Q Core Medical , Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Q Core Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Sapphire Infusion Pump, Sapphire administration sets
5
Total
5
Cleared
0
Denied
Q Core Medical , Ltd. has 5 FDA 510(k) cleared medical devices. Based in Gaithersburg, US.
Historical record: 5 cleared submissions from 2013 to 2020. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Q Core Medical , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Z&B Enterprises, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Q Core Medical , Ltd.
5 devices
Cleared
Nov 19, 2020
Sapphire Infusion Pump, Sapphire administration sets
General Hospital
412d
Cleared
Mar 27, 2017
Sapphire Infusion Pump
General Hospital
284d
Cleared
Dec 11, 2014
SAPPHIRE INFUSION PUMP
General Hospital
198d
Cleared
Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
General Hospital
29d
Cleared
Oct 17, 2013
SAPPHIRE INFUSION PUMP
General Hospital
384d