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Data / Medical devices / Ireland / Boston Scientific Limited

Boston Scientific Limited: FDA-registered device maker in GALWAY Galway(County), Ireland, 231 510(k) clearances and 22 PMA approvals

Boston Scientific Limited is registered with the FDA (registration 9681260) in GALWAY Galway(County), Ireland. It lists 107 device types. The FDA files 231 510(k) clearances and 22 PMA approvals under its listings, the newest dated September 3, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Boston Scientific Limited
FDA registration number
9681260
FEI number
3002806565
Address
Ballybrit Business Park, GALWAY Galway(County), Ireland, --
Owner or operator
Boston Scientific Corporation (9912058)
Roles
Manufacturer, Specification developer
First device listed
September 9, 1983
Registered through
2027
Brand names listed
AGENT Paclitaxel-Coated Balloon Catheter, AngioJet Spiroflex Thrombecotmy Set, AngioJet Spiroflex VG Thrombectomy Set, AngioJet Ultra 5000A Console, AutoElite Thrombectomy System Console, Blazer II HTD Temperature Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II XP Temperature Ablation Catheter and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufactureraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Manufactureraccessdata.fda.gov
Aspiration Thrombectomy CatheterQEZ2Manufactureraccessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA2Manufactureraccessdata.fda.gov
Biliary Stent System For Benign StricturesPNB2Manufactureraccessdata.fda.gov
Biopsy NeedleFCG2Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Manufactureraccessdata.fda.gov
Bronchoscope AccessoryKTI2Manufactureraccessdata.fda.gov
Brush, Biopsy, Bronchoscope (Non-Rigid)BTG2Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Manufactureraccessdata.fda.gov
Catheter, Angioplasty, Peripheral, TransluminalLIT2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, CholangiographyGBZ1Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufactureraccessdata.fda.gov
Catheter, Coronary, AtherectomyMCX3Manufactureraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Manufactureraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Manufactureraccessdata.fda.gov
Catheter, NephrostomyLJEUManufactureraccessdata.fda.gov
Catheter, Nephrostomy, General & Plastic SurgeryGBO1Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/ScoringNWX3Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cutting/ScoringPNO2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, SteerableDRA2Manufactureraccessdata.fda.gov
Catheter, UrethralGBM2Manufactureraccessdata.fda.gov
Catheter, UrologicalKOD2Manufactureraccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Manufactureraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Manufactureraccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Manufacturer, Specification developeraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Manufactureraccessdata.fda.gov
Dilator, Catheter, UreteralEZN2Manufactureraccessdata.fda.gov
Dilator, EsophagealKNQ2Manufacturer, Specification developeraccessdata.fda.gov
Dilator, UrethralKOE2Manufactureraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufactureraccessdata.fda.gov
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty CatheterOOB3Manufactureraccessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU3Manufactureraccessdata.fda.gov
Duodenoscope And Accessories, Flexible/RigidFDT2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Endoscope Channel AccessoryODC2Manufactureraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Manufactureraccessdata.fda.gov
Endoscopic Cholangiogram KitNWT2Manufactureraccessdata.fda.gov
Endoscopic Cytology BrushFDX2Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufactureraccessdata.fda.gov
Endoscopic Retrograde Cholangiopancreatography (Ercp) CannulaODD2Manufactureraccessdata.fda.gov
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight LossQTD2Manufactureraccessdata.fda.gov
Endoscopic Tissue Approximation DeviceOCW2Manufactureraccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Manufactureraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ ProlapsePWI2Manufactureraccessdata.fda.gov
Intracranial Neurovascular StentNJEfManufactureraccessdata.fda.gov
Introducer, CatheterDYB2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Manufactureraccessdata.fda.gov
Lithotriptor, Electro-HydraulicFFK2Manufactureraccessdata.fda.gov
Mechanical Thrombolysis CatheterQEY2Manufactureraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Manufactureraccessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH2Manufactureraccessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN2Manufactureraccessdata.fda.gov
Needle, CatheterGCB1Manufactureraccessdata.fda.gov
Pancreatic Stent, Covered, Metallic, RemovablePCU2Manufactureraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Manufactureraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.fda.gov
Prosthesis, EsophagealESW2Manufactureraccessdata.fda.gov
Prosthesis, PenileFAE2Manufactureraccessdata.fda.gov
Prosthesis, Tracheal, ExpandableJCT2Manufacturer, Specification developeraccessdata.fda.gov
