Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009348684

FEI Number

3009348684

Entity Name

Beeken Biomedical LLC

City/State/Country

Newton, MA, US

Establishment Address

100 Carlson Ave, Newton, MA 02459, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Beeken Biomedical, LLC (Owner Number: 10039222)

Owner / Operator Contact Address

100 Carlson Avenue, Building 25, Suite 019C, Newton, MA 02459, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183190

PMA Number

N/A

All Registered Proprietary Names

NuStat NuStat Trauma Pad XR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2018-08-15
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2020-09-22

Official Correspondent

Richard Kendall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beeken Biomedical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009348684. Last updated year: 2026. Please use registration number 3009348684 when referencing this establishment in official correspondence.