249 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
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 Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·June 3, 2020
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·March 17, 2021
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
FDA Enforcement
Class III
·Terminated·Medtronic Vascular·October 3, 2018
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
FDA Enforcement
Class II
·Terminated·Medtronic Vascular·November 19, 2014