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

881 results for "boston scientific"
265–288 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 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
Cleared Nov 01, 2013
SCANNING LASERLINK
K130195 · HQF
Lumenis, Inc.
Ophthalmic · 277d
Cleared 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 Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Boston Scientific Corp
Cardiovascular · 145d