Panels › Gastroenterology, Urology › Product code FAE · Class 2
Prosthesis, Penile
Regulation 876.3630
0510(k)s in 12 months (32 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in FAE
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems, Inc. | 11 | 2 |
| Dacomed Corp. | 7 | 0 |
| Mentor Corp. | 5 | 0 |
| Medical Engineering Corp. | 2 | 0 |
| American Medical Corp. | 1 | 0 |
| Boston Scientific Corporation | 1 | 0 |
| Burditt & Calkins-Siemens-Elema | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Coloplast Manufacturing US, LLC | 0 | 1 |
| Rigicon, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2019 | K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device Boston Scientific Corporation | FAE |
| Apr 15, 2019 | K181673 | Rigi10 Malleable Penile Prosthesis Rigicon, Inc. | FAE |
| Apr 9, 2009 | K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Oct 20, 2008 | K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Oct 29, 2004 | K040959 | MENTOR GENESIS PENILE PROSTHESIS Mentor Corp. | FAE |
| Dec 4, 1996 | K963328 | AMS AMBICOR PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Oct 27, 1995 | K953640 | DUNA II PENILE PROSTHESIS Dacomed Corp. | FAE |
| Jul 6, 1995 | K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS American Medical Systems, Inc. | FAE |
| Apr 16, 1992 | K920420 | DURA II PENILE PROSTHESIS Dacomed Corp. | FAE |
| Mar 18, 1992 | K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Oct 11, 1991 | K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS Dacomed Corp. | FAE |
| Apr 25, 1991 | K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS American Medical Corp. | FAE |
| Dec 13, 1990 | K904262 | MINNOW PENILE IMPLANT PROTECTOR Ruja-Med Medical Marketing | FAE |
| Nov 2, 1990 | K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES Mentor Corp. | FAE |
| Jun 27, 1990 | K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER American Medical Systems, Inc. | FAE |
| Mar 6, 1990 | K896941 | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Aug 3, 1989 | K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) Mentor Corp. | FAE |
| Sep 18, 1987 | K871653 | DURAPHASE PENILE PROSTHESIS Dacomed Corp. | FAE |
| Oct 24, 1986 | K864040 | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS C.R. Bard, Inc. | FAE |
| Mar 11, 1986 | K860517 | MENTOR CORPORAL DILATORS Mentor Corp. | FAE |
| Apr 9, 1985 | K850019 | OMNI PHASE PENILE PROSTHESIS Dacomed Corp. | FAE |
| Oct 24, 1984 | K843280 | MALLEABLE PENILE PROSTHESIS Mentor Corp. | FAE |
| Apr 2, 1984 | K834347 | FLEXI-FLATE PENILE IMPLANT Surgitek | FAE |
| Feb 4, 1984 | K834504 | ESKA JONAS SILICON-SILVER PENILE Dacomed Corp. | FAE |
| Oct 20, 1983 | K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND Medical Engineering Corp. | FAE |
| Aug 8, 1983 | K831660 | AMS MALLEABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Apr 12, 1983 | K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS Medical Engineering Corp. | FAE |
| Apr 12, 1983 | K830048 | INFLATABLE PENILE PROSTH. - CYLINDER American Medical Systems, Inc. | FAE |
| Aug 10, 1982 | K821628 | THE INFLATABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Jan 25, 1982 | K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST Dacomed Corp. | FAE |
| Jan 23, 1981 | K803111 | ERECTAID Burditt & Calkins-Siemens-Elema | FAE |
| Sep 9, 1980 | K792724 | AMS MALLEABLE OR JONAS SILICONE-SILVER American Medical Systems, Inc. | FAE |
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