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"
649–672 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165 · LDF
Boston Scientific Corp
Cardiovascular · 114d
Cleared Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254 · DQX
Boston Scientific Corp
Cardiovascular · 89d
Cleared Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 189d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · MBI
Boston Scientific Corp
Orthopedic · 89d
Cleared May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 275d
Cleared May 20, 1997
ULTRAFLEX DIAMOND
K962899 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 299d
Cleared May 16, 1997
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953647 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 651d
Cleared May 01, 1997
CHANNEL BALLOON CATHETER
K970379 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K964119 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 02, 1997
STONE DISLODGER, BASKET
K970121 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Mar 28, 1997
ULTRATOMERX
K970053 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Mar 25, 1997
EXTRACTORRX
K970052 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · DYF
Meadox Medicals, Div. Boston...
Cardiovascular · 387d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 266d
Cleared Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · LJT
Boston Scientific Corp
General Hospital · 118d
Cleared Mar 04, 1997
IMAGER TORQUE CATHETER
K965229 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Feb 13, 1997
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Feb 10, 1997
TANDEMRX
K970054 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 34d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067 · GBM
Boston Scientific Corp
Gastroenterology & Urology · 41d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611 · DQX
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jan 24, 1997
A LITHOTRIPTER-COMPATIBLE BASKET
K964937 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Jan 22, 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 254d
Cleared Jan 13, 1997
11F GUIDING CATHETER
K963663 · DQY
Boston Scientific /International...
Cardiovascular · 122d