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"
265–288 of 898
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 275d
Cleared Jun 06, 2014
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · DQK
Boston Scientific Corp
Cardiovascular · 30d
Cleared May 23, 2014
WALLFLEX BILIARY RX STENT SYSTEM
K140630 · FGE
Boston Scientific
Gastroenterology & Urology · 73d
Cleared May 15, 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · KRA
Boston Scientific
Cardiovascular · 94d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY...
K133700 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 162d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Boston Scientific Corporation
Cardiovascular · 35d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745 · MAV
Boston Scientific Corp
Cardiovascular · 23d
Cleared Apr 17, 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
K140495 · GEI
Boston Scientific Corp
General & Plastic Surgery · 49d
Cleared Apr 16, 2014
INSERTION TOOL
K140673 · DQX
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 16, 2014
TRUEPATH CTO DEVICE
K140288 · PDU
Boston Scientific Corp
Cardiovascular · 70d
Cleared Apr 15, 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
K140503 · GEX
Boston Scientific
General & Plastic Surgery · 47d
Cleared Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · DQY
Boston Scientific
Cardiovascular · 198d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Mar 20, 2014
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
K133319 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 143d
Cleared Mar 07, 2014
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
K140323 · FED
Boston Scientific
Gastroenterology & Urology · 25d
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 16, 2013
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · DSA
Boston Scientific
Cardiovascular · 150d
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