Coloplast Corp. - FDA 510(k) Cleared Devices
Recent clearances: Heylo™ System, Luja Coudé, Luja Set
54
Total
47
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast Corp. Obstetrics & Gynecology ✕
4 devices
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
RESTORELLE L
Obstetrics & Gynecology
101d
Cleared
Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Obstetrics & Gynecology
21d