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

898 results for "Boston Scientific"
49–72 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
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 Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
K232633 · KNS
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Nov 22, 2023
IceSeed 1.5 CX 90º Needle (H7493967433170)
K232635 · GEH
Boston Scientific
General & Plastic Surgery · 84d
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
Cleared Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jun 27, 2023
EMBOLD™ Soft Detachable Coil System
K230706 · KRD
Boston Scientific Corporation
Cardiovascular · 105d
Cleared Jun 21, 2023
Habib EndoHPB
K231533 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Jun 15, 2023
WallFlex™ Biliary RX Stent System
K223469 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 210d