FDA.reportPublic FDA data

Inflatable penile prosthesis

Definition
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.
GUDID devices
222
Last updated
2025-08-06 18:51:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05701780278034TitanColoplast A/S5193002025-07-29
05708932768115Titan ClassicColoplast A/SES88242024-10-29
05708932768139Titan ClassicColoplast A/SES89242024-10-29
05708932768153Titan TouchColoplast A/SES28242024-10-29
05708932768177Titan TouchColoplast A/SES29242024-10-29
00191506021214AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044082024-01-26
00191506021290AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044202024-01-26
00191506021306AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044392024-01-26
00191506021412AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044502024-01-26
00191506021429AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044512024-01-26
00191506021436AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044522024-01-26
00191506021443AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044532024-01-26
00191506021450AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044552024-01-26
00191506021467AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044562024-01-26
00191506021474AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044572024-01-26
00191506021481AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044582024-01-26
00191506021498AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044602024-01-26
00191506021504AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044612024-01-26
00191506021511AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044622024-01-26
00191506021528AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044632024-01-26
00191506021535AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044642024-01-26
00191506021542AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044652024-01-26
00191506021559AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044662024-01-26
00191506021566AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044672024-01-26
00191506021573AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044682024-01-26
00191506021580AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044692024-01-26
00191506021597AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044802024-01-26
00191506021603AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044812024-01-26
00191506021610AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044822024-01-26
00191506021627AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044832024-01-26
00191506021634AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044842024-01-26
00191506021641AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044852024-01-26
00191506021658AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044862024-01-26
00191506021665AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044872024-01-26
00191506021672AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044882024-01-26
00191506021689AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATION724044892024-01-26
05701780276979TitanColoplast A/S5191502023-05-11
05701780277006TitanColoplast A/S5193102023-05-11
05708932072519Titan®Coloplast A/STitan Touch2017-10-16
05708932072526Titan®Coloplast A/STitan Touch2017-10-16
05708932072557Titan®Coloplast A/STitan Touch2017-10-16
05708932072564Titan®Coloplast A/STitan Touch2017-10-16
05708932072595Titan®Coloplast A/STitan2017-10-16
05708932072601Titan®Coloplast A/STitan2017-10-16
05708932072632Titan®Coloplast A/STitan2017-10-16
05708932072649Titan®Coloplast A/STitan2017-10-16
05708932319621TitanColoplast A/S90-9000KC2014-07-21
05708932319744TitanColoplast A/S90-9000KCOTR2014-07-21
05708932322348TitanColoplast A/S90-9816INC2014-09-19
05708932322584TitanColoplast A/S90-9818INC2014-09-19
05708932323604TitanColoplast A/S90-9916SNC2014-09-19
05708932323901TitanColoplast A/S90-9918SNC2014-09-19
05708932473910TitanColoplast A/SER80752014-07-25
05708932473927TitanColoplast A/SER81252014-07-25
05708932487146TitanColoplast A/SES88112014-09-19
05708932487160TitanColoplast A/SES88142014-09-19
05708932487184TitanColoplast A/SES88162014-07-21
05708932487221TitanColoplast A/SES88182014-07-21
05708932487245TitanColoplast A/SES88202014-07-21
05708932487269TitanColoplast A/SES88222014-07-21
05708932487283TitanColoplast A/SES89112014-09-19
05708932487306TitanColoplast A/SES89142014-09-19
05708932487320TitanColoplast A/SES89162014-07-21