Prosthesis, Penile
FDA product code FAE · 32 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.3630
- Review panel
- GU
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1980-09-09 – 2019-04-16
FAE
2019-04-16
FAE
2019-04-15
Rigi10 Malleable Penile Prosthesis
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FAE
2009-04-09
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
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FAE
2008-10-20
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
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FAE
2004-10-29
MENTOR GENESIS PENILE PROSTHESIS
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FAE
1996-12-04
AMS AMBICOR PENILE PROSTHESIS
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FAE
1995-10-27
DUNA II PENILE PROSTHESIS
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FAE
1995-07-06
AMS 650 MALLERABLE PENIEL PROSTHESIS
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FAE
1992-04-16
DURA II PENILE PROSTHESIS
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FAE
1992-03-18
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
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FAE
1991-10-11
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
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FAE
1991-04-25
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
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FAE
1990-12-13
MINNOW PENILE IMPLANT PROTECTOR
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FAE
1990-11-02
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
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FAE
1990-06-27
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
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FAE
1990-03-06
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
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FAE
1989-08-03
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
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FAE
1987-09-18
DURAPHASE PENILE PROSTHESIS
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FAE
1986-10-24
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
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FAE
1986-03-11
MENTOR CORPORAL DILATORS
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FAE
1985-04-09
OMNI PHASE PENILE PROSTHESIS
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FAE
1984-10-24
MALLEABLE PENILE PROSTHESIS
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FAE
1984-04-02
FLEXI-FLATE PENILE IMPLANT
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FAE
1984-02-04
ESKA JONAS SILICON-SILVER PENILE
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FAE
1983-10-20
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
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FAE
1983-08-08
AMS MALLEABLE PENILE PROSTHESIS
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FAE
1983-04-12
SURGITEK SIZER FOR PENILE PROSTHESIS
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FAE
1983-04-12
INFLATABLE PENILE PROSTH. - CYLINDER
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FAE
1982-08-10
THE INFLATABLE PENILE PROSTHESIS
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FAE
1982-01-25
ESKA JONAS SILICONE-SILVER PENILE PROST
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FAE
1981-01-23
ERECTAID
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FAE
1980-09-09
AMS MALLEABLE OR JONAS SILICONE-SILVER
View details →No matching devices.
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