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"
217–240 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz...
K160173 · DXK
Boston Scientific Corporation
Cardiovascular · 30d
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 27, 2015
Express SD Biliary Monorail Premounted Stent System
K152607 · FGE
Boston Scientific
Gastroenterology & Urology · 46d
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 22, 2015
Permanent Sled Bag
K152403 · ITX
Boston Scientific
Radiology · 28d
Cleared Sep 21, 2015
ZelanteDVT Thrombectomy Set
K151313 · QEW
Boston Scientific Corporation
Cardiovascular · 126d
Cleared Sep 18, 2015
iLab Ultrasound Imaging System
K152316 · IYO
Boston Scientific
Radiology · 32d
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 Jul 24, 2015
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · LIT
Boston Scientific
Cardiovascular · 260d
Cleared Jun 15, 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · LIT
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 10, 2015
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · PNO
Boston Scientific Limited
Cardiovascular · 29d