Panels › Gastroenterology, Urology › Product code FHW · Class 3

Device, Impotence, Mechanical/Hydraulic

Regulation 876.3350

0510(k)s in 12 months (0 all time)

0recalls in 12 months (20 all time)

0recalls that name a 510(k)

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Top companies in FHW

Company	510(k)s	Recalls
Coloplast Manufacturing US, LLC	0	20

Date	Firm and product	Code	Linked 510(k)
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Apr 12, 2023	Coloplast Manufacturing US, LLC Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis Open, Classified	FHW	None listed
Nov 9, 2021	Coloplast Manufacturing US, LLC Torosa Saline-Filled Testicular Prosthesis (Size Small) Terminated	FHW	None listed
Oct 23, 2020	Coloplast Manufacturing US, LLC 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. Terminated	FHW	None listed
Nov 10, 2009	Coloplast Manufacturing US, LLC 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 Cor Terminated	FHW	None listed

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