Company · AT
MED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2026 | K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesi MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Apr 3, 2026 | K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58 MED-EL Elektromedizinische Geräte GmbH, AT | ETA |
| Apr 3, 2026 | K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Jan 17, 2025 | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit MED-EL Elektromedizinische Geräte GmbH, AT | ETA |
| Jan 17, 2025 | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Jan 17, 2025 | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||