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Bayer Healthcare, LLC

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
55
Inspections
23
Compliance Actions
2

Known Names

bayer healthcare, bayer healthcare co

Recent Recalls

NumberClassProductDate
Z-0927-2017Class IIMEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose oNovember 7, 2016
Z-0400-2017Class IIPET Infusion PumpSeptember 30, 2016
Z-2768-2016Class IICertegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number #August 2, 2016
Z-2244-2016Class IIAngiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile DiJune 9, 2016
Z-0627-2016Class IIMedrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion November 30, 2015
Z-2775-2015Class IIAngiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 0August 4, 2015
Z-2482-2015Class IIContour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control soJune 22, 2015
Z-0136-2014Class IIBayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c MoniAugust 26, 2013
D-177-2013Class IIIBronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/ExpectorantDecember 7, 2012
D-1423-2012Class IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, DistributApril 26, 2012
D-1424-2012Class IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 02April 26, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)March 7, 2018
K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)December 22, 2015
K150942Contour Next USB Blood Glucose Monitoring SystemNovember 25, 2015
K151742Contour Next Control SolutionSeptember 23, 2015
K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERJune 23, 2014
K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORSeptember 26, 2013
K121190CONTOUR NEXT BLOOD GLUCOSE METERJuly 26, 2012
K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMJune 28, 2012
K110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH,March 28, 2012
K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERMarch 28, 2012
K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMMarch 6, 2012
K093930DIDGET WORLD REPORTSMarch 12, 2010
K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080December 4, 2009
K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMAugust 26, 2009
K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 302May 14, 2009
K082486GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWAREOctober 8, 2008
K063845ADVIA CHEMISTRY TOTAL BILIRUBIN_2December 7, 2007
K063276CLINITEK ADVANTUS, MODEL 1420December 28, 2006
K062347ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEMNovember 22, 2006
K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080September 11, 2006