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"
289–312 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · DQY
Boston Scientific
Cardiovascular · 102d
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
Cleared Jan 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · IYO
Boston Scientific Corp
Radiology · 60d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · OTO
Boston Scientific Corp
Obstetrics & Gynecology · 97d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT...
K122459 · OTP
Boston Scientific Corporation
Obstetrics & Gynecology · 122d
Cleared Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · FED
Boston Scientific Corp
Gastroenterology & Urology · 104d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 94d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Oct 10, 2012
BLUE SUI SLING
K121754 · OTN
Boston Scientific Corp
Gastroenterology & Urology · 118d
Cleared Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY...
K122072 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614 · LJE
Boston Scientific Corp
Gastroenterology & Urology · 109d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694 · DQO
Boston Scientific Corp
Cardiovascular · 99d
Cleared Sep 13, 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · MCW
Boston Scientific Corp
Cardiovascular · 87d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K121196 · LOX
Boston Scientific Corp
Cardiovascular · 134d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Aug 17, 2012
TRUETOME
K122203 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 23d