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

729 results for "Boston Scientific Corp"
289–312 of 729
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Dec 10, 2010
INZONE DETACHMENT SYSTEM
K103008 · HCG
Boston Scientific Corp
Neurology · 59d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 64d
Cleared Oct 15, 2010
TARGET DETACHABLE COIL
K102672 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · KGE
Boston Scientific Corp
Gastroenterology & Urology · 116d
Cleared Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS,...
K102082 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · NAJ
Boston Scientific Corporation
Obstetrics & Gynecology · 39d
Cleared Apr 12, 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · KRA
Boston Scientific Corp
Cardiovascular · 12d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 18d
Cleared Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · GEX
Boston Scientific Corp
General & Plastic Surgery · 31d
Cleared Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · HCG
Boston Scientific Corp
Neurology · 122d
Cleared Dec 23, 2009
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL...
K093720 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Dec 23, 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL...
K093636 · LIT
Boston Scientific Corp
Cardiovascular · 29d
Cleared Dec 11, 2009
ACCUMAX
K093691 · GEX
Boston Scientific Corp
General & Plastic Surgery · 11d
Cleared Nov 06, 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260,...
K092009 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 123d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL...
K092666 · HCG
Boston Scientific Corp
Neurology · 30d
Cleared Sep 04, 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
K092455 · LIT
Boston Scientific Corporation
Cardiovascular · 25d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · DQX
Boston Scientific Corp
Cardiovascular · 122d
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 Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330,...
K091340 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 34d
Cleared CT Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 160d