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"
553–576 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Oct 02, 2001
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952 · DSY
Boston Scientific/Medi-Tech
Cardiovascular · 28d
Cleared Sep 07, 2001
IMAGER II ANGIOGRAPHIC CATHETER
K011664 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 100d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Boston Scientific Corp
Cardiovascular · 55d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · LJS
Boston Scientific Corp
General Hospital · 232d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 18d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Boston Scientific Corp
Cardiovascular · 90d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 18, 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · DQY
Boston Scientific, Target
Cardiovascular · 28d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · GEI
Boston Scientific Corp
General & Plastic Surgery · 14d
Cleared Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
K010707 · DQO
Boston Scientific, Target
Radiology · 20d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Boston Scientific Corp
Cardiovascular · 125d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Boston Scientific Corp
Cardiovascular · 69d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 20d
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · JCT
Boston Scientific Corp
General & Plastic Surgery · 78d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Boston Scientific Corp
Cardiovascular · 239d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 183d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Boston Scientific Corp
Cardiovascular · 143d