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Sign in to claim this brandBayer Healthcare
US
Last updated May 23, 2026
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Catalogue (86)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Jetstream Sc | 112260-001 | FDA UDI | Class II | Active |
| Jetstream Xc | 112266-001 | FDA UDI | Class II | Active |
| Solent Dista | 111303-001 | FDA UDI | Class II | Active |
| Distaflex | 111304-001 | FDA UDI | Class III | Active |
| Aleve | 1613579 | FDA UDI | Class II | Unknown |
| Jetstream | 050599-001 | FDA UDI | Class II | Active |
| Angiojet | 105650-001 | FDA UDI | Class III | Active |
| Dr. Scholl's | 1612171 | FDA UDI | Class II | Unknown |
| Solent Omni | 109681-001 | FDA UDI | Class II | Active |
| Xvg | 105042-001 | FDA UDI | Class II | Active |
| Aleve | 1613538 | FDA UDI | Class II | Unknown |
| Jetstream Sc | 112262-001 | FDA UDI | Class II | Active |
| Avx | 105039-001 | FDA UDI | Class II | Active |
| Spiroflex | 106553-001 | FDA UDI | Class II | Active |
| Xmi | 105041-001 | FDA UDI | Class II | Active |
| Dr. Scholl's | 1612171 | FDA UDI | Class II | Unknown |
| Dr. Scholl's | 1612171 | FDA UDI | Class II | Unknown |
| Essure | ESS305 | FDA UDI | Class III | Unknown |
| Fetch 2 | 109400-001 | FDA UDI | Class II | Active |
| Essure | ESS305 (Kit) | FDA UDI | Class III | Unknown |
| Aleve | 1613538 | FDA UDI | Class II | Unknown |
| Solent Proxi | 109676-001 | FDA UDI | Class II | Active |
| Essure | ESS305-R1 | FDA UDI | Class III | Unknown |
| Spiroflex Vg | 106608-001 | FDA UDI | Class II | Active |
| Dr. Scholl's | 1612171 | FDA UDI | Class II | Unknown |
| Jetstream Xc | 112264-001 | FDA UDI | Class II | Active |
| Power Pulse | 104834-002 | FDA UDI | Class II | Active |
| Jetwire | 011525-001 | FDA UDI | Class II | Active |
| Tox Ammonia Calibrator | K031683 | FDA 510(k) | Class II | Active |
| Advia Ims Valproic Acid Method | K042807 | FDA 510(k) | Class II | Active |
| Glucofacts Express Diabetes Management Software | K082486 | FDA 510(k) | Class II | Active |
| Contour Next Ez Blood Glucose Meter | K130265 | FDA 510(k) | Class II | Active |
| Ascensia Breeze 2 Blood Glucose Monitoring System | K062347 | FDA 510(k) | Class II | Active |
| Acs:180 And Advia Centaur B-Type Natriuretic Peptide (bnp) Assays | K040425 | FDA 510(k) | Class II | Active |
| Contour Next Usb Blood Glucose Monitoring System | K121087 | FDA 510(k) | Class II | Active |
| Bayer Advia Chemistry Special Chemistry Control | K031644 | FDA 510(k) | Class I | Active |
| Advia Immuno Modular System (ims) B-Type Natriuretic Peptide (bnp) Assay | K051265 | FDA 510(k) | Class II | Active |
| Clinitest Hcg Pregnancy Test | K032563 | FDA 510(k) | Class II | Active |
| Bayer Advia Ims Psa Calibrator And Advia Ims Cpsa Calibrators | K061139 | FDA 510(k) | Class II | Active |
| Ascensia Elite Diabetes Care System | K043311 | FDA 510(k) | Class II | Active |
| Setpoint Chemistry Calibrator | K030169 | FDA 510(k) | Class II | Active |
| Clinitek Advantus, Model 1420 | K063276 | FDA 510(k) | Class II | Active |
| Advia Ims Direct Hdl Cholesterol Assay | K050632 | FDA 510(k) | Class I | Active |
| Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (high, Normal, Low) | K110587 | FDA 510(k) | Class II | Active |
| Troponin I Ultra Assay And Calibrator For The Advia Ims System | K052503 | FDA 510(k) | Class II | Active |
| Modification To Bayer Advia Centaur Automated Chemiluminescence Analyzer | K041133 | FDA 510(k) | Class II | Active |
| Contour Next Link Wireless Blood Glucose Monitor | K122370 | FDA 510(k) | Class II | Active |
| Lipoprotein Calibrator | K031682 | FDA 510(k) | Class II | Active |
| A1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self Chec | K090413 | FDA 510(k) | Class II | Active |
| Advia Ims Carbamazepine Method | K042808 | FDA 510(k) | Class II | Active |
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FDA Recalls (12)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 7, 2016 | Z-0927-2017 | — | terminated | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted. |
| Sep 30, 2016 | Z-0400-2017 | — | terminated | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date. |
| Aug 2, 2016 | Z-2768-2016 | — | terminated | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. |
| Jun 9, 2016 | Z-2244-2016 | — | terminated | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. |
| Nov 30, 2015 | Z-0627-2016 | — | terminated | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail |
| Aug 4, 2015 | Z-2775-2015 | — | terminated | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. |
| Jun 22, 2015 | Z-2482-2015 | — | terminated | If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low. |
| Aug 26, 2013 | Z-0136-2014 | — | terminated | Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release. |
| Aug 12, 2011 | Z-3268-2011 | — | terminated | All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood |
| Dec 21, 2007 | Z-0931-2008 | — | terminated | InaccurateTest Strip Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher. |
| Dec 21, 2007 | Z-0932-2008 | — | terminated | Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher. |
| Jun 6, 2007 | Z-1001-2007 | — | terminated | Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users. |