Bayer Healthcare is one of 13027 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bayer Healthcare - FDA 510(k) Cleared Devices
Recent clearances: Contour Next USB Blood Glucose Monitoring System, Contour Next Control Solution, CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
9
Total
9
Cleared
0
Denied
Bayer Healthcare has 9 FDA 510(k) cleared medical devices. Based in Mishawaka, US.
Historical record: 9 cleared submissions from 2006 to 2015. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Bayer Healthcare Filter by specialty or product code using the sidebar.
3 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Bayer Healthcare
9 devices
Cleared
Nov 25, 2015
Contour Next USB Blood Glucose Monitoring System
Chemistry
231d
Cleared
Sep 23, 2015
Contour Next Control Solution
Chemistry
86d
Cleared
Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
Chemistry
416d
Cleared
CT
Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
79d
Cleared
CT
Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
Chemistry
364d
Cleared
CT
Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
307d
Cleared
Aug 26, 2009
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS
Chemistry
69d
Cleared
Sep 11, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
Chemistry
53d
Cleared
Apr 12, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
Chemistry
48d