4 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
VITEK 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·May 6, 2011
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013