27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·May 6, 2015
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·June 12, 2013
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·May 29, 2013
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·April 27, 2016
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 Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020
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