FDA 510(k) Applications Submitted by InΘs Romßn Santiago

FDA 510(k) Number Submission Date Device Name Applicant
K241269 04/24/2024 mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit MED-EL Elektromedizinische GerΣte GmbH
K241142 04/25/2024 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis Med-El Elektromedizinische GerΣte GmbH
K241261 04/26/2024 mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit MED-EL Elektromedizinische GerΣte GmbH


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