BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Medtronic Mexico S. de R.L. de CV

    Reg #: 9617601 · FEI: 3002534070 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    282
    Establishment Types
    1
    Classifications
    59

    Registration Details

    Registration Name
    Medtronic Mexico S. de R.L. de CV
    Registration Number
    9617601
    FEI Number
    3002534070
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Av. Paseo Cucapah 10510 El Lago
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K884129
    PMA Number
    P130021

    Owner / Operator

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

    US Agent

    Business Name
    Medtronic
    Contact Name
    Celia Encinas
    Address
    1610 Landmark Rd
    City
    San Diego
    State
    CA
    ZIP
    92154
    Country
    US
    Email
    [email protected]
    Phone
    949 7983913

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Oxygenator, Cardiopulmonary Bypass DTZ
    Ring, Annuloplasty KRH
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Tamp HXG
    Arthroscope HRX
    Device, Monitoring, Intracranial Pressure GWM
    Shunt, Central Nervous System And Components JXG
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Continuous Flush KRA
    Catheter, Percutaneous, Neurovasculature QJP
    Tools, Pacemaker Service DTF
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Needle, Aspiration And Injection, Disposable GAA
    Device, Percutaneous, Biopsy MJG
    Catheter, Ventricular HCA
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Defoamer, Cardiopulmonary Bypass DTP
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Cardiac Ablation Percutaneous Catheter LPB
    Cement, Bone, Vertebroplasty NDN
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Apparatus, Autotransfusion CAC
    Single Lumen Ecmo Cannula QHW
    Instruments, Surgical, Cardiovascular DWS
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
    Catheter, Steerable DRA
    Instrument, Manual, Surgical, General Use MDM
    External Cerebrospinal Fluid (Csf) Diversion PCB
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Blood Pump For Ecmo, Long-Term (> 6 Hours) Use QNR
    Oxygenator, Long Term Support Greater Than 6 Hours BYS
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ
    Tubing, Long Term Support Greater Than 6 Hours QWF
    Dispenser, Cement KIH
    Probe, Blood-Flow, Extravascular DPT
    Sizer, Heart-Valve, Prosthesis DTI
    Heart-Valve, Non-Allograft Tissue LWR
    Orthopedic Manual Surgical Instrument LXH
    Container, I.V. KPE
    Forceps HTD
    Catheter, Intravascular, Diagnostic DQO
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Temporary Carotid Catheter For Embolic Capture NTE
    Container, Specimen, Sterile FMH
    Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass JOD
    Continuous Measurement Thermometer FLL
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Apparatus, Electrosurgical HAM

