Coloplast Manufacturing Us, LLC is one of 15078 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Coloplast Manufacturing Us, LLC - FDA 510(k) Cleared Devices
Recent clearances: SELF CATH CATHETER, DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE, VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
4
Total
4
Cleared
0
Denied
Coloplast Manufacturing Us, LLC has 4 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Historical record: 4 cleared submissions from 2007 to 2010. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Coloplast Manufacturing Us, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Coloplast Manufacturing Us, LLC
4 devices
Cleared
May 26, 2010
SELF CATH CATHETER
Gastroenterology & Urology
57d
Cleared
Feb 01, 2010
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE...
General & Plastic Surgery
123d
Cleared
Oct 17, 2008
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
Gastroenterology & Urology
37d
Cleared
Jun 01, 2007
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
Gastroenterology & Urology
58d