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Endologix

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22- recall (Z-0006-2019)Endologix2018-10-03
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: recall (Z-0007-2019)Endologix2018-10-03
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proxim recall (Z-0008-2019)Endologix2018-10-03
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Access recall (Z-0009-2019)Endologix2018-10-03
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory recall (Z-1039-2017)Endologix2017-01-19
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA Sy recall (Z-1047-2017)Endologix2017-01-19
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A28 recall (Z-1048-2017)Endologix2017-01-19
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-0 recall (Z-1049-2017)Endologix2017-01-19
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory recall (Z-1054-2017)Endologix2017-01-19
AFX Endovascular AAA System, Endoleak Type IIIA recall (Z-1035-2017)Endologix2017-01-18
AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory recall (Z-1037-2017)Endologix2017-01-18
AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intend recall (Z-1038-2017)Endologix2017-01-18

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Every clearance here is in the API, with alerts when new ones post.