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"
457–480 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Aug 06, 2004
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
K032884 · NFA
Boston Scientific Epi
Cardiovascular · 325d
Cleared Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · OBJ
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716 · DXZ
Boston Scientific Corp
Cardiovascular · 28d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 22d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155 · PNO
Boston Scientific Corp
Cardiovascular · 160d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 06, 2004
EASY CORE BIOPSY SYSTEM
K040893 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · DQX
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776 · DQO
Boston Scientific Corp
Cardiovascular · 34d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · GEI
Boston Scientific Corp
General & Plastic Surgery · 30d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · MCH
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Apr 14, 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
K040787 · OTN
Boston Scientific
Gastroenterology & Urology · 16d
Cleared Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342 · KRD
Boston Scientific Corp
Cardiovascular · 61d
Cleared Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · FGE
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068 · KRD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Feb 24, 2004
COBRA SURGICAL PROBE
K040219 · GEI
Boston Scientific Corp
General & Plastic Surgery · 22d
Cleared Feb 18, 2004
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
K040104 · GEI
Boston Scientific Corp
General & Plastic Surgery · 29d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140 · DQX
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jan 30, 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · DYB
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742 · DQX
Boston Scientific Corp
Cardiovascular · 45d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · DQY
Boston Scientific Corp
Cardiovascular · 23d