FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

881 results for "Boston Scientific"
1–24 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
K262165 · DRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2026
OBSIDIO Conformable Embolic
K261488 · KRD
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Jul 10, 2026
WallFlex Esophageal Stent System
K261978 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Jun 17, 2026
RIVOS™ EUS Access Device (M00553900)
K260428 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 127d
Cleared May 18, 2026
MOSES Raydar™
K260100 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 125d
Cleared May 15, 2026
TruSelect™ 2.6 Microcatheter
K260771 · KRA
Boston Scientific Corporation
Cardiovascular · 67d
Cleared Apr 08, 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · OBJ
Boston Scientific
Cardiovascular · 26d
Cleared Mar 27, 2026
Asurys Fluid Management System
K251273 · HIG
Boston Scientific Corporation
Obstetrics & Gynecology · 337d
Cleared Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · LLZ
Boston Scientific Corporation
Radiology · 28d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d
Cleared Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · DSI
Boston Scientific Cardiac Diagnostic...
Cardiovascular · 452d
Cleared Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
K252405 · NLH
Surgical Instrument Service and...
Cardiovascular · 118d
Cleared Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · KRD
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
K252529 · GEX
Boston Scientific Corporation
General & Plastic Surgery · 80d
Cleared Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
K252547 · LLZ
Boston Scientific Corporation
Radiology · 77d
Cleared Oct 09, 2025
Orca Air/Water and Suction Valves
K252910 · ODC
Boston Scientific
Gastroenterology & Urology · 27d
Cleared Sep 26, 2025
Radial Jaw 4 Pulmonary Biopsy Forceps
K252921 · BWH
Boston Scientific Corporation
Anesthesiology · 14d
Cleared Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
K252703 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · MXD
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · GXD
Boston Scientific Neuromodulation...
Neurology · 106d
Cleared Jul 11, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional...
K250772 · NLH
Surgical Instrument Service and...
Cardiovascular · 120d
Cleared Jul 09, 2025
Flexiva Pulse Laser Fiber
K251759 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jul 03, 2025
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K251291 · FGE
Boston Scientific
Gastroenterology & Urology · 69d