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"
145–168 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
K181439 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 83d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Boston Scientific Corporation
Cardiovascular · 219d