Data / Medical devices / Germany / Bayer Pharma, AG
Bayer Pharma, AG: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance and 1 PMA approval
Bayer Pharma, AG is registered with the FDA (registration 3002808086) in Berlin, Germany. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 10, 2004. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002808086
- Address
- Mullerstrasse 178, Berlin, Germany, D-13353
- Owner or operator
- Bayer Pharma, AG (10045903)
- Roles
- Complaint file establishment, Exporter to the US
- First device listed
- January 10, 2014
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment | accessdata.fda.gov |
| Transcervical Contraceptive Tubal Occlusion Device | HHS | 3 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2004 | K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 4, 2002 | P020014 | ESSURE SYSTEM | HHS | 47 | April 9, 2018 | accessdata.fda.gov |
Compare with other makers
Updated April 9, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.