FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

881 results for "boston scientific"
73–96 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
K213593 · OBJ
Boston Scientific Corporation
Cardiovascular · 63d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Boston Scientific Corporation
Cardiovascular · 55d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 151d
Cleared Nov 19, 2021
EkoSonic Endovascular Device
K211080 · QEY
Boston Scientific
Cardiovascular · 221d
Cleared Oct 20, 2021
AVVIGO Guidance System II
K212490 · DQK
Boston Scientific Corporation
Cardiovascular · 72d