BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC, INC.

    Reg #: 2182208 · FEI: 2182208 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    387
    Establishment Types
    4
    Classifications
    46

    Registration Details

    Registration Name
    MEDTRONIC, INC.
    Registration Number
    2182208
    FEI Number
    2182208
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8200 Coral Sea Street NE
    City
    Mounds View
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183547
    PMA Number
    P230017

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) MXD
    Pulse-Generator, Pacemaker, External DTE
    Mesh, Surgical, Polymeric FTL
    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) JOQ
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY
    Catheter, Steerable DRA
    Catheter, Percutaneous DQY
    Computer, Diagnostic, Programmable DQK
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Pacemaker Pulse-Generator DXY
    Leadless Pacemaker PNJ
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Electrode, Pacemaker, Temporary LDF
    Introducer, Catheter DYB
    Medical Device Data System OUG
    Detector And Alarm, Arrhythmia DSI
    Instruments, Surgical, Cardiovascular DWS
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Analyzer, Pacemaker Generator Function, Indirect KRE
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Programmer, Pacemaker KRG
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Cardiac Ablation Percutaneous Catheter LPB
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Permanent Pacemaker Electrode DTB
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Magnet, Test, Pacemaker DTG
    Analyzer, Pacemaker Generator Function DTC
    Tester, Pacemaker Electrode Function DTA
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Pacemaker Lead Adaptor DTD
    Outpatient Cardiac Telemetry QYX
    Ventricular (Assist) Bypass DSQ
    Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) MXC
    Wire, Guide, Catheter DQX
    Tools, Pacemaker Service DTF
    Catheter, Flow Directed DYG
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD

