BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOSTON SCIENTIFIC CORPORATION

    Reg #: 3005099803 · FEI: 3005099803 · Expires 2026
    View on FDA
    Products
    112
    Proprietary Names
    40
    Establishment Types
    2
    Classifications
    112

    Registration Details

    Registration Name
    BOSTON SCIENTIFIC CORPORATION
    Registration Number
    3005099803
    FEI Number
    3005099803
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 BOSTON SCIENTIFIC WAY
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163248
    PMA Number
    P080032

    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
    Bronchoscope (Flexible Or Rigid) EOQ
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Biopsy Needle FCG
    Bedding, Disposable, Medical KME
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Lavage, Jet FQH
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Endoscopic Tissue Approximation Device OCW
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Hydrogel Spacer OVB
    Holder, Needle, Gastroenterologic FHQ
    Dilator, Catheter, Ureteral EZN
    Stent, Colonic, Metallic, Expandable MQR
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Camera, Surgical And Accessories KQM
    Led Light Source NTN
    Snare, Flexible FDI
    Powered Laser Surgical Instrument GEX
    Instrument, Manual, Surgical, General Use MDM
    Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss QTD
    Endoscopic Bite Block MNK
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Hemostatic Metal Clip For The Gi Tract PKL
    Catheter, Urological KOD
    Laparoscope, General & Plastic Surgery GCJ
    Lithotriptor, Electro-Hydraulic FFK
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
    Catheter, Retention, Barium Enema With Bag FGD
    Stent, Ureteral FAD
    Catheter, Ureteral, Gastro-Urology EYB
    Dislodger, Stone, Biliary LQR
    Forceps, Biopsy, Bronchoscope (Non-Rigid) BWH
    Endoscope Channel Accessory ODC
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Prosthesis, Tracheal, Expandable JCT
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Prosthesis, Esophageal ESW
    Stent, Metallic, Expandable, Duodenal MUM
    Tube, Feeding FPD
    Tubes, Gastrointestinal (And Accessories) KNT
    Catheter, Nephrostomy LJE
    Stylet For Catheter, Gastro-Urology EZB
    Pump, Air, Non-Manual, For Endoscope FEQ
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    System, Irrigation, Urological LJH
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Ligator, Hemorrhoidal FHN
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscopic Cholangiogram Kit NWT
    Bottle, Collection, Vacuum KDQ
    Dislodger, Stone, Flexible FGO
    Catheter, Cholangiography GBZ
    Penile Implant Surgical Accessories QGA
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Snare, Non-Electrical FGX
    Tube, Drainage, Suprapubic FFA
    Dilator, Esophageal KNQ
    Tubing, Noninvasive GAZ
    Catheter, Urethral GBM
    Ligator, Esophageal MND
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Gynecological Laparoscopic Kit OHD
    Forceps, Biopsy, Non-Electric FCL
    Evacuator, Bladder, Manually Operated FFD
    Dilator, Catheter GCC
    Esophageal Dilator Balloon With Or Without Electrode Sensors PID
    Bronchial Thermoplasty System OOY
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Medical Glove, Specialty LZC
    Syringe, Irrigating (Non Dental) KYZ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Gastroscope And Accessories, Flexible/Rigid FDS
    Catheter, Balloon Type GBA
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Accessories, Cleaning Brushes, For Endoscope MNL
    Lithotriptor, Biliary Mechanical LQC
    Bronchoscope Accessory KTI
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Endoscopic Cytology Brush FDX
    Device, Incontinence, Mechanical/Hydraulic EZY
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Syringe, Balloon Inflation, Exempt PTM
    Evacuator, Gastro-Urology KQT
    Device, Impotence, Mechanical/Hydraulic FHW
    Prosthesis, Penis, Inflatable JCW
    Dilator, Urethral KOE
    Implant, Intragastric For Morbid Obesity LTI
    Pancreatic Stent, Covered, Metallic, Removable PCU
    Gown, Surgical FYA
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Tube, Gastro-Enterostomy KGC
    Insufflator, Hysteroscopic HIG
    Biliary Stent System For Benign Strictures PNB
    Endoscopic Irrigation/Suction System OCX
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Connector, Ureteral Catheter EYK
    Syringe, Balloon Inflation MAV
    Submucosal Injection Agent PLL
    Forceps, Biopsy, Electric KGE
    Accelerator, Linear, Medical IYE
    Prosthesis, Penile FAE
    Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories QGD

    Proprietary Names

    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 Stone Cone Nitinol Urological Retrieval Coil Urovac Bladder Evacuator Alair RF Controller Accessory Kit Alair Bronchial Thermoplasty Controller Alair Bronchial Thermoplasty Catheter Ureteral Stent Positioners Pneumatic Inflator Trapezoid RX Wireguided Retrieval Basket AMS 800 with Inhibizone AMS 800 without Inhibizone Ambicor AMS 700 with Inhibizone AMS 700 without Inhibizone ORBERA Intragastric Balloon Colpassist Vaginal Positioning Device Connector Ureteral Catheter Connector Connector Drainage Bag Connector Connecting Tube

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198