Omnitech Systems, Inc. is one of 4782 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Omnitech Systems, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Omnitech Systems, Inc. has 6 FDA 510(k) cleared medical devices. Based in Valparaiso, US.
Historical record: 6 cleared submissions from 1997 to 2016. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Omnitech Systems, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Omnitech Systems, Inc.
6 devices
Cleared
Jun 27, 2016
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Gastroenterology & Urology
347d
Cleared
May 27, 2005
OMNITECH FULGURATING ELECTRODE
Gastroenterology & Urology
94d
Cleared
Jul 17, 1998
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
Obstetrics & Gynecology
85d
Cleared
Jul 10, 1998
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
Obstetrics & Gynecology
78d
Cleared
Apr 22, 1997
RESECTOSCOPE CUTTING LOOP ELECTRODE
Gastroenterology & Urology
172d
Cleared
Mar 19, 1997
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
Gastroenterology & Urology
90d