Data / Medical devices / United States / Xpress BCD LLC
Xpress BCD LLC: FDA-registered device maker in Frederick, MD, United States, 1 510(k) clearance
Xpress BCD LLC is registered with the FDA (registration 3026674642) in Frederick, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026674642
- Address
- 6024 White Flint Drive, Frederick, MD, United States, 21702
- Owner or operator
- XPress BCD LLC (10087201)
- Roles
- Specification developer
- First device listed
- March 8, 2023
- Registered through
- 2026
- Brand names listed
- XPress BCD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Post Breast Biopsy Hemostatic Breast Compression Device | POY | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 19, 2017 | K163388 | XPress BCD Breast Compression Device | POY | Substantially Equivalent | Xpress Bcd, LLC | accessdata.fda.gov |
Updated July 19, 2017. 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.