6 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·December 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·December 2, 2020
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 19, 2020
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 19, 2020