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"
25–48 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
K250310 · DRF
Boston Scientific Corporation
Cardiovascular · 144d
Cleared Jun 11, 2025
Rezum System
K250584 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared May 28, 2025
OptiMap™ System
K251344 · DQK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 15, 2025
Percuflex Ureteral Stent
K250824 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
K250517 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 20, 2025
iSLEEVE Introducer Set
K250468 · DYB
Boston Scientific
Cardiovascular · 30d
Cleared Feb 06, 2025
Resolution Clip (M00522600)
K250066 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
K242950 · FGE
Boston Scientific
Gastroenterology & Urology · 74d
Cleared Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
K242960 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Nov 01, 2024
EP•XT™ Unidirectional Steerable Diagnostic Catheter
K240366 · DRF
Boston Scientific Corporation
Cardiovascular · 269d
Cleared Oct 18, 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
K243245 · GEH
Boston Scientific Corp
General & Plastic Surgery · 7d
Cleared Oct 03, 2024
OBSIDIO™ Conformable Embolic
K242507 · KRD
Boston Scientific
Cardiovascular · 42d
Cleared Aug 30, 2024
WallFlex Biliary RX Stent System
K240464 · FGE
Boston Scientific
Gastroenterology & Urology · 196d
Cleared Aug 29, 2024
RHYTHMIA HDx™ Mapping System
K241227 · DQK
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · GZB
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF
Boston Scientific Neuromodulation
Neurology · 376d
Cleared Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
K241683 · LIT
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
K241598 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 27d