Coloplast A/S - FDA 510(k) Cleared Devices
Recent clearances: Luja Soft, Altis Single Incision Sling System, Saffron Fixation System
72
Total
69
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast A/S Obstetrics & Gynecology ✕
6 devices
Cleared
Jun 10, 2022
Saffron Fixation System
Obstetrics & Gynecology
116d
Cleared
Feb 12, 2018
Digitex Delivery Device
Obstetrics & Gynecology
90d
Cleared
Feb 12, 2014
RESTORELLE Y CONTOUR MESH
Obstetrics & Gynecology
27d
Cleared
Mar 05, 2013
RESTORELLE Y CONTOUR
Obstetrics & Gynecology
76d
Cleared
May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
Obstetrics & Gynecology
279d
Cleared
May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Obstetrics & Gynecology
164d