FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

881 results for "Boston Scientific"
25–48 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
K250310 · DRF
Boston Scientific Corporation
Cardiovascular · 144d
Cleared Jun 11, 2025
Rezum System
K250584 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared May 28, 2025
OptiMap™ System
K251344 · DQK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 15, 2025
Percuflex Ureteral Stent
K250824 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
K250517 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 20, 2025
iSLEEVE Introducer Set
K250468 · DYB
Boston Scientific
Cardiovascular · 30d
Cleared Feb 06, 2025
Resolution Clip (M00522600)
K250066 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
K242950 · FGE
Boston Scientific
Gastroenterology & Urology · 74d
Cleared Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
K242960 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Nov 01, 2024
EP•XT™ Unidirectional Steerable Diagnostic Catheter
K240366 · DRF
Boston Scientific Corporation
Cardiovascular · 269d
Cleared Oct 18, 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
K243245 · GEH
Boston Scientific Corp
General & Plastic Surgery · 7d
Cleared Oct 03, 2024
OBSIDIO™ Conformable Embolic
K242507 · KRD
Boston Scientific
Cardiovascular · 42d
Cleared Aug 30, 2024
WallFlex Biliary RX Stent System
K240464 · FGE
Boston Scientific
Gastroenterology & Urology · 196d
Cleared Aug 29, 2024
RHYTHMIA HDx™ Mapping System
K241227 · DQK
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · GZB
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF
Boston Scientific Neuromodulation
Neurology · 376d
Cleared Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
K241683 · LIT
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
K241598 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Apr 29, 2024
Ultraflex Esophageal NG Stent System
K233939 · ESW
Boston Scientific
Gastroenterology & Urology · 137d
Cleared Apr 04, 2024
Agile Esophageal Stent System
K233837 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 122d
Cleared Mar 13, 2024
ICEfx Cryoablation System (FPRCH8000-02)
K234002 · GEH
Boston Scientific
Orthopedic · 85d
Cleared Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
K234046 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 78d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · DQY
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
K233645 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d