Bayer Corp
Bayer Corp appears in FDA public data with 1 recall, 96 510(k) clearances, 38 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1673-2014, Class II) was initiated on April 3, 2014. Its most recent 510(k) clearance was granted on March 3, 2003.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 96
- Inspections
- 38
- Compliance Actions
- 2
Known Names
bayer, bayer healthcare manufacturing, bayer de mexico, s.a de c.v, bayer healthcare, bayer healthcare, diagnostics division, bayer medical care, bayer medical, bayer de colombia, bayer (south east asia), bayer sa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1673-2014 | Class II | Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System | April 3, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | March 3, 2003 |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | February 11, 2003 |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | January 30, 2003 |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | January 23, 2003 |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | December 17, 2002 |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | November 20, 2002 |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | July 24, 2002 |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | July 5, 2002 |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | March 27, 2002 |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | December 21, 2001 |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | December 6, 2001 |
| K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | November 20, 2001 |
| K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | October 25, 2001 |
| K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | October 22, 2001 |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | October 1, 2001 |
| K012205 | GLUCOMETER DEX TEST SENSOR | September 12, 2001 |
| K010755 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY | August 20, 2001 |
| K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY | July 5, 2001 |
| K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY | April 13, 2001 |
| K010201 | BAYER ADVIA IMS SYSTEM | March 29, 2001 |