Pump, Air, Non-Manual, For EndoscopeFEQ2Manufactureraccessdata.fda.gov
Radiographic Protective GloveIWP1Manufactureraccessdata.fda.gov
Shunt, Portosystemic, EndoprosthesisMIR3Manufacturer, Specification developeraccessdata.fda.gov
Snare, FlexibleFDI2Manufactureraccessdata.fda.gov
Snare, Non-ElectricalFGX1Manufactureraccessdata.fda.gov
Stent, CarotidNIM3Manufacturer, Specification developeraccessdata.fda.gov
Stent, Central VenousQKJ3Manufactureraccessdata.fda.gov
Stent, Colonic, Metallic, ExpandableMQR2Manufactureraccessdata.fda.gov
Stent, CoronaryMAF3Manufacturer, Specification developeraccessdata.fda.gov
Stent, IliacNIO3Manufacturer, Specification developeraccessdata.fda.gov
Stent, Iliac VeinQAN3Manufactureraccessdata.fda.gov
Stent, Metallic, Expandable, DuodenalMUM2Manufactureraccessdata.fda.gov
Stent, RenalNIN3Manufactureraccessdata.fda.gov
Stent, Superficial Femoral ArteryNIP3Manufacturer, Specification developeraccessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-ElutingNIU3Manufactureraccessdata.fda.gov
Stent, UreteralFAD2Manufactureraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufacturer, Specification developeraccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Manufactureraccessdata.fda.gov
Syringe, Balloon InflationMAV2Manufactureraccessdata.fda.gov
Syringe, Balloon Inflation, ExemptPTM2Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufactureraccessdata.fda.gov
System, Appendage Closure, Left AtrialNGV3Manufactureraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Manufactureraccessdata.fda.gov
Tube, Drainage, SuprapubicFFA2Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 231.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 3, 2026K262460Rezum SystemKNSSubstantially EquivalentBoston Scientificaccessdata.fda.gov
August 26, 2026K261153LithoVue Elite Digital Flexible Ureteroscope SystemFGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 15, 2026K260771TruSelect™ 2.6 MicrocatheterKRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 9, 2025K252910Orca Air/Water and Suction ValvesODCUnknownBoston Scientificaccessdata.fda.gov
September 24, 2025K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)FGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 9, 2025K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersGEXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 3, 2025K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersFGESubstantially EquivalentBoston Scientificaccessdata.fda.gov
June 27, 2025K250310VIKING™ Fixed Curve Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 11, 2025K250584Rezum SystemKNSSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 15, 2025K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetFADSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 21, 2025K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006FEDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 20, 2025K250468iSLEEVE Introducer SetDYBSubstantially EquivalentBoston Scientificaccessdata.fda.gov
February 6, 2025K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)PKLSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 6, 2024K242950WallFlex Biliary PLUS RX Stent SystemFGEUnknownBoston Scientificaccessdata.fda.gov
November 1, 2024K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 30, 2024K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVFGEUnknownBoston Scientificaccessdata.fda.gov
July 10, 2024K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314LITSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 1, 2024K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)FGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 29, 2024K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESWSubstantially EquivalentBoston Scientificaccessdata.fda.gov
April 4, 2024K233837Agile Esophageal Stent SystemESWSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 8, 2024K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemMQRSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
February 1, 2024K240018WATCHMAN TruSteer Access System (M635TU90050)DQYSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 12, 2023K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionFGBSubstantially EquivalentBoston Scientific Corporation -accessdata.fda.gov
November 30, 2023K23350314F iSLEEVE Introducer SetDYBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 27, 2023K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)KNSSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 27, 2023K233207Polaris X™ Unidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
September 29, 2023K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
September 18, 2023K232544Apollo ESG NXT System, Apollo REVISE NXT SystemQTDSubstantially EquivalentApollo Endosurgery, Inc.accessdata.fda.gov
August 14, 2023K232162Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 SphincterotomeKNSSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 8, 2023K223633Rubicon™ Control Support Catheter (H749394323506A1)DQYSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 14, 2023K230269Ultraflex™ Tracheobronchial Stent SystemJCTSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 29, 2023K231553OverStitch NXT Endoscopic Suturing SystemOCWSubstantially EquivalentApollo Endosurgery, Inc.accessdata.fda.gov
