BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNAPSE BIOMEDICAL INC.

    Reg #: 3005868392 · FEI: 3005868392 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SYNAPSE BIOMEDICAL INC.
    Registration Number
    3005868392
    FEI Number
    3005868392
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    300 Artino Street
    City
    Oberlin
    State
    OH
    ZIP
    44074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242704
    PMA Number
    H100006

    Owner / Operator

    Firm Name
    Synapse Biomedical Inc.
    Operator Number
    10024968
    Address
    300 Artino Street
    City
    Oberlin
    State
    OH
    Postal Code
    44074
    Country
    US
    Correspondent
    Gaurav Pawar

    Products

    Device Name Product Code
    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator OIR
    Goniometer, Ac-Powered KQX
    Stimulator, Muscle, Powered IPF
    Stimulator, Neuromuscular, External Functional GZI

    Proprietary Names

    NeuRx DPS NeuRx Diaphragm Pacing System Synchrony

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device