FAE

AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

Advisory panel: Gastroenterology, Urology
Total cleared: 32

Adverse events under product code FAE

product code FAE

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 →

Recent clearances under product code FAE

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.