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

245 results for "Boston Scientific Corporation"
193–216 of 245
Search insights Median review: 77d Cleared: 100% Top manufacturer: Boston Scientific Corporation Lead specialty: Cardiovascular
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Boston Scientific Corporation
Cardiovascular · 86d
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Boston Scientific Corporation
Cardiovascular · 202d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 275d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY...
K133700 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 162d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Boston Scientific Corporation
Cardiovascular · 35d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 29d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · EYB
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 338d
Cleared Jun 05, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · DXC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · EZN
Boston Scientific Corporation
Gastroenterology & Urology · 58d
Cleared Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
K130121 · GCJ
Boston Scientific Corporation
General & Plastic Surgery · 84d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT...
K122459 · OTP
Boston Scientific Corporation
Obstetrics & Gynecology · 122d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 94d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY...
K122072 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K113220 · LOX
Boston Scientific Corporation
Cardiovascular · 142d
Cleared Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 148d
Cleared Feb 10, 2012
CRE DITATATION BALLON
K112994 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 126d
Cleared Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · DSY
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · KRD
Boston Scientific Corporation
Cardiovascular · 30d