BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Scientific Corporation

    Reg #: 2648729 · FEI: 2648729 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    260
    Establishment Types
    2
    Classifications
    19

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    2648729
    FEI Number
    2648729
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 12, RD. No. 698
    City
    Dorado
    State
    PR
    ZIP
    00646
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101406
    PMA Number
    P910073

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Continuous Flush KRA
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Permanent Pacemaker Electrode DTB
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Catheter, Percutaneous DQY
    Implantable Pacemaker Pulse-Generator DXY
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Catheter, Coronary, Atherectomy MCX

    Proprietary Names

    ENDOTAK RELIANCE G Connector Tools Lead Repair Kit Lead Pulling Tip RELIANCE 4-FRONT Defibrillation Lead Suture Sleeve Accessory Lead Stylets Lead Adapter Lead Cap Kit ENDOTAK RELIANCE ENDOTAK RELIANCE SG ENDOTAK RELIANCE S ACUITY STEERABLE FLEXTEND Lead Stabilizer Kit Fixation Tool EMBLEM S-ICD Subcutaneous Electrode EMBLEM S-ICD Electrode EMBLEM S-ICD Programmer EMBLEM S-ICD Pulse Generator EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD Electrode Delivery System EMBLEM S-ICD Electrode Insertion System EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD System Patient Screen Tool Log Data Card for the Model 3200 EMBLEM S-ICD Programmer Power Supply for S-ICD Programmer Tool Wand for SICD Programmer 3200 SQ-RX Pulse Generator Precision Battery AAA 1.5 Alkaline Precision Charger Artisan Surgical Lead Kit Cable, USB Serial Precision Spectra Patient Trial Belt Precision Lead Blank O.R. Cable and Extension Precision Spectra External Trial Stimulator Precision AC/DC Power Supply Charger Belt Extension Precision Precision Spectra Remote Control Enhanced Steering Kit with Stylet Cap Introducer Remote Control Silicone Case Clik X MRI Anchor D4 Splitter Kit Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision Patient Trial Belt Linear 3-6 Lead Kit USB Splitter Power Unlimited, Power Adapter Precision Implantable Pulse Generator and Charging Kit Precision Adhesive Kit Clik X Anchor Precision Novi Implantable Pulse Generator Kit Precision IPG Port Plug Precision Lithium Manganese Dioxide Battery 6 Volts Precision Cable, USB-Serial Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision IRDA Dongle Holder Charger Spacer Precision Spectra IPG Port Plug Precision Patient Trial Kit Tablet Pen Charger Belt Loops Replacement Paddle Blank for CoverEdge 32 Surgical Lead Precision Connector Clinician Programmer Insertion Needle Precision OMG Connector-A Precision Primary Lithium Battery AA Type STD Precision Charging System Kit Precision Base Station Precision External Trial Stimulator Linear Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit CoverEdge X 32 Surgical Lead Kit Splitter Kit Precision Passing Elevator Programming Wand Spectra Implantable Pulse Generator Kit Charger Belt Precision Epimed Needle Clik Anchor Hex Wrench Medical Adhesive Precision PC SC-7150 CoverEdge 32 Surgical Lead Kit Installer for BN3.1 Entrada Needle Precision Suture Sleeve Precision Remote Control Case Precision Charging Belt Precision Patient Controller Entrada Spare Sheath Precision Hex Wrench Precision S8 Adapter Precision OMG Connector-M Power Supply for Tablet Computer USB Power Supply Remote Control (U.S.) Precision Power Supply & Adapter For Charger Precision Clinician Programmer Stylet Kit with Stylet Cap Precision Spectra OMG Adapter Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Patient