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"
217–240 of 245
Search insights Median review: 77d Cleared: 100% Top manufacturer: Boston Scientific Corporation Lead specialty: Cardiovascular
Cleared Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY...
K112543 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 119d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · DQX
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared May 31, 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · LIT
Boston Scientific Corporation
Cardiovascular · 21d
Cleared Apr 20, 2011
CRE BALLOON DILATATION CATHETER
K110833 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · BWH
Boston Scientific Corporation
Ear, Nose, Throat · 159d
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 64d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · NAJ
Boston Scientific Corporation
Obstetrics & Gynecology · 39d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 18d
Cleared Nov 06, 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260,...
K092009 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 123d
Cleared Sep 04, 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
K092455 · LIT
Boston Scientific Corporation
Cardiovascular · 25d
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 13d
Cleared Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710,...
K091510 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 35d
Cleared CT Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510,...
K083627 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 120d
Cleared Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280,...
K080332 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 211d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 101d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594 · DQY
Boston Scientific Corporation
Cardiovascular · 19d
Cleared May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 92d
Cleared Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572 · DQY
Boston Scientific Corporation
Cardiovascular · 9d