Boston Scientific
FDA 510(k) & PMA Approved Devices — 43 products
Total Devices43
Categories26
Latest FDA decision2026-08-12
SEC Filings: 1 filings on record. Latest: 8-K (2026-07-29). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K262406 | EluPro Antibiotic-Eluting BioEnvelope | FTM | 2026-08-12 | View |
| PMA | P960040 | Implantable cardioverter defibrillator (non-CRT) | LWS | 2026-07-23 | View |
| PMA | P150012 | Implantable pulse generator, pacemaker (non-CRT) | LWP | 2026-07-23 | View |
| PMA | P910077 | Implantable cardioverter defibrillator (non-CRT) | LWS | 2026-07-01 | View |
| PMA | P910073 | Implantable cardioverter defibrillator (non-CRT) | LWS | 2026-06-09 | View |
| PMA | P960004 | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | NVN | 2026-06-03 | View |
| PMA | P830060 | Implantable cardioverter defibrillator (non-CRT) | LWS | 2026-05-15 | View |
| PMA | P960006 | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | NVN | 2026-05-15 | View |
| PMA | P930035 | Implantable cardioverter defibrillator (non-CRT) | LWS | 2026-05-15 | View |
| 510(k) | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | OBJ | 2026-04-08 | View |
| PMA | P020025 | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | OAD | 2025-10-17 | View |
| 510(k) | K252910 | Orca Air/Water and Suction Valves | ODC | 2025-10-09 | View |
| 510(k) | K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | 2025-07-03 | View |
| 510(k) | K250468 | iSLEEVE Introducer Set | DYB | 2025-03-20 | View |
| 510(k) | K242950 | WallFlex Biliary PLUS RX Stent System | FGE | 2024-12-06 | View |
| 510(k) | K242507 | OBSIDIO™ Conformable Embolic | KRD | 2024-10-03 | View |
| 510(k) | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | FGE | 2024-08-30 | View |
| 510(k) | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | ESW | 2024-04-29 | View |
| 510(k) | K234002 | ICEfx Cryoablation System (FPRCH8000-02) | GEH | 2024-03-13 | View |
| 510(k) | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | KNS | 2023-11-28 | View |
No matching devices.
Page 1 of 3
Related Clinical Trials
NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITINGNCT01550575Patient Retrospective Outcomes (PRO)RECRUITINGNCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITINGNCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITINGNCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITINGNCT02928497Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationTERMINATEDNCT03053141RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)RECRUITINGNCT03273023PROMUS PREMIER™ China Post-Approval StudyCOMPLETEDNCT03664609Deep Brain Stimulation (DBS) Retrospective Outcomes StudyRECRUITINGNCT03729453Intra-operative Pancreatoscopy in Patients With IPMNACTIVE_NOT_RECRUITING