FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

892 results for "Boston Scientific"
49–72 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 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
Cleared May 25, 2023
Stingray LP Catheter
K231176 · DQY
Boston Scientific
Cardiovascular · 30d
Cleared May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
K230453 · OBJ
Boston Scientific Corporation
Cardiovascular · 86d