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

244 results for "Boston Scientific Corporation"
169–192 of 244
Search insights Median review: 74d Cleared: 100% Top manufacturer: Boston Scientific Corporation 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 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 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
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · KRD
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 70d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Boston Scientific Corporation
Cardiovascular · 86d