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Sources: EU EUDAMED, US FDA
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FDA Recall
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K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.
FDA Recall
Terminated
·Product code OLO·December 2, 2016
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DYB·November 23, 2015
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code QWR·March 4, 2025
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code QWR·March 4, 2025