Boston Scientific Corporation - FDA 510(k) Cleared Devices
229
Total
216
Cleared
1
Denied
97 devices
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
Gastroenterology & Urology
28d
Cleared
Jul 09, 2025
Flexiva Pulse Laser Fiber
Gastroenterology & Urology
30d
Cleared
Jun 11, 2025
Rezum System
Gastroenterology & Urology
104d
Cleared
Apr 15, 2025
Percuflex Ureteral Stent
Gastroenterology & Urology
28d
Cleared
Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
Gastroenterology & Urology
28d
Cleared
Feb 06, 2025
Resolution Clip (M00522600)
Gastroenterology & Urology
27d
Cleared
Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
Gastroenterology & Urology
51d
Cleared
Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
Gastroenterology & Urology
27d
Cleared
Apr 04, 2024
Agile Esophageal Stent System
Gastroenterology & Urology
122d
Cleared
Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
Gastroenterology & Urology
78d
Cleared
Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
Gastroenterology & Urology
28d
Cleared
Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
Gastroenterology & Urology
28d
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