5 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
FDA Enforcement
Class II
·Terminated·Imactis·March 24, 2021
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