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Coloplast Corp.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories14
Latest Approval2025-10-06
TypeNumberDevice NameCodeDate
510(k) K252140 Heylo™ System EXB 2025-10-06 View
510(k) K251116 Luja Coudé EZD 2025-06-27 View
510(k) K250270 Luja Set EZD 2025-04-17 View
510(k) K242049 SureCath Set EZD 2024-11-26 View
510(k) K241210 Luja Coude EZD 2024-11-21 View
510(k) K242173 Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) FED 2024-11-12 View
510(k) K242473 Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) PAH 2024-10-18 View
510(k) K233411 Folysil Silicone Catheter EZL 2024-04-15 View
510(k) K231953 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) FRO 2024-03-22 View
510(k) K233101 Luja Coude (20108 Male CH18 - large packaging) EZD 2023-10-26 View
510(k) K213185 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits FAD 2022-06-08 View
510(k) K211911 Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets LJE 2022-03-10 View
510(k) K213186 NovoFlow Reinforced Ureteral Stent FAD 2022-02-16 View
510(k) K201436 Vortek Single Loop Ureteral Stent FAD 2021-02-25 View
510(k) K201165 In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath LJE 2020-12-17 View
510(k) K201007 In-Ka Ureteral Balloon Dilatation Catheter EZN 2020-06-11 View
510(k) K182831 SabreLine and SabreGuard Laser Fibers GEX 2018-12-10 View
510(k) K180469 ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent FAD 2018-11-06 View
510(k) K182122 Ureteric Catheters EYB 2018-10-04 View
PMA P020003 Prosthesis, testicular FAF 2018-09-04 View

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