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

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 5, 2017

    Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.

    FDA Enforcement
    Class II ·Ongoing·Northgate Technologies, Inc.·December 15, 2021

    Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Enforcement
    Class II ·Terminated·Northgate Technologies, Inc.·November 15, 2017

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018