Is this your brand? Sign in to claim ownership.

Bayer Healthcare

Last updated May 23, 2026

What Bayer Healthcare makes

The company manufactures thrombectomy and atherectomy devices, including suction catheters like the JETSTREAM SC and XMI, as well as rotational atherectomy/thrombectomy catheters such as the SOLENT DISTA and ANGIOJET. It also produces general-purpose medical suction systems (e.g., JETSTREAM), sterile catheter connectors, and peripheral vascular guidewires like the SPIROFLEX and XVG.

These devices are regulated under FDA pathways, including 510(k) clearances, PMA approvals, and UDI listings, spanning Class I, Class II, and Class III classifications. The company’s products are listed in the US regulatory system.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (86)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Didget World Reports	K093930	FDA 510(k)	Class II	Active
Bayer Advia 2120 Hematology Analyzer With Autoslide System	K042251	FDA 510(k)	Class II	Active
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)	K171802	FDA 510(k)	Class II	Active
Bayer Advia 1650 Special Chemistry Control	K030801	FDA 510(k)	Class I	Active
Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System	K091820	FDA 510(k)	Class II	Active
Contour Next Link Wireless Blood Glucose Meter	K110894	FDA 510(k)	Class II	Active
Advia Chemistry Microalbumin Controls	K052242	FDA 510(k)	Class I	Active
Advia Centaur B-Type Natriuretic Peptide (bnp) Assay	K031038	FDA 510(k)	Class II	Active
Contour Next Blood Glucose Meter	K121190	FDA 510(k)	Class II	Active
Contour Next Control Solution	K151742	FDA 510(k)	Class I	Active
Contour Next USB Blood Glucose Monitoring System	K150942	FDA 510(k)	Class II	Active
Bayer Clinitek Status Analyzer	K031947	FDA 510(k)	Class I	Active
Tnl-Ultra Assay For The Advia Centaur System	K053020	FDA 510(k)	Class II	Active
Advia Chemistry Total Bilirubin_2	K063845	FDA 510(k)	Class II	Active
Bayer Advia Centaur Ca 19-9 Assay	K031393	FDA 510(k)	Class II	Active
Acs:180 And Advia Centaur B-Type Natriuretic Peptide (bnp) Assays	K043228	FDA 510(k)	Class II	Active
Bayer Advia Centaur Automated Chemiluminescence Analyzer	K032525	FDA 510(k)	Class II	Active
Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080	K062058	FDA 510(k)	Class II	Active
Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080	K090628	FDA 510(k)	Class II	Active
Advia Centaur And Acs:180 Liquid Cardiac Markers 1, 2, 3	K030102	FDA 510(k)	Class I	Active
Advia Ims Lithium Assay	K050374	FDA 510(k)	Class II	Active
Bayer Rapidlab 1200 System	K031560	FDA 510(k)	Class II	Active
Ascensia Brio Blood Glucose Monitoring System	K043158	FDA 510(k)	Class II	Active
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)	K152852	FDA 510(k)	Class II	Active
Contour (r) Next Blood Glucose Monitoring System	K111268	FDA 510(k)	Class II	Active
Advia 60 Hematology Analyzer	K032524	FDA 510(k)	Class II	Active
Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080	K060470	FDA 510(k)	Class II	Active
Lipoprotein For Multiple Analytes	K051619	FDA 510(k)	Class II	Active
Modification To Bayer Advia 2120 Hematology Analyzer With Autoslide System	K051693	FDA 510(k)	Class II	Active
Advia Ims Cpsa Control	K061137	FDA 510(k)	Class I	Active
Bayer Advia 1650 Special Chemistry Calibrator	K030804	FDA 510(k)	Class II	Active
Bayer Specific Protein Reference Serum	K033791	FDA 510(k)	Class II	Active
Advia Ims Glucose Assay	K052163	FDA 510(k)	Class II	Active
Advia Centaur Hav Igm Ready Pack Reagents, Advia Centaur Hav Igm Quality Control Materials	P040018	FDA PMA	Class II	Active
Ciba Corning Acs Psa Immunoassay	P920030	FDA PMA	Class II	Active
Biostator Gciis	P790028	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

Bayer Healthcare has initiated 12 recall records between June 6, 2007, and November 7, 2016, all of which are recorded as terminated. The recalls involve medical devices and diagnostic products, with reasons including inaccurate test results (e.g., glucose meters and test strips showing positive bias), unit measurement errors (e.g., incorrect display for Canadian users), specification deviations (e.g., tubing diameter issues in infusion systems), thermal events (e.g., smoke or sparks in injection systems), particulate contamination (e.g., in radiopharmaceutical vials), software malfunctions (e.g., purge enforcement removal in injectors), packaging defects (e.g., improperly functioning test strips), and compliance failures (e.g., error messages with scanners).

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.