June 29, 2023K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTNSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 27, 2023K230706EMBOLD™ Soft Detachable Coil SystemKRDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 21, 2023K231533Habib EndoHPBKNSSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 15, 2023K223469WallFlex™ Biliary RX Stent SystemFGEUnknownBoston Scientific Corporationaccessdata.fda.gov
May 25, 2023K231176Stingray LP CatheterDQYSubstantially EquivalentBoston Scientificaccessdata.fda.gov
April 25, 2023K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableDRFSubstantially EquivalentBoston Scientificaccessdata.fda.gov
March 22, 2023K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorDRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 30, 2022K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODGSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 29, 2022K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersFGESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 10, 2022K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergFADUnknownBoston Scientific Corporationaccessdata.fda.gov
September 14, 2022K222503Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipPKLSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 4, 2022K221124MANTIS ClipPKLSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 12, 2022DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX SystemQTDUnknownApollo Endosurgery, Inc.accessdata.fda.gov
June 10, 2022K220796IntellaMap Orion High Resolution Mapping CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 6, 2022K212582SpyGlass Discover Balloon Dilation CatheterGCASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 12, 2022K213398EMBOLD Fibered Detachable Coil SystemKRDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 24, 2022K220629Emerge Monorail PTCA Dilatation CatheterLOXSubstantially EquivalentBoston Scientificaccessdata.fda.gov
August 13, 2021K212228WATCHMAN FXD Curve Access SystemDQYSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 26, 2021K203322SpyGlass Discover Retrieval BasketLQRSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 6, 2021K210353AutoCap RXODCSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 27, 2021K211072Safety Trocar CannulaKNTSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 18, 2020K203162Advanix Biliary Stent with NaviFlex RX Delivery SystemFGESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 15, 2020K201808X-Tack Endoscopic HeliX Tacking SystemPKLSubstantially EquivalentApollo Endosurgery, Inc.accessdata.fda.gov
December 3, 2020K200404ORISE ProKnifeKNSSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 8, 2020K202478Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresFDISubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 2, 2020K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceQEWSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
September 15, 2020K201170Athletis PTA Balloon Dilatation CatheterLITSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 28, 2020K201792TRUSELECT MicrocatheterKRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 21, 2020K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerFBNSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 2, 2020K191446Ureteral Stent Systems, Biliary Drainage CathetersFADUnknownBoston Scientific Corporationaccessdata.fda.gov
December 23, 2019K193279Comet II Pressure GuidewireDXOSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 13, 2019K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerFDTSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 29, 2019K191439OverStitch 2-0 Polypropylene SutureOCWSubstantially EquivalentApollo Endosurgeryaccessdata.fda.gov
July 25, 2019K191789Stonetome Stone Removal DeviceLQRUnknownBoston Scientific Corporationaccessdata.fda.gov
April 16, 2019K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceFAESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 25, 2019K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemPCUSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 8, 2019K183085CoreDx™ Pulmonary Mini-ForcepsEOQSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 22, 2019K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerFBNSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 26, 2018K182324EkoSonic Endovascular SystemQEYSubstantially EquivalentBtg International, Inc.accessdata.fda.gov
September 26, 2018K182315Magic Torque DLVR GuidewireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 27, 2018K181141OverStitch Endoscopic Suturing System and AccessoriesOCWSubstantially EquivalentApollo Endosurgeryaccessdata.fda.gov
June 18, 2018K180726Savion DLVR Guidewire, Savion FLX GuidewireDQXSubstantially EquivalentBoston Scientific, Inc.accessdata.fda.gov
April 12, 2018K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQXSubstantially EquivalentBoston Scientificaccessdata.fda.gov
