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FDA 510(k) Applications for Medical Device Product Code "HDX"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K003380 | BIOTEQUE AMERICA, INC. | BIOTEQUE VAGINAL DILATOR | 01/29/2001 |
K071754 | KARL STORZ ENDOSCOPY-AMERICA, INC. | NEO-VAGINA SURGERY SET AND ACCESSORIES | 01/07/2009 |
K222492 | Lujena, Inc. | Hope&Her Vaginal Dilators | 06/27/2023 |
K211959 | Materna Medical | Milli Vaginal Dilator | 12/01/2021 |
K220035 | Materna Medical | Milli Vaginal Dilator | 02/27/2023 |
K130273 | Panpac Medical Corporation | PANPAC VAGINAL DILATORS | 08/08/2013 |
K231430 | Plus EV Holdings dba Intimate Rose | Intimate Rose Vaginal Dilators | 06/07/2023 |