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Boston Scientific Corporation FDA Approvals
0 new drug approvals and 85 device clearances on file. Matched by name to BSX.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| SpaceOAR Flex System510(k)Sep 11, 2026Radiology |
| LithoVue Elite Digital Flexible Ureteroscope System510(k)Aug 26, 2026Gastroenterology, Urology |
| Navigator Flex Ureteral Access Sheath Set510(k)Aug 4, 2026Gastroenterology, Urology |
| TheraSphere 360 Y-90 Management Platform510(k)Jul 24, 2026Radiology |
| OBSIDIO Conformable Embolic510(k)Jul 24, 2026Cardiovascular |
| FARADRIVE Steerable Sheath (M004PF21M402)510(k)Jul 24, 2026Cardiovascular |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System510(k)Jul 10, 2026General, Plastic Surgery |
| RIVOS EUS Access Device (M00553900)510(k)Jun 17, 2026Gastroenterology, Urology |
| MOSES Raydar510(k)May 18, 2026General, Plastic Surgery |
| TruSelect 2.6 Microcatheter510(k)May 15, 2026Cardiovascular |
| Asurys Fluid Management System510(k)Mar 27, 2026Obstetrics/Gynecology |
| TheraSphere 360 Y-90 Management Platform510(k)Mar 13, 2026Radiology |
| SpaceOAR Vue System (SV-2101)510(k)Feb 10, 2026Radiology |
| Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)510(k)Oct 30, 2025General, Plastic Surgery |
| OBSIDIO Conformable Embolic (M0013972101010)510(k)Oct 30, 2025Cardiovascular |
| TheraSphere 360 Y-90 Management Platform510(k)Oct 28, 2025Radiology |
| Radial Jaw 4 Pulmonary Biopsy Forceps510(k)Sep 26, 2025Ear, Nose, Throat |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)510(k)Sep 24, 2025Gastroenterology, Urology |
| LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)510(k)Sep 12, 2025Cardiovascular |
| Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers510(k)Jul 9, 2025General, Plastic Surgery |
| VIKING Fixed Curve Diagnostic Catheter510(k)Jun 27, 2025Cardiovascular |
| Rezum System510(k)Jun 11, 2025Gastroenterology, Urology |
| OptiMap System510(k)May 28, 2025Cardiovascular |
| Percuflex 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 Set510(k)Apr 15, 2025Gastroenterology, Urology |
| Navigator 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 (M006510(k)Mar 21, 2025Gastroenterology, Urology |
| Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)510(k)Feb 6, 2025Gastroenterology, Urology |
| AdVance XP Male Sling System (720163-03)510(k)Nov 15, 2024General, Plastic Surgery |
| EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter510(k)Nov 1, 2024Cardiovascular |
| RHYTHMIA HDx Mapping System510(k)Aug 29, 2024Cardiovascular |
| Sterling 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 (H749390314510(k)Jul 10, 2024Cardiovascular |
| LithoVue 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)510(k)Jul 1, 2024Gastroenterology, Urology |
| Agile Esophageal Stent System510(k)Apr 4, 2024General, Plastic Surgery |
| WallFlex 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 System510(k)Mar 8, 2024General, Plastic Surgery |
| WATCHMAN TruSteer Access System (M635TU90050)510(k)Feb 1, 2024Cardiovascular |
| StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection510(k)Dec 12, 2023Gastroenterology, Urology |
| FARADRIVE Steerable Sheath510(k)Dec 11, 2023Cardiovascular |
| 14F iSLEEVE Introducer Set510(k)Nov 30, 2023Cardiovascular |
| Polaris X Unidirectional Steerable Diagnostic Catheter510(k)Oct 27, 2023Cardiovascular |
| AXIOS 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)510(k)Oct 27, 2023Gastroenterology, Urology |
| BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter510(k)Sep 29, 2023Cardiovascular |
| AVVIGO'+ Multi-Modality Guidance System510(k)Sep 26, 2023Cardiovascular |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)510(k)Aug 18, 2023Gastroenterology, Urology |
