HEALTH BEACONS, INC.

FDA Device Registration & Listing · Marlborough, MA, US · Registration 3013649990

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013649990
FEI Number
3013649990
Entity Name
HEALTH BEACONS, INC.
City/State/Country
Marlborough, MA, US
Establishment Address
250 Campus Drive, Marlborough, MA 01752, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
HOLOGIC, INC. (Owner Number: 9007676)
Owner / Operator Contact Address
250 Campus Drive, --, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181692
PMA Number
N/A

All Registered Proprietary Names

LOCalizer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2025-12-08

Official Correspondent

Sue Dahlquist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012644426 ENDOMAGNETICS LTD Cambridge Cambridgeshire, GB
3005875675 GYNESONICS, INC. REDWOOD CITY, CA, US
3006330030 Hologic, Inc. Marlborough, MA, US
3010377594 BOLDER SURGICAL, LLC LOUISVILLE, CO, US
3014090621 SOMATEX Medical Technologies GmbH Blankenfelde-Mahlow Brandenburg, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013649990. Last updated year: 2026. Please use registration number 3013649990 when referencing this establishment in official correspondence.
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