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"
121–144 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Oct 06, 2020
iSleeve Introducer Set
K202584 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Boston Scientific Corporation
Cardiovascular · 57d
Cleared Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
K201170 · LIT
Boston Scientific Corporation
Cardiovascular · 137d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 266d
Cleared Aug 28, 2020
SpaceOAR System
K202224 · OVB
Boston Scientific Corporation
Radiology · 21d
Cleared Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Jul 28, 2020
TRUSELECT Microcatheter
K201792 · KRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 23, 2020
AVVIGO Guidance System
K201713 · DQK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jul 15, 2020
Nalu Neurostimulation SCS system
K201618 · GZB
Boston Scientific Neuromodulation
Neurology · 30d
Cleared Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Boston Scientific Corporation
Cardiovascular · 193d
Cleared May 29, 2020
iLab Polaris Multi-Modality Guidance System
K201178 · DQK
Boston Scientific
Cardiovascular · 28d
Cleared May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
K200483 · FBN
Boston Scientific Corporation
General & Plastic Surgery · 84d
Cleared Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · ITX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460 · PUM
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Jan 16, 2020
Resectr Tissue Resection Device
K191538 · HIH
Boston Scientific Corporation
Obstetrics & Gynecology · 220d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 216d
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279 · DXO
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Nov 27, 2019
Rhythmia HDxTM Mapping System
K192438 · DQK
Boston Scientific Corporation
Cardiovascular · 82d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Boston Scientific Corporation
Cardiovascular · 56d
Cleared Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K192043 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 26d