Coloplast Corp. - FDA 510(k) Cleared Devices
54
Total
47
Cleared
0
Denied
Coloplast Corp. has 47 FDA 510(k) cleared medical devices. Based in Marietta, US.
Latest FDA clearance: Oct 2025. Active since 1985. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Coloplast Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Coloplast Corp.
54 devices
Cleared
Oct 06, 2025
Heylo™ System
Gastroenterology & Urology
90d
Cleared
Jun 27, 2025
Luja Coudé
Gastroenterology & Urology
77d
Cleared
Apr 17, 2025
Luja Set
Gastroenterology & Urology
77d
Cleared
Nov 26, 2024
SureCath Set
Gastroenterology & Urology
137d
Cleared
Nov 21, 2024
Luja Coude
Gastroenterology & Urology
205d
Cleared
Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10,...
Gastroenterology & Urology
111d
Cleared
Oct 18, 2024
Altis Single Incision Sling System (519650)
Gastroenterology & Urology
59d
Cleared
Apr 15, 2024
Folysil Silicone Catheter
Gastroenterology & Urology
192d
Cleared
Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
General & Plastic Surgery
266d
Cleared
Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
Gastroenterology & Urology
30d
Cleared
Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone...
Gastroenterology & Urology
252d
Cleared
Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy...
Gastroenterology & Urology
262d
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