5 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
FDA Recall
Completed
·VIRTUAL INCISION CORPORATION·Product code SAB·April 23, 2025
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
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 Recall
Completed
·Bio-Rad Labs·Product code MVM·April 3, 2019