Unomedical A/S is one of 44 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
Unomedical A/S - FDA 510(k) Cleared Devices
Recent clearances: Medtronic Extended infusion set, neria guard Infusion Set, MiniMed Mio Advance infusion set
13
Total
13
Cleared
0
Denied
Unomedical A/S has 13 FDA 510(k) cleared general hospital devices. Based in Roskilde, DK.
Last cleared in 2021. Active since 2003.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Emergo Global Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Unomedical A/S
13 devices
Cleared
Jul 16, 2021
Medtronic Extended infusion set
Chemistry
142d
Cleared
Dec 13, 2019
neria guard Infusion Set
General Hospital
80d
Cleared
Mar 05, 2018
MiniMed Mio Advance infusion set
General Hospital
74d
Cleared
Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short...
General Hospital
391d
Cleared
Aug 10, 2016
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
General Hospital
156d
Cleared
Oct 08, 2013
NERIA SOFT 90 INFUSION SET
General Hospital
89d
Cleared
Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
General Hospital
13d
Cleared
Apr 04, 2007
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
General Hospital
50d
Cleared
Jul 31, 2006
INTUITION INFUSION SETS
General Hospital
75d
Cleared
Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
General Hospital
108d
Cleared
Jun 30, 2004
CONTACT DETACH
General Hospital
21d
Cleared
Apr 01, 2004
CLICK-ON
General Hospital
22d