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"
97–120 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Nov 09, 2020
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu...
K202274 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy...
K202478 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 41d