8 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
FDA Enforcement
Class II
·Ongoing·Imactis·September 23, 2020
Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,
FDA Enforcement
Class II
·Ongoing·Imactis·January 29, 2020
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
FDA Enforcement
Class II
·Terminated·Imactis·March 24, 2021
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·April 1, 2026
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.]
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 2, 2019
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·March 9, 2022
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 15, 2015
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
FDA Enforcement
Class II
·Terminated·Hologic, Inc.·January 24, 2018