FAE

Product Code: FAE


Products Classified as FAE

1719Prosthesis, PenilePenile Rigidity Implant.

Total Product Life Cycle (TPLC) Devices

1719Prosthesis, PenilePenile Rigidity Implant.

Pre-market Notifications for FAE

K183619Tactra Penile Prosthesis, 9.5 Mm Device, Tactra Penile Prosthesis, 11 Mm Device, Tactra Penile Prosthesis, 13 Mm DeviceBoston Scientific Corporation
K181673Rigi10 Malleable Penile ProsthesisRigicon Inc.
K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISAMERICAN MEDICAL SYSTEMS, INC.
K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESISAMERICAN MEDICAL SYSTEMS, INC.
K040959MENTOR GENESIS PENILE PROSTHESISMENTOR CORP.
K963328AMS AMBICOR PENILE PROSTHESISAMERICAN MEDICAL SYSTEMS, INC.
K953640DUNA II PENILE PROSTHESISDACOMED CORP.
K951716AMS 650 MALLERABLE PENIEL PROSTHESISAMERICAN MEDICAL SYSTEMS, INC.
K920420DURA II PENILE PROSTHESISDACOMED CORP.
K912935AMS MALLEABLE 600 AND 600M PENILE PROSTHESISAMERICAN MEDICAL SYSTEMS, INC.
K912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISDACOMED CORP.
K910214AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESISAMERICAN MEDICAL CORP.
K904262MINNOW PENILE IMPLANT PROTECTORRUJA-MED MEDICAL MARKETING
K901482700 ULTREX PENILE PROSTHESIS 12MM DIAMETERAMERICAN MEDICAL SYSTEMS, INC.
K900371MENTOR MODIFIED MALLEABLE PENILE PROSTHESESMENTOR CORP.

Global Unique Device Identification Database

00878953005409Prosthesis, Penile
00878953005393Prosthesis, Penile
00878953005294Prosthesis, Penile
00878953005287Prosthesis, Penile
00878953005270Prosthesis, Penile
00878953005256Prosthesis, Penile
00878953005249Prosthesis, Penile
00878953005232Prosthesis, Penile
00878953005225Prosthesis, Penile
00878953005218Prosthesis, Penile
00878953005201Prosthesis, Penile
00878953000503Prosthesis, Penile
00878953000497Prosthesis, Penile
05708932324809PROSTHESIS, PENILE
05708932324748PROSTHESIS, PENILE

Maude Adverse Events

AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-31
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-31
TACTRA MALLEABLE PENILE PROTHESISBOSTON SCIENTIFIC CORPORATION2020-03-30
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-30
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-30
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-26
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-25
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-24
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-24
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-20
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-18
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-17
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-17
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-12
GENESIS MALLEABLECOLOPLAST A/S2020-03-12
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-10
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-05
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-03-04
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-20
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-20
TACTRA MALLEABLE PENILE PROTHESISBOSTON SCIENTIFIC CORPORATION2020-02-19
GENESIS KIT 11 COATEDCOLOPLAST A/S2020-02-19
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-19
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-11
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-07
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-06
TACTRA MALLEABLE PENILE PROTHESISBOSTON SCIENTIFIC CORPORATION2020-02-06
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-05
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-05
GENESIS KIT 11 COATEDCOLOPLAST A/S2020-02-03
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-02-03
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-31
GENESIS KIT 11 COATEDCOLOPLAST A/S2020-01-30
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-29
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-29
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-28
GENESIS KIT 13 COATEDCOLOPLAST A/S2020-01-22
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-22
TACTRA MALLEABLE PENILE PROTHESISBOSTON SCIENTIFIC CORPORATION2020-01-22
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-17
GENESISCOLOPLAST A/S2020-01-16
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-16
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-14
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-14
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-13
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-13
TACTRA MALLEABLE PENILE PROTHESISBOSTON SCIENTIFIC CORPORATION2020-01-10
GENESIS KIT 13 COATEDCOLOPLAST A/S2020-01-10
GENESIS KIT 13 COATEDCOLOPLAST A/S2020-01-08
AMS SPECTRA CONCEALABLE PENILE PROSTHESISBOSTON SCIENTIFIC CORPORATION2020-01-08
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