Product code FAE— Gastroenterology, Urology

Injury

995

Total

995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific Corporation·2019-04-16
• K181673 — Rigi10 Malleable Penile ProsthesisRigicon, Inc.·2019-04-15
• K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.·2009-04-09
• K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.·2008-10-20
• K040959 — MENTOR GENESIS PENILE PROSTHESISMentor Corp.·2004-10-29
• K963328 — AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.·1996-12-04
• K953640 — DUNA II PENILE PROSTHESISDacomed Corp.·1995-10-27
• K951716 — AMS 650 MALLERABLE PENIEL PROSTHESISAmerican Medical Systems, Inc.·1995-07-06
• K920420 — DURA II PENILE PROSTHESISDacomed Corp.·1992-04-16
• K912935 — AMS MALLEABLE 600 AND 600M PENILE PROSTHESISAmerican Medical Systems, Inc.·1992-03-18
• K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISDacomed Corp.·1991-10-11
• K910214 — AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESISAmerican Medical Corp.·1991-04-25
• K904262 — MINNOW PENILE IMPLANT PROTECTORRuja-Med Medical Marketing·1990-12-13
• K900371 — MENTOR MODIFIED MALLEABLE PENILE PROSTHESESMentor Corp.·1990-11-02
• K901482 — 700 ULTREX PENILE PROSTHESIS 12MM DIAMETERAmerican Medical Systems, Inc.·1990-06-27
• K896941 — AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESISAmerican Medical Systems, Inc.·1990-03-06
• K890402 — MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)Mentor Corp.·1989-08-03
• K871653 — DURAPHASE PENILE PROSTHESISDacomed Corp.·1987-09-18
• K864040 — BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESISC.R. Bard, Inc.·1986-10-24
• K860517 — MENTOR CORPORAL DILATORSMentor Corp.·1986-03-11
• K850019 — OMNI PHASE PENILE PROSTHESISDacomed Corp.·1985-04-09
• K843280 — MALLEABLE PENILE PROSTHESISMentor Corp.·1984-10-24
• K834347 — FLEXI-FLATE PENILE IMPLANTSurgitek·1984-04-02
• K834504 — ESKA JONAS SILICON-SILVER PENILEDacomed Corp.·1984-02-04
• K832043 — SURGIKEK PENILE PROSTHESIS TAIL EXTENDMedical Engineering Corp.·1983-10-20
• K831660 — AMS MALLEABLE PENILE PROSTHESISAmerican Medical Systems, Inc.·1983-08-08
• K830048 — INFLATABLE PENILE PROSTH. - CYLINDERAmerican Medical Systems, Inc.·1983-04-12
• K830917 — SURGITEK SIZER FOR PENILE PROSTHESISMedical Engineering Corp.·1983-04-12
• K821628 — THE INFLATABLE PENILE PROSTHESISAmerican Medical Systems, Inc.·1982-08-10
• K820081 — ESKA JONAS SILICONE-SILVER PENILE PROSTDacomed Corp.·1982-01-25
• K803111 — ERECTAIDBurditt & Calkins-Siemens-Elema·1981-01-23
• K792724 — AMS MALLEABLE OR JONAS SILICONE-SILVERAmerican Medical Systems, Inc.·1980-09-09