BEUDAMED
    8 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 21, 2016

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·August 24, 2016

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015

    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015

    Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    FDA Enforcement
    Class II ·Terminated·Westmed, Inc.·January 6, 2021

    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025