14 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
FDA Recall
Terminated
·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·February 11, 2021
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
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 Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code NHX·August 14, 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
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
FDA Recall
Terminated
·Hologic, Inc.·Product code OIJ·July 7, 2017
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 6, 2014
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 6, 2014
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 6, 2014
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 Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JGJ·December 8, 2021
IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JLS·July 21, 2008