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

242 results for "Boston Scientific Corporation"
217–240 of 242
Search insights Median review: 74d Cleared: 100% Top manufacturer: Boston Scientific Corporation Lead specialty: Cardiovascular
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 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
Cleared Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · KRD
Boston Scientific Corporation
Cardiovascular · 21d
Cleared Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · LIT
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d