BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROBO MEDICAL, INC.

    Reg #: 3012411160 · FEI: 3012411160 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PROBO MEDICAL, INC.
    Registration Number
    3012411160
    FEI Number
    3012411160
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9715 Kincaid Dr Ste 1000
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210743

    Owner / Operator

    Firm Name
    Probo Medical, Inc.
    Operator Number
    10051673
    Address
    9715 Kincaid Dr Suite 1000
    City
    Fishers
    State
    IN
    Postal Code
    46037
    Country
    US

    Products

    Device Name Product Code
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    ACUSON Redwood Diagnostic Ultrasound System M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9Premium Diagnostic Ultrasound System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198