Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

236 submissions · 223 cleared · Since 2005
236
Total
223
Cleared
1
Denied
236 devices
101-125 of 236
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279 · DXO
Cardiovascular · 26d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Gastroenterology & Urology · 23d
Cleared Nov 27, 2019
Rhythmia HDxTM Mapping System
K192438 · DQK
Cardiovascular · 82d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Cardiovascular · 56d
Cleared Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K192043 · PCU
Gastroenterology & Urology · 26d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Gastroenterology & Urology · 60d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Cardiovascular · 26d
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789 · LQR
Gastroenterology & Urology · 22d
Cleared Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
K191008 · DQK
Cardiovascular · 77d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Gastroenterology & Urology · 77d
Cleared May 21, 2019
MAKO 7
K182975 · HIH
Obstetrics & Gynecology · 208d
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
K183619 · FAE
Gastroenterology & Urology · 111d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Gastroenterology & Urology · 252d
Cleared Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
K190401 · DQY
Cardiovascular · 24d
Cleared Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · EOQ
Anesthesiology · 122d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · GXI
Neurology · 112d
Cleared Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
K183636 · FBN
Gastroenterology & Urology · 27d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Gastroenterology & Urology · 109d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Cardiovascular · 30d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Gastroenterology & Urology · 246d
Cleared Sep 13, 2018
Seal Single Use Biopsy Valve
K182275 · OCX
Gastroenterology & Urology · 22d
Cleared Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
K181439 · FBN
Gastroenterology & Urology · 83d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Cardiovascular · 219d
Cleared Jun 22, 2018
iSLEEVE Introducer Set
K180785 · DYB
Cardiovascular · 88d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Cardiovascular · 28d

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