FDA 510(k) Applications for Medical Device Product Code "FAE"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K963328 | AMERICAN MEDICAL SYSTEMS, INC. | AMS AMBICOR PENILE PROSTHESIS | 12/04/1996 |
K082006 | AMERICAN MEDICAL SYSTEMS, INC. | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | 10/20/2008 |
K090663 | AMERICAN MEDICAL SYSTEMS, INC. | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | 04/09/2009 |
K183619 | Boston Scientific Corporation | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | 04/16/2019 |
K040959 | MENTOR CORP. | MENTOR GENESIS PENILE PROSTHESIS | 10/29/2004 |
K181673 | Rigicon Inc. | Rigi10 Malleable Penile Prosthesis | 04/15/2019 |