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"
193–216 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · KTI
Boston Scientific Corporation
Ear, Nose, Throat · 102d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 199d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Boston Scientific Corporation
Cardiovascular · 138d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 129d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204 · DRG
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314 · DQY
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Mar 22, 2017
Fathom-16 Steerable Guidewires
K170636 · DQX
Boston Scientific Corporation
Cardiovascular · 20d
Cleared Mar 10, 2017
RHYTHMIA HDx Mapping System
K162793 · DQK
Boston Scientific Corporation
Cardiovascular · 157d
Cleared Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Jan 30, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K163058 · ODG
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
K163200 · LOX
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Dec 14, 2016
Emerge PTCA Dilatation Catheter
K163174 · LOX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
K162350 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · LOX
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
K160514 · OBJ
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit...
K161003 · PIF
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jun 14, 2016
Symphion Endoscope and Symphion Cervical Sheath
K160751 · HIH
Boston Scientific
Obstetrics & Gynecology · 88d
Not Cleared Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
DEN150040 · PNB
Boston Scientific
Gastroenterology & Urology · 280d
Cleared May 19, 2016
OptiCross X, 40 MHz Coronary Imaging Catheter
K161125 · OBJ
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS...
K152842 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 233d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 36d
Cleared Mar 30, 2016
Rotatable Snares
K160637 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 23d