FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

892 results for "Boston Scientific"
409–432 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · NTE
Boston Scientific Corp
Cardiovascular · 33d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS...
K062750 · MUM
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS,...
K063312 · DQO
Boston Scientific Corp
Radiology · 28d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202 · DQY
Boston Scientific Corp
Cardiovascular · 80d
Cleared Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · PNO
Boston Scientific
Cardiovascular · 51d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594 · DQY
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 122d
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · NFA
Boston Scientific Corp
Cardiovascular · 91d
Cleared Jul 31, 2006
FLEXVIEW SYSTEM
K062050 · GCJ
Boston Scientific
General & Plastic Surgery · 11d
Cleared May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 92d
Cleared Apr 19, 2006
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
K060947 · ITX
Boston Scientific Corp
Radiology · 13d
Cleared Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · LIT
Boston Scientific Corporation
Cardiovascular · 5d
Cleared Apr 10, 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190,...
K051984 · NFA
Boston Scientific Corp
Cardiovascular · 262d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · DQO
Boston Scientific Corp
Cardiovascular · 60d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572 · DQY
Boston Scientific Corporation
Cardiovascular · 9d
Cleared Mar 13, 2006
CONCERTO BIPOLAR NEEDLE ELECTRODE
K060419 · GEI
Boston Scientific Corp
General & Plastic Surgery · 24d
Cleared Mar 13, 2006
PVS 2000 SYNCHRO2 GUIDEWIRE
K053268 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 110d
Cleared Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · KRD
Boston Scientific Corporation
Cardiovascular · 21d
Cleared Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED...
K052964 · DSY
Boston Scientific Corp
Cardiovascular · 77d
Cleared Jan 04, 2006
RIO ASPIRATION CATHETER
K051880 · QEZ
Boston Scientific Corp
Cardiovascular · 177d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118 · DQY
Boston Scientific Corp
Cardiovascular · 39d