I.E.M. GmbH is one of 4771 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
I.E.M. GmbH - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
I.E.M. GmbH has 5 FDA 510(k) cleared medical devices. Based in Bonita Springs, US.
Historical record: 5 cleared submissions from 2004 to 2016. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by I.E.M. GmbH Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - I.E.M. GmbH
5 devices
Cleared
Jul 19, 2016
ABPM 7100, Hypertension Management Software
Cardiovascular
218d
Cleared
Sep 15, 2014
ABPM7100
Cardiovascular
157d
Cleared
Dec 16, 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
Cardiovascular
288d
Cleared
Nov 29, 2007
MOBIL-O-GRAPH NG 24 H ABP-CONTROL
Cardiovascular
91d
Cleared
Jun 18, 2004
STABIL-O-GRAPH
Cardiovascular
32d