7 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Recall
Completed
·Basic Reset Inc.·Product code N/A·October 18, 2019
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Enforcement
Class II
·Completed·Basic Reset Inc.·November 20, 2019
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Enforcement
Class II
·Completed·Bio-Rad Labs·May 6, 2020
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Recall
Completed
·Fresenius Kabi USA, LLC·Product code FRN·September 16, 2022
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA Recall
Completed
·Fresenius Kabi USA, LLC·Product code FRN·May 10, 2023
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA Enforcement
Class II
·Completed·Fresenius Kabi USA, LLC·March 20, 2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Enforcement
Class II
·Completed·Fresenius Kabi USA, LLC·March 20, 2024