FDA 510(k) Applications Submitted by Min Ye

FDA 510(k) Number Submission Date Device Name Applicant
K243296 10/18/2024 Disposable Biopsy Needle Carbon (Shenzhen) Medical Device Co., Ltd.
K243298 10/18/2024 Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System Carbon (Shenzhen) Medical Device Co., Ltd.
K160358 02/09/2016 DT-100 Mediana Co., Ltd.
K221745 06/16/2022 Sterile Posterior Spinal Fixation System Shanghai REACH Medical Instrument Co., Ltd
K201737 06/25/2020 Posterior Spinal Fixation System Shanghai REACH Medical Instrument Co., Ltd
K233630 11/13/2023 Ambu« aScopeÖ 5 Uretero (Standard Deflection); Ambu« aScopeÖ 5 Uretero (Reverse Deflection); Ambu« aBoxÖ 2 Ambu A/S


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