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Boston Scientific

58 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (K260816)Boston Scientific2026-04-08
Orca Air/Water and Suction Valves (K252910)Boston Scientific2025-10-09
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K251291)Boston Scientific2025-07-03
iSLEEVE Introducer Set (K250468)Boston Scientific2025-03-20
WallFlex Biliary PLUS RX Stent System (K242950)Boston Scientific2024-12-06
OBSIDIO™ Conformable Embolic (K242507)Boston Scientific2024-10-03
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV (K240464)Boston Scientific2024-08-30
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939)Boston Scientific2024-04-29
ICEfx Cryoablation System (FPRCH8000-02) (K234002)Boston Scientific2024-03-13
Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (K232633)Boston Scientific2023-11-28
IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) (K232635)Boston Scientific2023-11-22
Stingray LP Catheter (K231176)Boston Scientific2023-05-25
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503)Boston Scientific2023-04-25
EKOS+ Endovascular Device (K220866)Boston Scientific2022-04-20
Emerge Monorail PTCA Dilatation Catheter (K220629)Boston Scientific2022-03-24
EkoSonic Endovascular Device (K211080)Boston Scientific2021-11-19
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber (K210925)Boston Scientific2021-04-28
iLab Polaris Multi-Modality Guidance System (K201178)Boston Scientific2020-05-29
iSLEEVE Introducer Set (K190184)Boston Scientific2019-03-07
ORISE Gel (K180068)Boston Scientific2018-09-28
WATCHMAN TruSeal Access System (K180864)Boston Scientific2018-07-20
Embozene Color-Advanced Microspheres (K180102)Boston Scientific2018-04-19
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire (K180795)Boston Scientific2018-04-12
ORISE Tissue Retractor System (K173400)Boston Scientific2018-02-09
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K173184)Boston Scientific2017-10-27
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058)Boston Scientific2017-01-30
Symphion Endoscope and Symphion Cervical Sheath (K160751)Boston Scientific2016-06-14
WallFlex Biliary RX Fully Covered Stent System RMV (DEN150040)Boston Scientific2016-06-03
Express SD Biliary Monorail Premounted Stent System (K152607)Boston Scientific2015-10-27
Permanent Sled Bag (K152403)Boston Scientific2015-09-22
iLab Ultrasound Imaging System (K152316)Boston Scientific2015-09-18
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters (K143193)Boston Scientific2015-07-24
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER (K141112)Boston Scientific2014-07-16
WALLFLEX BILIARY RX STENT SYSTEM (K140630)Boston Scientific2014-05-23
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT (K140329)Boston Scientific2014-05-15
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER (K140503)Boston Scientific2014-04-15
ACUITY PRO LEAD DELIVERY SYSTEM (K132914)Boston Scientific2014-04-03
NAVIGATOR HD URETERAL ACCESS SHEATH SETS (K140323)Boston Scientific2014-03-07
REMOVABLE PATIENT LEADS ECG CABLE (K132253)Boston Scientific2013-12-16
GUIDEZILLA GUIDE EXTENSION CATHETER (K123765)Boston Scientific2013-03-19
GLADIATOR PTA BALLOON DILATION CATHETER (K113681)Boston Scientific2012-01-11
CHARGER PTA BALLON DILATATION CATHETER (K112697)Boston Scientific2011-11-30
RUBICON SUPPORT CATHETER (K112303)Boston Scientific2011-11-09
CHARGER BALLOON DILATATION CATHETER (K112701)Boston Scientific2011-10-25
MUSTANG BALLOON DILATAION CATHETERS (K110122)Boston Scientific2011-05-12
MUSTANG BALLOON DILATATION CATHETERS (K103751)Boston Scientific2011-03-22
INTERLOCK FIBERED IDC OCCLUSION SYSTEM (K102912)Boston Scientific2011-03-03
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER (K070002)Boston Scientific2007-08-17
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS (K070951)Boston Scientific2007-06-04
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM (K062387)Boston Scientific2006-10-05
FLEXVIEW SYSTEM (K062050)Boston Scientific2006-07-31
MODIFICATION TO SURGICAL MESH POLYMERIC (K040787)Boston Scientific2004-04-14
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM (K040027)Boston Scientific2004-03-30
CONVOY ADVANCED DELIVERY SHEATH (K022067)Boston Scientific2002-09-11
MODIFICATION TO TRELEX MESH SURGICAL MESH (K020110)Boston Scientific2002-04-03
6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX (K020028)Boston Scientific2002-01-22
CONVOY ADVANCED DELIVERY SHEATH KIT (K013866)Boston Scientific2001-12-14

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Every clearance here is in the API, with alerts when new ones post.