Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

729 results for "Boston Scientific Corp"
25–48 of 729
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 Feb 06, 2025
Resolution Clip (M00522600)
K250066 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
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 Aug 29, 2024
RHYTHMIA HDx™ Mapping System
K241227 · DQK
Boston Scientific Corporation
Cardiovascular · 119d
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 04, 2024
Agile Esophageal Stent System
K233837 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 122d
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
Cleared Dec 11, 2023
FARADRIVE™ Steerable Sheath
K233248 · DRA
Boston Scientific Corporation
Cardiovascular · 74d
Cleared Nov 30, 2023
14F iSLEEVE Introducer Set
K233503 · DYB
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
K233318 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Oct 27, 2023
Polaris X™ Unidirectional Steerable Diagnostic Catheter
K233207 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Sep 29, 2023
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K232651 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Sep 26, 2023
AVVIGO'+ Multi-Modality Guidance System
K230884 · DQK
Boston Scientific Corporation
Cardiovascular · 180d
Cleared Aug 19, 2023
LUX-Dx II (M302)
K231328 · MXD
Boston Scientific Corp
Cardiovascular · 103d
Not Cleared Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
DEN230019 · QXH
Boston Scientific Corporation
Gastroenterology & Urology · 144d
Cleared Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
K232162 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared CT Aug 08, 2023
Visual-ICE Cryoablation System
K230551 · GEH
Boston Scientific Corporation
Orthopedic · 161d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · DQY
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Jul 14, 2023
Ultraflex™ Tracheobronchial Stent System
K230269 · JCT
Boston Scientific Corporation
Anesthesiology · 164d