Medical Device Manufacturer · US , Marietta , GA

Coloplast Corp. - FDA 510(k) Cleared Devices

56 submissions · 49 cleared · Since 1985

Recent clearances: Luja female, Triad Hydrophilic Wound Dresssing (1964, 2.5 oz), Heylo™ System

56
Total
49
Cleared
0
Denied

Coloplast Corp. has 49 FDA 510(k) cleared medical devices. Based in Marietta, US.

Latest FDA clearance: Oct 2026. 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.

510(k) submissions have been managed by Kompass Regulatory Consulting as regulatory consultant.

FDA 510(k) Regulatory Record - Coloplast Corp.

56 devices
1-12 of 56

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