42 results
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15ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·July 3, 2013
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
FDA Enforcement
Class II
·Terminated·Medtronic Cardiovascular Surgery-the Heart Valve Division·August 24, 2016
Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·May 27, 2026
Vein & Vascular Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·March 17, 2021
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·November 19, 2014
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·March 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·March 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·March 17, 2021
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·May 2, 2018
Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231
FDA Enforcement
Class II
·Ongoing·Medtronic Vascular, Inc.·December 1, 2021