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

View 56 510(k) Devices ↓

56

Total

49

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coloplast Corp. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Aug 02, 2013

RESTORELLE M, RESTORELLE XL

Obstetrics & Gynecology · 30d

Cleared Dec 18, 2012

NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015

Obstetrics & Gynecology · 84d

Cleared Nov 19, 2012

Obstetrics & Gynecology · 101d

Cleared Sep 08, 2011

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

Obstetrics & Gynecology · 21d