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"
505–528 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 67d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · HCG
Boston Scientific, Target
Neurology · 29d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083 · LJT
Boston Scientific Corp
General Hospital · 19d
Cleared Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Boston Scientific Corp
Cardiovascular · 25d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · DQO
Boston Scientific Corp
Cardiovascular · 28d
Cleared Aug 22, 2002
CONTOUR SE MICROSPHERES
K022427 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 267d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · GEI
Boston Scientific Corp
General & Plastic Surgery · 232d
Cleared Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 190d