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"
145–168 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 60d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Aug 02, 2019
Rezum System
K191505 · KNS
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 57d
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789 · LQR
Boston Scientific Corporation
Gastroenterology & Urology · 22d
Cleared Jul 19, 2019
SpaceOAR Vue Hydrogel
K182971 · OVB
Augmenix, Inc.
Radiology · 266d
Cleared Jul 11, 2019
Nalu Lead Blank (50cm)
K190960 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
K191008 · DQK
Boston Scientific Corporation
Cardiovascular · 77d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 77d
Cleared May 21, 2019
MAKO 7
K182975 · HIH
Boston Scientific Corporation
Obstetrics & Gynecology · 208d
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
K183619 · FAE
Boston Scientific Corporation
Gastroenterology & Urology · 111d
Cleared Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu...
K183579 · GZF
Boston Scientific Neuromodulation
Neurology · 98d
Cleared Mar 25, 2019
Rezum Delivery Device, Rezum Generator
K190093 · KNS
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 66d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 252d
Cleared Mar 22, 2019
Nalu Neurostimulation System
K183047 · GZB
Boston Scientific Neuromodulation
Neurology · 140d
Cleared Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
K190401 · DQY
Boston Scientific Corporation
Cardiovascular · 24d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · GXI
Boston Scientific Corporation
Neurology · 112d
Cleared Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · EOQ
Boston Scientific Corporation
Anesthesiology · 122d
Cleared Mar 07, 2019
iSLEEVE Introducer Set
K190184 · DYB
Boston Scientific
Cardiovascular · 34d
Cleared Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
K183636 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Sep 28, 2018
ORISE Gel
K180068 · PLL
Boston Scientific
Gastroenterology & Urology · 262d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 246d
Cleared Sep 13, 2018
Seal Single Use Biopsy Valve
K182275 · OCX
Boston Scientific Corporation
Gastroenterology & Urology · 22d