MEDINOL LTD

FDA Filings

This page includes the latest FDA filings for MEDINOL LTD. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Medinol, Ltd.
Gallant PTCA Dilatation Catheter2018-01-25

Latest Premarket Applications

PMAManufacturerDevice NameDate
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2019-11-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2019-11-07
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-09-20
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-08-16
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-07-17
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2019-07-17
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-05-14
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2019-04-12
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2019-04-12
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-02-22
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-02-15
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2019-02-13
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-11-16
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-11-16
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2018-08-23
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2018-07-18
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2018-07-17
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-06-14
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-06-14
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-06-07
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-06-07
MEDINOL LTD.
Nirxcell CoCr Coronary Stent on RX System2018-04-17
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-04-17
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-04-05
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-04-05
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-03-07
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-02-08
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2017-12-19
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2017-11-28
MEDINOL LTD.
NIRTRAKS Clinical Study2017-11-01

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
NIRxcell™ CoCr Coronary Stent on RX System
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07
Gallant™ PTCA Dilatation Catheter
MEDINOL LTD.2019-10-07

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