| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |
| TheraSphere 360™ Y-90 Management Platform (K260479) | Boston Scientific Corporation | 2026-03-13 |
| SpaceOAR Vue System (SV-2101) (K260119) | Boston Scientific Corporation | 2026-02-10 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) (K252529) | Boston Scientific Corporation | 2025-10-30 |
| TheraSphere 360™ Y-90 Management Platform (K252547) | Boston Scientific Corporation | 2025-10-28 |
| Radial Jaw 4 Pulmonary Biopsy Forceps (K252921) | Boston Scientific Corporation | 2025-09-26 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703) | Boston Scientific Corporation | 2025-09-24 |
| LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (K252593) | Boston Scientific Corporation | 2025-09-12 |
| Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (K251759) | Boston Scientific Corporation | 2025-07-09 |
| VIKING™ Fixed Curve Diagnostic Catheter (K250310) | Boston Scientific Corporation | 2025-06-27 |
| Rezum System (K250584) | Boston Scientific Corporation | 2025-06-11 |
| OptiMap™ System (K251344) | Boston Scientific Corporation | 2025-05-28 |
| 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 Set (K250824) | Boston Scientific Corporation | 2025-04-15 |
| 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 (M006 (K250517) | Boston Scientific Corporation | 2025-03-21 |
| Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (K250066) | Boston Scientific Corporation | 2025-02-06 |
| AdVance™ XP Male Sling System (720163-03) (K242960) | Boston Scientific Corporation | 2024-11-15 |
| EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (K240366) | Boston Scientific Corporation | 2024-11-01 |
| RHYTHMIA HDx™ Mapping System (K241227) | Boston Scientific Corporation | 2024-08-29 |
| 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 (H749390314 (K241683) | Boston Scientific Corporation | 2024-07-10 |
| 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) (K241598) | Boston Scientific Corporation | 2024-07-01 |
| Agile Esophageal Stent System (K233837) | Boston Scientific Corporation | 2024-04-04 |
| 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 System (K234046) | Boston Scientific Corporation | 2024-03-08 |
| WATCHMAN TruSteer Access System (M635TU90050) (K240018) | Boston Scientific Corporation | 2024-02-01 |
| StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection (K233645) | Boston Scientific Corporation - | 2023-12-12 |
| FARADRIVE™ Steerable Sheath (K233248) | Boston Scientific Corporation | 2023-12-11 |
| 14F iSLEEVE Introducer Set (K233503) | Boston Scientific Corporation | 2023-11-30 |
| 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) (K233318) | Boston Scientific Corporation | 2023-10-27 |
| Polaris X™ Unidirectional Steerable Diagnostic Catheter (K233207) | Boston Scientific Corporation | 2023-10-27 |
| BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651) | Boston Scientific Corporation | 2023-09-29 |
| AVVIGO'+ Multi-Modality Guidance System (K230884) | Boston Scientific Corporation | 2023-09-26 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) (DEN230019) | Boston Scientific Corporation | 2023-08-18 |
| 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 Sphincterotome (K232162) | Boston Scientific Corporation | 2023-08-14 |
| Rubicon™ Control Support Catheter (H749394323506A1) (K223633) | Boston Scientific Corporation | 2023-08-08 |
| Visual-ICE Cryoablation System (K230551) | Boston Scientific Corporation | 2023-08-08 |
| Ultraflex™ Tracheobronchial Stent System (K230269) | Boston Scientific Corporation | 2023-07-14 |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K231549) | Boston Scientific Corporation | 2023-06-29 |
| EMBOLD™ Soft Detachable Coil System (K230706) | Boston Scientific Corporation | 2023-06-27 |
| Habib EndoHPB (K231533) | Boston Scientific Corporation | 2023-06-21 |
| WallFlex™ Biliary RX Stent System (K223469) | Boston Scientific Corporation | 2023-06-15 |
| OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter (K230453) | Boston Scientific Corporation | 2023-05-18 |
| 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 Sensor (K223824) | Boston Scientific Corporation | 2023-03-22 |
| iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340) | Boston Scientific Corporation | 2023-03-02 |
| 14F iSLEEVE™ Introducer Set (K230051) | Boston Scientific Corporation | 2023-02-03 |
| StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring (K221515) | Boston Scientific Corporation | 2023-02-02 |
| Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) | Boston Scientific Corporation | 2022-12-30 |
| Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K223592) | Boston Scientific Corporation | 2022-12-29 |
| 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, vanSonnenberg (K211934) | Boston Scientific Corporation | 2022-11-10 |
| OptiCross™ 18 Peripheral Imaging Catheter (K222568) | Boston Scientific Corporation | 2022-09-23 |
| Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (K222503) | Boston Scientific Corporation | 2022-09-14 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (K220112) | Boston Scientific Corporation | 2022-09-07 |
| ROTAPRO Rotational Atherectomy System (K220962) | Boston Scientific Corporation | 2022-09-06 |
| MANTIS Clip (K221124) | Boston Scientific Corporation | 2022-08-04 |
| EXALT Model B Single-Use Bronchoscope (K222014) | Boston Scientific Corporation | 2022-07-28 |
| IntellaMap Orion High Resolution Mapping Catheter (K220796) | Boston Scientific Corporation | 2022-06-10 |
| SpyGlass Discover Balloon Dilation Catheter (K212582) | Boston Scientific Corporation | 2022-05-06 |
| EMBOLD Fibered Detachable Coil System (K213398) | Boston Scientific Corporation | 2022-04-12 |
| EndoArmor™ + Surgical Gown (K203548) | Boston Scientific Corporation | 2022-02-21 |
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) | Boston Scientific Corporation | 2022-01-14 |
| AdVance XP Male Sling System (K211847) | Boston Scientific Corporation | 2021-12-20 |
| EkoSonic Endovascular Device, EKOS+ Endovascular Device (K213422) | Boston Scientific Corporation | 2021-12-14 |
| Agile Esophageal OTW Stent System (K211960) | Boston Scientific Corporation | 2021-11-22 |
| AVVIGO Guidance System II (K212490) | Boston Scientific Corporation | 2021-10-20 |
| Polaris X Unidirectional Steerable Diagnostic Catheter (K211494) | Boston Scientific Corporation | 2021-09-14 |
| Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K211375) | Boston Scientific Corporation | 2021-09-10 |
| WATCHMAN FXD Curve Access System (K212228) | Boston Scientific Corporation | 2021-08-13 |
| EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor (K211030) | Boston Scientific Corporation | 2021-08-09 |
| Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K211223) | Boston Scientific Corporation | 2021-07-21 |
| iLab Polaris Multi-Modality Guidance System (K210889) | Boston Scientific Corporation | 2021-06-25 |
| SpyGlass Discover Retrieval Basket (K203322) | Boston Scientific Corporation | 2021-05-26 |
| LUX-Dx Insertable Cardiac Monitor (K210608) | Boston Scientific Corporation | 2021-05-25 |
| AutoCap RX (K210353) | Boston Scientific Corporation | 2021-05-06 |
| Safety Trocar Cannula (K211072) | Boston Scientific Corporation | 2021-04-27 |
| Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System (K200260) | Boston Scientific Corporation | 2021-04-26 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K203132) | Boston Scientific Corporation | 2021-04-15 |
| Advanix Biliary Stent with NaviFlex RX Delivery System (K203162) | Boston Scientific Corporation | 2020-12-18 |
| ORISE ProKnife (K200404) | Boston Scientific Corporation | 2020-12-03 |
| Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478) | Boston Scientific Corporation | 2020-10-08 |
| iSleeve Introducer Set (K202584) | Boston Scientific Corporation | 2020-10-06 |
| ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device (K202218) | Boston Scientific Corporation | 2020-10-02 |
| Athletis PTA Balloon Dilatation Catheter (K201170) | Boston Scientific Corporation | 2020-09-15 |
| Resolution 360™ ULTRA Clip (K193424) | Boston Scientific Corporation | 2020-09-01 |
| SpaceOAR System (K202224) | Boston Scientific Corporation | 2020-08-28 |
| WallFlex Colonic Stent System with Anchor Lock Delivery System (K201159) | Boston Scientific Corporation | 2020-08-17 |
| TRUSELECT Microcatheter (K201792) | Boston Scientific Corporation | 2020-07-28 |
| AVVIGO Guidance System (K201713) | Boston Scientific Corporation | 2020-07-23 |
| LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473) | Boston Scientific Corporation | 2020-06-26 |
| SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (K200483) | Boston Scientific Corporation | 2020-05-21 |
| WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K200257) | Boston Scientific Corporation | 2020-04-17 |
| Opticross 35 15 MHz Peripheral Imaging Catheter (K200733) | Boston Scientific Corporation | 2020-04-17 |
| Sentinel Cerebral Protection System (K192460) | Boston Scientific Corporation | 2020-02-19 |
| Resectr Tissue Resection Device (K191538) | Boston Scientific Corporation | 2020-01-16 |
| Ureteral Stent Systems, Biliary Drainage Catheters (K191446) | Boston Scientific Corporation | 2020-01-02 |