33 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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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 Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
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