59 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FHW·October 23, 2020
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FHW·October 6, 2009
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Torosa Saline-Filled Testicular Prosthesis (Size Small)
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FHW·November 9, 2021