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"
169–192 of 726
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Feb 25, 2016
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6,...
K153617 · OBJ
Boston Scientific Corporation
Cardiovascular · 69d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · DQX
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,...
K151840 · DQX
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced...
K153088 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 46d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401 · DQY
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Nov 20, 2015
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis...
K152853 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 52d
Cleared Nov 13, 2015
LithoVue System
K153049 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 176d
Cleared Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605 · DQO
Boston Scientific Corporation
Cardiovascular · 48d
Cleared Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared Oct 21, 2015
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels,...
K152693 · DRQ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 06, 2015
AXIOS Stent and Delivery System
K152572 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Oct 06, 2015
iLab Polaris Multi-Modality Guidance System
K151613 · DQK
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Oct 06, 2015
Comet Pressure Guidewire
K151610 · DXO
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Sep 21, 2015
ZelanteDVT Thrombectomy Set
K151313 · QEW
Boston Scientific Corporation
Cardiovascular · 126d
Cleared Aug 06, 2015
Resolution Clip
K151802 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 35d
Cleared Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · PCU
Boston Scientific Corp
Gastroenterology & Urology · 140d
Cleared Jun 15, 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · LIT
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 05, 2015
Chariot Guiding Sheath
K150186 · DYB
Boston Scientific Corp
Cardiovascular · 129d
Cleared May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive...
K150679 · PIF
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Apr 22, 2015
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels,...
K150235 · DRQ
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Jan 16, 2015
SpyGlass DS Direct Visualization System
K142922 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire,...
K143587 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 48d