Boston Scientific Corporation
Boston Scientific Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 639 FDA device recalls on record.
Clearances by Boston Scientific Corporation — page 2
101–200 of 239- K192460 — Sentinel Cerebral Protection System
- K191538 — Resectr Tissue Resection Device
- K191446 — Ureteral Stent Systems, Biliary Drainage Catheters
- K193279 — Comet II Pressure Guidewire
- K193202 — EXALT Model D Single-Use Duodenoscope, EXALT Controller
- K192438 — Rhythmia HDxTM Mapping System
- K192360 — IntellaMap Orion High Resolution Mapping Catheter
- K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K191609 — Tria Soft Ureteral Stent
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K191789 — Stonetome Stone Removal Device
- K191008 — iLab Polaris Multi-Modality Guidance System
- K190603 — Tria Firm Ureteral Stent
- K182975 — MAKO 7
- K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- K181905 — AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
- K190401 — MAMBA and MAMBA Flex Microcatheters
- K183085 — CoreDx Pulmonary Mini-Forceps
- K183177 — Nitinol Thermocouple (TCN) Electrode
- K183636 — SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
- K182169 — AdVance XP Male Sling
- K182315 — Magic Torque DLVR Guidewire
- K180144 — Agile Esophageal Stent System
- K182275 — Seal Single Use Biopsy Valve
- K181439 — SpyGlass DS and DS II Direct Visualization System
- K173837 — RHYTHMIA HDx Mapping System (with software Version 2.0)
- K180785 — iSLEEVE Introducer Set
- K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
- K180530 — Imager II Urology Torque Catheter
- K173820 — OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K172929 — Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
- K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
- K173251 — LumiCoil Platinum Fiducial Marker
- K171271 — Polyform Synthetic Mesh
- K173284 — OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K172453 — WATCHDOG Hemostasis Valve Kit
- K172060 — Capio SLIM Suture Capturing Device
- K172591 — Fixed Patient Leads ECG Cable (Model 3153)
- K172520 — CRE RX Biliary Balloon Dilatation Catheter
- K171452 — MAMBA and MAMBA FLEX Microcatheters
- K171809 — Epic Biliary Endoscopic Stent System
- K171913 — Rubicon 14, 18 and 35 Support Catheters
- K171454 — Interject Injection Therapy Needle Catheter
- K170815 — PSA Cable
- K171612 — ACUITY Pro Lead Delivery System
- K170759 — CRE Pulmonary Balloon Dilatation Catheter
- K163399 — Tria Firm Ureteral Stent
- K163701 — Direxion and Direxion HI-FLO Torqueable Microcatheters
- K163248 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K170204 — FFR Link, FFR Signal Processing Module
- K163314 — Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
- K170636 — Fathom-16 Steerable Guidewires
- K162793 — RHYTHMIA HDx Mapping System
- K163272 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K163174 — Emerge PTCA Dilatation Catheter
- K163200 — Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
- K162350 — Coyote 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 0.018
- K162404 — Express SD Biliary Monorail Premounted Stent System
- K160823 — NC Quantum Apex PTCA Dilatation Catheter
- K160514 — OptiCross 18, 30 MHz Peripheral Imaging Catheter
- K161003 — EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
- K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
- K161125 — OptiCross X, 40 MHz Coronary Imaging Catheter
- K160845 — Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K160637 — Rotatable Snares
- K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
- K153617 — OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
- K152231 — Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
- K151840 — Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
- K153088 — AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
- K152401 — Stingray LP Catheter
- K153049 — LithoVue System
- K151315 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K152605 — Impulse Angiographic Catheter, Expo Angiographic Catheter
- K151895 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K152693 — CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels
- K151610 — Comet Pressure Guidewire
- K151613 — iLab Polaris Multi-Modality Guidance System
- K152572 — AXIOS Stent and Delivery System
- K151313 — ZelanteDVT Thrombectomy Set
- K151802 — Resolution Clip
- K150235 — CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
- K142922 — SpyGlass DS Direct Visualization System
- K143587 — ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
- K142973 — Resolution Clip
- K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
- K141378 — IDC INTERLOCKING DETACHABLE COIL
- K141597 — MUSTANG BALLOON DIALATION CATHETER
- K141521 — MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
- K141236 — NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
- K134031 — THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
- K140641 — VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
- K133110 — EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
- K133700 — ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
- K140733 — CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
- K133933 — INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
- K133987 — CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
- K133750 — OCCLUDER OCCLUSION BALLOON CATHETER
- K133312 — EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- K130004 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.