Ypsomed AG is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
Ypsomed AG - FDA 510(k) Cleared Devices
Recent clearances: SmartPilot YpsoMate NS-A2.25
12
Total
12
Cleared
0
Denied
Ypsomed AG has 12 FDA 510(k) cleared general hospital devices. Based in Burgdorf, CH.
Latest FDA clearance: Aug 2025. Active since 2010.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ypsomed AG
12 devices
Cleared
Aug 28, 2025
SmartPilot YpsoMate NS-A2.25
General Hospital
252d
Cleared
Oct 11, 2017
Clickfine Pen Needle, Penfine Classic Pen Needle
General Hospital
103d
Cleared
Jul 26, 2017
Orbit Inserter
General Hospital
233d
Cleared
Apr 12, 2016
Orbit Infusion Set
General Hospital
372d
Cleared
Nov 18, 2015
Clickfine AutoProtect Pen Needle
General Hospital
77d
Cleared
Jun 09, 2015
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
General Hospital
88d
Cleared
Jul 05, 2013
CLICKFINE AUTOPROTECT PEN NEEDLE
General Hospital
74d
Cleared
Jul 05, 2013
CLICKFINE PEN NEEDLE
General Hospital
74d
Cleared
Mar 19, 2013
ORBIT INFUSION SET
General Hospital
22d
Cleared
Jan 26, 2012
CLICKFINE AUTOPROTECT PEN NEEDLE
General Hospital
358d
Cleared
Nov 23, 2010
CLICKFINE PEN NEEDLE
General Hospital
119d
Cleared
Apr 30, 2010
CLICKFINE PEN NEEDLE
General Hospital
73d