FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

726 results for "Boston Scientific Corp"
121–144 of 726
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · EOQ
Boston Scientific Corporation
Anesthesiology · 122d
Cleared Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
K183636 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 246d
Cleared Sep 13, 2018
Seal Single Use Biopsy Valve
K182275 · OCX
Boston Scientific Corporation
Gastroenterology & Urology · 22d
Cleared Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
K181439 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 83d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Boston Scientific Corporation
Cardiovascular · 219d
Cleared Jun 22, 2018
iSLEEVE Introducer Set
K180785 · DYB
Boston Scientific Corporation
Cardiovascular · 88d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
K173820 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
K172929 · LJE
Boston Scientific Corporation
Gastroenterology & Urology · 107d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx...
K172565 · PWJ
Boston Scientific Corporation
Gastroenterology & Urology · 117d
Cleared Dec 19, 2017
LumiCoil Platinum Fiducial Marker
K173251 · IYE
Boston Scientific Corporation
Radiology · 70d
Cleared Dec 15, 2017
Polyform Synthetic Mesh
K171271 · OTO
Boston Scientific Corporation
Obstetrics & Gynecology · 228d
Cleared Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · OBJ
Boston Scientific Corporation
Cardiovascular · 31d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · DQX
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · DSA
Boston Scientific Corporation
Cardiovascular · 66d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060 · PWI
Boston Scientific Corporation
Obstetrics & Gynecology · 119d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Boston Scientific Corporation
Cardiovascular · 29d