November 3, 2017K172060Capio SLIM Suture Capturing DevicePWISubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 27, 2017K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleODGSubstantially EquivalentBoston Scientificaccessdata.fda.gov
October 4, 2017K172520CRE RX Biliary Balloon Dilatation CatheterFGESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 9, 2017K171809Epic Biliary Endoscopic Stent SystemFGEUnknownBoston Scientific Corporationaccessdata.fda.gov
July 25, 2017K171913Rubicon 14, 18 and 35 Support CathetersDQYSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 7, 2017K171454Interject Injection Therapy Needle CatheterFBKSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 23, 2017K170759CRE Pulmonary Balloon Dilatation CatheterKTISubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 16, 2017K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersKRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 27, 2017K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleEOQSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 23, 2017K163314Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension CatheterDQYSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 30, 2017K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleODGSubstantially EquivalentBoston Scientificaccessdata.fda.gov
December 14, 2016K163174Emerge PTCA Dilatation CatheterLOXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 4, 2016K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018LITSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 12, 2016K162404Express SD Biliary Monorail Premounted Stent SystemFGESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 27, 2016K161482EndoChoice Water Bottle Cap Irrigation SystemFEQSubstantially EquivalentEndochoice, Inc.accessdata.fda.gov
June 23, 2016K160823NC Quantum Apex PTCA Dilatation CatheterLOXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 19, 2016K160403SmartStart Air/Water and Suction ValvesODCSubstantially EquivalentEndochoice, Inc.accessdata.fda.gov
May 19, 2016K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALJCTSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 3, 2016K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODGSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 30, 2016K160637Rotatable SnaresFDISubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
February 24, 2016K153588EndoChoice Water Bottle Cap SystemFEQSubstantially EquivalentEndochoice, Inc.accessdata.fda.gov
February 12, 2016K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 16, 2015K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension WireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 20, 2015K152853WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic BiliaryFGESubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
November 13, 2015K153049LithoVue SystemFGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 10, 2026P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF75March 10, 2026accessdata.fda.gov
February 29, 2024P230035AGENT Paclitaxel-Coated Balloon CatheterOOB8August 28, 2026accessdata.fda.gov
January 30, 2024P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI24October 2, 2026accessdata.fda.gov
August 8, 2023P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE12May 29, 2026accessdata.fda.gov
October 30, 2020P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU41August 4, 2026accessdata.fda.gov
September 18, 2018P180011Eluvia Drug-Eluting Vascular Stent SystemNIU67August 21, 2026accessdata.fda.gov
February 24, 2016P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD91December 5, 2025accessdata.fda.gov
October 2, 2015P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ109August 21, 2026accessdata.fda.gov
July 21, 2015P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP86August 21, 2026accessdata.fda.gov
March 13, 2015P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV84August 28, 2026accessdata.fda.gov
April 13, 2012P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO76August 21, 2026accessdata.fda.gov
November 22, 2011P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ207January 14, 2025accessdata.fda.gov
March 5, 2010P090003EXPRESS LD ILIAC PREMOUNTED STENT SYSTEMNIO53May 6, 2026accessdata.fda.gov
December 11, 2008P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN104December 12, 2023accessdata.fda.gov
October 23, 2008P050019CAROTID WALLSTENT MONORAIL ENDOPROSTHESISNIM41September 19, 2025accessdata.fda.gov
August 25, 2003P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD141October 17, 2025accessdata.fda.gov
November 16, 2001P980033WALLSTENT ENDOPROSTHESISQKJ65May 6, 2026accessdata.fda.gov
April 18, 2000P950020FLEXATOME CUTTING BALLOONNWX139January 27, 2026accessdata.fda.gov
March 12, 1999P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX93August 1, 2025accessdata.fda.gov
May 28, 1996P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO63May 6, 2026accessdata.fda.gov
September 29, 1995P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR72June 27, 2024accessdata.fda.gov
October 28, 1994P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB133October 17, 2025accessdata.fda.gov

Compare with other makers

Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.