyrus ACMI, LLCSUPER E PISTON — Grace Medical, Inc.ECLIPSE FLAT RIBBON PISTON — Grace Medical, Inc.MAZZAWI PISTON — Grace Medical, Inc.GLUTH ALTO PARTIAL — Grace Medical, Inc.CliP Piston àWengen Titanium — Heinz Kurz GmbHSUPER E PISTON — Grace Medical, Inc.PRECISE CENTERED PARTIAL — Grace Medical, Inc.Gyrus ACMI — Gyrus ACMI, LLCNiTiFLEX Nitinol/Titanium — Heinz Kurz GmbHFLUOROPLASTIC PISTON — Grace Medical, Inc.MatriX SlimLine Stapes Prosthesis Titanium — Heinz Kurz GmbHGyrus ACMI — Gyrus ACMI, LLCBailey Pappas — MEDTRONIC XOMED, INC.PARTIAL TILT TOP 3.50MM HEAD NOTCHED — Grace Medical, Inc.Vincent Flex H/A® — MEDTRONIC XOMED, INC.Gyrus ACMI — Gyrus ACMI, LLCSoft CliP Titanium — Heinz Kurz GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-03 | Grace Medical, Inc. | Due to incorrect functional length on device labeling. |
| 2020-07-14 | Olympus Corporation of the Americas | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 701421 |
| 2020-07-14 | Olympus Corporation of the Americas | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 701421 |
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