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"
217–240 of 729
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Apr 16, 2014
TRUEPATH CTO DEVICE
K140288 · PDU
Boston Scientific Corp
Cardiovascular · 70d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Feb 28, 2014
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
K132810 · LIT
Boston Scientific Corp
Cardiovascular · 172d
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 20, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · MCW
Boston Scientific Corp
Cardiovascular · 30d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 338d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · KRD
Boston Scientific Corp
Cardiovascular · 27d
Cleared Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE,...
K131700 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 146d
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 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 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