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"
337–360 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252 · DQY
Boston Scientific Corp
Cardiovascular · 30d
Cleared May 31, 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · LIT
Boston Scientific Corporation
Cardiovascular · 21d
Cleared May 12, 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · FGE
Boston Scientific
Gastroenterology & Urology · 114d
Cleared Apr 20, 2011
CRE BALLOON DILATATION CATHETER
K110833 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · DQX
Boston Scientific Corp
Cardiovascular · 49d
Cleared Mar 29, 2011
FLEXIVA TRACTIP
K110685 · GEX
Boston Scientific Corp
General & Plastic Surgery · 18d
Cleared Mar 28, 2011
ACCUTRAC
K110686 · GEX
Boston Scientific Corp
General & Plastic Surgery · 17d
Cleared Mar 22, 2011
MUSTANG BALLOON DILATATION CATHETERS
K103751 · LIT
Boston Scientific
Cardiovascular · 89d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · KRD
Boston Scientific Corp
Cardiovascular · 30d
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912 · KRD
Boston Scientific
Cardiovascular · 153d
Cleared Feb 16, 2011
GDC 360 DETEACHABLE COIL
K103355 · HCG
Boston Scientific Corp
Neurology · 92d
Cleared Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM...
K102714 · KRD
Boston Scientific Corp
Cardiovascular · 144d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · BWH
Boston Scientific Corporation
Ear, Nose, Throat · 159d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · ODG
Boston Scientific Corp
Gastroenterology & Urology · 7d
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Dec 10, 2010
INZONE DETACHMENT SYSTEM
K103008 · HCG
Boston Scientific Corp
Neurology · 59d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 64d
Cleared Oct 15, 2010
TARGET DETACHABLE COIL
K102672 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · KGE
Boston Scientific Corp
Gastroenterology & Urology · 116d
Cleared Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS,...
K102082 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · NAJ
Boston Scientific Corporation
Obstetrics & Gynecology · 39d