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"
169–192 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 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
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 06, 2017
PSA Cable
K170815 · DTC
Boston Scientific Corporation
Cardiovascular · 111d