Bayer Healthcare, LLC is one of 5574 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bayer Healthcare, LLC - FDA 510(k) Cleared Devices
Recent clearances: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device), ALEVE Direct Therapy (ALEVE Direct Therapy TENS device), CONTOUR NEXT EZ BLOOD GLUCOSE METER
46
Total
46
Cleared
0
Denied
Bayer Healthcare, LLC has 46 FDA 510(k) cleared chemistry devices. Based in New York, US.
Historical record: 46 cleared submissions from 2003 to 2018.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
5 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Bayer Healthcare, LLC
46 devices
Cleared
Mar 07, 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Neurology
261d
Cleared
Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
Neurology
84d
Cleared
Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
Chemistry
504d
Cleared
CT
Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
Chemistry
98d
Cleared
CT
Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
Chemistry
393d
Cleared
CT
Mar 12, 2010
DIDGET WORLD REPORTS
Chemistry
80d
Cleared
CT
Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
Chemistry
270d
Cleared
CT
May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
Chemistry
85d
Cleared
Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
Chemistry
41d
Cleared
Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
Chemistry
345d
Cleared
Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
Chemistry
59d
Cleared
Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
104d
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