BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    Torosa Saline-Filled Testicular Prosthesis (Size Small)

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 29, 2021