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"
433–456 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · LIT
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Jul 14, 2005
ILAB ULTRASOUND IMAGING SYSTEM
K051679 · OBJ
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jun 22, 2005
PERIPHERAL CUTTING BALLOON
K051254 · PNO
Boston Scientific Ivt
Cardiovascular · 37d
Cleared Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · FED
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 22d
Cleared Jun 13, 2005
PV 1900 SYNCHRO 0.016 GUIDEWIRE
K050964 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 56d
Cleared Jun 08, 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · NFA
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599 · DQY
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389 · DQY
Boston Scientific Corp
Cardiovascular · 99d
Cleared May 20, 2005
ATLANTIS PV
K050684 · DQO
Boston Scientific Corp
Radiology · 64d
Cleared Apr 15, 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · DQO
Boston Scientific Corp
Cardiovascular · 23d
Cleared Mar 22, 2005
PIVOT STEERABLE MICROCATHETER
K050630 · KRA
Boston Scientific - Precision Vascular
Cardiovascular · 11d
Cleared Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · GEI
Boston Scientific Corp
General & Plastic Surgery · 28d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · PID
Boston Scientific Corp
Gastroenterology & Urology · 38d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · ITX
Boston Scientific Corp
Radiology · 127d
Cleared Nov 09, 2004
ENTERYX INJECTION CATHETER
K042882 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Oct 19, 2004
GDC-10 360 DEGREE COIL SR
K042539 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · DQY
Boston Scientific Corp
Cardiovascular · 24d
Cleared Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Aug 16, 2004
2 CM PERIPHERAL CUTTING BALOON
K041993 · PNO
Boston Scientific Ivt
Cardiovascular · 24d
Cleared Aug 06, 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 30d