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"
169–192 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Apr 19, 2018
Embozene Color-Advanced Microspheres
K180102 · NOY
Boston Scientific
Gastroenterology & Urology · 93d
Cleared Apr 12, 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
K180795 · DQX
Boston Scientific
Cardiovascular · 16d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Feb 09, 2018
ORISE Tissue Retractor System
K173400 · FED
Boston Scientific
Gastroenterology & Urology · 101d
Cleared Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
K173820 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
K172929 · LJE
Boston Scientific Corporation
Gastroenterology & Urology · 107d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx...
K172565 · PWJ
Boston Scientific Corporation
Gastroenterology & Urology · 117d
Cleared Dec 19, 2017
LumiCoil Platinum Fiducial Marker
K173251 · IYE
Boston Scientific Corporation
Radiology · 70d
Cleared Dec 15, 2017
Polyform Synthetic Mesh
K171271 · OTO
Boston Scientific Corporation
Obstetrics & Gynecology · 228d
Cleared Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · OBJ
Boston Scientific Corporation
Cardiovascular · 31d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · DQX
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · DSA
Boston Scientific Corporation
Cardiovascular · 66d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060 · PWI
Boston Scientific Corporation
Obstetrics & Gynecology · 119d
Cleared Oct 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · ODG
Boston Scientific
Gastroenterology & Urology · 28d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 06, 2017
PSA Cable
K170815 · DTC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · KTI
Boston Scientific Corporation
Ear, Nose, Throat · 102d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 199d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Boston Scientific Corporation
Cardiovascular · 138d