Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

898 results for "Boston Scientific"
193–216 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
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