Asahi Kasei Medical Co., Ltd. is one of 15076 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Asahi Kasei Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Asahi ViE-U Series Dialyzer, Asahi REXEED-S Series Dialyzer, ASAHI REXEED-SX/LX SERIES DIALYZER
5
Total
5
Cleared
0
Denied
Asahi Kasei Medical Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Rockville, US.
Historical record: 5 cleared submissions from 2005 to 2017. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Asahi Kasei Medical Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Qserve Group, Us, Inc. and Boston Biomedical Associates. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Asahi Kasei Medical Co., Ltd.
5 devices
Cleared
CT
May 03, 2017
Asahi ViE-U Series Dialyzer
Gastroenterology & Urology
266d
Cleared
Dec 17, 2015
Asahi REXEED-S Series Dialyzer
Gastroenterology & Urology
28d
Cleared
Feb 06, 2013
ASAHI REXEED-SX/LX SERIES DIALYZER
Gastroenterology & Urology
271d
Cleared
Oct 03, 2008
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX,...
Gastroenterology & Urology
31d
Cleared
Jun 08, 2005
REXEED SERIES DIALYZERS
Gastroenterology & Urology
30d