20 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Ureteral dilator, REF RBD014
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023