Medtronic Inc.
83 FDA actions
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f
Medtronic, Inc.
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
Medtronic, Inc.
Retrograde Coronary Sinus Perfusion Cannulae
Medtronic, Inc.
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060
Medtronic Inc
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
Concerto Versa Detachable Coil
Medtronic, Inc.
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LB
Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product
Medtronic, Inc.
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr
Medtronic, Inc.
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo
Medtronic, Inc.
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwar
Medtronic, Inc.
MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
Medtronic, Inc.
Azure S DR MRI SureScan, Product number W3DR01
Medtronic, Inc.
Medtronic Stedi Extra Support Guidewire
Medtronic, Inc.
VitalFlow Console
Medtronic, Inc.
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Medtronic, Inc.
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Strea
Medtronic, Inc.
Affera Integrated Mapping System
Medtronic, Inc.
Magnetic Localization Patch Kit (AFR-00021)
Medtronic, Inc.
Affera Integrated Mapping System; Impedance Localization Patch Kit
Medtronic, Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT
Medtronic Inc.
VitalFlow Set with Balance Biosurface
Medtronic, Inc.
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc.
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB
Medtronic Inc.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc.
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc.
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Medtronic Inc.
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface a
Medtronic, Inc.
Amplatz Goose Neck Snare Kit
Medtronic, Inc.
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
LINQ II Insertable Cardiac Monitor (ICM)
Medtronic, Inc.
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint
Medtronic, Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medtronic Inc.
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
Medtronic, Inc.
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medtronic Inc.
Medtronic SynchroMed, Model A10
Medtronic Inc.
DLP Silicone Coronary Artery Ostial Cannulae
Medtronic, Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Medtronic Inc.
LINQ II Insertable Cardiac Monitor
Medtronic, Inc.
Cosine-10TM Diagnostic Catheter
Medtronic, Inc.
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medtronic Inc
FlexCath Contour Steerable Sheath
Medtronic, Inc.
LINQ II Insertable Cardiac Monitor (LNQ22)
Medtronic, Inc.
DLP Silicone Coronary Artery Ostial Cannulae
Medtronic, Inc.
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Medtronic, Inc.
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
Medtronic, Inc.
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Medtronic, Inc.
ClosureFast Endovenous Radiofrequency Ablation Catheter
Medtronic, Inc.
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Medtronic, Inc.
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Medtronic Inc.
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxia
Medtronic Inc
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medtronic Inc
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) Sys
Medtronic Inc
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst
Medtronic Inc
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
Chocolate PTA Balloon Catheter
Medtronic, Inc.
TurboHawk Plus Directional Atherectomy System
Medtronic, Inc.
Reveal LINQ Insertable Cardiac Monitor
Medtronic, Inc.
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Medtronic, Inc.