MED-EL Elektromedizinische Geräte GmbH
MED-EL Elektromedizinische Geräte GmbH appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 3, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mW | April 3, 2026 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial | April 3, 2026 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Pros | April 3, 2026 |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | January 17, 2025 |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | January 17, 2025 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Parti | January 17, 2025 |