| Autotome 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 Sphincterotome510(k)Aug 14, 2023Gastroenterology, Urology |
| Rubicon Control Support Catheter (H749394323506A1)510(k)Aug 8, 2023Cardiovascular |
| Visual-ICE Cryoablation System510(k)Aug 8, 2023General, Plastic Surgery |
| Ultraflex Tracheobronchial Stent System510(k)Jul 14, 2023General, Plastic Surgery |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System510(k)Jun 29, 2023General, Plastic Surgery |
| EMBOLD Soft Detachable Coil System510(k)Jun 27, 2023Cardiovascular |
| Habib EndoHPB510(k)Jun 21, 2023Gastroenterology, Urology |
| WallFlex Biliary RX Stent System510(k)Jun 15, 2023Gastroenterology, Urology |
| OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter510(k)May 18, 2023Cardiovascular |
| POLARSHEATH 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 Sensor510(k)Mar 22, 2023Cardiovascular |
| iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)510(k)Mar 2, 2023Ear, Nose, Throat |
| 14F iSLEEVE Introducer Set510(k)Feb 3, 2023Cardiovascular |
| StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring510(k)Feb 2, 2023Gastroenterology, Urology |
| Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device510(k)Dec 30, 2022Gastroenterology, Urology |
| Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers510(k)Dec 29, 2022Gastroenterology, Urology |
| APDL 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, vanSonnenberg510(k)Nov 10, 2022Gastroenterology, Urology |
| OptiCross 18 Peripheral Imaging Catheter510(k)Sep 23, 2022Cardiovascular |
| Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip510(k)Sep 14, 2022Gastroenterology, Urology |
| AXIOS Stent and Electrocautery-Enhanced Delivery System510(k)Sep 7, 2022Gastroenterology, Urology |
| ROTAPRO Rotational Atherectomy System510(k)Sep 6, 2022Cardiovascular |
| MANTIS Clip510(k)Aug 4, 2022Gastroenterology, Urology |
| EXALT Model B Single-Use Bronchoscope510(k)Jul 28, 2022Ear, Nose, Throat |
| IntellaMap Orion High Resolution Mapping Catheter510(k)Jun 10, 2022Cardiovascular |
| SpyGlass Discover Balloon Dilation Catheter510(k)May 6, 2022Gastroenterology, Urology |
| EMBOLD Fibered Detachable Coil System510(k)Apr 12, 2022Cardiovascular |
| EndoArmor + Surgical Gown510(k)Feb 21, 2022General, Plastic Surgery |
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD510(k)Jan 14, 2022Cardiovascular |
| AdVance XP Male Sling System510(k)Dec 20, 2021General, Plastic Surgery |
| EkoSonic Endovascular Device, EKOS+ Endovascular Device510(k)Dec 14, 2021Cardiovascular |
| Agile Esophageal OTW Stent System510(k)Nov 22, 2021General, Plastic Surgery |
| AVVIGO Guidance System II510(k)Oct 20, 2021Cardiovascular |
| Polaris X Unidirectional Steerable Diagnostic Catheter510(k)Sep 14, 2021Cardiovascular |
| Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter510(k)Sep 10, 2021Cardiovascular |
| WATCHMAN FXD Curve Access System510(k)Aug 13, 2021Cardiovascular |
| EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor510(k)Aug 9, 2021Ear, Nose, Throat |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System510(k)Jul 21, 2021General, Plastic Surgery |
| iLab Polaris Multi-Modality Guidance System510(k)Jun 25, 2021Cardiovascular |
| SpyGlass Discover Retrieval Basket510(k)May 26, 2021Gastroenterology, Urology |
| LUX-Dx Insertable Cardiac Monitor510(k)May 25, 2021Cardiovascular |
| AutoCap RX510(k)May 6, 2021Gastroenterology, Urology |
| Safety Trocar Cannula510(k)Apr 27, 2021Gastroenterology, Urology |
| Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System510(k)Apr 26, 2021Gastroenterology, Urology |
| AXIOS Stent and Electrocautery Enhanced Delivery System510(k)Apr 15, 2021Gastroenterology, Urology |