BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medtronic Grand Rapids

    Reg #: 3003955307 · FEI: 3003955307 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    97
    Establishment Types
    1
    Classifications
    20

    Registration Details

    Registration Name
    Medtronic Grand Rapids
    Registration Number
    3003955307
    FEI Number
    3003955307
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    620 Watson SW
    City
    Grand Rapids
    State
    MI
    ZIP
    49504
    Country
    US

    Regulatory Submissions

    510(k) Number
    K840001

    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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Container, I.V. KPE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Stereotaxic Instrument OLO
    Apparatus, Electrosurgical HAM
    Clamp, Surgical, General & Plastic Surgery GDJ
    Gauge, Pressure, Coronary, Cardiopulmonary Bypass DXS
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Catheter, Percutaneous DQY
    Neurological Stereotaxic Instrument HAW
    Catheter, Steerable DRA
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Lavage, Jet FQH
    Stabilizer, Heart MWS
    Instruments, Surgical, Cardiovascular DWS
    Electrode, Pacemaker, Temporary LDF
    Retractor GAD
    Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS

    Proprietary Names

    DLP Cannula EGM Cable Cardioblate MAPS Cardioblate Surgical Ablation Pen Cardioblate XL Surg Abl Pen Cardioblate Surg Abl System ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES DLP™ Silicone Coronary Artery Ostial Cannulae OVAL MC2Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2Two-Stage Venous Cannula MC2XThree-Stage Venous Cannula DLP Rapid Prime Set, 14 DLP Air Aspirating Needle DLP Aortic Root Cannula MC2X™ Three-Stage Venous Cannula MC2™ Two-Stage Venous Cannula DLP Tourniquet Set, Pediatric EOPA 3D Arterial Cannula CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Carpentier Bi-Caval Femoral Cannula Gauge, Pressure, Coronary, Cardiopulmonary Bypass Bio-Medicus Cannula DLP Coronary Artery Ostial Cannula CATHETER, CANNULA &TUBING, VASCULAR, CARDIOPULMONARY BYPASS Select 3D Adaptors Quickflow DPS Vacuum Relief Valve Distal Perfusion Kit Connectors Cardiopulmonary bypass vascular catheter, cannula, or tubing EOPA Signature Cannula Vent Catheter DLP Suction Tube Clearview Gundry RSCP DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12 in. (30.5 cm) length - Smooth preformed Cuff, short fluted, bullet nosed DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Smooth preformed Cuff -guidewire Stylet/ DLP PVC RCSP Cannulae Auto-Inflate Cuff, 10 in. (25.4 cm) length - Smooth preformed Cuff, short fluted tip, and integ DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, Multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8cm) length - Ridged preformed Silicone Cuff, short fluted, bulle DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length-WW Body/Smooth preformed Cuff -Solid Stylet/Tru-T DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, a DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Solid Stylet DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Ridged preformed Cuff- Solid Stylet/Tru- DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Guidewire Sty DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) - WW Body/Ridged preformed Cuff- guidewire Stylet/Tru-To DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length -Ridged preformed Silicone Cuff, short fluted, bulle DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Ridged preformed Silicone Cuff, short fluted, bull DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, DLP Pericardial Sump RCSP ClearView Intracoronary Shunts Cardioblate 49313 Surgical Ablation Pen Cardioblate 49314 XL Surgical Ablation Pen Urchin Starfish Octopus 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 ABLATION PEN 4920501 W/PACING Bio-Medicus MC2 Multistage Cardioblate™ Gemini™ SELECT RETRACTOR RadiaLux™ Spacekeeper DLP Single Stage Venous Cannula DLP Pressure Monitoring Catheter DLP Silicone RCSP Cannula DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr DLP Retrograde Coronary Sinus Cannula Without Pressure Monitoring Line DLP Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Lumen

    Establishment Types

    Manufacture Medical Device