Medical Device Manufacturer · US , San Jose , CA

Boston Scientific Corp - FDA 510(k) Cleared Devices

432 submissions · 411 cleared · Since 1988
432
Total
411
Cleared
0
Denied
432 devices
26-50 of 432
Cleared Oct 18, 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · KRA
Cardiovascular · 29d
Cleared Oct 17, 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · LIT
Cardiovascular · 73d
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · KRD
Cardiovascular · 28d
Cleared Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · FGE
Gastroenterology & Urology · 165d
Cleared Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Cardiovascular · 145d
Cleared May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · OCX
Gastroenterology & Urology · 45d
Cleared Apr 15, 2013
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K123621 · OBJ
Cardiovascular · 143d
Cleared Mar 01, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · IYO
Radiology · 29d
Cleared Feb 20, 2013
MDU5 PLUS STERILE BAG
K123424 · ITX
Radiology · 105d
Cleared Jan 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · IYO
Radiology · 60d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · OTO
Obstetrics & Gynecology · 97d
Cleared Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · FED
Gastroenterology & Urology · 104d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Cardiovascular · 29d
Cleared Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · KNQ
Gastroenterology & Urology · 30d
Cleared Oct 10, 2012
BLUE SUI SLING
K121754 · OTN
Gastroenterology & Urology · 118d
Cleared Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614 · LJE
Gastroenterology & Urology · 109d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694 · DQO
Cardiovascular · 99d
Cleared Sep 13, 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · MCW
Cardiovascular · 87d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K121196 · LOX
Cardiovascular · 134d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394 · DQY
Cardiovascular · 23d
Cleared Aug 17, 2012
TRUETOME
K122203 · KNS
Gastroenterology & Urology · 23d
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · LOX
Cardiovascular · 68d
Cleared Aug 03, 2012
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · JCT
General & Plastic Surgery · 119d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · DQO
Cardiovascular · 94d
Cleared May 16, 2012
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
K121186 · BWH
Ear, Nose, Throat · 28d

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