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"
313–336 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · LOX
Boston Scientific Corp
Cardiovascular · 68d
Cleared Aug 03, 2012
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · JCT
Boston Scientific Corp
General & Plastic Surgery · 119d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · DQO
Boston Scientific Corp
Cardiovascular · 94d
Cleared May 16, 2012
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
K121186 · BWH
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · MAV
Boston Scientific Corp
Cardiovascular · 27d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · DQO
Boston Scientific Corp
Cardiovascular · 6d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K113220 · LOX
Boston Scientific Corporation
Cardiovascular · 142d
Cleared Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 148d
Cleared Feb 10, 2012
CRE DITATATION BALLON
K112994 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 126d
Cleared Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · DSY
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jan 11, 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · LIT
Boston Scientific
Cardiovascular · 27d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · KRD
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY...
K112543 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 119d
Cleared Nov 30, 2011
CHARGER PTA BALLON DILATATION CATHETER
K112697 · LIT
Boston Scientific
Cardiovascular · 75d
Cleared Nov 09, 2011
RUBICON SUPPORT CATHETER
K112303 · DQY
Boston Scientific
Cardiovascular · 90d
Cleared Oct 25, 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · FGE
Boston Scientific
Gastroenterology & Urology · 39d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · DQX
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426 · OTP
Boston Scientific Corp
Obstetrics & Gynecology · 296d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · KRD
Boston Scientific Corp
Cardiovascular · 21d
Cleared Aug 04, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
K111043 · OBJ
Boston Scientific Corp
Radiology · 111d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · DQX
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485 · DQX
Boston Scientific Corporation
Cardiovascular · 30d