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Bayer Corp

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
96
Inspections
38
Compliance Actions
2

Known Names

bayer, bayer healthcare manufacturing, bayer medical care, bayer medical, bayer healthcare, bayer healthcare, diagnostics division, bayer sa, bayer (south east asia)

Recent Recalls

NumberClassProductDate
Z-1673-2014Class IIMedrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System April 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K024062ASCENSIA BREEZE BLOOD GLUCOSE METERMarch 3, 2003
K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTFebruary 11, 2003
K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYJanuary 30, 2003
K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALJanuary 23, 2003
K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMDecember 17, 2002
K023584ASCENSIA DEX 2 DIABETES CARE SYSTEMNovember 20, 2002
K020828CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEMJuly 24, 2002
K021428CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEMJuly 5, 2002
K020806ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYMarch 27, 2002
K013568CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMDecember 21, 2001
K012337BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEMDecember 6, 2001
K011963ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAYNovember 20, 2001
K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYOctober 25, 2001
K012777ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYSOctober 22, 2001
K012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)October 1, 2001
K012205GLUCOMETER DEX TEST SENSORSeptember 12, 2001
K010755BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAYAugust 20, 2001
K010668BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAYJuly 5, 2001
K003412ADVIA CENTAUR RUBELLA IGG ASSAYApril 13, 2001
K010201BAYER ADVIA IMS SYSTEMMarch 29, 2001