37 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
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
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026