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"
25–48 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Apr 29, 2024
Ultraflex Esophageal NG Stent System
K233939 · ESW
Boston Scientific
Gastroenterology & Urology · 137d
Cleared Apr 04, 2024
Agile Esophageal Stent System
K233837 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 122d