Med-El Elektromedizinische Ger?te GmbH - FDA 510(k) Cleared Devices
Recent clearances: mGRIP Partial Prosthesis (0.75 mm) (58669), mGRIP Total Prosthesis (3.00 mm) (58689), mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Med-El Elektromedizinische Ger?te GmbH Ear, Nose, Throat ✕
6 devices
Cleared
Apr 03, 2026
mGRIP Partial Prosthesis (0.75 mm) (58669)
Ear, Nose, Throat
29d
Cleared
Apr 03, 2026
mGRIP Total Prosthesis (3.00 mm) (58689)
Ear, Nose, Throat
29d
Cleared
Apr 03, 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
Ear, Nose, Throat
29d
Cleared
Jan 17, 2025
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and...
Ear, Nose, Throat
267d
Cleared
Jan 17, 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial...
Ear, Nose, Throat
266d
Cleared
Jan 17, 2025
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO...
Ear, Nose, Throat
268d