Beeken Biomedical, LLC
Beeken Biomedical is dedicated to improving patient outcomes for blood loss through innovative hemostatic wound dressings and medical devices. They develop, license, and commercialize FDA-cleared and patent-protected products for surgical, trauma, and public safety markets, emphasizing quality, customer satisfaction, and community responsibility.
Industries
Nr. of Employees
small (1-50)
Beeken Biomedical, LLC
100 Carlson Avenue, Building 11, Suite 206, Newton, MA 02459, USA
Patents
Products
Surgical/trauma hemostatic pad with X‑ray-detectable marker
Advanced hemostatic dressing sized and packaged for operative and traumatic bleeding; includes an X‑ray-detectable marker for surgical traceability and is cleared for certain internal use indications.
Flexible hemostatic dressing for surgical/trauma use
Flexible, conformable hemostatic dressing designed to adapt to anatomy and provide compression for surgical and trauma applications; offered in X‑ray-detectable variants.
Over‑the‑counter hemostatic dressings for public safety
Hemostatic dressings packaged and sized for public safety and consumer markets, including multi‑pack and bulk configurations for first responders and lay users.
Surgical/trauma hemostatic pad with X‑ray-detectable marker
Advanced hemostatic dressing sized and packaged for operative and traumatic bleeding; includes an X‑ray-detectable marker for surgical traceability and is cleared for certain internal use indications.
Flexible hemostatic dressing for surgical/trauma use
Flexible, conformable hemostatic dressing designed to adapt to anatomy and provide compression for surgical and trauma applications; offered in X‑ray-detectable variants.
Over‑the‑counter hemostatic dressings for public safety
Hemostatic dressings packaged and sized for public safety and consumer markets, including multi‑pack and bulk configurations for first responders and lay users.
Services
Online instructional videos and training materials demonstrating proper application of hemostatic dressings.
Customer service for product ordering, quotations, returns processing and account setup including new-customer onboarding forms.
Execution of QMS activities including regulatory submissions, audit preparation, supplier audits, CAPA management, and document control to support commercial release.
Online instructional videos and training materials demonstrating proper application of hemostatic dressings.
Customer service for product ordering, quotations, returns processing and account setup including new-customer onboarding forms.
Execution of QMS activities including regulatory submissions, audit preparation, supplier audits, CAPA management, and document control to support commercial release.
Expertise Areas
- Hemostatic dressing development and manufacturing
- Regulatory compliance and submissions (510(k), ISO 13485/MDSAP)
- Quality management systems and QSR compliance
- Verification & validation (sterilization, biocompatibility, packaging)
Key Technologies
- Hemostatic fiber dressing technology
- X‑ray-detectable/radiopaque markers in devices
- Sterilization validation methods
- Biocompatibility testing
News & Updates
Beeken Biomedical was featured at the Warrior Ice Arena, highlighting their partnership with the Boston Bruins and their community engagement.
The company received FDA Class II clearance for the NuStat Hospital Product Line, enabling internal use in various medical settings.
As of July 13th, 2023, Beeken Biomedical is certified under the Medical Device Single Audit Program (MDSAP) for ISO 13485:2016.
Beeken Biomedical was featured at the Warrior Ice Arena, highlighting their partnership with the Boston Bruins and their community engagement.
The company received FDA Class II clearance for the NuStat Hospital Product Line, enabling internal use in various medical settings.
As of July 13th, 2023, Beeken Biomedical is certified under the Medical Device Single Audit Program (MDSAP) for ISO 13485:2016.