Medinol L T D

FDA Filings

This page includes the latest FDA filings for Medinol L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9710284
FEI Number3003084171
NameMEDINOL LTD.
Owner & OperatorMEDINOL LTD.
Contact Address625 Bakers Bridge Ave., Suite 105, Box 1
Franklin TN 37067 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressKIRYAT ATIDIM, BLDG. 8
TEL-AVIV Tel-Aviv, 6158101 IL
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3003084171
FEI Number3003084171
NameMEDINOL LTD.
Owner & OperatorMEDINOL LTD.
Contact Address625 Bakers Bridge Ave., Suite 105, Box 1
Franklin TN 37067 US
US Agent
Importing Logistics Registration
ImporterMEDINOL USA Inc.
Address300 Frank W Burr BLVD STE,
Teaneck, NJ 07666 UNITED STATES
Email Addressdand@medinol.com
Phone1 954 8644484
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8 Hartom Street Beck Tech Bldg. Har Hotzvim B,
Jerusalem Yerushalayim, 9777508 IL
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2020-08-20
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2020-04-09
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2020-04-09
MEDINOL LTD.
EluNIR Ridaforolimus Eluting Coronary Stent System 2020-01-17
MEDINOL LTD.
EluNIR Ridaforolimus Eluting Coronary Stent System 2020-01-17
MEDINOL LTD.
EluNIR Ridaforolimus Eluting Coronary Stent System 2020-01-17
MEDINOL LTD.
EluNIR Ridaforolimus Eluting Coronary Stent System 2020-01-17
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2019-11-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2019-11-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NC Gallant™ PTCA Catheter 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System 2019-10-07
MEDINOL LTD.
NIRxcell™ CoCr Coronary Stent on RX System 2019-10-07
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.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-11-16
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX 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.
Gallant PTCA Dilatation Catheter2018-06-24
MEDINOL LTD.
Gallant PTCA Dilatation Catheter2018-06-24
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-06-14
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-06-14
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-06-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2018-06-07
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2018-04-17
MEDINOL LTD.
Nirxcell CoCr Coronary Stent on RX 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.
Gallant PTCA Dilatation Catheter2018-01-25
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2017-12-19
MEDINOL LTD.
EluNIR? Ridaforolimus Eluting Coronary Stent System2017-11-30
MEDINOL LTD.
EluNIR? Ridaforolimus Eluting Coronary Stent System2017-11-30
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2017-11-28
MEDINOL LTD.
NIRTRAKS Clinical Study2017-11-01
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2017-09-19
MEDINOL LTD.
NIRXCELL COCR CORONARYSTENT ON RX SYSTEM2017-08-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX2017-06-07
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2017-04-26
MEDINOL LTD.
NIRXCELL PMS US STUDY NIRTRAKS2017-02-10
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2017-01-31
MEDINOL LTD.
NC Gallant PTCA Dilatation Catheter2017-01-22
MEDINOL LTD.
NC Gallant PTCA Dilatation Catheter2017-01-22
MEDINOL LTD.
NC Gallant PTCA Catheter2017-01-19
MEDINOL LTD.
NIRxcell CoCr Cornary Stent on RX System2016-08-25
MEDINOL LTD.
NIRxcell CoCr Coronary Stent on RX System2016-08-23
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)2016-06-24
MEDINOL LTD.
X-Suit NIR Biliary Metallic Stent2016-02-12
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2015-10-02
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2015-10-01
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2015-09-03
MEDINOL LTD.
NIRXCELL COCR-CORONARY STENT ON RX SYSTEM2015-05-14
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX2015-03-17
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX2014-09-11
MEDINOL LTD.
NIRXCELL COCR CORNARY STENT ON RX2014-06-04
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX2014-06-02
MEDINOL LTD.
NIRXCELL COCR CORONARY SENT ON RX2014-05-12
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2014-05-01
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2014-03-23
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2014-03-23
MEDINOL LTD.
NIRXCELL COCR CORONARY STENT ON RX SYSTEM2013-12-19
MEDINOL LTD.
PRESILLION PLUS COCR CORONARY STENT RX SYSTEM2012-04-12
MEDINOL LTD.
X-Suit NIR? Biliary Metallic Stent2009-03-23
MEDINOL LTD.
X-Suit NIR? Biliary Metallic Stent2009-03-23
MEDINOL LTD.
MEDINOL X-SUIT NIR BILIARY METALLIC STENT2009-01-09
MEDINOL LTD.
NIR BILIARY STENT2000-10-30
MEDINOL LTD.
NIR BILIARY STENT1998-11-13

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