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"
241–264 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire,...
K143587 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 48d
Cleared Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 106d
Cleared Oct 17, 2014
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL...
K141344 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 148d
Cleared Oct 17, 2014
EXPEL APD DRAINAGE CATHETER SYSTEM
K141335 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 149d
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · KRD
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Sep 25, 2014
PTA BALLOON DILATATION CATHETER
K141150 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Sep 10, 2014
Direxion Torqueable Microcatheter
K142259 · KRA
Boston Scientific Corp
Cardiovascular · 27d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 70d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Boston Scientific Corporation
Cardiovascular · 86d
Cleared Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · MJN
Boston Scientific Corp
Cardiovascular · 169d
Cleared Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR...
K140726 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 119d
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Boston Scientific Corporation
Cardiovascular · 202d
Cleared Jul 16, 2014
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
K141112 · LIT
Boston Scientific
Cardiovascular · 77d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Boston Scientific Corporation
Cardiovascular · 113d
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