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 System2021-06-16
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2021-04-16
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2021-04-07
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2021-03-31
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2020-12-21
Medinol, Ltd.
EluNIR™ Ridaforolimus Eluting Coronary Stent System2020-12-08
Medinol, Ltd.
EluNIR Ridaforolimus Eluting Coronary Stent System2020-11-24
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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