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"
73–96 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared May 25, 2023
Stingray LP Catheter
K231176 · DQY
Boston Scientific
Cardiovascular · 30d
Cleared May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
K230453 · OBJ
Boston Scientific Corporation
Cardiovascular · 86d
Cleared Apr 25, 2023
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
K230503 · DRF
Boston Scientific
Cardiovascular · 60d
Cleared Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
K223824 · DRA
Boston Scientific Corporation
Cardiovascular · 91d
Cleared Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound...
K221340 · EOQ
Boston Scientific Corporation
Anesthesiology · 297d
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible...
K221515 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 253d
Cleared Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 25d
Cleared Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K223592 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima...
K211934 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 506d
Cleared Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
K222568 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
K220112 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 237d
Cleared Sep 06, 2022
ROTAPRO Rotational Atherectomy System
K220962 · MCW
Boston Scientific Corporation
Cardiovascular · 158d
Cleared Aug 04, 2022
MANTIS Clip
K221124 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 108d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 20d
Cleared Jul 01, 2022
GEM
K213385 · KRD
Obsidio, Inc.
Cardiovascular · 261d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376 · GZB
Boston Scientific Neuromodulation
Neurology · 29d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Boston Scientific Corporation
Cardiovascular · 84d
Cleared May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
K212582 · GCA
Boston Scientific Corporation
Gastroenterology & Urology · 263d
Cleared Apr 20, 2022
EKOS+ Endovascular Device
K220866 · QEY
Boston Scientific
Cardiovascular · 26d
Cleared Apr 12, 2022
EMBOLD Fibered Detachable Coil System
K213398 · KRD
Boston Scientific Corporation
Cardiovascular · 176d
Cleared Mar 24, 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · LOX
Boston Scientific
Cardiovascular · 20d
Cleared Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548 · FYA
Boston Scientific Corporation
General Hospital · 444d