14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
FDA Enforcement
Class I
·Terminated·Cook Medical Incorporated·August 16, 2017
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FQA·December 4, 2018
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 8515520 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013