Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

236 submissions · 223 cleared · Since 2005
236
Total
223
Cleared
1
Denied
236 devices
51-75 of 236
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Cardiovascular · 28d
Cleared Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible...
K221515 · FGB
Gastroenterology & Urology · 253d
Cleared Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616 · ODG
Gastroenterology & Urology · 25d
Cleared Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K223592 · FGE
Gastroenterology & Urology · 28d
Cleared Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima...
K211934 · FAD
Gastroenterology & Urology · 506d
Cleared Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
K222568 · OBJ
Cardiovascular · 30d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Gastroenterology & Urology · 27d
Cleared Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
K220112 · PCU
Gastroenterology & Urology · 237d
Cleared Sep 06, 2022
ROTAPRO Rotational Atherectomy System
K220962 · MCW
Cardiovascular · 158d
Cleared Aug 04, 2022
MANTIS Clip
K221124 · PKL
Gastroenterology & Urology · 108d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014 · EOQ
Ear, Nose, Throat · 20d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Cardiovascular · 84d
Cleared May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
K212582 · GCA
Gastroenterology & Urology · 263d
Cleared Apr 12, 2022
EMBOLD Fibered Detachable Coil System
K213398 · KRD
Cardiovascular · 176d
Cleared Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548 · FYA
General Hospital · 444d
Cleared Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
K213593 · OBJ
Cardiovascular · 63d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Gastroenterology & Urology · 188d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Cardiovascular · 55d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Gastroenterology & Urology · 151d
Cleared Oct 20, 2021
AVVIGO Guidance System II
K212490 · DQK
Cardiovascular · 72d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Cardiovascular · 124d
Cleared Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · DRF
Cardiovascular · 129d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228 · DQY
Cardiovascular · 28d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
K211030 · EOQ
Ear, Nose, Throat · 125d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · OTN
Gastroenterology & Urology · 89d

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