BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOSTON SCIENTIFIC CORPORATION

    Reg #: 1828132 · FEI: 1828132 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    43
    Establishment Types
    3
    Classifications
    48

    Registration Details

    Registration Name
    BOSTON SCIENTIFIC CORPORATION
    Registration Number
    1828132
    FEI Number
    1828132
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    780 BROOKSIDE DRIVE
    City
    SPENCER
    State
    IN
    ZIP
    47460
    Country
    US

    Regulatory Submissions

    510(k) Number
    K010610
    PMA Number
    P110042

    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
    Endoscope Channel Accessory ODC
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Biopsy Needle FCG
    Catheter, Balloon Type GBA
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Lithotriptor, Biliary Mechanical LQC
    Bronchoscope (Flexible Or Rigid) EOQ
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
    Catheter, Urological KOD
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Evacuator, Bladder, Manually Operated FFD
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Catheter, Urethral GBM
    Radiographic Protective Glove IWP
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Endoscopic Cytology Brush FDX
    Dilator, Catheter GCC
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Tubes, Gastrointestinal (And Accessories) KNT
    Connector, Ureteral Catheter EYK
    Stent, Ureteral FAD
    Catheter, Nephrostomy LJE
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Cholangiography GBZ
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Permanent Defibrillator Electrodes NVY
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Dilator, Catheter, Ureteral EZN
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Lithotriptor, Electro-Hydraulic FFK
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Evacuator, Gastro-Urology KQT
    Needle, Catheter GCB
    Accessories, Catheter KGZ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Dislodger, Stone, Biliary LQR
    Camera, Surgical And Accessories KQM
    Led Light Source NTN
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Syringe, Irrigating (Non Dental) KYZ
    Catheter, Peritoneal GBW
    Medical Glove, Specialty LZC
    Catheter, Percutaneous DQY

    Proprietary Names

    Pneumatic Inflator Trapezoid RX Wireguided Retrieval Basket Urovac Bladder Evacuator Connector Ureteral Catheter Connector Connector Drainage Bag Connector Connecting Tube 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 AdVance XP Male Sling System Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle Endovive Securi-T Percutaneous Replacement Gastrostomy Tube

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device