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Prosthesis, Partial Ossicular Replacement

FDA product code ETB · Class 2 · Ear, Nose, Throat

1,103
Registered devices
101
Adverse events
3
Recalls
74
510(k) clearances

Devices with this code

Fisch — MEDTRONIC XOMED, INC.ECLIPSE FLAT RIBBON PISTON — Grace Medical, Inc.Angular CliP Prosthesis Titanium — Heinz Kurz GmbHDORNHOFFER ALTO PARTIAL — Grace Medical, Inc.NITINIL SRP — Grace Medical, Inc.NANO ALTO BYTE — Grace Medical, Inc.OFFSET ALTO PARTIAL — Grace Medical, Inc.NiTiFLEX Nitinol/Titanium — Heinz Kurz GmbHNiTiFLEX Nitinol/Titanium — Heinz Kurz GmbHGyrus ACMI — Gyrus ACMI, LLCGyrus ACMI — Gyrus ACMI, LLCNITINIL SRP — Grace Medical, Inc.Soft CliP Titanium — Heinz Kurz GmbHHA PARTIAL PROSTHESIS — Grace Medical, Inc.MatriX SlimLine Stapes Prosthesis Titanium — Heinz Kurz GmbHGyrus ACMI — Gyrus ACMI, LLCPartial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbHPartial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbHSMART — Gyrus ACMI, LLCGyrus ACMI — Gyrus ACMI, LLCMatriX Stapes Prosthesis Titanium — Heinz Kurz GmbHPRECISE CENTERED PARTIAL — Grace Medical, Inc.Gyrus ACMI — Gyrus ACMI, LLCDel La Cruz — MEDTRONIC XOMED, INC.

Recent recalls

DateFirmReason
2026-04-03Grace Medical, Inc.Due to incorrect functional length on device labeling.
2020-07-14Olympus Corporation of the AmericasMislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 701421
2020-07-14Olympus Corporation of the AmericasMislabeled 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.