3 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
FDA Recall
Open, Classified
·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·August 15, 2025
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