BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARBON MEDICAL TECHNOLOGIES, INC.

    Reg #: 2134494 · FEI: 3002619738 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    CARBON MEDICAL TECHNOLOGIES, INC.
    Registration Number
    2134494
    FEI Number
    3002619738
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1290 HAMMOND RD STE 2
    City
    Saint Paul
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132708
    PMA Number
    P980053

    Owner / Operator

    Firm Name
    Carbon Medical Technologies, Inc.
    Operator Number
    9034784
    Address
    1290 Hammond Road, --
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US

    Products

    Device Name Product Code
    Marker, Radiographic, Implantable NEU
    Agent, Bulking, Injectable For Gastro-Urology Use LNM
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Staple, Implantable GDW
    Accelerator, Linear, Medical IYE

    Proprietary Names

    BiomarC PRO Marker / Marker System Durasphere Injectable Bulking Agent InjecSURE Injection System BiomarC Tissue Marker System BiomarC Preloaded Tissue Marker Dev BiomarC Tissue Marker Device BiomarC Gold Fiducial Marker BiomarC EX Marker / Marker System MammoSTAR Biopsy Site Identifier BiomarC Tissue Marker Injection Needle Durasphere Injection Needle BiomarC Fiducial Marker / Marker System BiomarC Coaxial Needle

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)