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"
1–24 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared CT Sep 11, 2026
SpaceOAR Flex™ System
K262151 · OVB
Boston Scientific Corporation
Radiology · 78d
Cleared Sep 03, 2026
Rezum System
K262460 · KNS
Boston Scientific
Gastroenterology & Urology · 48d
Cleared Aug 26, 2026
LithoVue Elite Digital Flexible Ureteroscope System
K261153 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 140d
Cleared Aug 21, 2026
AVVIGO™+ Multi-Modality Guidance System
K253692 · DQK
Boston Scientific
Cardiovascular · 273d
Cleared Aug 12, 2026
EluPro Antibiotic-Eluting BioEnvelope
K262406 · FTM
Boston Scientific
Cardiovascular · 28d
Cleared Aug 04, 2026
Navigator™ Flex Ureteral Access Sheath Set
K261915 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 56d
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