BREAST-MED INC.

FDA Device Registration & Listing · Hopkins, MN, US · Registration 3009192245

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
3009192245
FEI Number
3009192245
Entity Name
BREAST-MED INC.
City/State/Country
Hopkins, MN, US
Establishment Address
10580 Wayzata Blvd Ste 150, Hopkins, MN 55305, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Breast-Med Inc. (Owner Number: 10093970)
Owner / Operator Contact Address
10580 Wayzata Blvd. Suite 150, Hopkins, MN 55305, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251989
PMA Number
N/A

All Registered Proprietary Names

Breast-Med Tissue Marker VizMark Preloaded Tissue Marker

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 2025-08-26
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2026-01-09

Official Correspondent

Michael Nelson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Breast-Med Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009192245. Last updated year: 2026. Please use registration number 3009192245 when referencing this establishment in official correspondence.
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