    Proprietary Names

    Marinr Steerable Intracardiac Electrode Catheter StableMapr Steerable Intracardiac Electrode Catheter Reveal LINQ Mobile Manager Application Medtronic Temporary External Pacemaker TYRX Absorbable Antibacterial Envelope PROGRAM STIMULATOR PulseSelect™ Pulsed Field Ablation (PFA) CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025 Epsila EV™ MRI SureScan™ extravascular lead Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator Epsila EV™ Sternal Tunneling Tool AURORA EV-ICD™ MRI SURESCAN™ SW041 Epsila EV™ Transverse Tunneling Tool Pulse Select Sphere 360 Achieve Advance Mapping Catheter and Catheter Connecting Cable 10-Lead 2ACHC FlexCath Advance SELECTSITE™ C304-HIS Deflectable catheter system Impedance Localization Patch Kit TYRX™ Absorbable Antibacterial Envelope Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM Vitatron C20 SR IPG Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS Surgical Cable Disposable Patient Safety Cable PLI Kit Reveal LINQ Paceart Optima and Mainspring Data Express Version 6 Discovery Link MDDS N'Vision Report Link Paceart System Get Connected III, Connected Systems Gateway Paceart Optima Clinic Management Component Medtronic CareLink Website DiscoveryLink MDDS Session Management MyCareLink Smart Application iOS CareLink SmartSync Host Application MyCareLink Smart Application Android CareLink Mobile Application Paceart Optima Data Transformation Engine Component CareLink SmartSync Platform iOS CareLink SmartSync Platform Android Patient Connector Patient Data Service App for Intellis Communicator Reveal DX Reveal XT MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter Adjustable Valve StableMapr Reveal LINQ™ Insertion Tools REVEAL LINQ MyCareLink Patient Monitor Model 24950 Patient Assistant Attain Ability Lead Attain Performa MRI SureScan Lead Attain Performa S MRI SureScan Lead Attain Performa S Lead Attain Ability MRI SureScan Lead Attain Ability Straight Lead Attain Performa Straight MRI SureScan Lead Attain Ability Straight MRI SureScan Lead Attain Performa Straight Lead Attain Ability Plus Lead Attain Performa Lead Attain Ability Plus MRI SureScan Lead Attain Stability Quad MRI SureScan Lead AccuRhythm AI (Zelda AI) Paceart Optima System 1.6 with Analytics Paceart Optima Paceart Optima System 1.7 Paceart Optima System 1.8 Attain 6227DEF Torqr Intracardiac Electrode Catheter Soloist Intracardiac Electrode Catheter Percutaneous Lead Introducers TYRX™ Neuro Absorbable Antibacterial Envelope Percutaneous Lead Introducer Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) FlexCath Cross™ Transseptal Solution SELECTSITE™ FlexCath Advance Steerable Sheath and Dilator ATAKR Accessory RF ENHANCR II RF CONTACTR Cable RF MARINR RF CONDUCTR CareLink Network Software Protecta VR Protecta XT CRT-D Marquis VR ICD Visia AF MRI VR SureScan Evera XT VR Protecta DR Visia AF MRI S VR SureScan Virtuoso II DR/VR ICD Maximo II DR Visia AF VR Evera MRI S VR Evera XT DR Evera MRI XT DR SureScan Maximo VR ICD Evera S DR Evera MRI S DR SureScan Marquis DR ICD Evera S VR Secura DR Protecta XT VR Protecta XT DR Intrinsic ICD Evera MRI XT VR SureScan EnTrust ICD Secura VR Evera Medtronic Longevity Maximo II VR Maximo DR ICD Primo MRI VR SureScan Primo MRI DR SureScan Cobalt XT DR MRI Surescan Cobalt VR MRI Surescan Cobalt DR MRI Surescan Crome DR MRI Surescan Crome VR MRI Surescan Cobalt XT VR MRI Surescan Attain Command + SureValve Guide Catheters for Left Heart Delivery Attain Select II + SureValve Delivery Catheter System Attain Command + SureValve Left Heart Delivery System C315 Delivery Catheter PCD End Cap GEM Patient Cable Lead Patch MICRO JEWEL Patient Magnet MICRO JEWEL II Ace Header Emulator Epicardial Patch Lead Upsizing Sleeve Sizing Sleeve GEM VR Capsure SP Novus Vitatron Crystalline Lead CapSure Sense Adhesive Vitatron Excellence PS+ Lead stylet kit CapSure Unipolar Lead CapSure Sense MRI SureScan Leads Attain Command + SureValve Left-Heart Delivery System Attain Command + SureValve Guide Catheter for Left-Heart Delivery Affera™ Integrated Mapping System Achieve TORQR Cables DiamondTemp™ Generator Connection Box E DiamondTemp™ RF Generator DiamondTemp™ EGM Cable DiamondTemp™ GenConnect Cable DiamondTemp™ Irrigation Tubing Set DiamondTemp Ablation System DiamondTemp™ Catheter-to-RF Generator Cable DiamondTemp™ Irrigation Pump DiamondTemp™ Ablation Catheter DiamondTemp™ Foot Switch SOLOIST CareLink SmartSync Common Application Android Adaptor Disposable Pouch Disposable EPG Cover OmniaSecure™ MRI SureScan™ ECVUE Cardiac Mapping System Surgical cable Lead Adaptor Kit FlexCath Contour™ Steerable Sheath External Pacemaker Pulse Generator Reveal LINQ Mobile Manager patient connector Reveal XT Patient Assistant LINQ II™ Insertable Cardiac Monitor (ICM) Attain Prevail 6228 CTH Cosine-10 Diagnostic Catheter Magnetic localization Patch Kit Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan CareLink SmartSync Azure Astra Application LINQ II™ Insertable Cardiac Monitor (LNQ22) Freezor MAX External Pulse Generator EPG Cover Paceart Percutaneous lead introducer LINQ Tool Kit LINQ II Insertable Cardiac Monitor SEEQ Mobile Cardiac Telemetry (MCT) System NUVANT Mobile Cardiac Telemetry (MCT) System SEEQ External Cardiac Monitor (ECM) System CapSureFix Lead CapSureFix Novus MRI SureScan Leads SureFix CapSureFix Novus Leads Lead Adaptor HeartWare Ventricular Assist System Achieve Advance Mapping Catheter Micra Introducer Sheath with Hydrophilic Coating Epicardial Lead Implant Tool C320LBB Delivery System MARINR Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead Syncra CRT-P Attain Viva CRT-P Solara CRT-P MRI SureScan Percepta CRT-P MRI SureScan Solara Quad CRT-P MRI SureScan Insync Attain Bipolar OTW Lead Consulta CRT-P Percepta Quad CRT-P MRI SureScan Attain OTW Serena CRT-P MRI SureScan Serena Quad CRT-P MRI SureScan CareLink SmartSync Percepta, Solera, Serena Application PATIENT PROGRAMMER CardioInsight Cardiac Mapping System Reveal Plus Activator ICM CareLink SmartSync LINQ II Platform Application Torclip Pacemaker Repair Kit Temporary Pacing Lead System, Model 6416 AccuRhythm™ AI Pause Algorithm AccuRhythm™ AI Post Processor AccuRhythm™ AI AF Algorithm Disposable patient safety cables PIN PLUG KIT Medtronic Kappa 400 SR IPG Kappa 400 DR IPG Remote Assistant Model 9462 Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation catheter Freezor Xtra Surgical cardiac cryoablation catheter Cryoconsole Freezor Xtra cardiac cryoablation catheter Coaxial Cable Nitron Remote Nitron CryoConsole Impulse II Lead CapSure SP Novus CapSure Z Novus Affera™ Mapping System System Cart Location Reference Patch Kit FlexCath Select Sphere-9™ Catheter Affera™ Ablation System CapSureFix MRI SureScan Lead Revo MRI SureScan Freezor Freezor Xtra CareLink SmartSync LINQ II ICM Application Attain Select LEAD INTRODUCER Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG TYRX Neuro Absorbable Antibacterial Envelope Lead anchoring Sleeve SELECTSECURE SelectSecure MRI SureScan

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only