Data / Medical devices / United States / Beeken Biomedical LLC
Beeken Biomedical LLC: FDA-registered device maker in Newton, MA, United States, 2 510(k) clearances
Beeken Biomedical LLC is registered with the FDA (registration 3009348684) in Newton, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009348684
- Address
- 100 Carlson Ave, Newton, MA, United States, 02459
- Owner or operator
- Beeken Biomedical, LLC (10039222)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 15, 2018
- Registered through
- 2026
- Brand names listed
- NuStat, NuStat Trauma Pad XR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Temporary, Internal Use Hemostatic | POD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 25, 2019 | K183190 | NuStat | POD | Substantially Equivalent | Beeken Biomedical, LLC | accessdata.fda.gov |
| June 29, 2016 | K160578 | Nustat XR | QSY | Substantially Equivalent | Beeken Biomedical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 14, 2021 | 88941 | Class II | Ongoing | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5 | Endotoxin levels exceeded allowable limits. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Temporary, Internal Use Hemostatic
Updated September 25, 2019. 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.