    Proprietary Names

    Bio-Medicus Cannula Bio-MedicusTM Insertion Kit Adapter Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir Cannula Simulus Flexible Annuloplasty Band CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System SimuPlus, SimuForm Tubing Pack Carpentier Bi-Caval Femoral Cannula OVAL MC2Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2Two-Stage Venous Cannula MC2XThree-Stage Venous Cannula BIO-PUMP Axium Detachable Coil System DLP Aortic Root Cannula DLP Pressure Monitoring Catheter Affinity Pixie Arterial Filter with Balance Biosurface Cannulae, Femoral Venous 1-Piece, BioMedicus Kyphon Xpander II Inflatable Bone Tamp Tri-Ad Adams Annuloplasty Ring Becker External Drainage and Monitoring System PS MEDICAL BIOGLIDE CSF Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Catheter Phenom Catheters Torclip Pacemaker Repair Kit Achieve Preset Needles KyphX 11 Gauge Bone Access Needle Coaxial Aspiration Needles ORO-TRACHEAL INJECTOR NEEDLE Pacific Plus PTA Catheter MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM POLE CLAMP MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM KyphX Bone Biopsy Device Exacta External Drainage and Monitoring System (EDMS) Harmony Transcatheter Pulmonary Valve System DLP Single Stage Venous Cannula Intersept Filtered Cardiotomy Reservoir Valiant Thoracic Stent Graft System INTRACRANIAL PRESSURING MONITORING SYSTEM Biotherm Myotherm Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation catheter Freezor Xtra Surgical cardiac cryoablation catheter Cryoconsole Freezor Xtra cardiac cryoablation catheter ECG Cable Coaxial Cable Nitron Remote Nitron CryoConsole DLP Cannula Amphirion Deep 014" OTW PTA Balloon Catheter Amphirion Deep PTA Catheter Select 3D Cement, Bone BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER Pulmonary Valve Ensemble Intersept Affinity ECMO Minimax Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile MYOtherm XP with Cortiva BioActive Surface, Sterile Uncoated MYOtherm XP Cardioplegia Delivery Systems, Sterile MYOtherm XP with Cortiva BioActive Surface, Non-Sterile Affinity® Pediatric Arterial Filter Affinity Pixie™ Arterial Filter with Balance™ Biosurface NC Euphora" Rapid Exchange Balloon Dilatation Catheter Autolog Autotransfusion Bio-Medicus Life Support Catheter and Introducer Signature Bio-Medicus EL Reservoir 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 Pacific Xtreme PTA Balloon Dilatation Catheter Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Oxygenator Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo Connectors Adapters Simulus Flexible Annuloplasty Ring MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER MONITOR TEMPERATURE Autolog Medtronic External Drainage and Monitoring System (EDMS) Simulus Adjustable Annuloplasty Band Medtronic External Drive Motor Affinity™ CP Centrifugal Blood Pump Quickflow DPS Distal Perfusion Kit DLP Phrenic Nerve Pad Bio-Medicus" Adult Cannula Kit Simulus Semi-Rigid Annuloplasty Band Simplici-T DLP Pericardial Sump DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr DLP Suction Tube Sprinter Legend RX Sprinter Over-the-Wire NC Sprinter RX NC Stormer Over-the-Wire Simulus Adjustable Annuloplasty Ring Bio-Pump BP50 Affinity CP Centrifugal Blood Pump Emergency Hand Crank External Motor Affinity CP Adapter Simulus Semi-Rigid Annuloplasty Ring DLP Silicone RCSP Cannula Tubing, Connectors, and Accessories Vent Catheter SELECT Amphirion Deep 014" OTW PTA Balloon Catheter (Balloon Extension) Amphirion Deep 014” OTW PTA Balloon Catheter MICRO-FRANCE Manual Surgical Instr MULTIPLE Manual Surgical Instruments KyphX Handle; Introducer XOMED Visualase DUET External Drainage And Monitoring System Medtronic DUET External Drainage And Monitoring System DUET DUET EDMS Cannulae Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM CG Future Ring Duran Ancore Band Duran Ancore Ring 6F Launcher Guiding Catheter Euphora Rapid Exchange Balloon Dilatation Catheter VitalFlow™ Set with Balance™ Biosurface MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated Profile 3D Annuloplasty Ring EOPA Instant Detacher MYOtherm CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT BIOPUMP (VARIOUS MODELS) KYPHON ELEMENT" Inflatable Bone Tamp Launcher Guide Catheters Bio-probe Hancock II ULTRA Supra-X Aortic Sizers TriAd sizers Contour 3D sizers Mosaic Ultra Supra-X Aortic Sizers CG Future Sizers Hancock II Aortic and Mitral Obturators Simulus Sizers Avalus™ Sizers Open Pivot sizers Profile 3D Ring Sizers Mosaic Aortic and Mitral Obturators Freestyle Obturators Duran Ancore Sizers Mosaic Neo Endurant II AUI Stent Graft System Endurant Stent Graft System Endurant IIs Stent Graft System Endurant II Stent Graft System Talent Occluder with Occluder Delivery System Rist™ 079 Radial Access Guide Catheter Concerto Detachable Coil System Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™BioActive Surface and Cardiotomy/ Venous Reservoi Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface Affinity CP Centrifugal Blood Pump w/ Carmeda Bioactive Surf Ring, Annuloplasty - Contour 3D Ring Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon) Sprinter Legend Rapid Exchange Balloon Dilatation Catheter 6F Sherpa NX Balanced7F Sherpa NX Balanced Admiral Xtreme Affinity CP Centrifugal Bloop Pump w/ Balance Biosurface DLP Air Aspirating Needle MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface Amphirion Deep 014" OTW PTA Balloon Catheter (Long Balloon) Kyphon Inflation Syringe Avalus™ bioprosthesis General Instrument PASS LP Spinal System CSF-VENTRICULAR CATHETER, STANDARD MC2 Multistage DLP Rapid Prime Set, 14 Tissue Approximating Forceps FORCEPS (MANUAL INSTRU MULTIPLE FORCEPS Posterior Annuloplasty Band Cannulae, Femoral, Insertion Kits Marksman Catheter Axium Prime Detachable Coil System (FitzRoy) Rist 071 Radial Access Guide Catheter Rist Radial Access Selective Catheter Rist 079 Radial Access Guide Catheter DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr. Mo.Ma Ultra Proximal Cerebral Protection Device Axium Prime Detachable Coil System Container AUTOLOG Affinity Pixie Oxygenator with Cortiva BioActive Surface Affinity Pixie Oxygenator with Balance Biosurface Adaptors Vacuum Relief Valve Rist™ 071 Radial Access Guide Catheter Pixie Oxygenation and CVR Combo, Balance coated Pixie Oxygenator, Balance coated Pixie Oxygenator, Carmeda coated Affinity Temperature Probe Pixie Oxygenation and CVR Combo, Carmeda coated BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM FILTER,O2,BI-DIRECTIONAL,CAP- DUST,3/16IN,GREEN,VENT,ST MC2X™ Three-Stage Venous Cannula MC2™ Two-Stage Venous Cannula Attain Prevail 6228 CTH RCSP Affinity Fusion Recirculation Line Duet EDMS Kyphon Express Inflatable Bone Tamp Inflate FX Fracture Management Inflatable Bone Tamp Kyphon Exact Inflatable Bone Tamp Affinity Pixie CVR PS MEDICAL CSF-LUMBOPERITONEAL SHU CG Future Band Duet External Drainage and Monitoring System (EDMS) Amphirion Deep 014" OTW PTA Balloon Catheter (Shaft Extension) Affinity CP Centrifugal Pump Launcher Guide Catheter Sherpa NX Balanced Guide Catheter 6F Taiga Sprinter Legend 1.25 OTW Sprinter Legend 1.25 RX Axium™ Detachable Coil Axium™ Prime Detachable Coil CD HORIZON® Fenestrated Screw Set KYPHON Cement Delivery System KyphX Bone Filler Device PS MEDICAL CSF-FLOW CONTROL VALVE DLP Tourniquet Set, Pediatric

    Establishment Types

    Manufacture Medical Device