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"
121–144 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 60d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Boston Scientific Corporation
Cardiovascular · 26d