Data / Medical devices / United States / Bayer HealthCare, LLC
Bayer HealthCare, LLC: FDA-registered device maker in Morristown, NJ, United States, 1 510(k) clearance and 1 PMA approval
Bayer HealthCare, LLC is registered with the FDA (registration 2243252) in Morristown, NJ, United States. 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
- 2243252
- Address
- 36 Columbia Rd, Morristown, NJ, United States, 07960
- Owner or operator
- Bayer Pharma, AG (10045903)
- Roles
- Complaint file establishment
- 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 | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment | accessdata.fda.gov |
| Transcervical Contraceptive Tubal Occlusion Device | HHS | 3 | Complaint file establishment | 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.