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

728 results for "Boston Scientific Corp"
97–120 of 728
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Boston Scientific Corporation
Cardiovascular · 193d
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
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789 · LQR
Boston Scientific Corporation
Gastroenterology & Urology · 22d
Cleared Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
K191008 · DQK
Boston Scientific Corporation
Cardiovascular · 77d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 77d
Cleared May 21, 2019
MAKO 7
K182975 · HIH
Boston Scientific Corporation
Obstetrics & Gynecology · 208d
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
K183619 · FAE
Boston Scientific Corporation
Gastroenterology & Urology · 111d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 252d