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Coloplast Corp. FDA Approvals
0 new drug approvals and 14 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 |
|---|
| Heylo System510(k)Oct 6, 2025Gastroenterology, Urology |
| Luja Coudé510(k)Jun 27, 2025Gastroenterology, Urology |
| Luja Set510(k)Apr 17, 2025Gastroenterology, Urology |
| SureCath Set510(k)Nov 26, 2024Gastroenterology, Urology |
| Luja Coude510(k)Nov 21, 2024Gastroenterology, Urology |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)510(k)Nov 12, 2024Gastroenterology, Urology |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)510(k)Oct 18, 2024General, Plastic Surgery |
| Folysil Silicone Catheter510(k)Apr 15, 2024Gastroenterology, Urology |
| Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)510(k)Mar 22, 2024 |
| Luja Coude (20108 Male CH18 - large packaging)510(k)Oct 26, 2023Gastroenterology, Urology |
| ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits510(k)Jun 8, 2022Gastroenterology, Urology |
| Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets510(k)Mar 10, 2022 |
| NovoFlow Reinforced Ureteral Stent510(k)Feb 16, 2022Gastroenterology, Urology |
| Vortek Single Loop Ureteral Stent510(k)Feb 25, 2021Gastroenterology, Urology |