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Coloplast FDA Approvals
0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)510(k)Jul 26, 2024Gastroenterology, Urology |
| Virtue Male Sling System with Alexis Wound Retractor Convenience Kit510(k)Sep 25, 2023General, Plastic Surgery |
| Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)510(k)Aug 25, 2023Gastroenterology, Urology |
| Self-Cath Closed System510(k)Aug 2, 2023Gastroenterology, Urology |
| Self-Cath and Self-Cath Plus510(k)Dec 2, 2022Gastroenterology, Urology |
| SpeediCath Flex Set510(k)Sep 21, 2022Gastroenterology, Urology |
| SpeedCath Compact Male510(k)Apr 26, 2022Gastroenterology, Urology |
| SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)510(k)Mar 8, 2022Gastroenterology, Urology |