Programmer Kit Infinion Lead Kit W4 Splitter Kit Precision Holster Click Anchor Spectra External Trial Stimulator Linear ST Lead Kit Avista MRI Lead Kit Infinion CX Lead Kit Tunneling Tool SCS Implantable Materials Kit Linear Lead Kit Precision Spectra Remote Control Kit Spectra WaveWriter Implantable Pulse Generator Precision Spectra Implantable Pulse Generator Kit Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Precision Implantable Pulse Generator Kit Precision Remote Control Artisan MRI Surgical Lead Kit Bionic Navigator 3D Installer Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Precision Spectra Patient Trial Kit Precision IR Interface Precision Montage MRI Implantable Pulse Generator and Charging Kit Precision Montage Implantable Pulse Generator Kit Precision M8 Adapter WaveWriter Alpha 16 IPG and Charging Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha IPG and Charging Kit Pairing Magnet WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer Freelink Remote Control WaveWriter Alpha IPG Kit CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt Freelink Remote Control Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit Bionic Navigator Installer WaveWriter Alpha Prime 16 IPG Kit Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit mySCS GO Therapy Controller App Infinion Pro Lead Kit mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit Vercise DBS Controller Clinician Kit Vercise Physician's Spare Kit 8 Contact Extension Kit Vercise M8 Adapter Vercise Remote Control Vercise External Trial Stimulator Base Station Charger Vercise Implantable Pulse Generator Kit Vercise Remote Control Kit Bionic Navigator 24 Installer Patient Travel Case Remote Control Case Adhesive Kit IR Interface ETS battery Vercise Charger Collar SureTek Burr Hole Cover Kit Lead Kit Vercise Charging System Vercise DBS External Trial Stimulator 2 IR Interface Holder Vercise Charger Collar Accessories Vercise PC Implantable Pulse Generator Kit AC/DC Power Supply Vercise Neural Navigator 2.1 Installer OR Cable 2x8, 61cm and Extension Precision Spectra IPG Port Plug SP3 Platform Update Installer Vercise DBS Remote Control 3 Vercise Gevia Implantable Pulse Generator Kit Vercise ETS Vercise DBS Remote Control 3 Kit Vercise DBS Directional Lead Kit Vercise Genus Implantable Pulse Generator Kits Vercise Neural Navigator 4 Installer Vercise DBS Remote Control 4 and Kit Vercise Neural Navigator 3.1 Installer Vercise ETS 3 Charger Belt and accessories Vercise Charging System with Belt Push Button OR Cable 2x8 Contact Lead Extension Kit Vercise Charger Vercise Neural Navigator 5 Vercise S8 Adapter Vercise ETS Adapter Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Vercise Cartesia HX Directional Lead Kit Lead Extension Kit, 16 Contact Vercise Cartesia X Directional Lead Kit Vercise DBS Controller Patient Kit Vercise Cartesia Directional Lead Kit J Shaped Lead Stylet Straight Lead Stylet FINELINE II Sterox FINELINE II EZ Sterox Suture Sleeves ACUITY Spiral Bi Directional Torque Wrench INOGEN CRT-D DYNAGEN CRT-D INOGEN X4 CRT-D DYNAGEN X4 CRT-D ACUITY X4 Spiral CONTAK RENEWAL AVT Software CONTAK RENEWAL Software Application ACUITY X4 Straight ACUITY X4 Flushing Tool/Wire Guide CONTAK CD Software Application VIGILIANT X4 CRT-D VIGILIANT CRT-D AUTOGEN X4 CRT-D MOMENTUM X4 CRT-D RESONATE X4 CRT-D MOMENTUM CRT-D RESONATE HF CRT-D RESONATE CRT-D CONTAK CD2 Software Application AUTOGEN CRT-D ENERGEN CRT-D Suture Sleeve INCEPTA CRT-D Lead Cap EASYTRAK 3 EASYTRAK 3 IS-1 PUNCTUA CRT-D EASYTRAK 2 IS-1 EASYTRAK 2 AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console Stylet INGEVITY MRI FORMIO MRI VITALIO MRI INGENIO MRI ESSENTIO MRI PROPONENT MRI ACCOLADE MRI

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only