Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

236 submissions · 223 cleared · Since 2005

Recent clearances: OBSIDIO Conformable Embolic, FARADRIVE™ Steerable Sheath (M004PF21M402), TheraSphere 360™ Y-90 Management Platform

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236

Total

223

Cleared

1

Denied

FDA 510(k) Regulatory Record - Boston Scientific Corporation Anesthesiology ✕

4 devices

1-4 of 4

Cleared Sep 26, 2025

Radial Jaw 4 Pulmonary Biopsy Forceps

Anesthesiology · 14d

Cleared Jul 14, 2023

Ultraflex™ Tracheobronchial Stent System

Anesthesiology · 164d

Cleared Mar 02, 2023

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound...

Anesthesiology · 297d

Cleared Mar 08, 2019

CoreDx™ Pulmonary Mini-Forceps

Anesthesiology · 122d