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Boston Scientific Corporation

FDA 510(k) & PMA Approved Devices — 207 products

Total Devices207
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262151 SpaceOAR Flex™ SystemOVB2026-09-11 View
510(k) K261153 LithoVue Elite Digital Flexible Ureteroscope SystemFGB2026-08-26 View
510(k) K261915 Navigator™ Flex Ureteral Access Sheath SetFED2026-08-04 View
510(k) K262462 TheraSphere 360™ Y-90 Management PlatformLLZ2026-07-24 View
510(k) K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)DRA2026-07-24 View
510(k) K261488 OBSIDIO Conformable EmbolicKRD2026-07-24 View
510(k) K261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW2026-07-10 View
510(k) K260428 RIVOS™ EUS Access Device (M00553900)ODG2026-06-17 View
510(k) K260100 MOSES Raydar™GEX2026-05-18 View
510(k) K260771 TruSelect™ 2.6 MicrocatheterKRA2026-05-15 View
510(k) K251273 Asurys Fluid Management SystemHIG2026-03-27 View
510(k) K260479 TheraSphere 360™ Y-90 Management PlatformLLZ2026-03-13 View
510(k) K260119 SpaceOAR Vue System (SV-2101)OVB2026-02-10 View
510(k) K253376 OBSIDIO™ Conformable Embolic (M0013972101010)KRD2025-10-30 View
510(k) K252529 Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)GEX2025-10-30 View
510(k) K252547 TheraSphere 360™ Y-90 Management PlatformLLZ2025-10-28 View
510(k) K252921 Radial Jaw 4 Pulmonary Biopsy ForcepsBWH2025-09-26 View
510(k) K252703 LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)FGB2025-09-24 View
510(k) K252593 LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD2025-09-12 View
510(k) K251759 Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersGEX2025-07-09 View
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