B. Braun Avitum AG is one of 15078 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
B. Braun Avitum AG - FDA 510(k) Cleared Devices
Recent clearances: Diacap Pro Dialyzer, xevonta dialyzer, SOLCART B
5
Total
5
Cleared
0
Denied
B. Braun Avitum AG has 5 FDA 510(k) cleared medical devices. Based in Allentown, US.
Historical record: 5 cleared submissions from 2010 to 2017. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by B. Braun Avitum AG Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by B.Braun Medical, Inc. as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - B. Braun Avitum AG
5 devices
Cleared
CT
Aug 11, 2017
Diacap Pro Dialyzer
Gastroenterology & Urology
165d
Cleared
CT
Mar 01, 2016
xevonta dialyzer
Gastroenterology & Urology
449d
Cleared
Apr 25, 2011
SOLCART B
Gastroenterology & Urology
264d
Cleared
Apr 22, 2010
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
Gastroenterology & Urology
76d
Cleared
Feb 18, 2010
DIALOG WITH ADIMEA OPTION
Gastroenterology & Urology
454d