Boston Scientific

FDA Filings

This page includes the latest FDA filings for Boston Scientific. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
FDA Owner/Operator Registration

































FDA Filings

Device
Company
DeviceDate
Boston Scientific
EKOS+ Endovascular Device2022-04-20
Boston Scientific
Emerge Monorail PTCA Dilatation Catheter2022-03-24
BOSTON SCIENTIFIC
ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI2021-12-21
BOSTON SCIENTIFIC
LATITUDE Programming System2021-11-30
Boston Scientific
EkoSonic Endovascular Device2021-11-19
Boston Scientific
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber2021-04-28
Boston Scientific
ILab Polaris Multi-Modality Guidance System2020-05-29
Boston Scientific
ISLEEVE Introducer Set2019-03-07
Boston Scientific
ORISE Gel2018-09-28
Boston Scientific
WATCHMAN TruSeal Access System2018-07-20
Boston Scientific
Embozene Color-Advanced Microspheres2018-04-19
Boston Scientific
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire2018-04-12
Boston Scientific
ORISE Tissue Retractor System2018-02-09
Boston Scientific
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle2017-10-27
BOSTON SCIENTIFIC
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle2017-01-30
BOSTON SCIENTIFIC
WallFlex Biliary RX Fully Covered Stent System RMV2016-06-03

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091254765Ringaskiddy,Ireland -> Wilmington, North CarolinaMEDICAL DEVICES ORCA POD 3 BOX STC 216 PIECES PACKED ON 6 PALLETS INVOICE # 973686128 PO# 6000227292 HS-CODE 901839006 PCS
2020070216342Shanghai ,China (Mainland) -> Boston, MassachusettsCOMMUNICATOR LATITUDE WAVE MIC10 PKG
2020063030394Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020062640601Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020061958800Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE STC 18 CARTONS PACKED ON 1 PALLET INVOICE # 36003574 & 36003575 HS-CODE 9018390018 PKG
2020060455537Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES SG TRANSRADIAL LC HYPOTUBE PACKED ON 1 PALLET INVOICE # 1002167 HS-CODE 9018390012 PKG
2020052127964Shanghai ,China (Mainland) -> Seattle, WashingtonCOMMUNICATOR LATITUDE WAVE MIC20 CTN
2020051841215Shanghai ,China (Mainland) -> Seattle, WashingtonCOMMUNICATOR LATITUDE WAVE MIC20 CTN

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