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"
169–192 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 Jul 20, 2018
WATCHMAN TruSeal Access System
K180864 · DQY
Boston Scientific
Cardiovascular · 109d
Cleared Jun 22, 2018
iSLEEVE Introducer Set
K180785 · DYB
Boston Scientific Corporation
Cardiovascular · 88d
Cleared Jun 18, 2018
Savion DLVR Guidewire, Savion FLX Guidewire
K180726 · DQX
Boston Scientific, Inc.
Cardiovascular · 90d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared CT Apr 19, 2018
Embozene Color-Advanced Microspheres
K180102 · NOY
Boston Scientific
Gastroenterology & Urology · 93d
Cleared Apr 12, 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
K180795 · DQX
Boston Scientific
Cardiovascular · 16d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Feb 09, 2018
ORISE Tissue Retractor System
K173400 · FED
Boston Scientific
Gastroenterology & Urology · 101d
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 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · ODG
Boston Scientific
Gastroenterology & Urology · 28d
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