BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GIVEN IMAGING LTD.

    Reg #: 9710107 · FEI: 3003348376 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    GIVEN IMAGING LTD.
    Registration Number
    9710107
    FEI Number
    3003348376
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Hacarmel St., NEW INDUSTRIAL Park, POB 258
    City
    Yoqneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K140284

    Owner / Operator

    Firm Name
    GIVEN IMAGING INC.
    Operator Number
    10091555
    Address
    15 HAMPSHIRE STREET
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US
    Correspondent
    AVISHAG METZER

    US Agent

    Business Name
    Medtronic, Inc.
    Contact Name
    Marsha Seetaram
    Address
    710 Medtronic Pkwy
    City
    Minneapolis
    State
    MN
    ZIP
    55432
    Country
    US
    Email
    [email protected]
    Phone
    904 2812763

    Products

    Device Name Product Code
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    System, Imaging, Esophageal, Wireless, Capsule NSI
    Colon Capsule Imaging System PGD
    Electrode, Ph, Stomach FFT
    Gastrointestinal Motility System, Capsule NYV
    System, Gastrointestinal Motility (Electrical) FFX

    Proprietary Names

    RAPID 8 PillCam UGI Capsule Accessories DR3 SB 3 Patency Capsule Reflux and AccuView software Bravo System Bravo™ Reflux Capsule with Delivery Device Bravo™ CF reflux recorder Versaflex pH Z catheters pHersaflex pH catheters Digitrapper pH Z Versaflex pH catheters Reflux software AccuView pH & pH-Z software SB 3 capsule imaging system- PillCam SB 3 capsule; PillCam endoscopy system; PillCam Software SmartPill GI Monitoring System, version 2 SmartPill pH.p Capsule SmartPill Capsule Calibration Fluid SmartPill Data Receiver SmartPill Docking Station Activation Fixture SmartPill MotiliGI Software PillCam software PillCam Crohn capsule PillCam endoscopy system Disposable Balloons Manoscan catheters ManoScan sw ManoView AR sw ManoScan Impedance module (Z) A200 ManoShield (disposable sanitary sheaths) ManoView ESO sw ManoScan 3D HRM A300 module ManoScan base pressure module ( A120) ManoScan System RAPID Software PillCam COLON 2 Capsule Endoscopy System PillCam™ Cloud Reader Software PillCam™ Genius SB System with PillCam Software v9.7 PillCam Cloud Reader Software

    Establishment Types

    Manufacture Medical Device