Coloplast Manufacturing US, LLC

FDA Regulatory Profile

Summary

Total Recalls
28
510(k) Clearances
4
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0844-2025Class IIFolysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, ADecember 2, 2024
Z-0845-2025Class IIX-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB61December 2, 2024
Z-1463-2024Class IIUreteral dilator, REF RBD014March 11, 2024
Z-1370-2023Class IITitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ProsthesisMarch 1, 2023
Z-1368-2023Class IITitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile ProsthesisMarch 1, 2023
Z-1359-2023Class IITitan Touch Pump, Catalog Numbers 5177502400; inflatable penile ProsthesisMarch 1, 2023
Z-1374-2023Class IITitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile ProsthesisMarch 1, 2023
Z-1373-2023Class IITitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile ProsthesisMarch 1, 2023
Z-1361-2023Class IITitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile ProsthesisMarch 1, 2023
Z-1365-2023Class IITitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile ProsthesisMarch 1, 2023
Z-1375-2023Class IITitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile ProsthesisMarch 1, 2023
Z-1369-2023Class IITitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ProsthesisMarch 1, 2023
Z-1363-2023Class IITitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ProsthesisMarch 1, 2023
Z-1372-2023Class IITitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile ProsthesisMarch 1, 2023
Z-1362-2023Class IITitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile ProsthesisMarch 1, 2023
Z-1364-2023Class IITitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ProsthesisMarch 1, 2023
Z-1366-2023Class IITitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ProsthesisMarch 1, 2023
Z-1371-2023Class IITitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ProsthesisMarch 1, 2023
Z-1367-2023Class IITitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ProsthesisMarch 1, 2023
Z-1360-2023Class IITitan Pump Assembly, Catalog Number 5177701400; inflatable penile ProsthesisMarch 1, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K100878SELF CATH CATHETERMay 26, 2010
K093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEXFebruary 1, 2010
K082640VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEMOctober 17, 2008
K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMJune 1, 2007