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"
97–120 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
K213593 · OBJ
Boston Scientific Corporation
Cardiovascular · 63d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Boston Scientific Corporation
Cardiovascular · 55d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 151d
Cleared Nov 19, 2021
EkoSonic Endovascular Device
K211080 · QEY
Boston Scientific
Cardiovascular · 221d
Cleared Oct 20, 2021
AVVIGO Guidance System II
K212490 · DQK
Boston Scientific Corporation
Cardiovascular · 72d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Boston Scientific Corporation
Cardiovascular · 124d
Cleared Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · DRF
Boston Scientific Corporation
Cardiovascular · 129d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228 · DQY
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
K211030 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 125d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
K210889 · DQK
Boston Scientific Corporation
Cardiovascular · 92d
Cleared May 26, 2021
SpyGlass Discover Retrieval Basket
K203322 · LQR
Boston Scientific Corporation
Gastroenterology & Urology · 195d
Cleared May 25, 2021
LUX-Dx Insertable Cardiac Monitor
K210608 · MXD
Boston Scientific Corporation
Cardiovascular · 85d
Cleared May 06, 2021
AutoCap RX
K210353 · ODC
Boston Scientific Corporation
Gastroenterology & Urology · 87d
Cleared Apr 29, 2021
Rescue Pulmonary Grasping Forceps
K202987 · EOQ
Anrei Medical (Hangzhou) Co., Ltd.
Anesthesiology · 211d
Cleared Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse...
K210925 · GEX
Boston Scientific
Gastroenterology & Urology · 30d
Cleared Apr 27, 2021
Safety Trocar Cannula
K211072 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit,...
K200260 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 448d
Cleared Apr 20, 2021
Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500...
K203276 · NOY
Biocompatibles UK Ltd (Part of Boston...
Neurology · 165d
Cleared Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
K203132 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 178d
Cleared Mar 25, 2021
Nalu Neurostimulation System
K203547 · GZB
Boston Scientific Neuromodulation
Neurology · 111d
Cleared Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 56d
Cleared Dec 03, 2020
ORISE ProKnife
K200404 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 288d