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

898 results for "Boston Scientific"
289–312 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Nov 01, 2013
SCANNING LASERLINK
K130195 · HQF
Lumenis, Inc.
Ophthalmic · 277d
Cleared CT Oct 31, 2013
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · PDU
Boston Scientific Corp
Cardiovascular · 127d
Cleared Oct 22, 2013
OCCLUSION BALLOON CATHETER
K132990 · MJN
Boston Scientific Corp
Cardiovascular · 28d
Cleared Oct 18, 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · KRA
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 17, 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · LIT
Boston Scientific Corp
Cardiovascular · 73d
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · KRD
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 03, 2013
RESURFX 1565NM LASER MODULE
K130028 · ONG
Lumenis, Ltd.
General & Plastic Surgery · 243d
Cleared Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 165d
Cleared CT Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Boston Scientific Corp
Cardiovascular · 145d
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 May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · OCX
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Apr 15, 2013
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K123621 · OBJ
Boston Scientific Corp
Cardiovascular · 143d
Cleared Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
K130121 · GCJ
Boston Scientific Corporation
General & Plastic Surgery · 84d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · DQY
Boston Scientific
Cardiovascular · 102d
Cleared Mar 01, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · IYO
Boston Scientific Corp
Radiology · 29d
Cleared Feb 20, 2013
MDU5 PLUS STERILE BAG
K123424 · ITX
Boston Scientific Corp
Radiology · 105d
Cleared Jan 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · IYO
Boston Scientific Corp
Radiology · 60d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · OTO
Boston Scientific Corp
Obstetrics & Gynecology · 97d
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 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · FED
Boston Scientific Corp
Gastroenterology & Urology · 104d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 94d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d