BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EBR SYSTEMS INC.

    Reg #: 3044322716 · FEI: 3044322716 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    EBR SYSTEMS INC.
    Registration Number
    3044322716
    FEI Number
    3044322716
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4600 Patrick Henry Dr
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K792558
    PMA Number
    P240028

    Owner / Operator

    Firm Name
    EBR Systems Inc.
    Operator Number
    10092727
    Address
    480 Oakmead Parkway
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Pharoah Garma

    Products

    Device Name Product Code
    Sterilizer, Steam FLE
    Forceps HTD
    Retractor GAD
    Leadless Cardiac Resynchronization Therapy (Crt) SEG
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
    Dilator, Cervical, Fixed Size HDQ
    Wrap, Sterilization FRG

    Proprietary Names

    Steam Sterilization Top Container Surgical Forceps Retractor WiSE (Wireless Stimulation of the Endocardium Technology) CRT System Coupler Uterine Dilator Sterilization wrap Bottom Container

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device